FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson's and Alzheimer's disease

FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

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U.S. Food and Drug Administration

Oct 22, 2019, 10:27 ET

SILVER SPRING, Md., Oct. 22, 2019 /PRNewswire/ -- Today, the U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson's and Alzheimer's disease, among other conditions or diseases.

"Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children," said Acting FDA Commissioner Ned Sharpless, M.D. "We've sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products."

As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through its online store and social media websites, to make unfounded claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.

Examples of the unsupported claims made by the company include:

"Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one."
"No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame."
"Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children."
"CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson's and Alzheimer's disease."
"[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It's often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk."

Additionally, under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products' labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecary's products are FDA-approved.

The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.

The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. 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.

The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products while maintaining the FDA's rigorous public health standards.

"The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. "We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence."

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may 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.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

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

For more information:

What You Need to Know (And What We're Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

FDA is Committed to Sound, Science-based Policy on CBD

FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Michael Felberbaum, 240-402-9548, [email protected]
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration