FDA Sends 15 Warning Letters to CBD Companies Ahead of Update Regarding Regulatory Approach 2

FDA Sends 15 Warning Letters to CBD Companies Ahead of Update Regarding Regulatory Approach



FDA Sends 15 Warning Letters to CBD Companies Ahead of Update Regarding Regulatory Approach – RICH TV LIVE – NOVEMBER 26, 2019 – Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.

Today’s actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks. – The companies receiving warning letters are:

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 illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.

Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

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