Tag: Epidiolex

CBD ALERT: Class Action Lawsuits Filed Against CBD Manufacturers

Posted on December 9, 2019 by - Government Affairs

By: Dae Y. Lee, Pharm.D., Esq., CPBS

Six class action lawsuits have been filed against cannabidiol (CBD) manufacturers immediately following the November 25, 2019 warning letters issued by the United States Food & Drug Administration (FDA). These warning letters were sent to 15 companies for selling products containing CBD. The FDA maintains that food and dietary supplements are not allowed, under the Food, Drug, and Cosmetic Act (FD&C Act), to contain any level of CBD. The FD&C Act makes it clear that any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than 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 Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy. The FDA has sent numerous warning letters to companies that sell CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases. However, the FDA has not launched a judicial action against a CBD manufacturer.

The class action lawsuits are identical to each other and each complaint mimics the FDA’s concerns over illegal sale of the CBD products. Four cases, DaSilva v. Infinite Product Co. LLC, Davis v. Green Roads of Florida, LLC, McCarthy v. Charlotte’s Web Holdings, Inc., and Colette v. CV Sciences, Inc., alleging that the manufacturers’ CBD products were mislabeled as dietary supplements. Two cases, McCarthy v. Elixinol, LLC, and Fausett v. KOI CBD, LLC, note that the defendants sold CBD products as dietary supplements as well as animal foods. KOI CBD, LLC is among the 15 companies that received the most recent FDA warning letters. Prior to these lawsuits, there have been several lawsuits that have been filed against CBD manufacturers including a shareholder class action lawsuit filed against Curaleaf Inc. when the company’s stock fell abruptly after it received a warning letter from the FDA.

The recent lawsuits suggest a new wave of litigation in the CBD industry given that the FD&C Act does not provide for a private right of action under which members of the public can commence a civil action to enforce the FD&C Act. The putative classes assert, instead of arguing that the use of CBD in products violates the FD&C Act, that the CBD products are mislabeled and falsely advertised under state consumer protection laws. More specifically, the plaintiffs allege that the defendants manufactured and sold CBD products in violation of California and Arizona state laws including, but not limited to, California’s Unfair Competition Law, False Advertising Law, and Consumer Legal Remedies Act, and Arizona’s Consumer Fraud Act.

Many future lawsuits are expected to focus on allegations of mislabeling, accusing the companies of falsely representing the CBD content of their products. The lawsuits will likely involve not only the manufacturers but also other stakeholders in the supply chain including extraction and remediation companies. CBD stakeholders should prepare for the possibility of litigation and actively seek to mitigate the risks of unwanted attention by FDA or civil lawsuits. It is likely that more issues will surface given the ever-evolving regulations in the CBD industry. Frier Levitt helps CBD companies and manufacturers navigate complex issues, including many services based on flat fees. Contact Frier Levitt today to speak to an attorney.

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

Posted on October 23, 2019 by - Government Affairs

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.