• Skip to content
  • Skip to primary sidebar

Davis+Gilbert LLP

From our base in New York, we represent a diverse range of clients across the country and around the world.

  • People
  • Services
  • Emerging Issues
Insights + Events
bookmarkprintPDFShare>

Alert, Balancing Compliance and Creativity in Regulated Industries - October 4, 2021

New California CBD Law Highlights the Federal / State Regulatory Divide

The Bottom Line

  • Assembly Bill 45 in California now permits food and dietary supplement products to include CBD.
  • The differing approaches by the California and federal governments highlights the complicated regulatory environment for ingestible CBD products.
  • Brands, agencies and media companies looking to get involved in CBD advertising need to remain cognizant of the risks before choosing to delve into the space.

California’s newly passed Assembly Bill 45 now explicitly permits cannabidiol (CBD) to be included in food and dietary supplement products and creates advertising and labeling restrictions. This is a stark departure from the California Department of Public Health’s prior decision to follow the U.S. Food and Drug Administration’s ban on ingestible CBD products, especially as the FDA has only become stricter in recent months by going after more innocuous activities involving CBD.

Epidiolex Changed CBD’s Classification

Under the 2018 United States Farm Bill, it is lawful to manufacture industrial hemp, and to sell CBD — marijuana’s non-intoxicating cousin — derived therefrom, so long as the product contains less than 0.3% THC. However, due to the approval of Epidiolex, an epilepsy medication, the Food and Drug Administration (FDA) considers CBD to be a drug, and prohibits its use in any food and dietary supplement products.

In 2018, the California Department of Public Health (CDPH) publicly stated that, consistent with FDA guidance, it considered all ingestible products containing CBD to be illegal.

A Reclassification for CBD

This new bill reverses the CDPH’s position, and explicitly permits CBD to be included in food and dietary supplement products sold in California.

The bill also:

  • Establishes a detailed regulatory system with respect to ingestible CBD products.
  • Requires several different warning labels to be included on product packaging.
  • Creates a number of advertising requirements, including:
    • A prohibition on untrue health-related statements.
    • A requirement that advertising only be displayed in 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 policing food and dietary supplements that include CBD. As discussed in a previous alert, the FDA has made efforts to go after CBD marketers that make certain aggressive health claims — including claims that the these products can treat a variety of illnesses and conditions such as COVID-19 — but the FDA historically showed little appetite to police the market more broadly.

However, the FDA has issued warning letters in 2021 to a number of manufacturers for more benign marketing practices. For example, the FDA sent a warning letter in July to MB Solutions, LLC / BioSpectrum CBD over the inclusion of CBD in its “Sour Gummy Worms,” “Watermelon Slices,” “CBD Oil Tincture,” and “CBD Gummy Bears,” even though no problematic health claims were identified with respect to those products.

The FDA also recently rejected two New Dietary Ingredient notifications for full-spectrum CBD extracts, finding that there was insufficient evidence to show that ingestible CBD would reasonably be expected to be safe.


Download a PDF of this alert.Download

Possessing, using, distributing, and/or selling marijuana or marijuana-based products is illegal under federal law, regardless of any state law that may legalize or decriminalize such activity under certain circumstances. Although federal enforcement policy may at times defer to states’ laws and not enforce conflicting federal laws, interested businesses and individuals should be aware that compliance with state law in no way assures compliance with federal law, and there is a risk that conflicting federal laws may be enforced in the future. No legal advice we give is intended to provide any guidance or assistance in violating federal law.

Primary Sidebar

Related People

  • Attorney Gary Kibel

    Gary Kibel

    Partner

    Area Of Focus

    • Privacy, Technology + Data Security
    • Advertising + Marketing
    212 468 4918
    gkibel@dglaw.com
  • Attorney Louis DiLorenzo

    Louis P. DiLorenzo

    Partner

    Area Of Focus

    • Advertising + Marketing
    212 468 4805
    ldilorenzo@dglaw.com
  • View All

Related Services

  • Advertising + Marketing
  • Advertising Review, Production and Media
  • Regulated Products and Industries

Get the latest insights from Davis+Gilbert

Subscribe
  • Sitemap
  • Privacy Policy
  • Terms and Conditions
  • Accessibility Statement
  • About Us
  • Location
  • Subscribe
© 2025 Copyright Davis+Gilbert LLP. Attorney Advertising.
  • People
  • Services
  • Emerging Issues
  • Insights + Events
  • Culture + Community
  • Pro Bono + Corporate Social Responsibility
  • Careers
  • About Us
  • Subscribe
  • Location
This site uses cookies to store information on your device. These cookies either support essential functions of the site or are used to develop analytics regarding usage of our site. Click Accept to continue using the site with our recommended settings or click Decline to disable non-essential cookies.AcceptDecline