The FDA has sent warning letters to 15 companies illegally marketing cannabidiol (CBD) products, enforcing existing provisions in the Federal Food, Drug, and Cosmetic Act.

The agency also published a revised Consumer Update detailing safety concerns about CBD products more broadly.

The FDA has indicated that it cannot conclude that CBD is generally recognized as safe among qualified experts for its use in human or animal food based on the lack of scientific information supporting the safety of CBD in food, according to the press release.1

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said Amy Abernethy, MD, PhD, principal deputy commissioner of the FDA, in a prepared statement. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’”1

The following companies received warning letters1:
  • Koi CBD LLC, of Norwalk, California
  • Pink Collections Inc., of Beverly Hills, California
  • Noli Oil, of Southlake, Texas
  • Natural Native LLC, of Norman, Oklahoma
  • Whole Leaf Organics LLC, of Sherman Oaks, California
  • Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado
  • Apex Hemp Oil LLC, of Redmond, Oregon
  • Bella Rose Labs, of Brooklyn, New York
  • Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida
  • Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California
  • Private I Salon LLC, of Charlotte, North Carolina
  • Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California
  • Red Pill Medical Inc., of Phoenix, Arizona
  • Sabai Ventures Ltd., of Los Angeles, California
  • Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky

The FDA has previously sent warning letters to other companies selling CBD products that they had claimed would prevent, diagnose, mitigate, treat, or cure serious diseases, such as cancer.1

The Consumer Healthcare Products Association (CHPA) has voiced its support of the action, noting that “companies that violate the law put public health at risk and the FDA should continue to take actions like this to keep consumers safe while also working to establish a proper, date-driven pathway for CBD products to come to market.”2

Earlier this month, the CPHA submitted a citizen petition to the FDA urging the agency to exercise its existing statutory authority to issue regulations establishing a clear pathway for manufacturers to lawfully market CBD in dietary supplements.3

“Yesterday’s FDA actions are a very welcome development that will help protect consumers from fraud or the possibility of a negative health outcome,” said Scott Melville, president and CEO of CHPA. “Intense consumer demand and commercial interest has created an urgent need for FDA to act.”2

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.1


REFERENCES
 
  1. FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns [press release]. FDA website. Published November 25, 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Accessed November 26, 2019.
  2. CHPA Applauds FDA Actions Against 15 Companies Illegally Marketing CBD Products [press release]. Washington. CPHA website. Published November 26, 2019. https://www.chpa.org/CBD_Warning_Letters.aspx. Accessed November 26, 2019.
  3. CHPA Petitions FDA to Establish a Clear Path for CBD in Dietary Supplements [press release]. Washington. CPHA website. Published November 14, 2019. https://chpa.org/CBD_Petition.aspx. Accessed November 26, 2019.