FDA concerned people mistakenly believe CBD 'can't hurt' them

Andrew Cummings
November 27, 2019

CBD may be easy to shop for these days, but the FDA is reminding consumers that these products are still heavily unregulated, making it hard to pinpoint exactly how they affect the human body. FDA repeats its long-standing position that CBD is not eligible to be used as an ingredient in conventional foods and dietary supplements, although the letters invite companies to submit evidence to rebut this conclusion.

Cannabidiol, or CBD - a component of cannabis that does not contain intoxicating properties - has the potential to harm users, the Food and Drug Administration (FDA) warned Monday in an updated consumer advisory. There is significant interest in CBD and we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.

FDA stated: "The FDA is concerned that people may mistakenly believe that trying CBD 'can't hurt.' The agency wants to be clear that we have seen only limited data about CBD's safety and these data point to real risks that need to be considered".

Beyond the warnings, the FDA said that there were many aspects about CBD that remain unknown, such as the effects of taking CBD daily for extended periods, on the developing brain or how it interacts with herbs and botanicals. The FDA said in its consumer update that the benefits outweighed the risks in that particular case.

Under the FD&C Act, any product meant to treat a disease, has a therapeutic or medicinal use or intends to affect the structure or function of a human or animal body is a drug, the FDA reiterated. The agency lays out possible risks of using CBD, such as liver injury, drug interactions and possibly even negative effects on male reproductive health.

"It could be that this FDA thing causes the chains to either cut back or discontinue their CBD businesses", Horvath said in a phone interview Tuesday.

"Today's actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed", the statement continued. The FDA said it has tested the chemical content of CBD in some products and found "many" did not contain the amount of CBD they said they did. FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions, but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode. The agency noted its efforts so far to gather information about CBD, including the FDA an open meeting held on May 31 of this year and comments it recently collected via public docket. If taken without medical supervision, the damage could prove more extensive, the FDA said in a consumer update on cannabis-derived compounds. It is worth noting the CBD prescription drug Epidiolex uses daily doses that could be as high as 1,500 mg; many supplement products in the market provide suggested daily doses of 50 mg/day or less.

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.

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