Senate Health

SENATE COMMITTEE ON HEALTH Senator Dr. Richard Pan, Chair BILL NO: SB 235 AUTHOR: Allen VERSION: March 1, 2021 HEARING DATE: March 10, 2021 CONSULTANT: Vincent D. Marchand SUBJECT: Industrial hemp products SUMMARY: Establishes a regulatory structure in the California Department of Public Health (CDPH) for food, beverage and cosmetic products containing industrial hemp, and limits these products to containing no more than 0.3% concentration of Delta-9 tetrahydrocannabinol. Requires industrial hemp product manufacturers to register with CDPH, and requires industrial hemp to be tested prior to it being incorporated as an ingredient into a product. Existing law: 1) Enacts the Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA) to establish a comprehensive system to control and regulate the cultivation, distribution, transport, storage, manufacturing, processing, and sale of both medicinal cannabis and cannabis products, and adult-use cannabis and cannabis products for adults 21 years of age and over. [BPC §26000, et seq.] 2) Defines “cannabis,” for purposes of MAUCRSA, as all parts of the plant Cannabis sativa Linnaeus, Cannabis indica, or Cannabis ruderalis, the seeds thereof, the resin, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin. Excludes “industrial hemp,” as defined in the California Uniform Controlled Substances Act (UCS Act), from the definition of cannabis for purposes of MAUCRSA. [BPC §26001 (f)] 3) Defines industrial hemp, under the UCS Act, as a crop that is limited to types of the plant Cannabis sativa L. having no more than 0.3% THC. Excludes industrial hemp from the UCS Act, and from MAUCRSA, and instead requires industrial hemp to be regulated by the California Department of Food and Agriculture (DFA), as specified. [HSC §11018.5] 4) Establishes a regulatory structure for the cultivation of industrial hemp, and an Industrial Hemp Advisory Board, under the DFA. Requires a grower of industrial hemp for commercial purposes to register with the county agricultural commissioner. [FAC §81000, et seq.] 5) Prohibits any person from engaging in the manufacture, packing, or holding of any processed food unless the person has a valid registration as a food processing facility from the CDPH under the Sherman Food, Drug, and Cosmetic Law. [HSC §110460] 6) Prohibits, under the Alcoholic Beverage Control Act, the manufacture or sale of alcoholic beverages that contain tetrahydrocannabinol (THC) or cannabinoids, regardless of the source. [BPC §25621.5] SB 235 (Allen) Page 2 of 10 This bill: 1) Revises the definition of “industrial hemp,” for purposes of the USC Act and for purposes of this bill, to be consistent with the definition in federal law, which is an agricultural product that is limited to types of the plant Cannabis sativa L. and any part of that plant, including the seeds of the plant and all derivatives, extracts, cannabinoids, isomers, acids, and salts, with a Delta-9 THC of no more than 0.3% on a dry weight basis. 2) Defines various other terms for purposes of this bill, including the following: a) “Industrial hemp product” means a finished product containing industrial hemp that is a cosmetic, food, food additive, dietary supplement, or herb, and is for human or animal consumption. Excludes hemp products that have been approved by the FDA, or a hemp product that includes industrial hemp that has received Generally Recognized as Safe designation; b) “Manufacture” means to compound, blend, extract, infuse, or otherwise make or prepare an industrial hemp product, including all aspects of the extraction process, infusion process, and packaging and labeling processes; c) “Raw extract” means extract not intended for consumer use and that contains a THC concentration of no more than an amount determined by DPH in regulation; d) “Raw hemp product” means a product that is derived from industrial hemp that is intended to be included in a food, beverage, dietary supplement, or cosmetic; e) “THC” and “Delta-9 THC” means tetrahydrocannabinol, Chemical Abstracts Service (CAS) number 1972-08-3; f) “THCA” means THC acid, CAS number 23978-85-0; and, g) “Total THC” means the sum of THC and THCA. Requires total THC to be calculated using the following equation: total THC concentration (mg/g) = (THCA concentration (mg/g) x 0.877) + THC concentration (mg/g). 3) Requires a hemp manufacturer who produces a hemp product that is a food or beverage, or that produces raw hemp extract, to register as a food processing facility, as specified in existing law; requires a hemp manufacturer that produces a cosmetic product containing industrial hemp to register as a cosmetic manufacturer, as specified in existing law; and, requires a hemp manufacturer that produces processed pet food that contains industrial hemp to obtain a license as a pet food manufacturer, as specified under existing law. 4) Requires a hemp manufacturer, in addition to any licensing and registration requirements required to be a food processing facility, cosmetic manufacturer, or pet food manufacturer, to also obtain an industrial hemp enrollment and oversight authorization from CDPH, which must be renewed annually. Requires CDPH to assess a fee for this to cover costs of the regulatory program, not to exceed $1,000 per company. Permits fees to be set at different amounts for different hemp manufacturer types. 5) Permits CDPH to adopt emergency regulations to implement this bill, and to readopt any emergency regulation that is the same as, or substantially equivalent to, an emergency regulation previously adopted, limited to one readoption for each regulation. Limits the emergency regulations to remaining in effect for no more than 180 days, by which time final regulations shall be adopted. SB 235 (Allen) Page 3 of 10 6) Exempts initial regulations regarding industrial hemp from the Administrative Procedures Act, with the exception of a 30-day public comment period. However, any regulations to impose an age requirement on the sale of industrial hemp products, or to determine maximum serving sizes must still comply with the Administrative Procedures Act. 7) Prohibits a manufacturer, distributor, or seller of an industrial hemp product from including 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 or that tends to create a misleading impression as to the health effects of consuming products containing industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp. Specifies that a “health-related statement” includes a statement of a curative or therapeutic nature, but does not include statements required to be made by the FDA, or properly substantiated structure-function claims allowed for dietary supplements. 8) Specifies that foods, beverages, dietary supplements, cosmetics, and pet food are not adulterated by the inclusion of industrial hemp as long as the cannabinoids meet the requirements of this bill, and prohibits restricting the sale of these products based solely on the inclusion of industrial hemp in these products. 9) Prohibits an industrial hemp product from being distributed or sold in the state unless it has documentation that it was produced from industrial hemp grown regulated by the Department of Food and Agriculture, if sourced within California, or licensed in accordance with the US Department of Agriculture requirements if sourced from outside the state. 10) Permits CDPH to adopt regulations imposing an age requirement for the sale of certain industrial hemp products upon a finding of a threat to public health based on scientific research. 11) Prohibits industrial hemp, unless explicitly approved by the federal Food and Drug Administration (FDA), from being included in products in any of the following categories: a) Medical devices; b) Prescription drugs; c) Processed smokable products, including, but not limited to, electronic cigarettes with nicotine; d) Smokable flower, including, but not limited to, hookah and shisha with nicotine; e) A product containing nicotine or tobacco; or, f) Alcoholic beverages. 12) Permits CDPH to prohibit the inclusion of industrial hemp in other products when it poses a risk to human or animal health through regulation. 13) Permits CDPH, through regulation, to determine maximum serving sizes for hemp-derived products, active cannabinoid concentration per serving size, the number of servings per container, and any other requirements for foods and beverages. 14) Permits a hemp manufacturer or retailer who is operating in conformance with existing food and drug laws, and in good faith compliance with their responsibilities under the provisions of this bill, to manufacture or sell industrial hemp products or raw hemp extract without authorization on and after the effective date of this bill. SB 235 (Allen) Page 4 of 10 15) Permits CDPH to adopt regulations for recordkeeping standards that apply to transporters, manufacturers, and retailers of industrial hemp product and raw extract. 16) Requires a hemp manufacturer to meet all of the following testing requirements: a) Requires industrial hemp to be tested in raw extract final form, to allow its use as an ingredient, prior to being incorporated into a product; b) Requires testing to be completed by an independent testing laboratory, as defined; and, c) Requires the manufacturer of the hemp extract in its final form or the final form product to be able to prove total THC concentration

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