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cbd warning

U.S. Food and Drug Administration

FDA News Release

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

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.

“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. “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.”

Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.

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 today, 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, 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.

Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes. Consumers may also put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.

Additionally, some of the products outlined in the warning letters issued today raise other legal and public health concerns:

  • Some of the products are marketed for infants and children – a vulnerable population that may be at greater risk for adverse reactions due to differences in the ability to absorb, metabolize, distribute or excrete a substance such as CBD.
  • Some of the products are foods to which CBD has been added. Under the FD&C Act, it is illegal to introduce into interstate commerce any human or animal food to which certain drug ingredients, such as CBD, have been added. In addition, the FDA is not aware of any basis to conclude that CBD is GRAS among qualified experts for its use in human or animal food. There also is no food additive regulation which authorizes the use of CBD as an ingredient in human food or animal food, and the agency is not aware of any other exemption from the food additive definition that would apply to CBD. CBD is therefore an unapproved food additive, and its use in human or animal food violates the FD&C Act for reasons that are independent of its status as a drug ingredient.
  • Some of the products are marketed as dietary supplements. However, CBD products cannot be dietary supplements because they do not meet the definition of a dietary supplement under the FD&C Act.
  • One product outlined in a warning letter to Apex Hemp Oil LLC is intended for food-producing animals. The agency remains concerned about the safety of human food products (e.g. meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels.

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.

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.

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

FDA Issues Five More Warning Letters to Marketers of CBD-Containing Products

It has been a tough week for cannabidiol (CBD) products.

In a December 22 post, we discussed the Federal Trade Commission’s first legal action taken against marketers of deceptively marketed CBD products. Later that day, the Food and Drug Administration (FDA) issued its latest round of warning letters to companies marketing unapproved CBD products that claim to treat medical conditions.

FDA continues to take a risk-based enforcement strategy with respect to CBD products. The products that were the subject of the most recent warning letters were particularly troubling from a public health perspective not only because of their impermissible health claims, but also due to their routes of administration, including nasal (e.g., nasal sprays), ophthalmic (e.g., eye drops), and inhalation (e.g., inhalers and vapor products).[1]

Many of the CBD products cited by FDA in this latest group of five warning letters were marketed with claims that rendered the products unapproved new drugs, such as:

  • “May reduce acne. CBD has anti-inflammatory properties that may have a beneficial effect on acne.”
  • “Applications of CBD as an anti-inflammatory, anti-bacterial, neuroprotective and vasodilator compound are well researched and documented”
  • “Pain . . . Several studies have shown a significant decrease in joint pain and chronic pain for users of CBD”
  • “VISION+CBD Eye DROPS . . . Also assists in combating ocular degeneration or inflammatory conditions such as (but not limited to) #glaucoma, #cataracts, #floaters, and diabetic #retinopathy. #HempCBD #CBDeyeDrops #EyeHealth”
  • “Cannabidiol in Anxiety and Sleep: . . . Cannabidiol may hold benefits for anxiety-related disorders”

The warning letters point out that the cited products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body of humans or animals. The letters then observe that because the products are not generally recognized as safe and effective for their intended uses, they are “new drugs” under section 201(p) of the FFDCA. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior FDA approval unless they are over-the-counter (OTC) drugs lawfully marketed under section 505G of the FFDCA (which is not the case for these products). In its press release announcing the warning letters,[2] FDA further points out that it is unknown whether the cited products “are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products[,] whether they have dangerous side effects or other safety concerns . . . or what the manufacturing conditions of, or contaminant levels in these products may be.”

Notably, not all of the claims cited by FDA as indicative of a drug intended use reference CBD specifically. For example, FDA called out the following statements on the “Why Honey + CBD?” section of Bee Delightful’s website:[3]

  • “It contains antibacterial and antifungal properties. Did you know that raw honey naturally contains the antiseptic hydrogen peroxide? While it can kill unwanted bacteria and fungus, the effectiveness depends on the type of honey.”
  • “Phytonutrients, containing . . . antibacterial and antifungal properties . . . can also help protect us. The phytonutrients in raw honey have also shown to have . . . anticancer benefits.”

Thus, while any unauthorized drug claims present risk of FDA enforcement, the mere presence of CBD in a product may elicit even greater scrutiny from the FDA.

In other cases, marketers added CBD to various conventional food products (e.g., lollipops, gummies, chocolate, etc.).[4] In order for an ingredient to be included in a conventional food product, it must either be approved as a food additive or “generally recognized as safe” (GRAS). However, as FDA indicated, there is no food additive regulation authorizing the use of CBD and the Agency is not aware of any basis to conclude that CBD is GRAS. Consequently, FDA deemed the ingredient an unsafe food additive, rendering the products adulterated. Further, FDA alleged that it is a “prohibited act” to introduce CBD-containing foods into interstate commerce under section 301(ll) of the FFDCA.

FDA also asserted that a variety of products intended for animals – eye drops, cookie treats, tinctures, and pet shampoo – were unapproved new animal drugs.[5]

The allegations in these warning letters are similar to those that FDA has made in prior warning letters since at least 2017. FDA continues to be active in its monitoring and enforcement related to the growing CBD market, particularly where the products could present a meaningful risk of harm to the public. Nevertheless, in its press release announcing these warning letters, FDA purports to also be focused on “exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.”[6] It remains to be seen whether this week’s actions by the FTC and FDA against CBD products will make a dent in this rapidly proliferating marketplace – and it also remains to be seen whether enforcement practices might change under the incoming Biden Administration.

[1] Press Release, FDA Warns Companies Illegally Selling CBD Products (Dec. 22, 2020).

[2] Press Release, FDA Warns Companies Illegally Selling CBD Products (Dec. 22, 2020).

[3] Warning Letter to Bee Delightful (December 22, 2020).

[4] See Warning Letter to Bee Delightful (December 22, 2020); Warning Letter to NextL3vel Services Group, LLC dba This Stuff Is Good For You (December 22, 2020); Warning Letter to Wellness BioSciences Rx (December 22, 2020).

[5] See Warning Letter to G & L Wellness, LLC (December 22, 2020); Warning Letter to NextL3vel Services Group, LLC dba This Stuff Is Good For You (December 22, 2020).

[6] Press Release, FDA Warns Companies Illegally Selling CBD Products (Dec. 22, 2020).

By Stacy L. Ehrlich and Justine E. Lenehan It has been a tough week for cannabidiol (CBD) products. In a December 22 post, we discussed the Federal Trade