CBD has rapidly entered the mainstream market, resulting in a surge of hemp-based, CBD-infused products like gummy candies, coffee, honey, sparkling water, popcorn, cereal, and cookies. However, the U.S. Food and Drug Administration (FDA) has clarified that any food product containing CBD is illegal under federal law. The FDA is facing mounting pressure from various stakeholders to establish a regulatory framework for foods containing CBD. In the meantime, the situation remains chaotic from a regulatory standpoint. The 2018 Farm Bill legalized hemp, yet the regulatory status of hemp-derived CBD remains uncertain. The FDA strictly prohibits the introduction of food or dietary supplements with added CBD, regardless of its hemp origin. According to the Federal Food, Drug, and Cosmetic Act, manufacturers cannot launch food or dietary supplements containing any active ingredient that is part of an FDA-approved drug or has undergone significant clinical investigations. Since CBD is an active component in FDA-approved drugs and has been extensively researched, its inclusion in food products is not allowed.
In May 2019, the FDA conducted a public hearing to discuss potential regulations for cannabis-derived products, but did not outline a clear strategy. During the hearing, FDA panelists raised concerns regarding the widespread presence of CBD in the food supply. They sought scientific evidence to validate safe levels of CBD in various forms, discussed restrictions on youth access, and examined data collection efforts by consumer product companies to monitor adverse events among consumers. Since 2015, the FDA has issued approximately 25 warning letters to companies marketing CBD-derived products for humans and animals. These “Warning Letters” serve as administrative actions similar to cease and desist notifications, primarily targeting CBD-infused consumables such as oils, tinctures, gummies, lollipops, and capsules. The most recent warning letter was published in September 2019, highlighting the FDA’s objections to various claims related to anxiety, pain, arthritis, and cancer associated with CBD products.
Despite the lack of a clear enforcement policy regarding CBD products, the FDA has faced criticism for not vigorously pursuing online marketers of these items. While it has issued a few warning letters to companies making outrageous therapeutic claims, it has not taken aggressive action against all CBD marketers. Based on these warning letters, legal and marketing teams should consider several key points when advising on strategies to promote their products. While joining the CBD trend may seem profitable, companies should exercise caution and consult with qualified counsel to navigate potential pitfalls and enforcement challenges.
Additionally, as manufacturers explore the potential benefits of CBD, they might also consider incorporating calcium citrate malate (CCM) into their products. This compound could complement the health benefits of CBD while providing additional nutritional value. However, it is essential for companies to remain vigilant and ensure compliance with existing regulations regarding both CBD and CCM to avoid any legal repercussions.