Tag: cannabidiol products

The FDA and FTC issue Warning Letter to Florida CBD Company for Unsubstantiated Disease Claims and Marketing to Children

On October 10, 2019, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint warning letter to Florida-based Rooted Apothecary, LLC, for selling cannabidiol (CBD) products with unsubstantiated claims that the products treat or cure a variety of serious diseases and health conditions, including claims that the products treat certain conditions in infants. The warning letter reflects the FDA’s continuing concern over CBD products marketed for therapeutic or medical uses, and emphasizes the FDA’s concern over CBD products marketed for use by infants and/or children.

The FDA found various products marketed by Rooted Apothecary to be unapproved new drugs because the company’s website and its social media website included claims that the products are intended to diagnose, cure, mitigate, treat or prevent diseases including Parkinson’s, Alzheimer’s, depression, anxiety, PTSD, attention deficit/hyperactivity disorder (ADHD), cancer, and diabetes.

In addition, the FDA found that Rooted Apothecary unlawfully marketed certain CBD products as dietary supplements. As noted in previous warning letters, the FDA considers products containing CBD to be excluded from the definition of dietary supplements because CBD is the active ingredient in the FDA-approved drug Epidiolex, and CBD was not marketed as a dietary supplement or conventional food prior to the authorization of the clinical investigations of Epidiolex.

The FDA was particularly concerned that Rooted Apothecary markets certain CBD products to infants and children. For example, the company claimed that the “Teeth/TMJ – Essential Oil + CBD Infusion” product will “help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.” The “Ears – Essential Oil + CBD Infusion” product included the claim, “We formulated this for the entire family including our precious little ones.” Further, the company’s website included webpages with statements such as “CBD oil . . . seems like an attractive and safe option for children” and “children can use high amounts of CBD safely and without any risk.”

Regarding the warning letter, Acting FDA Commissioner Ned Sharpless, M.D., said, “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.” Dr. Sharpless added, “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.”

The FTC warned Rooted Apothecary that it is concerned that the company lacks the requisite “competent and reliable scientific evidence” to substantiate claims that its products can prevent, treat or cure human disease.

This latest warning letter from the FDA and FTC again highlights the potential pitfalls of marketing CBD products without a thorough understanding of the unsettled and complex regulatory environment for such products. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt today to speak with an attorney.

Federal Trade Commission Issues New Warning Letters for CBD Products

On September 10, 2019, the Federal Trade Commission (FTC) issued warning letters to three unidentified companies that sell cannabidiol (CBD) products with claims that the products treat or cure serious diseases or health conditions. The warning letters send a message to the CBD industry that any such claims must be supported by sound scientific data.  Specifically, FTC requires competent and reliable scientific evidence to support any claims that a product prevents, treats or cures a medical condition.

One company claimed that its CBD product relieves pain better than prescription opioid painkillers, and was “clinically proven” by “thousands of hours of research” to treat cancer, Alzheimer’s disease, multiple sclerosis, fibromyalgia and colitis.

A second company claimed that its CBD products are proven to treat a litany of serious diseases including autism, anorexia, schizophrenia, ALS, stroke, Parkinson’s disease, Crohn’s disease and AIDS.

The third company claimed its CBD gummies were highly effective in treating “the root cause of most major degenerative diseases, including arthritis, heart disease, fibromyalgia, cancer, asthma, and wide spectrum of autoimmune disorders” along with various other serious conditions.

FTC warned these companies that selling CBD products without competent and reliable scientific evidence substantiating their claims could violate the FTC Act and may result in legal action resulting in penalties including injunction and the return of money to consumers.

These warning letters echo the March 2019 warning letters sent jointly by FTC and the Food and Drug Administration warning companies against making disease claims without adequate substantiation.

This latest round of warning letters highlights the potential pitfalls of marketing CBD products without a thorough understanding of the unsettled and complex regulatory environment for such products. If you need assistance navigating the regulatory environment for CBD or other cannabis-derived products, contact Frier Levitt Government Affairs to speak with an attorney.