FDA Steps-Up CBD Enforcement With New Warning Letters
Editor’s note: In this article, Kight Law attorney Kamran Aryah discusses the latest round of warning letters from the FDA to CBD companies. As Kamran notes, the letters do not represent a policy shift, though they are part of a ramping up of enforcement activity that appears to be timed with the USDA’s release of its interim final rule regarding hemp production. -Rod Kight
On November 25th the Food and Drug Administration (FDA) issued warning letters to fifteen (15) companies that sell hemp and cannabidiol (CBD) products, alleging violations of the Food Drug and Cosmetics Act (FDCA). The cited violations include:
- “Unapproved New Drug”: Improper health claims for products containing CBD cause the FDA to treat that item as a drug.
- “Misbranded Drugs”: Failure to bear adequate directions for use.
- Improperly labeling a CBD product as a “Dietary Supplement”.
- Marketing or selling an “adulterated” food product. (This includes any food product containing CBD, according to FDA.)
The FDA also cited non-compliance for:
- Marketing products to children.
- Marketing / selling unapproved new animal drugs. (The FDCA applies equally to food and drugs for human and non-human animals.)
These letters do not add anything to what we already know about the FDA’s views on CBD in relation to the FDCA. (We have written about the FDA’s view on CBD many times, including here, here, here, here, and here.) However, they do represent an uptick in the level of enforcement since the enactment of the 2018 Farm Act and their timing seems to be roughly in sync with the USDA’s release of the Interim Rule. With this round of fifteen letters, the total number of warning letters issued by the FDA in 2019 more than tripled from seven to twenty-two. The letters also take a more aggressive stance on improper health claims for topical products.
Considering the large and growing number of hemp and CBD companies doing business in the US right now, the companies that received warning letters might rightly consider themselves unlucky. Recipients of warning letters have fifteen (15) days in which to respond to the FDA indicating what steps they have taken to comply with the FDCA. Failure to comply can result in product seizure and an injunction on sales, among other sanctions.
For companies that engage in the same activities but did not receive a letter, these letters should serve as further evidence that the FDA does not take violations of the FDCA lightly.
The hemp industry has been waiting for the FDA to release regulations regarding hemp and CBD products. The wait is not over. It is important to note that this new round of letters and statements about potential health risks associated with CBD does not represent a substantive policy change for the FDA. It remains to be seen the extent to which the warning letter campaign might expand, and what other enforcement actions the FDA might take.
If you have received a warning letter or are concerned that your hemp products and/or marketing practices may run afoul of the FDA, we invite you to contact us. Our hemp lawyers routinely advise clients on these matters.
November 26, 2019
This post was written by Kight on Cannabis attorney Kamran Aryah. Kight on Cannabis is a law firm founded by attorney Rod Kight that represents legal cannabis businesses. You can contact us by clicking here.