The warning letters were sent to two companies marketing CBD products that were deemed to be making impermissible pain relief clams. The twist is that the two companies manufacture OTC products, though one of them also manufactures nutritional products for pets.
“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, MD, PhD. “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 — prioritizing those that pose a risk to public health.”
Companies find different ways to say ‘pain relief’
The two companies, Biolyte Laboratories, Inc. and Honest Globe, Inc., are among the many companies selling CBD/hemp products in an OTC guise. Indications seem to be that more companies selling these kinds of products choose to position themselves as quasi dietary supplement manufacturers, but in either case it’s a matter of emphasis, at least as far as the products on the shelves are concerned. Some of these are sold with ‘Drug Facts’ panels, while others have their ingredients listed on the labels as ‘Product Information’ or ‘Additional Information.’
Companies marketing CBD/hemp products in an OTC fashion are more likely to be making overt pain relief claims than are those flying the supplement flag, but the aims of the products seem to be similar. How different is a statement in a testimonial that a topical CBD product made by one of the ‘supplement’ manufacturers that says, “really saves my neck and shoulders” from one of the OTC firms that says, “relieves muscle soreness”?
Clinical trial evidence accumulates
The evidence for the use of CBD in pain relief is accumulating. A study published last year by German researchers found that the molecule may have some activity against specific types of inflammation in rheumatoid arthritis.
“CBD might be beneficial as an adjuvant treatment in rheumatoid arthritis that might support the action of currently used disease-modifying anti-rheumatic drugs,” the authors wrote.
And a review in 2018 found that cannabinoids such as CBD show promise for chronic pain management and that most people tolerate them well. Other studies corroborate these findings.
While that may be, many mainstream health professionals, who cite the lack of full blown, pharmaceutical-style trials, remain unconvinced. They also cite the evidence that products on the market vary widely in quality, making it difficult to know for sure what patients are getting.
NFL seeks info on use of CBD for pain relief
Nevertheless, the evidence that the products may have some benefits is seen as strong enough that several weeks ago the National Football League and the NFLPA (National Football League Players Association) issued the formal request for information (RFI) on the use of CBD to alleviate players' chronic pain.
“The NFL-NFLPA is working to improve player health through evidence-based treatment of acute and chronic pain, and to facilitate research to better understand and improve potential alternative treatments,” the groups’ formal statement says.
Marketing consultant and natural products industry veteran Steve Hoffman, who has worked on a number of CBD/hemp issues, said the information request is a sign of the times.
“It is a sign of the relaxing attitudes regarding restrictive laws and policies regarding cannabis and CBD that have been obstacles to research regarding the medicinal benefits and potential of cannabis and CBD, compared to opioids to treat pain, which can often lead to addiction and adverse health effects from overuse,” Hoffman said.