The U.S. Food and Drug Administration (FDA) is back, sniffing out and threatening to shut down cannabidiol (“CBD”) companies across the land. Yes, in case you didn’t know, the FDA is inserting itself into the cannabis industry — sort of.
In April 2015, the FDA sent warning letters to six companies whose products allegedly contained CBD. The FDA warned these companies about marketing and selling unapproved drugs to diagnose, mitigate, treat or prevent diseases in humans or animals.
The FDA recently sent out a fresh round of warning letters to eight new companies. The FDA’s February 4th letter to PainBomb, LLC about the company’s “PainBomb+CBD” products is representative of the letters, and it states as follows:
- PainBomb’s websites and accompanying literature seek to sell drugs covered by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act [(the “FDC Act”)] [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
- PainBomb’s products are “new drugs” under the FDC Act (and not dietary supplements exempt from FDA approval prior to hitting the marketplace) because they are not recognized as safe and effective for the health conditions PainBomb lists for them on their product labels.
- New drugs cannot be legally introduced into interstate commerce without the FDA’s prior written approval. Such approval requires scientific information to demonstrate the new drug is safe and effective.
- PainBomb violated the FDC Act by misbranding its products. The diseases for which PainBomb marketed its products cannot be self-diagnosed or self-treated by people other than health care professionals. For this reason, PainBomb’s instruction labels informing users whether and how to use its products violate the FDC Act.
- PainBomb is responsible for investigating the FDA’s alleged violations and for preventing future violations.
- PainBomb must ensure its compliance with all federal laws and FDA regulations.
- If PainBomb fails to promptly address the violations listed in the FDA’s letter, the FDA can take legal action without further notice – including seizing goods belonging to PainBomb and taking measures to suspend PainBomb’s business operations.
- The FDA gave PainBomb 15 business days to notify the FDA how it will correct the foregoing violations.
The “catch-all” above in bold font makes clear that PainBomb is responsible for ensuring its own compliance with all federal laws and FDA regulations and this is important for all commercial marijuana companies, not just those selling CBD. With this sentence the FDA is making clear that even though marijuana is federally illegal, cannabis companies do not have a license to violate other federal regulations, including those of the FDA.
The FDA has yet to pursue cannabis companies for making health and medical claims about their products, but we are convinced that it soon will. These eight FDA warning letters demonstrate that marijuana companies are not immune from federal regulatory oversight simply because they are involved in federally illegal cannabis-related commercial activity. If you are a cannabis company that ignores federal commercial regulations, you do so at your own peril.