The Food and Drug Administration (FDA) has issued a new set of warning letters to companies for illegally selling food and beverage products that contain cannabidiol (CBD). These warning letters focus on CBD products that consumers may confuse for traditional foods or beverages, resulting in unintentional consumption or overconsumption of CBD.
The 2018 Farm Bill legalized the production of hemp and products derived from hemp, such as CBD. However, the CBD industry remains subject to federal regulation. The FDA and the Federal Trade Commission (FTC) have joint enforcement authority over the marketing of CBD, while the FDA has primary authority over the labeling.
Both the FDA and the FTC have issued warning letters to CBD companies regarding the marketing of their products. The FDA and the FTC issued the first set of warning letters to CBD companies in April 2019, and they have issued many warning letters since then. Previous FDA and FTC warning letters have focused on companies marketing their products as treatments for a variety of diseases and illnesses. The letters have warned companies that it is illegal to advertise that a product can prevent, treat, or cure human disease without competent and reliable scientific evidence to support such claims.
The new set of FDA warning letters has a different focus: consumer confusion resulting in unintentional consumption or overconsumption of CBD, potential health risks from long-term CBD use, and CBD products that are appealing to children. These warning letters were sent to five companies.
Under current FDA policy, it is unlawful to market CBD in foods, beverages, and dietary supplements. In its press release announcing the new warning letters, the FDA stated that the use of CBD raises safety concerns, especially with long-term use. The FDA said that scientific studies demonstrate possible harm to the male reproductive system, including testicular atrophy; harm to the liver; and interactions with certain medications. For example, in a Q&A the FDA said: “Studies suggest CBD may increase and/or prolong caffeine’s effects, which could be a problem for people who are sensitive to caffeine.” What the FDA is Doing to Protect Consumers from Cannabidiol (CBD) in Foods | FDA
The FDA stated that it “has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.”
The products cited in the warning letters include gummies, hard candies, fruit snacks, tinctures, cookies, sparkling water, beverage shots, honey, gum, and coffees, teas and other beverages. The FDA said that these products were selected because “people may confuse [them] for traditional foods or beverages which may result in unintentional or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.”
The warning letters also discussed additional violations of the Food, Drug, and Cosmetic Act, including that several of the companies are illegally selling CBD products that claim to cure, mitigate, treat or prevent various diseases and are illegally adding CBD to animal foods, such as pet treats. The FDA critiqued one company because the labels on its herb-infused tea products did not specifically list CBD as an ingredient.
Although most of the products cited in the warning letters are foods and beverages, other products are also cited. One warning letter cited a “CBD + ZINC OXIDE Sunscreen” which claimed, “This all natural CBD sunscreen lotion is a natural way to protect yourself from harmful UV rays while using an all-natural product that won’t harm you or the planet!” The FDA stated that CBD is not an approved ingredient in sunscreens, and therefore the use of CBD in the product makes it an unapproved new drug and misbranded.
In addition, the FDA tested the chemical content of CBD in some of the products, and some were found to not contain the levels of CBD they claimed to contain.
Why It Matters
The new FDA warning letters are broader than previous warning letters regarding CBD products. The previous letters focused on claims that CBD could treat or cure diseases and illnesses. These letters focus not only on those claims but also on CBD products that are traditional foods and beverages and may cause consumer confusion, which may result in unintentional consumption or overconsumption of CBD and consumption by children.
The FDA requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. The FDA stated, “Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.”
Addressing its policy regarding CBD, the FDA stated: “We know that there’s a great public interest in CBD products, even though CBD cannot lawfully be added to foods or dietary supplements…. While we continue exploring policy solutions to address the large, violative market of CBD products, we will continue to monitor the marketplace and take action, as needed, against companies that pose the greatest risk of harm to the public.”