On Monday, the FDA issued Warning Letters to five companies that produce products with CBD (cannabidiol) and specifically zeroed in on products that would appeal to children. The FDA noted in some of the letters that it was concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children.
11-11-11 Brands, Naturally Infused LLC, Newhere Inc., Infusionz LLC, and CBD American Shaman LLC were all issued letters.
The letters from the FDA stated, “There is no food additive regulation which authorizes the use of CBD. We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS (generally recognized as safe) status.”
U.S. Hemp Roundtable General Counsel, Jonathan Miller, told Food-NavigatorUSA: “It’s become ever more apparent that Congress needs to act expeditiously to require FDA to establish a regulatory pathway to govern food and beverage products where CBD is an additive.” The Hemp Roundtable issued a statement saying, “This recent action by the FDA indicates the agency’s lack of urgency and reluctance to regulate CBD products, making it clear that Congress must act on behalf of our industry.”
Lollipops & Gummies
Naturally Infused was cited for its candy and coffee products. Its letter said, “For example, your CBD Lollipops, CBD Gummies, and Delta-8 THC Gummies are in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, you market other products that consumers may confuse with traditional foods for humans, including CBD Infused Sugar and CBD and Delta-8 THC Infused coffees. Therefore, there is a risk that consumers of these products, including children, will unintentionally consume CBD or Delta-8 THC ingredients. Additionally, we note that the CBD coffee products appear to contain caffeine. Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.”
Newhere was also cited for its products having an appeal to children. That letter stated, “FDA is particularly concerned that some of your products are in forms that are appealing to children. For example, your CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children.” Newhere was also called out for making medical claims about its CBD products on its websites and in blog posts.
Infusionz was also called out for its CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products. Its letter said, “The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.”
CBD American Shaman’s letter also stated, “Your CBD Suckers, CBD Hard Candies, various Cookies [with] 10mg CBD per Serving, and various CBD Gummies products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, your products have not been evaluated by the Agency for safety, effectiveness, and quality.”
11-11 Brands wasn’t cited for having products that appealed to children, however, the FDA had determined that the company’s Mood33 Hemp Infused Herbal Tea products were “adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your Mood33 Hemp Infused Herbal Tea products into interstate commerce under sections 301(ll) and 301(a) of the FD&C Act, 21 U.S.C. 331(ll) and 331(a).” FDA was particularly concerned that the products are in a form (herbal tea or beverage) that consumers may confuse with traditional foods.
The Hemp Roundtable noted that there are currently two bills that would empower the FDA to regulate CBD as a food and beverage. H.R. 6134 would ensure foods and beverages containing CBD derived from hemp conform with the current FDA requirements for food additives or be generally recognized as safe “GRAS,” while S. 1698 permits hemp-derived CBD in both dietary supplements and foods.
Hemp food products that don’t advertise CBD content have been on the shelves for years. The Hemp Food Association recently wrote, “Hempseed, hempseed oil, and hemp protein powder are Generally Recognized As Safe (GRAS) to the U.S. FDA, exempt from Novel Food registration in the European Union, and hemp products, in general, are exempt from the U.N. Single Convention Treaty on Drugs. They need no further approvals or certifications from any government in the U.S., Canada, or E.U. In other words… legal!” However, when CBD gets pulled into the mix that’s when the FDA steps in with its warning letters.