FDA & FTC Crackdown on Products Marketed For Opioid Withdrawal

FDA and FTC crackdown on products marketed for opioid withdrawal.

The FDA and FTC recently sent five joint warning letters to companies marketing products for opioid withdrawal. Joint FDA/FTC warning letters are rare and a good signal for the industry to pay attention. These are not just warning letters but also include cease and desist demands requiring the companies to stop making unsubstantiated claims or face injunction, civil penalties of up to $46,517 per violation, and requirements to refund customers. This is very serious!

Here are some key takeaways.

🔷Products marketed for opioid and substance withdrawals remain high risk. Those suffering from addiction are considered a “vulnerable population” and are top of mind for the FDA/FTC. Other vulnerable populations are the elderly, children, and those with mental illness. This is not a new trend, as opioid-related warning letters go back several years. Now is a great time to ensure these high-risk statements are not inadvertently lurking on a company website or social. The FDA is looking at several-year-old blogs and social media posts in the same manner as current ones. I developed a program to find any website keyword. Please get in touch with me for a free keyword compliance check.

🔷Other high-risk words such as depression and diabetes are mentioned in some of the letters. This should come as no surprise. Here is my blog from last year about depression claims. 

Here is my post about blood sugar claims enforcement. 

🔷Claims made in blogs are prevalent in these letters. Here are my “best practices for reducing risks in blogs” post. 

🔷Product reviews are also called out.

From a warning letter: “From a review on your webpage …“Its [sic] been great to give up the opioids and feel good.”

Four of the warning letters are directed toward kratom companies, and one is to an essential oil company. It is interesting to see what keywords and themes are common in these letters. Contact me for a deeper discussion on this.

From a warning letter: “EUCALYPTUS OIL . . . The oil produces a stimulating effect on the body and mind. This aids in reducing the lethargy that may be experienced during opiate withdrawal.”

Read the FDA roundup about this here.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.