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FDA Issues Warning Claiming CBD has the Potential to Harm

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On Nov 25 the U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies for illegally selling products containing CBD, and warned consumers about the “potential harm from CBD.” According to the FDA, the 15 companies violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) by claiming that their products had healing benefits.

The reasons for the warning letters were products that Warning letters were sent to Koi CBD LLC, Pink Collections Inc.Noli OilNatural Native LLCWhole Leaf Organics LLCInfinite Product Company LLLPApex Hemp Oil LLC, Bella Rose Labs, Sunflora Inc.Healthy Hemp Strategies LLC, doing business as CurapurePrivate I Salon LLC, Organix Industries Inc., doing business as Plant OrganixRed Pill Medical Inc.Sabai Ventures Ltd., and Daddy Burt LLC.

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,’” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety—including reports of products containing contaminants, such as pesticides and heavy metals—and there are real risks that need to be considered.”

Warning letters were sent to multiple companies for similar violations in the past. The FDA also posted a revised Consumer Update that outline specific safety concerns surrounding CBD products such as potential liver injury, interactions with other drugs, drowsiness, diarrhea and changes in mood.

The FDA also requested responses from the companies within 15 business days stating how the companies plan on correcting the violations. Failure to correct the violations could result in legal action, including product seizure or an injunction.

 

 

 

 

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