Tag Archives: CBD

FDA Issues Warning Letters To 15 Companies Selling CBD Products

This week, FDA issued warning letters to 15 companies for selling products containing cannabidiol (CBD) in violation of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). The covered products include pet products, topicals, dietary supplements, and conventional foods (including peanut butter, water and gummies).

As we have written about [here], 2019 has seen a flurry of enforcement actions against companies marketing CBD-containing products. In this latest batch of warning letters, FDA alleges that these companies marketed CBD products in ways that violate the FD&C Act by making claims that CBD products could prevent or cure diseases in humans and/or animals, and marketing CBD products as a dietary supplement or a food additive. Significantly, this is the first time FDA has clearly stated that CBD cannot be in a dietary supplement because it is a drug.

In surveying these companies’ websites and social media, FDA cited claims such as:

  • CBD product has “anti-inflammatory” properties” and can be “applied topically for temporary relief to treat pain and discomfort from arthritis, muscle strain, bruises, sprains, joint aches and backaches”.
  • “CBD lowers incidence of diabetes”
  • “Little known uses for CBD – CBD for opioid addiction”
  • “Our treats and oil can help your dog and cat with anxiety, skin conditions, arthritis, and more”
  • “What Does Conditions May CBD Be Effective For? [sic] IBS; Migraine headaches; Seizure disorders; MRSA; Cancer; Depression; PTSD; Autism; Parkinson’s; Alzheimer’s”

Some of the products cited by FDA are specifically marketed for infants and children and one product is intended for food-producing animals. These warning letters indicate that FDA remains concerned about products marketed for vulnerable populations, like infants and children, that may be at greater risk for adverse reactions, and that FDA continues to be focused on the safety of human food products.

Earlier this week, FDA also published a Consumer Update detailing its underlying safety concerns about CBD, stating that “CBD has the potential to harm you, and harm can happen even before you become aware of it.” Further, based on the lack of scientific information supporting the safety of CBD, FDA has indicated that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.  This is significant because without the GRAS designation, CBD would need to be the subject of an approved food additive regulation before it could legally be used in human or animal food.

These warning letters signal that FDA may be taking a more aggressive approach with increased scrutiny of CBD products.  Our food and dietary supplement lawyers regularly advise clients on the status of CBD in FDA-regulated products. If you have any questions about this Alert, or are considering marketing or selling CBD products, contact our Food and Dietary Supplement regulatory team. 

Share Button

Recent FDA Warning Letter Valuable Reminder To CBD Industry – Don’t Ignore Basic Regulatory Compliance

Following similar announcements by CVS and Walgreens, Kroger became the latest retailer to join the CBD craze when it announced plans to sell CBD-infused products. Sales of products containing CBD are expected to top $5 billion this year, a 700% increase from 2018, and could reach nearly $24 billion in sales by 2023, according to analysts. However, a recent warning letter from the FDA contains important reminders for the industry.

Although hemp-derived cannabidiol (CBD) was de-criminalized by the federal government in the 2018 Farm Bill, the Bill did not affect FDA or the States’ authority to regulate CBD or other cannabis or hemp products in FDA-regulated products. To date, the FDA has not approved CBD in food or drinks for humans or animals, dietary supplements or topical cosmetics and maintains its current position that it is illegal to sell a food or dietary supplement that contains added CBD in interstate commerce. Historically, however, the FDA has generally taken a passive approach to the enforcement of hemp-derived CBD products.

On July 22, 2019, FDA issued a warning letter to one of the largest producers of CBD-based products, Curaleaf, Inc. The FDA reiterated that certain hemp substances, including CBD, have a questionable regulatory and safety status in the eyes of FDA and some state governments despite the 2018 Farm Bill. But the more likely trigger for the action was the marketing claims that were associated with Curaleaf’s products.

The FDA surveyed Curaleaf’s website and social media pages, and found claims like:
• “[S]oothing tincture for chronic pain.”
• “CBD has been demonstrated to have properties that counteract the growth of spread of cancer.”
• “CBD has also been shown to be effective in treating Parkinson’s disease.”
• “CBD oil can be used in a variety of ways to help with chronic anxiety.”
• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

These are clear drug claims related to treating or preventing diseases, and FDA concluded that the products were misbranded and unapproved new drugs.

In response to the warning letter, the company stated that it’s removing statements from its website and social media that FDA identified as noncompliant. Also of note, following the warning letter, CVS immediately removed all Curaleaf products from its shelves, and Curaleaf’s stock tumbled.

The bottom line is that fundamental regulatory compliance matters. The full list of Curaleaf’s claims reinforce best practices for drafting and substantiating claims appearing on any food or dietary supplement labels (not just those containing CBD). And if the claim is on a product that is already under scrutiny for regulatory discretion, then compliance is especially important.

In addition to regulatory enforcement action, publicly issued warning letters may also lead to class action lawsuits based on a claim that statements are false and misleading and actionable under state consumer protection laws. While the statute the FDA is tasked with implementing (the Federal Food, Drug, and Cosmetic Act) does not include a private right of action, litigants and courts often use FDA warning letters for guidance as to whether a marketing claim is, or is not, susceptible to challenge under various consumer protection laws.

It is crucial for companies that market or sell CBD products to confirm that their marketing materials and labeling generally comply with FDA requirements and avoid making unapproved human or animal drug claims. If you currently market or are considering marketing CBD products, contact our Food and Dietary Supplement regulatory team to guide you through state and federal labeling and advertising requirements.

Share Button