FDA warns about lack of research, possible risks of CBD

Courtesy Lab to Beauty

Courtesy Lab to Beauty

FDA has the opportunity to receive meaningful safety data in the context of new dietary ingredient notifications and GRAS submissions from responsible companies in the industry.

The agency stated that there is no FDA evaluation of whether these products are effective for their intended use, guidance on proper dosage, how they may interact with FDA-approved drugs, side effects or other safety concerns or manufacturing practices.

Some reports have uncovered contaminants "such as pesticides and heavy metals" in CBD products, the FDA said. It's time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements. "In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate", said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.

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The agency sent warnings to 15 companies in the USA for illegally making specific medical treatment claims for people and animals.

The FD&C Act requires any product meant to treat a disease or otherwise have a therapeutic or medical use, and any product other than food that is meant to affect the structure or function of the body of humans/animals is a drug to be subject to the FDA approval process; now the FDA still has not approved any CBD products other than one prescription human drug to treat a severe and rare form of epilepsy. It also said, flat out, that it could not conclude that CBD could be "generally recognized as safe" for use in food for humans or animals.

"We're here to just be able to help educate and to help people at the end of the day and we really want to see people be able improve their quality of life and CBD may help in doing that", said Kropp. Consumer use of any CBD products should always be discussed with a healthcare provider. It went on to say that since there wasn't enough scientific information in its eyes, the FDA couldn't recognize CBD as being completely safe and that CBD could even be harmful under certain circumstances (such as impure/contaminated products, etc).

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One CBD company, CV Sciences (San Diego), applauded FDA's recent set of warning letters. The agency encouraged consumers to speak with health care professionals about how to treat diseases and conditions with existing drugs, and to be wary of "unsubstantiated claims" associated with CBD products. "These companies put consumers at risk, while giving responsible companies within the industry a black eye". The FDA said in its consumer update that the benefits outweighed the risks in that particular case. These responsible companies have been unfairly maligned by FDA's overbroad warnings on safety, and ironically, are actually deterred from sharing the safety data they have with the agency. "There are more direct ways for the FDA to address bad actors while still working with responsible companies to establish the appropriate scope of hemp-derived ingredients for supplements based on sound research".

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