5 firms obtain CBD warning letters

WASHINGTON — The US Food and Drug Administration sent warning letters dated Nov. 16 to five companies, saying they were illegally selling products containing cannabidiol (CBD).

Consumers may confuse the products for traditional foods or beverages, which may cause them to overconsume CBD, according to the FDA. Some of the products were in forms like gummies, hard candies and cookies that may appeal to children, which the FDA found concerning.

The five companies were 11-11-11 Brands, Naturally Infused LLC, Newhere Inc. doing business as CBDFX, Infusionz LLC and CBD American Shaman, LLC. The FDA requested responses from the companies within 15 working days.

Scientific studies have shown CBD, which may be extracted from hemp and marijuana, possibly may harm the male reproductive system, harm the liver and interact with certain medications, according to the FDA. The agency has not found adequate information showing how much CBD may be consumed, and for how long, before causing harm. The FDA also does not allow CBD in foods, beverages or dietary supplements because it is the active ingredient in Epidiolex, a drug approved by the FDA.

The FDA determined CBD American Shaman, Kansas City, sold suckers, hard candies, cookies, sparkling tea, sparkling water, honey and honey sticks that contained CBD. The company also sold CBD-containing pet treats such as doggy chews, “horsey” chews, doggy nugs and kitty nugs. A sunscreen with CBD and zinc oxide was cited as well.

Infusionz, Henderson, Nev., according to the FDA, sold CBD-containing gummies, fruit snacks, gum, candy, oil/tinctures and lollipops. Naturally Infused, New Port Richey, Fla., sold lollipops, sugar, gummies and coffee with CBD, according to the FDA, as well as coffee and gummies containing Delta-8 THC (tetrahydrocannabinol). The FDA has neither evaluated nor approved Delta-8 THC products for safe use.

Newhere Inc., Chatsworth, Calif., was called out for selling flavored shots, mixed berry gummies and cookies that contained CBD. Products for pets that contained CBD included dog tinctures, cat tinctures, pet treats for stress and anxiety, pet treats for joint health and mobility, and balms for calming and moisturizing pets.

11-11-11 Brands, Newtown, Pa., was cited for selling Mood33 hemp-infused herbal tea products with CBD. Some of the tea varieties also appeared to contain caffeine. Evidence suggests CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects, according to the FDA.