The U.S. Food and Drug Administration (FDA) has issued warning letters to 15 companies for selling products containing CBD in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). Product types containing CBD include oil drops, capsules, syrups, chocolate bars, teas, topical lotions and creams.
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The companies receiving the warning letters are using product web pages, online stores and social media to market their CBD Products in ways that violate the FD&C Act, like marketing the products to treat diseases and for other therapeutic uses for humans/animals. Other than one prescription medication used to treat epilepsy, the FDA has not approved any CBD products.
These unapproved CBD products have not been evaluated by the FDA, meaning it is unclear if they are effective, what proper dosages might be, how they interact with FDA-approved drugs or whether they have dangerous side effects, or cause other safety concerns. Additionally, there is concern consumers may hesitate with seeking medical care based on unsubstantiated claims associated with CBD products.
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
“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 FDA principal deputy commissioner Amy Abernethy, M.D., Ph.D. “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate.”
Abernethy continued, “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.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”