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 last week 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 that:
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 [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][(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 making clear that PainBomb is responsible for ensuring its own compliance with all federal laws and FDA regulations 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 have every reason to believe that will happen at some point. These eight FDA warning letters demonstrate that marijuana companies are not immune from federal regulatory oversight simply because they are involved in cannabis-related commercial activity. Cannabis companies that ignore federal commercial regulations do so at their own peril.[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]