FDA Raises Health Concerns Regarding CBD

The agency issues warnings to consumers and manufacturers.

December 02, 2019

WASHINGTON—The U.S. Food and Drug Administration recently updated its position on CBD, saying that the cannabis derivative may have the potential to harm users, reports Marketwatch.

Cannabidiol, or CBD, is derived from the cannabis plant and is believed to be nonintoxicating. It has been showing up in food, beverages, cosmetics and other consumer products, even in states where marijuana is not recreationally or medically legal. Those items are available from major retailers, including drug stores such as CVS, Walgreens and Rite Aid.

Last summer, the FDA announced that it was looking into CBD and its effects on the human body. The agency has approved CBD in only one product, Epidiolex from GW Pharmaceuticals, which is used to treat severe forms of childhood epilepsy. The FDA has updated its warning to consumers, using stronger language and adding that, “CBD has the potential to harm you, and harm can happen even before you become aware of it.”

Now, the FDA notes that based on a lack of scientific information, it cannot conclude that CBD is “generally recognized as safe among qualified experts for use in human and animal food.” Rather, the compound “can cause” liver injury, affect other drugs, and when combined with alcohol or other depressants can increase the risk of sedation or drowsiness. It also has the potential side effects of drowsiness, gastrointestinal distress and mood changes.

The FDA added that many aspects about CBD remain unknown, such as the effects of taking CBD daily for extended periods, its impact on the developing brain and how it interacts with herbs and botanicals.

Cannabis companies have been trying to break into the CBD market because of the potential for entry to states where marijuana sales are not legal. The FDA has issued warning letters to 15 companies for selling CBD products in ways that allegedly violate the Federal Food, Drug and Cosmetic Act, reports CNBC. According to the warning letters, the companies are marketing CBD products as remedies for diseases and other therapeutic uses in humans and animals. Some have promoted CBD products as dietary supplements and added CBD to human and animal foods or CBD products for infants and children.

The companies receiving warning letters are:

  • Koi CBD LLC, Norwalk, Calif.
  • Pink Collections Inc., Beverly Hills, Calif.
  • Noli Oil, Southlake, Texas
  • Natural Native LLC, Norman, Okla.
  • Whole Leaf Organics LLC, Sherman Oaks, Calif.
  • Infinite Product Company LLP, dba Infinite CBD, Lakewood, Colo.
  • Apex Hemp Oil LLC, Redmond, Ore.
  • Bella Rose Labs, New York
  • Sunflora Inc., Tampa, Fla./Your CBD Store, Bradenton, Fla.
  • Healthy Hemp Strategies LLC, dba Curapure, Concord, Calif.
  • Private I Salon LLC, Charlotte, N.C.
  • Organix Industries Inc., dba Plant Organix, San Bernardino, Calif.
  • Red Pill Medical Inc., Phoenix
  • Sabai Ventures Ltd., Los Angeles
  • Daddy Burt LLC, dba Daddy Burt Hemp Co., Lexington, Ky.

The FDA wants responses from each company within 15 working days stating how they will correct the violations. Failure to correct violations could result in legal action, including product seizure and/or injunction, the letters said.

CBD’s presence in food and beverages has been debated for months. In May 2019, the FDA held its first public hearing on CBD in food and beverages and created a working group to spearhead these questions and concerns. The agency will continue exploring ways for various types of CBD products to be lawfully marketed and plans to provide an update on this progress in the coming weeks.