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GAVIN NEWSOM
Governor

State of Californiaā€”Health and Human Services Agency
California Department of Public Health


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ā€‹ā€‹Warning to CDPH Licensees Concerning Illegal Hemp Products
4/26/2024



The California Department of Public Health (CDPH) is very concerned about the public health risk posed by the growing prevalence of potentially illegal industrial hemp products in the marketplace. Manufacturers and distributors are at risk of liability if they sell any illegal industrial hemp products.

Consumer dietary supplements, food, or beverage products manufactured using industrial hemp must comply with the Sherman Food, Drug, and Cosmetic Laws (starting with Health and Safety Code section 109875; ā€‹ā€œSherman Actā€‹ā€). Manufacturers and distributors of industrial hemp products must register with the CDPH's Food and Drug Branch (FDB) and obtain an Industrial Hemp Enrollment and Oversight authorization. The Sherman Act also specifies the allowed composition of industrial hemp products and imposes specific labeling and marketing restrictions.

Violations of the Sherman Act are misdemeanors and may subject a violator to fines and/or imprisonment. In addition, CDPH may pursue administrative disciplinary action against licenses of businesses found to be selling industrial hemp products that violate the Sherman Act. Such discipline may result in fines and suspension or revocation of the license with FDB.

Products in violation of the Sherman Act are subject to regulatory actions including recall, embargo, or product destruction. These actions may be taken by CDPH on illegal industrial hemp products. Furthermore, local health jurisdictions may take action on illegal industrial hemp food products sold at retail locations pursuant to the California Retail Food Code. California Department of Alcoholic Beverage Control (ABC) licensed retail locations that sell illegal industrial hemp products may be subject to additional actions by ABC.

FDB licensees are expected to comply with all laws that affect their business operations and are required to operate their licensed business in a lawful manner. This includes ensuring that any industrial hemp products being sold are lawful. There are a few steps that licensees can take to check if industrial hemp products they are selling are lawful, and thus help protect their business from legal action.

First, check the CDPH list (PDF) of industrial hemp businesses registered with FDB. While this does not mean that individual products are necessarily compliant, it is an available resource to aid in your decision as to whether or not an industrial hemp products manufacturer or distributor is licensed.ā€‹

Second, ensure industrial hemp products do not contain (1) tetrahydrocannabinol (THC) isolate or (2) chemically synthesized cannabinoids.

(1) Industrial hemp products that contain THC isolates are prohibited under the Sherman Act. THC isolates are produced from isolating THC from all other components in the cannabis plant. They are highly concentrated and can be used to increase the intoxicating THC levels in products and may be listed on the label as ā€œTHC extractā€‹ā€ or ā€œcannabis extract.ā€‹ā€

(2) Some examples of widely available chemically synthesized cannabinoids include Delta-8 THC, Delta-10 THC, THC-O, and HHC.

Third, ensure labeling requirements are met. As indicated above, there are a number of specific labeling requirements in Health and Safety Code section 111926.2. Packaging and labeling on industrial hemp products must include all of the following information:

(1) A label, scannable barcode, internet website, or quick response (QR) code linked to the certificate of analysis of the final form product batch by an independent testing laboratory that provides all of the following information:

ā€‹a.  ā€‹  The product name.
b.    The name of the product's manufacturer, packer, or distributor, and their address and telephone number.
c.    The batch number, which matches the batch number on the product.
d.    The concentration of cannabinoids present in the product batch, including, at minimum, total THC and any marketed cannabinoids.

e.    The levels within the product batch of contaminants.

(2) The product expiration or best by date, if applicable.

(3)  A statement indicating that children or those who are pregnant or breastfeeding should avoid using the product prior to consulting with a health care professional about its safety.

(4)  A statement that products containing cannabinoids should be kept out of reach of children.

(5)  The following statement, ā€œTHE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY.ā€‹ā€

If an industrial hemp product package or label does not fully comply with these requirements, then it is mislabeled or misbranded and is therefore illegal. It may even be prudent to verify that the phone number, QR code, or website are actually valid; if not, this would be a strong indication that the product is not lawful.ā€‹

Finally, be aware that manufacturers are specifically prohibited from advertising or marketing to children (among others), so packaging or products that might reasonably be considered as attractive to children should be treated with particular caution.