Cannabis Q&A: What’s Happening With Hemp in California?

Welcome to our Q&A with partner, Jennifer Gumer!

As a partner at CGL and our Regulatory and Compliance Practice Lead, Jennifer provides strategic counseling, practical advice, and expert advocacy to clients with production needs. As an Adjunct Professor of Law and Bioethics, she is uniquely qualified to handle all interactions with federal, state, and local regulators who oversee product development, manufacturing, and marketing activities, including the FDA and Local Hemp Regulators.

Q: What’s Happening with Hemp in California?

California’s hemp market looks set to finally be subject to regulation and oversight following the passing of AB45. The bill came into effect on October 6. So, what does the regulated hemp market look like in California? 

Well, We Still Aren’t Sure What the Regulated CBD Hemp Market Looks Like in California

AB 45 empowers CDPH to pass regulations to actually enact the law.  Therefore, many details of the law (such as how THC levels will be defined and measured) will not be fleshed out or become operable until CDPH devises and finalizes its regulations, which could take some time. 

Food, beverages, dietary supplements and cosmetics may be sold with industrial hemp as an ingredient.

Food, beverages, dietary supplements, cosmetics, and processed pet food are all declared by the new law to not be ‘adulterated’ by the inclusion of industrial hemp, so long as certain requirements are met. This means that these products may be sold in California, since it’s the designation as ‘adulterated’ that resulted in them not being permitted to be sold.  

This law overrides the previous California Department of Public Health (CDPH) policy that prohibited hemp CBD from being included in food, beverages or dietary supplements. 

However, since these products were sold in California previously without consequence (as the CDPH did not enforce its policy), this law is a mixed blessing. It legalizes the market, but now manufacturers need to comply with the forthcoming regulations, which will increase costs. 

Current Requirements for Legalized Hemp Products

The requirements that must be met include (but are not limited to): 

• Hemp and hemp CBD products must contain a THC concentration of 0.3% or less in its final form. The law gives CDPH the authority to determine which isomers of THC will count towards the .3% threshold. 
• Manufacturers of products containing hemp must demonstrate proper sourcing and good manufacturing practices. 
• Manufacturers of products containing hemp CBD must pay registration fees to the Industrial Hemp Enrollment and Oversight Fund.
• There will be testing requirements for these products for the first time in California. Additionally, packaging must have a QR code linked to the certificate of analysis. 

Regulations pertaining to record keeping and testing are likely to be forthcoming. 

Labelling Requirements In Force From 2022

Manufacturers must meet the new labelling requirements for products manufactured 90 days after this law is enacted, so from January 2022. The labelling requirements are stringent, and do vary depending on the product. 

Labelling laws for dietary supplements, food, and beverages containing hemp

Dietary supplements, food, and beverages containing industrial hemp must contain packaging and labelling that includes all the following information:

• The product expiration date (if any).
• A statement indicating that children or those who are pregnant or breastfeeding should avoid using the product prior to consulting a healthcare professional about its safety. 
• A statement that products containing cannabinoids should be kept out of reach of children. 
• The following statement: “THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY.”
• A label, scannable barcode, website, or QR code that links to the certificate of analysis provided by an independent testing laboratory. It must provide all of the following information: 
  • The product name.
  • The name of the product’s manufacturer, packer, or distributor, and their address and telephone number. 
  • The batch number (which must match the batch number on the product). 
  • The concentration of cannabinoids present in the product batch, including, at minimum, total THC and any marketed cannabinoids or ingredient, as required by the department in regulation.

• Contaminant levels within the product batch. 

Labelling laws for cosmetics containing hemp

Cosmetics containing industrial hemp must contain packaging and labelling that includes all the following information:

• The product expiration date (if any).
• The following statement: “THE FDA HAS NOT EVALUATED THIS PRODUCT FOR SAFETY OR EFFICACY.”
• A label, scannable barcode, website, or QR code that links to the certificate of analysis provided by an independent testing laboratory. It must provide all of the following information:
  • The product name.
  • The name of the product’s manufacturer, packer, or distributor, and their address and telephone number.
  • The batch number (which must match the batch number on the product).
  • The concentration of cannabinoids present in the product batch, including, at minimum, total THC and any marketed cannabinoids.

• Contaminant levels within the product batch.

Hemp cannot be included in certain products.

AB45 specifically bans the inclusion of industrial hemp in four products, namely medical devices, prescription drugs, products containing nicotine or tobacco, and alcoholic beverages, unless its inclusion is otherwise permitted by the federal Food and Drug Administration (FDA). The Bill also permits the Department to add further products to this list at a later date, if the products are deemed to pose a risk to human or animal health. 

Hemp-containing inhalables banned… for now.

Hemp inhalables are not permitted to be sold in California until regulators have carved out a taxation framework for the products.

The new requirements laid out in AB45 are rigorous. If you need assistance navigating these new requirements, reach out. We’d love to help!

You can read AB45 here.

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