FDA has announced the distribution of warning letters to five companies for products allegedly marketed as containing cannabidiol (CBD) and delta-8 tetrahydrocannabinol (delta-8 THC). FDA alleged that the companies made drug claims regarding their products on their websites, and presented the products in question as intended for use in the cure, mitigation, treatment, or prevention of disease.
FDA highlighted claims on company websites that allegedly established the products as drugs, including:
- “Fighting Cancer . . . Δ8 may also have cancer-fighting properties . . . [t]he researchers treated mice with cancer for 20 consecutive days with a combination of the isomer and cannabinol. The result? Tumors reduced in size.”
- “Cannabidiol (CBD) changes neurotransmission systems . . . Alters behavior response to Opioids . . . Pain management during Opioid withdrawal . . . Reduces Heroin cravings and relapse”
Among a number of other alleged violations, FDA asserted that products from all five companies were unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d), as well as that the products were misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
The agency has advised the companies to take prompt action to correct the alleged violations cited in the letters, and that failure to correct the alleged violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
AHPA’s guidance policy on the marketing of concentrated delta-8 THC, artificial, or synthesized cannabinoids (adopted June 2021) acknowledges delta-8 THC as a naturally occurring, but minor constituent in hemp, and discourages the marketing of goods for consumption by any route that both consist of or contain any amount of synthesized cannabinoids (including delta-8 THC) and are labeled as hemp products.
In addition, another AHPA guidance policy recommends that any product (food or supplement) derived from hemp should comply with all applicable FDA regulations. As with all AHPA guidance policies, AHPA encourages its members and non-member companies to adopt these policies to establish consistent and informed trade practices.
