FDA Issues New Crop of Warning Letters to Hemp Companies – Lexology

Yesterday, FDA issued a press release along with 15 new warning letters sent to companies who are alleged to be violating the Food, Drug & Cosmetics Act (FDCA) by selling products containing cannabidiol (CBD).

FDA’s policy position in the warning letters remains unchanged from its position taken in late 2018—CBD cannot be legally marketed as a dietary supplement, a food and beverage product, or as animal food or drug products. However, the warning letters provide a glimpse into FDA’s enforcement priorities and offers lessons for companies who operate in the space to mitigate enforcement risk.

While FDA’s policy has been generally steady and clear, its targeted enforcement of some companies, but not others, provides a more nuanced look at FDA’s enforcement priorities in the hemp industry. This most recent crop of letters continues FDA’s policy of targeting companies whose marketing may be viewed as a threat to public health. That is, the company’s marketing claims certain health or disease benefits from CBD that may cause an individual to forego other, doctor prescribed medications. An example of such claims from these recent letters are:

  • “People around the world are using hemp extracts for daily relief against insomnia, stress, anxiety, depression, and pain.”
  • “CBD acts effectively to reduce the number of seizures [in dogs]”

The warning letters also show that companies are citing to the increasing amount of research being released on the effects of CBD in humans and animals. However, FDA is citing companies’ references to those studies in its warning letters as evidence companies are marketing unapproved and misbranded drugs and supplements. FDA seems to be drawing a harder line in the sand that any health and disease claims made by a CBD company will be viewed as violating the FDCA.

Finally, the warning letters show that FDA is scouring social media – notably Facebook, Instagram, and Twitter – to identify whether companies are illegally marketing CBD products. Hemp companies should carefully monitor their social media accounts to ensure they or any customers do not post health and disease claims to their accounts. This will no doubt become increasingly difficult as more studies are released on the health impacts of CBD and cannabis generally, but until FDA has a chance to draft regulations for hemp products, those in the hemp industry that sell products containing CBD should avoid health and disease claims.

Source: https://www.lexology.com/library/detail.aspx?g=8dc066e4-18d9-4dc4-a94d-a549aab4db6f

« »