December 2, 2019

FDA Warns 15 Companies Producing CBD Products

The FDA last week sent warning letters to 15 companies – 13 of which produce CBD products for pets – for illegally selling products containing 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, indicating that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.

“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. 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,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.

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.”

CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, food products such as chocolate bars and teas, and topical lotions and creams. As outlined in the warning letters issued, these particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.

The companies receiving warning letters are:

  •     Koi CBD LLC, of Norwalk, CA (KOI Naturals CBD Spray for Pets, KOI CBD Soft Chews)
  •     Pink Collections Inc., of Beverly Hills, CA (Mr. Pink Natural CBD Oil for Pets aka ‘Vegan Bacon Flavored Pet CBD Oil’)
  •     Noli Oil, of Southlake, TX (Dog Treats (Beef Flavored)) and Pet CBD Oil)
  •     Natural Native LLC, of Norman, OK (Native Pet CBD Oil (150mg, 300mg, & 600mg))
  •     Whole Leaf Organics LLC, of Sherman Oaks, CA (CBD-EX, CBD-MAX 1000 mg, CBD-RX, CBD Defend, and CBD Enflame)
  •     Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, CO (Pet Droppers and Launch Pad)
  •     Apex Hemp Oil LLC, of Redmond, OR (Apex CBD Livestock Pellets, Apex Organic K9 Oil, and Apex CBD Dog Treats)
  •     Sunflora Inc., of Tampa, FL/Your CBD Store, of Bradenton, FL (SunMed Bacon Dog Treats, SunMed Pet Bark Bits Beef, SunMed Dog Lamb Bits, and SunMed Pet Tincture)
  •     Private I Salon LLC, of Charlotte, NC (Natural Flavor Pet Drops and CBD Pet Treats)
  •     Organix Industries Inc., doing business as Plant Organix, of San Bernardino, CA (Hemp Pet Tinctures and Hemp Pet Treats)
  •     Red Pill Medical Inc., of Phoenix, AZ (Red Pill CBD Pet)
  •     Sabai Ventures Ltd., of Los Angeles, CA (Pets Tincture and Chill Chews Soft Chews for Dogs)
  •     Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, KY (CBD Oil for Pets (250 mg Bacon Flavor))

Bella Rose Labs of Brooklyn, NY, and Healthy Hemp Strategies LLC (Curapure) of Concord, CA, rounded out the list.

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.

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

The FDA encourages human and animal health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

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