text: All food additive regulations and any amendments to the regulations adopted pursuant to the federal act in effect on November 23, 1970, or adopted on or after that date, are the food additive regulations of this state. The department may, by regulation, prescribe conditions under which a food additive may be used in this state whether or not these conditions are in accordance with the regulations adopted pursuant to the federal act.

article: 1. General


kind: section

code: HSC

text: All color additive regulations and any amendments to the regulations adopted pursuant to the federal act, in effect on November 23, 1970, or adopted on or after that date, are the color additive regulations of this state. The department may, by regulation, prescribe conditions under which a color additive may be used in this state whether or not those conditions are in accordance with regulations adopted pursuant to the federal act.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

division: 104. ENVIRONMENTAL HEALTH

chapter: 2. Administration

article: 1. General

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 2. Administration > 1. General


text: All special dietary use regulations and any amendments to regulations adopted pursuant to the federal act, in effect on November 23, 1970, or adopted on or after that date, are the special dietary use regulations of this state. If the department finds that it is necessary to inform purchasers of the value of a food for special dietary use, it may adopt any special dietary use regulation, whether or not the regulation is in accordance with the regulations adopted pursuant to the federal act.

part: 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS

article: 1. General


text:
(a) All food labeling regulations and any amendments to those regulations adopted pursuant to the federal act, in effect on January 1, 1993, or adopted on or after that date shall be the food labeling regulations of this state.

(b) The department may, by regulation, adopt additional food labeling regulations. Prior to the adoption of any food labeling regulation pursuant to this subdivision, the department shall seek comments from consumer groups and representatives of the food industry that have been identified by the department as being affected by the proposed regulation.

article: 1. General


text: All good manufacturing practices regulations for any food, drug, device, or cosmetic and any amendments to the regulations adopted pursuant to the federal act in effect on November 23, 1970, or adopted on or after such date, are the good manufacturing practices regulations of this state. If the department finds that it is necessary for the protection of consumers, it may adopt interpretative regulations as necessary to define “current good manufacturing practice” as used in this part.

article: 1. General


text:
(a) All regulations relating to (1) new drug applications, except for abbreviated new drug applications, adopted pursuant to Section 505 of the federal act (21 U.S.C. Sec. 355), (2) applications for premarket approval of new devices, adopted pursuant to Section 515 of the federal act (21 U.S.C. Sec. 360e), (3) postmarketing reports, recordkeeping, and other postapproval requirements for approved new drug applications or approved new device premarket approval applications, adopted pursuant to the federal act, that are in effect on January 1, 1993, or that are adopted on or after that date, shall be the new drug and new device application regulations of this state.

(b) The department may, by regulation, adopt any new drug or new device application regulation that it determines is necessary for the administration and enforcement of this part, whether or not the regulation is in accordance with the regulations adopted pursuant to the federal act.

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 4. Effective January 1, 2001.)

article: 1. General


text: All nonprescription drug regulations and any amendments to those regulations adopted pursuant to the federal act, that are in effect on January 1, 2000, or that are adopted on or after that date, shall be the nonprescription drug regulations of the state. The department may adopt any nonprescription drug regulation it deems necessary for the administration and enforcement of this part, provided that the regulation is not different from, or in addition to, any requirement for nonprescription drugs pursuant to Section 751 (21 U.S.C. Sec. 379r) of the federal act.

history: (History: Added by Stats. 2000, Ch. 796, Sec. 14. Effective January 1, 2001.)

article: 1. General


text: A federal regulation adopted pursuant to this part takes effect in this state 30 days after it becomes effective as a federal regulation. Any person who will be adversely affected by adoption of the federal regulation in this state may, within the 30 days prior to its becoming effective in this state, file with the department, in writing, objections and a request for a hearing. The timely filing of substantial objections to a regulation that has become effective under the federal act, stays the adoption of the regulation in this state.

article: 1. General


text: If no substantial objections are received and no hearing is requested within 30 days after publication of a newly proposed state regulation, it shall take effect on the date set by the department. The effective date shall be at least 60 days after the time for filing objections has expired.

article: 1. General


text: If substantial objections are made to a federal regulation within 30 days prior to its becoming effective in this state or to a proposed regulation within 30 days after it is published, the department, after notice, shall conduct a public hearing to receive evidence on issues raised by the objections. Any interested person or his or her representative may be heard. The department shall act upon objections by order and shall mail the order to objectors by certified mail as soon after the hearing as practicable. The order shall be based on evidence contained in the record of the hearing. If the order concerns a federal regulation, the department may adopt, rescind, or modify it. If the order concerns a proposed regulation, the department may withdraw it or set an effective date for the regulation as published or as modified by the order. The effective date shall be at least 60 days after publication of the order.

article: 1. General


text: Hearings authorized or required by this part shall be conducted by the department or agent as the department may designate for that purpose.

article: 1. General


text: Before any alleged violation of this part is reported to the Attorney General, a district attorney, or a city attorney for the institution of a criminal proceeding, the person against whom this proceeding is contemplated may be given appropriate notice and an opportunity to show cause why he or she should not be prosecuted and to present additional facts that may mitigate the action. The showing may be presented either orally or in writing, in person, or by attorney.

article: 1. General


text:
For purposes of enforcement of this part, any authorized agent of the department may, upon presenting appropriate credentials and at a reasonable time, do any of the following:

(a) Enter any factory, warehouse, or establishment in which any food, drug, device, or cosmetic is manufactured, packed, or held; enter any vehicle that is being used to transport or hold the food, drug, device, or cosmetic; or enter any place where any food, drug, device, or cosmetic is suspected of being held in violation of this part.

(b) Inspect any factory, warehouse, establishment, vehicle, or place, and all pertinent equipment, raw material, finished and unfinished materials, containers, and labeling in the factory, warehouse, establishment, vehicle, or place. In the case of any factory, warehouse, establishment, or consulting laboratory in which any food, drug, device, or cosmetic is manufactured, packed, or held, inspection shall include any record, file, paper, process, control, and facility that has a bearing on whether the food, drug, device, or cosmetic is adulterated or misbranded, or falsely advertised within the meaning of this part or whether it has been or is being manufactured, packed, transported, sold, or offered for sale in violation of this part.

article: 2. Inspection and Sampling

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 2. Administration > 2. Inspection and Sampling


text:
The inspection authorized by Section 110140 shall not include any of the following:

(a) Financial data.

(b) Sales data, other than shipment data.

(c) Pricing data.

(d) Personnel data, except data as to qualifications of technical and professional personnel.

(e) Research data, except data relating to any new drug or antibiotic drug that is subject to reporting and inspection under this part or the federal act.

article: 2. Inspection and Sampling


text: An authorized agent of the department may secure any sample or specimen of any food, drug, device, or cosmetic. If the agent obtains any samples prior to leaving the premises, he or she shall leave a receipt describing any sample obtained.

article: 2. Inspection and Sampling


text: An authorized agent of the department shall have access to all records of carriers in commerce relating to the movement in commerce of any food, drug, device, or cosmetic, or the holding of that food, drug, device, or cosmetic during or after the movement, and the quantity, shipper, and consignee of the food, drug, device, or cosmetic. Evidence obtained under this section shall not be used in a criminal prosecution of the person from whom it is obtained. The carrier shall not be subject to the other provisions of this part by reason of their receipt, carriage, holding, or delivery of any food, drug, device, or cosmetic in the usual course of business as carriers.

article: 2. Inspection and Sampling


text: It is unlawful for any person to refuse to permit entry or inspection, the taking of samples or other evidence, or access to copying of any record as authorized by this part, or to conceal the samples or evidence, or withhold evidence concerning them.

article: 2. Inspection and Sampling


text: It is unlawful for any person to use to his or her own advantage, or to reveal to any person other than to the director, officers, employees, or authorized agents of this department, or to the courts when relevant in any judicial proceeding under this part, any information acquired under authority of this part concerning any method or process which as a trade secret is entitled to protection. However, the department may reveal trade secret information in connection with the responsibilities of the department under this part, to any employee of the federal Food and Drug Administration who is authorized in writing by the Chief of the Food and Drug Branch of the department or his or her designee to receive this type of information. The employee receiving this type of information shall be informed in writing of the prohibitions under this section, shall be informed in writing that the information provided contains trade secrets, as defined under state and federal law, and shall agree in writing to keep the information confidential.

history: (History: Amended by Stats. 1997, Ch. 516, Sec. 2. Effective January 1, 1998.)

article: 2. Inspection and Sampling


text: The department may publish reports summarizing all judgments and court orders that have been rendered under this part, including the nature of the charge and the disposition of the charge.

article: 3. Publicity

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 2. Administration > 3. Publicity


text: The department may distribute information regarding any food, drug, device, or cosmetic as the department considers necessary for the protection of the health and safety of the consumer or for his or her protection from fraud.

article: 3. Publicity


text: The department may collect, report, or illustrate the results of any investigation of the department.

article: 3. Publicity


text:
(a) Any person who ships to another state or country a food, drug, device, or cosmetic manufactured or produced in this state may request the department to issue an export document to reference the shipment of the food, drug, device, or cosmetic. The food, drug, device, or cosmetic shall be manufactured or produced in this state by a person who has a valid registration, license, certificate, or permit issued by the department under this part or the Miscellaneous Food, Food Facility, and Hazardous Substances Act (Section 27). For each request, the requesting person shall submit to the department, in hardcopy or the electronic formats described in subdivision (c), all of the following:

(1) All labels, labeling, and advertising affixed to, accompanying, or relating to the food, drug, device, or cosmetic. The department shall accept electronic or paper copies of labels, labeling, or advertising.

(2) If not clearly evident from the materials submitted pursuant to paragraph (1), the requester shall submit both of the following:

(A) The name, place of business, and the type and number of the registration, license, certificate, or permit issued by the department to the manufacturer or producer of the food, drug, device, or cosmetic.

(B) The identity of the food, drug, device, or cosmetic being shipped.

(3) The name of the state or country to which the food, drug, device, or cosmetic is being shipped.

(4) The approximate date of shipment of the food, drug, device, or cosmetic.

(5) Additional statements the requesting person wishes to have incorporated into the export document.

(6) The name and telephone number of the requesting person to whom the department may refer questions or requests for additional information.

(b) The person making the request shall also submit the one-time fee required by paragraph (1) of subdivision (a) of Section 110210, if the fee has not yet been paid, and the minimum charge required by paragraph (2) of subdivision (a) of Section 110210.

(c) The department shall accept requests for an export document submitted by email or other electronic methods.

(1) For requests submitted by email or facsimile on or after January 1, 2014, payment of the fees described in subdivision (b) shall be provided to, and received by, the department within five business days after submittal of the request. The department shall suspend processing of a request if payment is not received within five business days, and shall resume processing once it receives the payment.

(2) For requests submitted using an electronic document request submittal process developed by the department and available on the department’s Internet Web site, payment shall be submitted at the time of the request.

(d) The department shall develop procedures to expedite approval of requests for an export document in which the labels, labeling, and advertising affixed to, accompanying, or relating to the food, drug, device, or cosmetic remain unchanged from a previously approved request for an export document for that food, drug, device, or cosmetic.

history: (History: Amended by Stats. 2013, Ch. 539, Sec. 1. (AB 1400) Effective January 1, 2014.)

article: 4. Export Documents

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 2. Administration > 4. Export Documents


text:
(a) Each export document issued by the department shall do all of the following:

(1) Identify either or both of the following:

(A) The name and place of business of the manufacturer or producer of the food, drug, device, or cosmetic.

(B) The name and place of business of the distributor of the food, drug, device, or cosmetic.

(2) Identify the food, drug, device, or cosmetic being shipped.

(3) Identify the state or country to which the food, drug, device, or cosmetic is being shipped.

(4) Identify the approximate date of shipment.

(5) Describe the department’s authority over the food, drug, device, or cosmetic to be shipped and its manufacturer or producer.

(6) State that the department does not object to the sale of the food, drug, device, or cosmetic in this state or the shipment of the food, drug, device, or cosmetic to any other state or country.

(b) Each export document issued by the department may, in the department’s sole discretion, include additional statements requested by the person who requested the export document.

(c) Each export document issued by the department shall be issued by the Chief of the Food and Drug Branch of the department, or his or her designee. The chief or his or her designee may issue an export document prepared by the department or by the requesting person.

(d) The export document shall expire one year after its issue date.

history: (History: Amended by Stats. 2013, Ch. 539, Sec. 2. (AB 1400) Effective January 1, 2014.)

article: 4. Export Documents


text:
(a) Each person requesting the department to issue an export document shall pay nonreturnable fees as follows:

(1) A one-time fee of one hundred dollars ($100).

(2) A fee for service charge at the rate of eighty dollars ($80) per hour, at a minimum of twenty-five dollars ($25) per request.

(3) Any attendant costs incurred by the department, including, but not limited to, the costs of additional inspection, priority mailing, or notary service necessitated by the request.

(b) The fee amounts shall be adjusted annually pursuant to Section 100425.

(c) In no case shall the fees exceed the reasonable costs of the department in administering this article.

(d) The department shall provide to the person who pays the fees a statement or invoice that describes the costs paid from the fees.

article: 4. Export Documents


text:
(a) The department may refuse to accept any request where the information required to be submitted by this article is incomplete.

(b) The department may refuse to issue an export document, or may invalidate an export document, if it finds, or has probable cause to believe, any of the following:

(1) The food, drug, device, or cosmetic, or requesting person violated any provision of this part, the Miscellaneous Food, Food Facility, and Hazardous Substances Act (Section 27), or any regulation adopted pursuant to this part or that act.

(2) Any information required to be submitted by this article is incomplete or false.

(3) The requesting person has not paid all outstanding fees required by this article.

(4) The food, drug, device, or cosmetic is not manufactured or produced in this state.

(5) The food, drug, device, or cosmetic is intended to be exported under Section 110655, 110790, 111315, 111460, 111720, or 111785.

(6) The food is a raw agricultural commodity or dairy product regulated by the Department of Food and Agriculture or a poultry or meat product regulated by the United States Department of Agriculture.

(c) If the department refuses to issue an export document, or invalidates an export document, the department shall inform the requesting person in writing of the reasons for the refusal or invalidation. The requesting person may request reconsideration by forwarding a written request to the Chief of the Division of Environmental Health of the department. The request for reconsideration must be postmarked or received by the department no later than 30 days after the date of the department’s refusal or invalidation, and shall include a complete statement of all arguments and evidence that support the request for reconsideration. The Chief of the Division of Environmental Health shall notify the requesting person of his or her decision within 30 days. The decision of the Chief of the Division of Environmental Health shall be final.

(d) It is the intent of the Legislature that the department shall respond to each request for issuance of an export document within five working days of receipt of the request by the Food and Drug Branch of the department.

article: 4. Export Documents


text: It is unlawful for any person to knowingly supply the department with false material facts in a request for an export document or to falsely represent that the department has issued an export document.

article: 4. Export Documents


text: Any person who has a valid registration, license, certificate, or permit issued by the department to manufacture or produce a food, drug, device, or cosmetic in this state may request the department to issue an official copy of the valid registration, license, certificate, or permit.

article: 4. Export Documents


text:
(a) Each person requesting the department to issue an official copy of a valid registration, license, certificate, or permit shall pay nonreturnable fees as follows:

(1) Fifteen dollars ($15) per official copy.

(2) Any attendant costs incurred by the department, including, but not limited to, the costs of additional inspection, priority mailing, or notary service necessitated by the request.

(b) The fee amount shall be adjusted annually pursuant to Section 100425.

(c) The department shall provide to the person who pays the fees a statement or invoice that describes the costs paid from the fees.

article: 4. Export Documents


text: There is established an Export Document Program Fund within the General Fund. All fees collected pursuant to Sections 110210 and 110235 shall be deposited into the Export Document Program Fund and, upon appropriation, shall be expended by the department for the purpose of administering this article.

article: 4. Export Documents


text: All fees collected by the department pursuant to requests to conduct a voluntary medical device review shall be deposited into the Export Document Program Fund and, upon appropriation, shall be expended for the purpose of determining if the device is a new device or is substantially equivalent to a current or previously marked device.

history: (History: Added by Stats. 1997, Ch. 294, Sec. 12. Effective August 18, 1997.)

article: 4. Export Documents


text:
(a) The California Rx Prescription Drug Web Site Program is hereby established.

(b) The State Department of Health Care Services shall administer the program. The purpose of the program shall be to provide information to California residents and health care providers about options for obtaining prescription drugs at affordable prices.

(c) The department shall establish a Web site on or before July 1, 2008, which shall, at a minimum, provide information about, and electronic links to, all of the following:

(1) Prescription drug benefits available to Medicare beneficiaries, including the Voluntary Prescription Drug Benefit Program.

(2) State programs that provide drugs at discounted prices for California residents.

(3) Pharmaceutical manufacturer patient assistance programs that provide free or low-cost prescription drugs to qualifying individuals.

(4) Other Web sites as deemed appropriate by the department that help California residents to safely obtain prescription drugs at affordable prices, including links to Web sites of health plans and health insurers regarding their prescription drug formularies.

(d) The department’s Web site shall include price comparisons of at least 150 commonly prescribed prescription drugs, including typical prices charged by licensed pharmacies in the state.

(e) The department shall ensure that the Web site established pursuant to this section is coordinated with, and does not duplicate, other Web sites that provide information about prescription drug options and costs.

(f) Implementation of this section shall be contingent upon an appropriation, if the department determines that the requirements of this section cannot be implemented without additional funding, in which case the department shall request an appropriation from the Legislature for that purpose.

history: (History: Amended by Stats. 2007, Ch. 483, Sec. 23. Effective January 1, 2008.)

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 2. Administration > 5. California Rx Prescription Drug Web Site Program


text:
(a) Contracts and change orders entered into pursuant to this article and any project or systems development notice shall be exempt from all of the following:

(1) The competitive bidding requirements of State Administrative Manual Management Memo 03-10.

(2) The project authority requirements of Sections 4800 and following of the State Administrative Manual.

(3) Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code.

(4) Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of the Government Code.

(5) Section 11.05 of, and Provision 6 of Item 4260-001-0001 of, Section 2.00 of the Budget Act of 2005 (Ch. 38, Stats. 2005).

(b) Change orders entered into pursuant to this article shall not require a contract amendment.

history: (History: Added by Stats. 2006, Ch. 720, Sec. 4. Effective January 1, 2007.)

article: 5. California Rx Prescription Drug Web Site Program


text:
No dealer shall be prosecuted under this part for a violation concerning any food, drug, device, or cosmetic that is contained in an original, unbroken, and undamaged package that bears the original labeling if all of the following requirements are satisfied:

(a) He or she has used reasonable care in the storage and handling of the food, drug, device, or cosmetic.

(b) He or she received the food, drug, device, or cosmetic in the usual channels of trade as first-class merchantable stock and not as seconds or damaged articles or job lots purchased under conditions that indicate that the food, drug, device, or cosmetic was not usual first-class merchandise.

(c) He or she can produce a guarantee to the effect that the food, drug, device, or cosmetic is not adulterated, misbranded, or falsely advertised, within the meaning of this part, or that it is not a food, drug, device, or cosmetic which, pursuant to this part, may not be sold or offered for sale in this state.

chapter: 3. Guarantees

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 3. Guarantees


text: The guarantee shall be dated prior to the date of sale of the food, drug, device, or cosmetic and it shall be signed by the wholesaler, jobber, manufacturer, or other person located or residing in this state from whom the dealer received the food, drug, device, or cosmetic in good faith.


text: A guarantee may be either a general guarantee or a special guarantee and shall be produced prior to the time of reporting an alleged violation to the Attorney General, the district attorney, or a city attorney for prosecution.


text: A general guarantee shall guarantee without condition or restriction any food, drug, device, or cosmetic that is produced, prepared, compounded, packed, distributed, or sold by the guarantor as not adulterated, mislabeled, misbranded, falsely advertised, or that the article is not an article under this part that may not be sold or offered for sale.


text: A special guarantee shall guarantee in the same manner as a general guarantee the particular food, drug, device, or cosmetic listed in an invoice of the food, drug, device, or cosmetic, and shall be attached to, or shall fully identify, the invoice.


text: All guarantees shall contain the name and address of the guarantor making the sale of food, drug, device, or cosmetic. A guarantee shall protect the person only when the food, drug, device, or cosmetic covered by the guarantee remains identical, both as to composition and labeling, with the food, drug, device, or cosmetic as composed and labeled when originally received from the guarantor.


text: It is unlawful for any person to give a guarantee or undertaking that is false.


text: If the guarantee is to the effect that the food, drug, device, or cosmetic is not in violation within the meaning of the federal act, it shall be sufficient for all the purposes of this part, and shall have the same force and effect as though it referred to this part, unless, pursuant to this part, the standard for the food, drug, device, or cosmetic concerned is higher than the standard for a like food, drug, device, or cosmetic under the federal act. In that case, this part shall prevail over the federal act.


text: In any case where the department has adopted a regulation prescribing a tolerance, including, but not limited to, a zero tolerance, for a poisonous or deleterious substance, food additive, pesticide chemical, or color additive in processed foods, the department may require manufacturers to guarantee that foods they market in the state comply with the tolerance. The department may require a guarantee periodically but in no case more often than once each calendar quarter.


text:
(a) A retailer shall not sell or offer for sale after the expiration date an over-the-counter drug.

(b) Notwithstanding Section 111825, any retailer who violates this section is guilty of an infraction, punishable by a fine of not more than ten dollars ($10) per day for each item sold or offered for sale after the expiration date. The fine shall be calculated based upon the number of days past the expiration date that the product is either found being offered for sale, or if the product is sold, the date of sale as established by evidence of proof of purchase, including, but not limited to, a sales receipt.

(c) The department may assess administrative penalties on a retailer who violates this section in the amount of ten dollars ($10) per day for each item sold or offered for sale, in addition to other penalties authorized by law.

(d) For purposes of this section,“over-the-counter drug” means a nonprescription drug regulated by the federal Food and Drug Administration that is required to have an expiration date on its packaging pursuant to the federal act and federal regulations adopted pursuant to the federal act, including, but not limited to, Section 211.137 of Title 21 of the Code of Federal Regulations.

history: (History: Added by Stats. 2011, Ch. 681, Sec. 1. (AB 688) Effective January 1, 2012.)

chapter: 3.5. Expiration Dates

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 3.5. Expiration Dates


text: In determining whether the labeling or advertisement of a food, drug, device, or cosmetic is misleading, all representations made or suggested by statement, word, design, device, sound, or any combination of these, shall be taken into account. The extent that the labeling or advertising fails to reveal facts concerning the food, drug, device, or cosmetic or consequences of customary use of the food, drug, device, or cosmetic shall also be considered.

chapter: 4. Packaging, Labeling,and Advertising

article: 1. General

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4. Packaging, Labeling,and Advertising > 1. General


text: The requirement that any word, statement, or other information appear on the label shall not be considered to be complied with unless the word, statement, or other information also appears on the outside container or wrapper of the retail package of any food, drug, device, or cosmetic, or is easily legible through the outside container or wrapper.

article: 1. General


text: It is unlawful for any person to forge, counterfeit, simulate, falsely represent, or without proper authority use, any mark, stamp, tag, label, or other identification device that is authorized or required by regulations adopted pursuant to this part or the federal act.

article: 1. General


text: It is unlawful for any manufacturer, packer, or distributor of a prescription drug or device offered for sale in this state to fail to maintain for transmittal or to fail to transmit to any practitioner licensed by applicable state law to administer the drug or device who makes written request for information as to the drug or device true and correct copies of all printed matter that is required to be included in any package in which that drug or device is distributed or sold. Nothing in this section shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this part.

article: 1. General


text: It is unlawful for any person, with the intent to deceive, to place, or cause to be placed upon any food, drug, device, or cosmetic, or its package, the trade name or other identifying mark or imprint of another person or any likeness of the trade name or other identifying mark or imprint of another person.

article: 1. General


text: It is unlawful for any person to sell, dispense, dispose of, hold, or conceal any food, drug, device, or cosmetic or its package, with knowledge that the trade name or other identifying marks, imprint, or likeness of the trade name or other identifying mark or imprint of another person has been placed on the food, drug, device, or cosmetic or its package in a manner prohibited by Section 110315.

article: 1. General


text: It is unlawful for any person to possess, make, sell, dispose of, cause to be made, or conceal any punch, die, plate, or other device that may be used to render a food, drug, device, or cosmetic or its package or labeling a counterfeit.

article: 1. General


text: It is unlawful for any person to do any act that causes any food, drug, device, or cosmetic to be a counterfeit, or to sell, dispense, or hold for sale or dispensing, the counterfeit food, drug, device, or cosmetic.

article: 1. General


text:
The department may adopt regulations exempting from any labeling or packaging requirements of this part any food, drug, device, or cosmetic that is in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed and packed, on condition that the food, drug, device, or cosmetic is not adulterated or misbranded under the provisions of this part upon removal from the processing, labeling, or repacking establishment. Such food, drug, device, or cosmetic is subject to all other applicable provisions of this part.

All regulations relating to the exemptions that are in effect on the effective date of this part, or that are adopted on or after that date, pursuant to the federal act, are automatically effective in this state. The department may, however, adopt any additional regulations concerning exemptions.

article: 1. General


text: All labels of foods, drugs, devices, or cosmetics shall conform with the requirements of the declaration of net quantity of contents of Section 4 of the Fair Packaging and Labeling Act (80 Stat. 1296; 15 U.S.C., Sec. 1451) and the regulations adopted pursuant thereto. Foods, drugs, devices, and cosmetics exempted from the requirements of Section 4 of the Fair Packaging and Labeling Act, however, are also exempt from this article.

article: 2. Fair Packaging and Labeling

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4. Packaging, Labeling,and Advertising > 2. Fair Packaging and Labeling


text: The label of any package of a food, drug, device, or cosmetic that bears a representation as to the number of servings of the commodity contained in the package shall bear a statement of the net quantity, in terms of weight, measure, or numerical count, of each serving.

article: 2. Fair Packaging and Labeling


text:
It is unlawful for any person to distribute, or cause to be distributed, in commerce any packaged food, drug, device, or cosmetic if any qualifying words or phrases appear in conjunction with the separate statement of the net quantity of contents required by Section 110340.

This section, however, does not prohibit supplemental statements, at other places on the package, describing in nondeceptive terms the net quantity of contents. Such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the commodity contained in the package.

article: 2. Fair Packaging and Labeling


text: Whenever the department determines that regulations containing prohibitions or requirements, other than those prescribed by Section 110340, are necessary to prevent the deception of consumers or to facilitate value comparisons as to any food, drug, device, or cosmetic, the department shall adopt regulations with respect to that commodity.

article: 2. Fair Packaging and Labeling


text: The department may establish and define standards for the characterization of the size of a package that encloses any food, drug, device, or cosmetic, that may be used to supplement the label statement of net quantity of contents of packages containing the commodity. This section, however, does not authorize any limitation on the size, shape, weight, dimension, or number of packages that may be used to enclose any food, drug, device, or cosmetic.

article: 2. Fair Packaging and Labeling


text: The department may regulate the placement upon any package that contains any food, drug, device, or cosmetic or upon any label affixed to the article, of any printed matter stating or representing by implication that the article is offered for retail sale at a price lower than the ordinary and customary retail sale price or that a retail sale price advantage is accorded to any purchaser of the article by reason of the size of that package or the quantity of its contents.

article: 2. Fair Packaging and Labeling


text: The department may require that the label on each package of a food, drug, device, or cosmetic bear the common or usual name of the article, if any, and in case the article consists of two or more ingredients, the common or usual name of each ingredient listed in order of decreasing predominance by weight. This section, however, does not require that any trade secret be divulged.

article: 2. Fair Packaging and Labeling


text:
(a) A professional cosmetic manufactured on or after July 1, 2020, for sale in this state shall have a label affixed on the container that satisfies all of the labeling requirements for any other cosmetic pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301, et seq.), and the federal Fair Packaging and Labeling Act (15 U.S.C. Sec. 1451, et seq.).

(b) The following definitions shall apply to this section:

(1) “Ingredient” has the same meaning as in Section 111791.5.

(2) “Professional” means a person that has been granted a license by the State Board of Barbering and Cosmetology to practice in the field of cosmetology, nail care, barbering, or esthetics.

(3) “Professional cosmetic” means a cosmetic product as it is defined in Section 109900 that is intended or marketed to be used only by a professional on account of a specific ingredient, increased concentration of an ingredient, or other quality that requires safe handling, or is otherwise used by a professional.

history: (History: Added by Stats. 2018, Ch. 393, Sec. 2. (AB 2775) Effective January 1, 2019.)

article: 2. Fair Packaging and Labeling


text:
(a) No container wherein commodities are packed shall have a false bottom, false sidewalls, false lid or covering, or be otherwise so constructed or filled, wholly or partially, as to facilitate the perpetration of deception or fraud.

(b) No container shall be made, formed, or filled as to be misleading. A container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack fill. Slack fill is the difference between the actual capacity of a container and the volume of product contained therein. Nonfunctional slack fill is the empty space in a package that is filled to substantially less than its capacity for reasons other than any one or more of the following:

(1) Protection of the contents of the package.

(2) The requirements of machines used for enclosing the contents of the package.

(3) Unavoidable product settling during shipping and handling.

(4) The need to utilize a larger than required package or container to provide adequate space for the legible presentation of mandatory and necessary labeling information, such as those based on the regulations adopted by the United States Food and Drug Administration or state or federal agencies under federal or state law, laws or regulations adopted by foreign governments, or under an industrywide voluntary labeling program.

(5) The fact that the product consists of a commodity that is packaged in a decorative or representational container where the container is part of the presentation of the product and has value that is both significant in proportion to the value of the product and independent of its function to hold the product, such as a gift combined with a container that is intended for further use after the product is consumed, or durable commemorative or promotional packages.

(6) An inability to increase the level of fill or to further reduce the size of the package, such as where some minimum package size is necessary to accommodate required labeling, discourage pilfering, facilitate handling, or accommodate tamper-resistant devices.

(7) The product container bears a reasonable relationship to the actual amount of product contained inside, and the dimensions of the actual product container, the product, or the amount of product therein is visible to the consumer at the point of sale, or where obvious secondary use packaging is involved.

(8) One or more of the following:

(A) The dimensions of the product or immediate product container are visible through the exterior packaging.

(B) The actual size of the product or immediate product container is clearly and conspicuously depicted on any side of the exterior packaging, excluding the bottom, accompanied by a clear and conspicuous disclosure that the depiction is the “actual size” of the product or immediate product container. If there are multiple units of the same product in a package, only one “actual size” depiction is required per same size product or immediate product container.

(C) A line or a graphic that represents the product or product fill and a statement communicating that the line or graphic represents the product or product fill such as “Fill Line,” both of which are clearly and conspicuously depicted on exterior packaging or the immediate product container if visible at point of sale. If the product is subject to settling, the line shall represent the minimum amount of product after settling.

(9) The presence of any headspace within an immediate product container necessary to facilitate the mixing, adding, shaking, or dispensing of liquids or powders by consumers before use.

(10) The exterior packaging contains a product delivery or dosing device if the device is visible, or a clear and conspicuous depiction of the device appears on the exterior packaging, or it is readily apparent from the conspicuous exterior disclosures or the nature and name of the product that a delivery or dosing device is contained in the package.

(11) The exterior packaging or immediate product container is a kit that consists of a system, or multiple components, designed to produce a particular result that is not dependent upon the quantity of the contents, if the purpose of the kit is clearly and conspicuously disclosed on the exterior packaging.

(12) The exterior packaging of the product is routinely displayed using tester units or demonstrations to consumers in retail stores, so that customers can see the actual, immediate container of the product being sold, or a depiction of the actual size of the container before purchase.

(13) The exterior packaging consists of single or multiunit presentation boxes of holiday or gift packages if the purchaser can adequately determine the quantity and sizes of the immediate product container at the point of sale.

(14) The exterior packaging is for a combination of one purchased product, together with a free sample or gift, wherein the exterior packaging is necessarily larger than it would otherwise be due to the inclusion of the sample or gift, if the presence of both products and the quantity of each product are clearly and conspicuously disclosed on the exterior packaging.

(15) The mode of commerce does not allow the consumer to view or handle the physical container or product.

(c) Slack fill in a package shall not be used as grounds to allege a violation of this section based solely on its presence unless it is nonfunctional slack fill.

(d) Any sealer may seize a container that facilitates the perpetration of deception or fraud and the contents of the container. By order of the superior court of the county within which a violation of this section occurs, the containers seized shall be condemned and destroyed or released upon any condition as the court may impose to ensure against their use in violation of this chapter. The contents of any condemned container shall be returned to the owner if the owner furnishes proper facilities for the return.

history: (History: Amended by Stats. 2018, Ch. 544, Sec. 3. (AB 2632) Effective January 1, 2019.)

article: 2. Fair Packaging and Labeling


text: All regulations and their amendments pertaining to foods, drugs, devices, and cosmetics that are in effect on the effective date of this part, or that are adopted on or after that date, pursuant to the Fair Packaging and Labeling Act (80 Stat. 1296; 15 U.S.C. Sec. 1451 et seq.) shall be the regulations of this state. The department may, when necessary, prescribe any packaging and labeling regulation for foods, drugs, devices, and cosmetics whether or not the regulation is in accordance with regulations adopted under the Fair Packaging and Labeling Act. No regulations shall be adopted that are contrary to the labeling requirements for the net quantity of contents required pursuant to Section 4 of the Federal Fair Packaging and Labeling Act and the regulations adopted pursuant to that section.

article: 2. Fair Packaging and Labeling


text: It is unlawful for any person to distribute in commerce any food, drug, device, or cosmetic, if its packaging or labeling does not conform to the provisions of this article or to regulations adopted pursuant to this article. This section does not apply to persons engaged in business as wholesale or retail distributors of foods, drugs, devices, or cosmetics, except to the extent that they are engaged in the packaging or labeling of the commodities or they prescribe or specify the manner in which the commodities are packaged or labeled. This section shall not be construed to repeal, invalidate, or supersede any other section of this part.

article: 2. Fair Packaging and Labeling


text: It is unlawful for any person to disseminate any false advertisement of any food, drug, device, or cosmetic. An advertisement is false if it is false or misleading in any particular.

article: 3. Advertising

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4. Packaging, Labeling,and Advertising > 3. Advertising


text: It is unlawful for any person to manufacture, sell, deliver, hold, or offer for sale any food, drug, device, or cosmetic that is falsely advertised.

article: 3. Advertising


text: It is unlawful for any person to advertise any food, drug, device, or cosmetic that is adulterated or misbranded.

article: 3. Advertising


text: It is unlawful for any person to receive in commerce any food, drug, device, or cosmetic that is falsely advertised or to deliver or proffer for delivery any such food, drug, device, or cosmetic.

article: 3. Advertising


text:
Except as otherwise provided in Section 110405, it is unlawful for a person to advertise a drug or device represented to have an effect in any of the following conditions, disorders, or diseases:

(a) Appendicitis.

(b) Blood disorders.

(c) Bone or joint diseases.

(d) Kidney diseases or disorders.

(e) Cancer.

(f) Carbuncles.

(g) Diseases, disorders, or conditions of the eye.

(h) Diabetes.

(i) Diphtheria.

(j) Gallbladder diseases or disorders.

(k) Heart and vascular diseases.

(l) High blood pressure.

(m) Diseases or disorders of the ear or auditory apparatus, including hearing loss and deafness.

(n) Measles.

(o) Meningitis.

(p) Mental disease or intellectual disability.

(q) Paralysis.

(r) Pneumonia.

(s) Poliomyelitis.

(t) Prostate gland disorders.

(u) Conditions of the scalp, affecting hair loss, or baldness.

(v) Alcoholism.

(w) Periodontal diseases.

(x) Epilepsy.

(y) Goiter.

(z) Endocrine disorders.

(aa) Sexual impotence.

(ab) Sinus infections.

(ac) Encephalitis.

(ad) Tumors.

(ae) Venereal diseases.

(af) Tuberculosis.

(ag) Ulcers of the stomach.

(ah) Varicose ulcers.

(ai) Scarlet fever.

(aj) Typhoid fever.

(ak) Whooping cough.

(al) Acquired immunodeficiency syndrome (AIDS).

(am) AIDS-related complex (ARC).

(an) Diseases, disorders, or conditions of the immune system.

history: (History: Amended by Stats. 2012, Ch. 457, Sec. 31. (SB 1381) Effective January 1, 2013.)

article: 3. Advertising


text:
An advertisement that is not unlawful under Section 110390 is not unlawful under Section 110403 if it is either one of the following:

(a) Disseminated only to members of the medical, dental, pharmaceutical, or veterinary professions, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of drugs or devices.

(b) An advertisement that a drug or device has a specific curative or therapeutic effect on a condition, disorder, or disease listed in Section 110403 if the drug or device is approved or cleared for marketing for that specific curative or therapeutic effect through any of the following means:

(1) A new drug application approved pursuant to Section 111500, or Section 505 of the federal act (21 U.S.C. Sec. 355).

(2) An abbreviated new drug application approved pursuant to Section 505 of the federal act (21 U.S.C. Sec. 355).

(3) A licensed biological product pursuant to Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262).

(4) A nonprescription drug that meets the requirements of Part 330 of Title 21 of the Code of Federal Regulations.

(5) A new animal drug application approved under Section 512 of the federal act (21 U.S.C. Sec. 360b).

(6) An abbreviated new animal drug application approved pursuant to Section 512 of the federal act (21 U.S.C. Sec. 360b).

(7) A new device application approved pursuant to Section 111550.

(8) A device premarket approval application approved under Section 515 of the federal act (21 U.S.C. Sec. 360e).

(9) A determination of substantial equivalence for a device pursuant to Section 513(f)(1) of the federal act (21 U.S.C. Sec. 360c(i)).

history: (History: Amended by Stats. 2000, Ch. 796, Sec. 6. Effective January 1, 2001.)

article: 3. Advertising


text:
(a) A manufacturer, distributor, or seller of an industrial hemp product shall not include on the label of the product, or publish or disseminate in advertising or marketing, any health-related statement that is untrue in any particular manner as to the health effects of consuming products containing industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp in violation of this part.

(b) For purposes of this section, “health-related statement” means a statement related to health, and includes a statement of a curative or therapeutic nature that, expressly or impliedly, suggests a relationship between the consumption of industrial hemp or industrial hemp products and health benefits or effects on health. However, “health-related statement” does not include statements required to be made pursuant to federal Food and Drug Administration regulations for active ingredients in prescription drugs, nonprescription over-the-counter drugs containing inactive ingredients, or structure-function claims allowed for dietary supplements made in accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 343(r)(6)).

history: (History: Added by Stats. 2021, Ch. 576, Sec. 6. (AB 45) Effective October 6, 2021.)

article: 3. Advertising


text: Section 110403 shall not be construed as indicating that self-medication for conditions, disorders, or diseases other than those named is safe or efficacious.

article: 3. Advertising


text: No publisher, radio or television broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the food, drug, device, or cosmetic to which a false advertisement relates, shall be liable under this article for the dissemination of the false advertisement, unless he or she has refused to furnish the department with the name and address of the manufacturer, packer, distributor, seller, or advertising agency, residing in this state who caused him or her to disseminate the advertisement.

article: 3. Advertising


text: It shall be unlawful to advertise or otherwise represent chopped or ground beef or hamburger in violation of Section 110805.

article: 3. Advertising


text:
(a) Any fragrance advertising insert contained in a newspaper, magazine, mailing, or other periodically printed material shall contain only microencapsulated oils. Glue tabs or binders shall be used to prevent premature activation of the fragrance advertising insert.

“Fragrance advertising insert” means a printed piece with encapsulated fragrance applied to it that is activated by opening a flap or removing an overlying ply of paper.

Paperstocks employed in the manufacture of fragrance advertising inserts shall have a maximum porosity of 20 Sheffield units or 172 Gurley-Hill units.

(b) Any person who distributes fragrance advertising inserts in violation of this section, is guilty of an infraction and shall, if convicted, be subject to a fine of one hundred dollars ($100) for each distribution. The fine shall apply to each mass mailing or distribution, and to each mass publication of a magazine or newspaper in violation of this section. The fine shall not apply, however, to each individual letter, magazine, newspaper, or fragrance advertising insert so distributed. Section 111825 is not applicable to violations of this section.

(c) This section shall become operative on January 1, 1992.

article: 3. Advertising


text:
(a) Whenever a warning label is included on any product defined as a dietary supplement pursuant to Section 321(ff) of Title 21 of the United States Code, that is manufactured or distributed in this state, the label shall be clear and conspicuous.

(b) Nothing in this section shall in any way limit or restrict any rights, remedies, or duties otherwise applicable by law.

(c) This section shall be implemented to the extent permitted by federal law.

history: (History: Added by Stats. 2002, Ch. 1006, Sec. 1. Effective January 1, 2003.)

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4. Packaging, Labeling,and Advertising > 4. Dietary Supplement Labeling and Advertising


text:
Violation of this article by any person, as defined in Section 109995, shall constitute an infraction, punishable by a fine not to exceed the following:

(a) One thousand dollars ($1,000) for the first violation.

(b) Two thousand dollars ($2,000) for the second violation.

(c) Five thousand dollars ($5,000) for the third and each subsequent violation.

history: (History: Added by renumbering Section 110424 by Stats. 2016, Ch. 86, Sec. 194. (SB 1171) Effective January 1, 2017.)

article: 4. Dietary Supplement Labeling and Advertising


text:
(a) (1) The sale or distribution of any dietary supplement product containing ephedrine group alkaloids is prohibited unless the product label clearly and conspicuously contains the following statement: “THIS PRODUCT HAS (INSERT THE AMOUNT OF PRODUCT) MILLIGRAMS OF CONCENTRATED EPHEDRINE GROUP ALKALOIDS PER SERVING IN THE FORM OF HERBAL EXTRACTS.”

(2) The sale or distribution of any dietary supplement product containing ephedrine group alkaloids is prohibited unless the product label clearly and conspicuously contains the following warning:

(A) “WARNING: NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 18 YEARS. DO NOT USE IF PREGNANT OR NURSING. Consult a physician or licensed qualified health care professional before using this product if you have, or have a family history of, heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, or if you are using a monoamine oxidase inhibitor (MAOI) or any other dietary supplement, prescription drug, or over-the-counter drug containing ephedrine, pseudoephedrine, or phenylpropanolamine (ingredients found in certain allergy, asthma, cough or cold, and weight control products).”

(B) “Do not exceed recommended serving. Exceeding recommended serving may cause serious adverse health effects, including heart attack and stroke.”

(C) “Discontinue use and call a physician or licensed qualified health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms.”

(D) “Individuals who are sensitive to the effects of caffeine should consult a licensed health care professional before consuming this product.”

(E) “KEEP OUT OF REACH OF CHILDREN.”

(b) The sale or distribution of dietary supplements containing steroid hormone precursors is prohibited unless the product label for these dietary supplements clearly and conspicuously contains the following warning:

“WARNING: NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 18 YEARS. DO NOT USE IF PREGNANT OR NURSING. Consult a physician or licensed qualified health care professional before using this product if you have, or have a family history of, prostate cancer, prostate enlargement, heart disease, low “good” cholesterol (HDL), or if you are using any other dietary supplement, prescription drug, or over-the-counter drug. Do not exceed recommended serving. Exceeding recommended serving may cause serious adverse health effects. Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen. Discontinue use and call a physician or licensed qualified health care professional immediately if you experience rapid heartbeat, dizziness, blurred vision, or other similar symptoms. KEEP OUT OF REACH OF CHILDREN.”

(c) The product label for any dietary supplement product containing ephedrine group alkaloids or steroid hormone precursors shall clearly and conspicuously display the following statement: “To report any adverse events call 1-800-332-1088.”

history: (History: Added by Stats. 2002, Ch. 1005, Sec. 1. Effective January 1, 2003.)

article: 4. Dietary Supplements

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4. Packaging, Labeling,and Advertising > 4. Dietary Supplements


text:
(a) It is a misdemeanor for any manufacturer, wholesaler, retailer, or other person, to sell, transfer, or otherwise furnish any of the following to a person under 18 years of age:

(1) A dietary supplement containing an ephedrine group alkaloid.

(2) A dietary supplement containing any of the following:

(A) Androstanediol.

(B) Androstanedione.

(C) Androstenedione.

(D) Norandrostenediol.

(E) Norandrostenedione.

(F) Dehydroepiandrosterone.

(b) A seller shall request valid identification from any individual who attempts to purchase a dietary supplement set forth in subdivision (a) if that individual reasonably appears to the seller to be under 18 years of age.

(c) Notwithstanding subdivisions (a) and (b), a retail clerk who fails to request identification pursuant to subdivision (b) shall not be guilty of a misdemeanor pursuant to subdivision (a), subject to any civil penalties, or subject to any disciplinary action or discharge by his or her employer. This subdivision shall not apply to a retail clerk who is a willful participant in an ongoing criminal conspiracy to violate this article.

history: (History: Amended by Stats. 2004, Ch. 859, Sec. 1. Effective January 1, 2005.)

article: 4. Dietary Supplements


text:
(a) This article shall not apply to a licensed health care practitioner practicing within his or her scope of practice who prescribes, dispenses, or both, herbs in the course of treatment of patients under the care of the licensed practitioner.

(b) This article shall not apply to herbal products that are sold or distributed directly to a licensed health care practitioner when the herbal product is used solely for the purpose of the treatment of patients under the care of the practitioner.

article: 4. Dietary Supplements


text:
(a) Except as provided in subdivision (b), a retail establishment that sells, transfers, or otherwise furnishes a dietary supplement product in violation of Section 110423.2 shall not be guilty of a misdemeanor pursuant to subdivision (a) of Section 110423.2 if all of the following conditions are met:

(1) Every checkout clerk at the retail establishment has completed standardized training that includes, but is not limited to, the law with respect to selling dietary supplement products subject to this article, methods of easily identifying dietary supplement products subject to this article when checking out customers, and procedures for requesting identification from any customer attempting to purchase dietary supplement products subject to this article who reasonably appears to the clerk to be a minor.

(2) Every checkout clerk at the retail establishment is provided with training updates that cover any changes in the law with respect to selling dietary supplement products subject to this article and any other responsibilities of the retail establishment under this article.

(3) Every programmable checkout scanner or computer used to check out customers with purchases is programmed to identify dietary supplement products subject to this article at the checkout station. A retail establishment that does not use programmable checkout scanners or computers is not required to satisfy this condition.

(4) Every checkout clerk has received a written list of dietary supplement products subject to this article that are sold by the retail establishment that may be posted at the checkout station for easy access.

(b) Notwithstanding the fact that a retail establishment has met all of the conditions specified in subdivision (a), the retail establishment shall be guilty of a misdemeanor pursuant to subdivision (a) of Section 110423.2 if the retail establishment violates this article three or more times in a 12-month period.

article: 4. Dietary Supplements


text: Nothing in this article limits or restricts any rights, remedies, or duties otherwise applicable by law.

article: 4. Dietary Supplements


text: Notwithstanding Article 4 (commencing with Section 110423), the sale or distribution of any dietary supplement products containing ephedrine group alkaloids is prohibited.

history: (History: Added by Stats. 2003, Ch. 903, Sec. 1. Effective January 1, 2004.)

article: 4.5. Ephedrine Group Alkaloids

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4. Packaging, Labeling,and Advertising > 4.5. Ephedrine Group Alkaloids


text:
This article shall not apply, but Article 4 (commencing with Section 110423) shall apply, to any of the following:

(a) A California licensed health care practitioner who is practicing within his or her scope of practice and who prescribes or dispenses, or both, dietary supplement products containing ephedrine group alkaloids in the course of the treatment of a patient under the direct care of that licensed health care practitioner, except that a licensed health care practitioner shall not prescribe or dispense dietary supplements containing ephedrine group alkaloids for purposes of weight loss, body building, or athletic performance enhancement.

(b) Dietary supplement products containing ephedrine group alkaloids that are sold or distributed directly to a licensed health care practitioner when the dietary supplement product containing ephedrine group alkaloids is used solely for the purpose of the treatment of patients under the direct care of the health care practitioner.

(c) Dietary supplement products containing ephedrine group alkaloids that are sold or distributed directly to a licensed pharmacist for resale to a patient for whom the products have been prescribed pursuant to subdivision (a).

(d) Dietary supplement products containing ephedrine group alkaloids that are not for resale in California and that are sold or distributed directly to businesses not located in California.

article: 4.5. Ephedrine Group Alkaloids


text:
For purposes of this chapter, the following definitions apply:

(a) “Brand owner” means the person who owns or licenses the trademark that is the most prominent trademark on the principal display panel of the prenatal multivitamin product label. The manufacturer of a prenatal multivitamin for another person who owns the trademark is not the brand owner.

(b) “Bulk prenatal multivitamin product” means the bulk prenatal multivitamin product in finished dosage form before it is packaged and labeled. Bulk prenatal multivitamin product does not mean the constituent ingredients of prenatal multivitamins.

(c) “Heavy metals” means arsenic, cadmium, lead, and mercury.

(d) “Lot” means a batch, or a specific identified portion of a batch, that is uniform and is intended to meet specifications for identity, purity, strength, and composition or, in the case of a dietary supplement produced by continuous process, a specific identified amount produced in a specified unit of time or quantity in a manner that is uniform and that is intended to meet specifications for identity, purity, strength, and composition.

(e) “Manufacturer” means a person who is either of the following:

(1) A brand owner who manufactures, as defined in Section 109970, a prenatal multivitamin.

(2) A person who manufactures, as defined in Section 109970, but is not the brand owner of a prenatal multivitamin.

(f) “Packaged prenatal multivitamin product” means the bulk prenatal multivitamin product that has been packaged for sale or distribution to the public or health care professionals. The product label may include, but is not required to have, a unique universal product code (UPC).

(g) “Prenatal multivitamin” means a dietary supplement that contains one or more vitamins or minerals and is represented or purported to be specifically used, or intended to be used, to support the health of an individual who is pregnant, planning to become pregnant, or lactating. Prenatal multivitamins may be in the form of, but are not limited to, capsules, tablets, gummies, liquids, or powder.

(h) “Product label” means a display of written, printed, or graphic material that is affixed to a product’s immediate container.

(i) “Product shelf life” means the time, measured in the number of months, as printed on the product label, between the date of manufacture and the expiration date for a packaged prenatal multivitamin product.

(j) “Proficient laboratory” is a laboratory that meets the criteria listed in subdivision (b) of Section 110424.1.

(k) “Representative sample” means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.

history: (History: Added by Stats. 2025, Ch. 602, Sec. 1. (SB 646) Effective January 1, 2026.)

chapter: 4.5. Prenatal Multivitamins

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 4.5. Prenatal Multivitamins


text:
(a) Commencing January 1, 2027, a manufacturer of a bulk prenatal multivitamin product or a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state shall test a representative sample of each lot of the manufacturer’s bulk prenatal multivitamin product or packaged prenatal multivitamin product at a proficient laboratory for heavy metals.

(b) The proficient laboratory, including a manufacturer’s in-house laboratory, that analyzes the bulk prenatal multivitamin product or packaged prenatal multivitamin product for heavy metals shall meet all of the following criteria:

(1) (A) Be accredited under the standards of the International Organization for Standardization’s (ISO) and the International Electrotechnical Commission’s (IEC) ISO/IEC 17025:2017 international standard regarding the general requirements for the competence of testing and calibration laboratories as they pertain to the testing of heavy metals.

(B) To the extent such standards contradict the requirements of any federal regulations promulgated pursuant to the Federal Food, Drug, and Cosmetic Act pertinent to supplements, the federal regulations shall control.

(2) Use an analytical method that is at least as sensitive and specific as that described in Section 4.7 of the United States Food and Drug Administration’s Elemental Analysis Manual for Food and Related Products: Inductively Coupled Plasma-Mass Spectrometric Determination of Arsenic, Cadmium, Chromium, Lead, Mercury, and Other Elements in Food Using Microwave Assisted Digestion.

(3) Demonstrate proficiency in quantifying each heavy metal to 10 micrograms or less of the heavy metal to kilogram of supplement (μg/kg) through an independent proficiency test. Proficiency means that a laboratory achieves a z-score that is less than, or equal to, plus or minus two (≤ ±2).

(c) Both manufacturers and brand owners shall provide test results to an authorized agent of the department upon their request pursuant to Article 2 (commencing with Section 110140) of Chapter 2 or Article 11 (commencing with Section 111015) of Chapter 5. If a brand owner does not manufacture the bulk prenatal multivitamin product or packaged prenatal multivitamin product, they may comply with this subdivision by providing the test results of the manufacturer they use to produce the bulk prenatal multivitamin product or packaged prenatal multivitamin product.


text:
Commencing January 1, 2027, a brand owner of a packaged prenatal multivitamin product that is sold, manufactured, delivered, held, or offered for sale in the state, including, without limitation, prenatal multivitamins that are sold by a retailer or that are sold directly to consumers, shall disclose product information to the public consistent with all of the following:

(a) (1) Make publicly available on the brand owner’s internet website, for the duration of the product shelf life for a packaged prenatal multivitamin product plus one month, all of the following:

(A) The name and level of each heavy metal present in each lot of a packaged prenatal multivitamin product.

(B) Information from the product’s supplement facts panel, including the amount per serving of each ingredient.

(C) The statement:

“Prenatal multivitamins containing certain minerals critical to support an expectant person’s health and proper development of their fetus may contain trace levels of heavy metals that occur in the environment naturally or from human activities. The levels of heavy metals in prenatal multivitamin ingredients may vary depending on whether and at what levels the prenatal multivitamin contains these ingredients, as well as the location from which the ingredients are sourced. Certain foods containing minerals critical to support an expectant person’s health and proper development of their fetus may also contain heavy metals. For more information, speak with your physician about choosing a prenatal multivitamin that meets your specific nutrient needs.”

(2) The information required in paragraph (1) shall all be provided on the same web page.

(b) The heavy metal testing information shall be available to the public without having to provide a UPC number, a lot number, or a proof of purchase.

(c) Provide descriptive information on its internet website to enable accurate identification of the packaged prenatal multivitamin product by the public, including information that makes the levels of heavy metals available to the public by lot. Descriptive information may include, but is not limited to, product name, UPC, size, or lot numbers.

(d) An internet website hyperlink to the United States Food and Drug Administration (FDA) where the public can find the most recent FDA internet website relating to heavy metals in food.

(e) On the brand owner’s internet website describing a packaged prenatal multivitamin product, include a prominent statement that reads “For information about heavy metal testing on this product” followed by a hyperlink to the internet website that contains the publicly available test results.

(f) (1) For a product sold in a retail store that is shipped to retailers on or after January 1, 2027, the outermost “package,” as defined in Section 1459(b) of Title 15 of the United States Code, of a packaged prenatal multivitamin product shall include a statement that reads: “For information about heavy metal testing on this product, visit” followed by the web address where the information required by subdivision (a) is posted.

(2) For a product sold online or directly to consumers that is shipped to consumers on or after January 1, 2027, the product details page for the product, on an internet website where the product is sold, shall include a statement that reads: “For information about heavy metal testing on this product, visit” followed by a hyperlink to the internet website where the information required by subdivision (a) is posted.

(3) On or after January 1, 2030, a person shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state a prenatal multivitamin, including, without limitation, a prenatal multivitamin that is sold by a retailer or that is sold directly to consumers, that does not include the packaging or online statements specified in paragraphs (1) and (2).


text: A person shall not sell in the state or manufacture, deliver, hold, or offer for sale in the state a prenatal multivitamin, including, without limitation, a prenatal multivitamin that is sold by a retailer or that is sold directly to consumers, that does not comply with the requirements described in this chapter.


text: Beer, that is subject to the Alcoholic Beverage Control Act, Division 9 (commencing with Section 23000) of the Business and Professions Code, shall only be subject to the provisions of this chapter that relate to adulteration and misbranding.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996.)

chapter: 5. Food

article: 1. Generally

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 1. Generally


text: Whenever the department finds that a class of food distributed in this state may, by reason of contamination with micro-organisms during manufacture, packing, or storage, be injurious to the health of any man or other animal that consumes it and that the injurious nature cannot be adequately determined after this food has entered commerce, the department shall adopt regulations providing for the issuance of permits to manufacturers, processors, or packers of the class of food. These permits shall establish conditions governing the manufacture, packing, or storage of the class of food for the period of time as may be necessary to protect the public health. The regulations shall prescribe a date after which no person shall introduce or deliver for introduction into commerce any food manufactured, packed, or stored by any manufacturer, processor, or packer, unless the person holds a permit issued by the department as provided by the regulations.

article: 1. Generally


text: The department may suspend immediately, upon written or oral notice, any permit issued pursuant to Section 110430 if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended may at any time apply for reinstatement of the permit. The department shall, after prompt hearing and inspection of the establishment, reinstate the permit immediately, if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit.

article: 1. Generally


text: Any authorized agent of the department shall have access to any factory or establishment that operates under permit from the department for the purpose of ascertaining whether or not the conditions of the permit are being complied with. Denial of access for such inspection shall be grounds for suspension of the permit until the access is freely given by the holder of the permit or his or her agent.

article: 1. Generally


text: Any added poisonous or deleterious substance, or any food additive, pesticide chemical, preservative, or color additive, shall be considered unsafe for use with respect to any food unless there is in effect a regulation adopted pursuant to Section 110080, 110085, or 110090, that limits the quantity and the use, or intended use, of the substance to the terms prescribed by the regulation.

article: 1. Generally


text:
On or before September 1, 1985, the department shall, within the limits of available resources, prepare and submit to the Legislature a program for detecting and monitoring chemical and pesticide residues in processed foods. In preparing the program, the department shall do all of the following:

(a) Establish a list of chemical and pesticides developed from a knowledge of chemicals used in the food industry in processed foods and from the 96 pesticides on the Department of Food and Agriculture residue scan, for which analysis will be done by the department. The list shall include an explanation of why the listed chemicals and pesticides were selected. The Department of Food and Agriculture shall cooperate with the department in establishing the list required by this subdivision. In selecting the chemicals and pesticides to be placed on the list, the department shall make use of the following criteria:

(1) Chemicals that have been identified as having possible carcinogenic, reproductive, or mutagenic effects.

(2) Patterns of use in California.

(3) Quantities of use in California.

(4) Chemicals appearing as residues in processed food because of environmental persistence or resistance to degradation under conditions existing in the processing, manufacturing, milling, or shipping of processed foods sold in California.

(5) Chemicals that have the potential of chronic toxicity due to low continuous exposure.

The department may revise the list and is authorized to add or remove chemicals or pesticides based on relevant information that becomes available to it after the list has been established and based on its experience in detecting the presence of chemical substances in processed foods under the sampling and testing program developed pursuant to subdivision (b).

(b) The department shall design a sampling and testing program that does all of the following:

(1) Samples and tests processed food products that form a significant portion of the diet of the general population, and that may contain residues of the chemical substances on the list established pursuant to subdivision (a).

(2) Provides for specific testing of individual chemicals on the list established pursuant to subdivision (a) when a chemical cannot be detected using multiresidue testing procedures and when the department determines that the chemical may be the cause of chronic health effects.

(3) Lists the foods to be sampled, the stages of processing in which the foods will be sampled, the sampling frequency, and the techniques used in sampling.

(4) A description of plans for sampling processed imported foods from other states and countries.

(c) As used in this section, “processed food” means any food chemically or physically altered from a raw agricultural commodity by chemical, mechanical, thermal, or other processes.

article: 1. Generally


text:
(a) On or before July 1, 1990, the department shall commence and maintain a program for monitoring processed foods for pesticide residues, chemicals, microbes, and other contaminants. In designing the program, the department shall take into consideration any information developed pursuant to Section 110450.

(b) The department shall consult with the Department of Food and Agriculture in designing the pesticide residue component of the monitoring program, to facilitate focusing the testing in areas of greatest concern. Among the pesticides to be reviewed for possible monitoring shall be those contained in the lists of pesticides identified in Section 12535 of the Food and Agricultural Code.

(c) In the development and ongoing operation of the department’s monitoring program, the department shall consider, in establishing priorities:

(1) Potential concentration effects that may occur during processing.

(2) Targeting foreign and domestic imported processed foods according to their estimated California market share.

(3) The extent to which processed foods are a part of the infant and child diet.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 6. Effective January 1, 1996. Note: See Section 26205.5 (from which this section is derived) as modified on July 17, 1991, in Governor's Reorganization Plan No. 1 of 1991.)

article: 1. Generally


text: No person shall engage in the manufacture, packing, or holding of any processed food in this state unless the person has a valid registration from the department, except those engaged exclusively in the storing, handling, or processing of dried beans. The registration shall be valid for one calendar year from the date of issue, unless it is revoked. The registration shall not be transferable. This section shall not apply to a cottage food operation that is registered or has a permit pursuant to Section 114365 or a microenterprise home kitchen, as defined in Section 113825.

history: (History: Amended by Stats. 2018, Ch. 470, Sec. 2. (AB 626) Effective January 1, 2019.)

article: 2. Registration

path: 104. ENVIRONMENTAL HEALTH > 5. SHERMAN FOOD, DRUG, AND COSMETIC LAWS > 5. Food > 2. Registration


text: It is unlawful for any person to manufacture, pack, or hold processed food in this state unless in a food processing facility duly registered, as provided in this part.

history: (History: Added by renumbering Section 110780 by Stats. 1999, Ch. 915, Sec. 6. Effective January 1, 2000.)

article: 2. Registration


text: It is unlawful for any person to willfully make a false statement or representation, or knowingly fail to disclose a fact required to be disclosed in the application for registration or renewal of registration, as provided in this article.

history: (History: Added by renumbering Section 110785 by Stats. 1999, Ch. 915, Sec. 7. Effective January 1, 2000.)

article: 2. Registration


text: A separate registration is required for each place of manufacture, packing, or holding.

article: 2. Registration


text:
(a) Commencing January 1, 2000, the department shall use the resources provided by the registration fees assessed by this article to inspect new and registered food processing facilities to determine compliance with this part. The department shall target the inspections and adjust their scope, depth, and frequency based on the department’s statewide assessment of public health risk potential. In assessing public health risk potential, the department shall consider, at a minimum, the potential and actual health risks associated with processed foods manufactured, packed, or held in this state, and the food safety practices and compliance histories of persons who manufacture, pack, or hold processed foods in this state.

(b) Commencing January 1, 2001, the department, pursuant to this chapter, shall conduct an annual inspection of each registered food processing facility and inspect each new food processing facility prior to issuing a new registration pursuant to Section 110460. This annual inspection requirement may be adjusted or waived based on an assessment of the food processing facility pursuant to subdivision (a).

(c) The department may perform one or more reinspections of each new and registered food processing facility as necessary to prevent repeated or continuing violations of this part and for the purposes of approving the issuance of a new registration. The department shall charge a fee of one hundred dollars ($100) per hour to cover the costs of performing the reinspections of the same food processing facility within any 12-month period.

history: (History: Amended by Stats. 2005, Ch. 401, Sec. 2. Effective January 1, 2006.)

article: 2. Registration


text: Any violation of any provision of this part or any regulation adopted pursuant to this part shall be grounds for denying a registration or for suspending or revoking a registration. Proceedings for the denial, suspension, or revocation of a registration shall be conducted in accordance with Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code, and the department shall have all the powers granted in that chapter.

history: (History: Added by Stats. 1999, Ch. 915, Sec. 9. Effective January 1, 2000.)

article: 2. Registration


text:
(a) A wholesale food manufacturing facility that manufactures products that contain industrial hemp shall be registered in accordance with Section 110460 and shall comply with good manufacturing practices as defined in Section 110105 and as determined by the department in regulation.

(b) Industrial hemp shall not be used in dietary supplements or food products unless the manufacturer demonstrates both of the following:

(1) All parts of the hemp plant used in dietary supplements or food products come from a state or country that has an established and approved industrial hemp program that inspects or regulates hemp under a food safety program or equivalent criteria to ensure safety for human or animal consumption.

(2) The industrial hemp cultivator or grower is in good standing and in compliance with the governing laws of the state or country of origin.

history: (History: Added by Stats. 2021, Ch. 576, Sec. 7. (AB 45) Effective October 6, 2021.)

article: 2. Registration


text:
A registration application provided by the department shall be completed annually and accompanied by a nonreturnable registration fee.

The fee for a new or renewal registration for a food processing facility shall be as follows:Holding Food Only:FeeFeeFeeFeethroughcommencingcommencingcommencing12/31/9901/01/200001/01/200101/01/2000throughandLos Angeles,12/31/2000ongoingOrange, SanBernardinoCounties andthe City ofVernonSize of Facility:0–5,000 sq. ft.$257.85$300$300$3005,001–10,000 sq. ft. 257.85 350 400 350Over 10,000 sq. ft. 386.77 500 600 500Manufacturing or Packing of Food:FeeFeeFeeFeethroughcommencingcommencingcommencing12/31/9901/01/200001/01/200101/01/2000throughandLos Angeles,12/31/2000ongoingOrange, SanBernardinoCounties andthe City ofVernonNumber ofSize ofEmployeesFacility0–2$257.85$300$300$3003–50–5,000 sq. ft. 257.85 350 400 3506–200–5,000 sq. ft. 386.77 500 600 500More than 200–5,000 sq. ft. 515.70 700 900 7003–5Over 5,000 sq. ft. 257.85 500 600 5006–20Over 5,000 sq. ft. 515.70 700 900 70021–50Over 5,000 sq. ft. 644.52 9351,250 85051–100Over 5,000 sq. ft. 644.52 9851,350 850101–200Over 5,000 sq. ft. 644.521,035 1,450 850201 or moreOver 5,000 sq. ft. 644.521,085 1,550 850A penalty of 1 percent per month shall be added to any registration fee not paid when due. The fee amount shall be adjusted annually pursuant to Section 100425.

history: (History: Repealed and added by Stats. 1999, Ch. 915, Sec. 11. Effective January 1, 2000.)

article: 2. Registration


text:
(a) Commencing January 1, 2006, the department shall make a one-time 15 percent cost-of-living adjustment to the registration fees established in Section 110470.

(b) Commencing January 1, 2006, every person engaged in the manufacture, packing, or holding of processed food in this state that is subject to the requirements of Part 120 or 123 of Title 21 of the Code of Federal Regulations shall pay two hundred fifty dollars ($250) in addition to their annual registration fee paid pursuant to Section 110470.

(c) Revenue received pursuant to this section shall be deposited into the Food Safety Fund created by Section 110050.

(d) Upon appropriation, the additional fee deposited in the Food Safety Fund shall be used by the department to conduct inspections and reviews of those facilities required to have Hazard Analysis Critical Control Point (HACCP) plans or Standard Sanitation Operating Procedures (SSOPs).

history: (History: Added by Stats. 2005, Ch. 401, Sec. 3. Effective January 1, 2006.)

article: 2. Registration


text: The department, in consultation with the California Conference of Directors of Environmental Health (CCDEH), representatives of the food processing industry, representatives of the local health departments of, Los Angeles, Orange, and San Bernardino Counties, and the City of Vernon, and any other person or entity deemed appropriate by the department shall develop, implement, and evaluate the processed food program in accordance with this chapter. In developing the processed food program, consideration shall be given to all aspects of the program provided for in this chapter.

history: (History: Added by Stats. 1999, Ch. 915, Sec. 12. Effective January 1, 2000.)

article: 2. Registration


text: Notwithstanding the requirements of Section 110470, any person who is required to be registered under this chapter and is operating the food processing facility exclusively for charitable purposes, and meets the requirements of Section 214 of the Revenue and Taxation Code, shall not be required to submit any fees required by Section 110470.

history: (History: Added by Stats. 1999, Ch. 915, Sec. 13. Effective January 1, 2000.)

article: 2. Registration


text: Nothing in this chapter shall relieve a person who has a valid registration to manufacture, pack, or hold processed food issued by the department from any other requirements for licensure, registration, or certification under Article 7 (commencing with Section 110810), Article 12 (commencing with Section 111070), or Part 6 (commencing with Section 111940). The registration fee due to the department under this article from a person who holds one or more licenses, registrations, or certificates issued by the department pursuant to Article 12 (commencing with Section 111070) or Chapters 5 to 10, inclusive of Part 6 (commencing with Section 112150) shall be the fee for the single highest cost license, registration, or certificate only. Cannery inspection fees collected pursuant to Section 112730 and organic processed food registration fees collected pursuant to Section 110875 shall be in addition to any registration fees that may be collected under this article.

history: (History: Added by Stats. 1999, Ch. 915, Sec. 14. Effective January 1, 2000.)

article: 2. Registration


text: Any person registered pursuant to this article shall immediately notify the department of any change in the information reported on the registration application.

history: (History: Amended by Stats. 1999, Ch. 915, Sec. 15. Effective January 1, 2000.)

article: 2. Registration


text:
(a) The registration requirements of this article do not apply to a person whose manufacturing, packing, or holding of processed food is limited solely to temporarily holding processed foods for up to seven days for further transport if the foods are not potentially hazardous foods, as defined in Section 110005, or to a person whose manufacturing, packing, or holding of processed food is limited solely to activities authorized by any of the following:

(1) A valid bottled water or water vending machine license issued pursuant to Article 12 (commencing with Section 111070).

(2) A valid pet food license issued pursuant to Chapter 10 (commencing with Section 113025) of Part 6.

(3) A valid permit issued pursuant to Chapter 4 (commencing with Section 113700) of Part 7 to a food facility including a food facility that manufactures, packs, or holds processed food for sale at wholesale, provided the food facility that manufactures, packs, or holds processed food for sale at wholesale does not meet any of the following conditions:

(A) Has gross annual wholesale sales of processed foods of more than 25 percent of total food sales.

(B) Sells processed foods outside the jurisdiction of the local health department.

(C) Sells processed foods that require labeling pursuant to this part.

(D) Processes or handles fresh seafood, frozen seafood held in bulk for further processing, or fresh or frozen raw shellfish.

(E) Salvages processed foods for sale other than at the retail food facility.

(4) A valid cold storage license issued pursuant to Chapter 6 (commencing with Section 112350) of Part 6.

(5) A valid cannery license issued pursuant to Chapter 8 (commencing with Section 112650) of Part 6.

(6) A valid shellfish certificate issued pursuant to Chapter 5 (commencing with Section 112150) of Part 6.

(7) A valid frozen food locker plant license issued pursuant to Chapter 7 (commencing with Section 112500) of Part 6.

(8) A valid beer manufacturer’s license, winegrower’s license, or wine blender’s license pursuant to Division 9 (commencing with Section 23000) of the Business and Professions Code.

(9) A valid milk products plant, margarine, imitation ice cream, imitation ice milk, or a products resembling milk products plant license, issued pursuant to Division 15 (commencing with Section 32501) of the Food and Agricultural Code.

(10) A valid permit issued by a local health department to operate a processing establishment, as defined in Section 111955, that only holds or warehouses processed food, pursuant to Article 1 (commencing with Section 111950) of Chapter 4 of Part 6, provided that all of the following conditions are met:

(A) The warehouse does not manufacture or pack processed food.

(B) The warehouse does not hold fresh seafood, frozen seafood held in bulk for further processing, or fresh or frozen raw shellfish.

(C) The warehouse is not operated as an integral part of a food processing facility required to be registered pursuant to Section 110460.

(D) The warehouse facilities are located entirely within the area under the jurisdiction of the local health department.

(E) The warehouse does not salvage food as the primary business.

(b) An entity that provides food services other than the manufacturing, packing, or holding of processed food is subject to applicable provisions of the California Retail Food Code, as set forth in Part 7 (commencing with Section 113700).

(c) This section does not limit the authority of the Counties of Los Angeles, San Bernardino, and Orange, or of the City of Vernon, to conduct any inspections otherwise authorized by Chapter 4 (commencing with Section 111950) of Part 6.

history: (History: Amended by Stats. 2019, Ch. 277, Sec. 1. (AB 746) Effective January 1, 2020.)

article: 2. Registration


text:
(a) Every person who is engaged in the manufacture, packing, or holding of processed food in this state shall pay a food safety fee of one hundred dollars ($100) to the department in addition to any fees paid pursuant to Section 110470.

(b) Revenue received pursuant to this section shall be deposited in the Food Safety Fund created pursuant to Section 110050. A penalty of 10 percent per month shall be added to any food safety fee not paid when due.

(c) Upon appropriation, the food safety fees deposited in the Food Safety Fund shall be used by the department to assist in developing and implementing education and training programs related to food safety. These programs shall be developed in consultation with representatives of the food processing industry. Implementation shall include education and training in the prevention of microbial contamination.

(d) This section does not apply to companies exclusively involved in flour milling, dried bean processing, or in the drying or milling of rice, or to those individual registrants the director determines should not be assessed because substantial economic hardship would result to those registrants. For the purposes of this subdivision, the substantial hardship exemption shall be extended only to registrants whose wholesale gross annual income from the registered business is twenty thousand dollars ($20,000) or less.

history: (History: Amended by Stats. 2015, Ch. 477, Sec. 1. (AB 384) Effective January 1, 2016.)

article: 2. Registration


text:
(a) A laboratory that performs analyses of foods for pesticide chemical residues for other persons shall be accredited pursuant to Article 3 (commencing with Section 100825) of Chapter 4 of Part 1 of Division 101. This subdivision shall not apply to any of the following:

(1) A laboratory operated by a government agency.

(2) A laboratory not operated for commercial purposes that performs pesticide chemical residue analysis on foods for research or quality control for the internal use of the person initiating the analysis. For purposes of this section, “commercial purposes” means that the laboratory performs pesticide chemical residue analysis on the foods primarily for the purpose of making a profit.

(b) A laboratory accredited pursuant to Section 12591 of the Food and Agricultural Code shall not be required to be accredited under this section until January 1, 1992.

(c) A laboratory that performs analyses of foods for pesticide chemical residues, but that is not required by subdivision (a) to be accredited may apply for accreditation pursuant to Article 3 (commencing with Section 100825) of Chapter 4 of Part 1 of Division 101.

(d) This section shall become operative on January 1, 1991, or 60 days after the initial set of regulations adopted pursuant to Sections 100830 and 100835 becomes effective, whichever is later.

article: 2. Registration