United States: California’s new CBD law highlights the federal / state regulatory division
October 7, 2021
Global Advertising Lawyers Alliance (GALA)
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The recently passed California 45th Assembly Bill now explicitly allows cannabidiol (CBD) to be included in food products and dietary supplements and creates restrictions on advertising and labeling. This is a major deviation from the previous decision by the California Department of Public Health to follow the U.S. Food and Drug Administration’s ban on ingestible CBD products, especially because the FDA has only tightened on the recent months in pursuing more innocuous CBD-related activities.
Epidiolex changed the classification of CBD
Under the 2018 U.S. Farm Bill, it is legal to manufacture industrial hemp and sell CBD, the non-intoxicating cousin of marijuana, as long as the product contains less than 0.3% THC. However, due to the approval of Epidiolex, a drug for epilepsy, the Food and Drug Administration (FDA) considers CBD to be a drug and prohibits its use in any food product and dietary supplement.
In 2018, the California Department of Public Health (CDPH) publicly stated that, in accordance with FDA guidelines, it considered all ingestible products containing CBD to be illegal.
A reclassification of the CBD
This new bill reverses the CDPH’s position and explicitly allows CBD to be included in food products and dietary supplements sold in California.
The invoice also:
- It establishes a detailed regulatory system with respect to ingestible CBD products.
- Several different warning labels must be included on the product packaging.
- Create various advertising requirements, such as:
– The prohibition of false statements related to health.
– A requirement that advertising be shown only on media where at least 70% of the audience is reasonably expected to be 18 years of age or older.
Meanwhile, the FDA has gone in the exact opposite direction by more strictly applying dietary and dietary supplements that include CBD. As discussed in an earlier alert, the FDA has made efforts to prosecute CBD vendors who make certain aggressive health claims, including claims that these products can treat various diseases and conditions such as COVID-19, but historically the FDA went show little appetite to control the market more broadly.
However, the FDA issued warning letters in 2021 to several manufacturers for more benign marketing practices. For example, the FDA sent a warning letter in July to MB Solutions, LLC / BioSpectrum CBD about the inclusion of CBD in its “Sour Gummy Worms,” “Watermelon Slices,” “CBD Oil Tincture,” and “CBD Gummy Bears “. although no problematic health claims were identified with respect to these products.
Recently, the FDA also rejected two notifications of new dietary ingredients for full-spectrum CBD extracts, finding that there was insufficient evidence to show that it was reasonably expected that ingestible CBD would be safe.
THE BOTTOM LINE
- Assembly Bill 45 in California now allows food and dietary supplements to include CBD.
- The different approaches of the California and federal governments highlight the complicated regulatory environment of ingestible CBD products.
- Brands, agencies and media companies wishing to participate in CBD advertising must be aware of the risks before choosing to enter the space.
The content of this article is intended to provide general guidance on the subject. Special advice should be sought on your specific circumstances.
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