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Merchants Who Market CBD with Health Claims Face Regulatory Scrutiny

Post Categories: Blog, CBD
cbd merchant

The FDA appears to be taking a three-pronged approach towards regulating CBD merchants. The agency is: (1) investigating the safety and effectiveness of CBD; (2) examining potential regulatory pathways for the lawful marketing of CBD products; and (3) actively cracking down on CBD products that are marketed with impermissible claims to treat health conditions.

 

The FDA recently issued a warning letter to a company that markets CBD products – including topicals, patches, vapes, and animal ingestibles – with claims to treat pain, depression, cancer, Alzheimer’s disease, opioid withdrawal, and pet anxiety. In a press release announcing the FDA’s latest action, Dr. Ned Sharpless, the acting FDA commissioner, made clear that the agency will not tolerate CBD products marketed with problematic claims:

 

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care.”

 

What types of claims are problematic?

With extremely limited exceptions, only FDA-authorized drugs may be marketed with claims to diagnose, cure, mitigate, treat, or prevent disease. “Disease claims” can be express (e.g., “treats cancer” or “prevents Alzheimer’s”) or implied (“relieves bronchospasm”). If a CBD product (that has not been approved as a drug by the FDA) is marketed with disease claims, it will be considered an “unapproved drug” by the FDA and will be subject to regulatory scrutiny.

 

With respect to CBD, the FDA has found many claims problematic, including the following:

  • “[F]or chronic pain.”
  • “CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.”
  • “Researchers suggest that it may be effective for panic disorder, obsessive-compulsive disorder, and post-traumatic stress disorder”
  • “Due to its anti-inflammatory effect, cannabinoids may provide relief of joint pain and swelling, and decrease joint destruction and disease progression.”
  • “CBD can be effective as a treatment in and of itself, or in combination with other treatments.”
  • “…CBD provides a safe, long term option for those suffering from skin disorders.”
  • “Directions…Rub into temples to help with headaches, and chest to relieve cold and flu.”
  • “Natural cannabinoids, such as CBD (cannabidiol), have been shown in research to have therapeutic possibilities in helping diabetes.”

 

Can a merchant make claims on social media?

Definitely not! In its most recent CBD-related warning letter, the FDA flagged claims found on the company’s website – but it also cited the following impermissible claims found on the company’s Twitter and Facebook pages:

  • “CBD [c]an be a powerful ally if you’re suffering from chronic inflammation and pain.”
  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
  • “The top five research-backed benefits of CBD include: 1) neuro[de]generative disease 2) depression and anxiety treatment 3) pain treatment 4) aids in the treatment of cancer and related symptoms to cancer . . ..”
  • “#ICBD to help lower anxiety.”

 

G2 helps its clients mitigate risk associated with CBD, while taking advantage of this growing market. To stay up-to-date on all-things-CBD, register for G2’s CBD News and Updates.

 

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