June 19, 2024

FDA Warns Companies Illegally Selling Foods Containing CBD

The FDA is warning five companies that are illegally selling foods containing CBD, a compound in marijuana. The FDA has not determined the safe dosage, especially for children and pregnant women.

FDA Warns Companies Illegally Selling Foods Containing CBD

The warning letters were sent to these companies:

11-11-11 Brands

Naturally Infused LLC

Newhere Inc dba CBDFX

Infusionz LLC

CBD American Shaman, LLC

The FDA says that these companies are selling CBD-containing products that consumers may think are traditional, which may result in unintentional consumption of overconsumption. Some of these products are appealing to children, including hard candies, cookies, and gummies.

One drug containing CBD has been approved by the FDA; it is used to treat certain severe seizures disorders. The drug, Epidiolex, has benefits that outweigh the risks for the intended population, when prescribed under close medical supervision.

The long term use of CBD may have serious health consequences, including possible harm to the male reproductive system, harm to the liver, and interactions with some medications. Other side effects can include changes in alertness. There is not enough information about how much CBD can be consumed, and for how long, before harmful health effects may manifest.

All ingredients used in food must be shown to be safe, with a “reasonable certainty” that the intended use will not cause harm. This standard considers different kinds of consumers, including pregnant women, children, the elderly, and people with health  problems. And using a compound in food makes it difficult for people to control how much they are consuming.

The warning letters also contain additional violations of the Food, Drug, and Cosmetics Act. Several of the companies are allegedly illegally selling unapproved CBD products that claim to cure, mitigate, treat, or prevent diseases. The companies are also allegedly adding CBD to animal foods.


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