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FDA warnings for companies selling CBD for pain

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The FDA is yet to authorise any over-the-counter CBD products

The US Food and Drug Administration (FDA) has issued warnings to companies selling over the counter CBD products for back pain.

The FDA has issued warning letters to two companies for selling products labeled as containing CBD, in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In a statement, the FDA said the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD.

The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products are said to meet the requirements to be legally marketed without an approved new drug application. 

The letters explain that, as CBD has “known pharmacological effects on humans”, with “demonstrated risks”, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. 

Additionally, the letters cite a failure to comply with current good manufacturing practices.

The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.

“It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects.

“We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety.

“Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritising those that pose a risk to public health.”

The FDA issued warning letters to Honest Globe Inc and Biolyte Laboratories LL for products that have not gone through the FDA drug approval process and are considered unapproved new drugs. 

There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns.

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. 

OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD.

Only one prescription drug containing CBD, for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients, has been approved by the FDA.

Sarah Sinclair is a respected cannabis journalist writing on subjects related to science, medicine, research, health and wellness. She is managing editor of Cannabis Health, the UK’s leading title covering medical cannabis and CBD, and sister titles, Cannabis Wealth and Psychedelic Health. Sarah has an NCTJ journalism qualification and an MA in Journalism from the University of Sunderland. Sarah has over six years experience working on newspapers, magazines and digital-first titles, the last two of which have been in the cannabis sector. She has also completed training through the Medical Cannabis Clinicians Society securing a certificate in Medical Cannabis Explained. She is a member of PLEA’s (Patient-Led Engagement for Access) advisory board, has hosted several webinars on cannabis and women's health and has moderated at industry events such as Cannabis Europa. Sarah Sinclair is the editor of Cannabis Health. Got a story? Email sarah@handwmedia.co.uk / Follow us on Twitter: @CannabisHNews / Instagram: @cannabishealthmag

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