Product Review Engagement

CBD in tampons?

During a GMP inspection at this company’s facility in Bulgaria, FDA determined that CBD is a drug product that deems the tampons adulterated. This, along with some disease claims and other violations related to vaginal microbiome screening kit claims, led to a warning letter.

This is the ninth CBD (or delta 8) related warning letter in 2024 which is 47% less than last year, showing that CBD enforcement continued to plummet. As we know FDA is not a fan of CBD, especially when they feel it can be harmful.

• From warning letter. “FDA evaluated the regulatory decision form that you provided the investigator to support not needing a 510(k) for the CBD Coated … Tampons and found the assessment was inadequate because the CBD coating raises significant concerns regarding safety and effectiveness of the devices due to the potential for local and systemic exposure of CBD, potential adverse events (e.g., reproductive/developmental toxicity) associated with CBD, and potential effects due to the uncertainty of the potency and quality of the CBD (e.g., psychoactive effects from possible contaminants like Delta-9-tetrahydrocannabinol).”

Product reviews: Agencies like FDA are typically “hands off” with third party product reviews if they are non-curated, non-compensated, are truthful, and are not showcased. The exception is when a company engages with third party reviews that contain disease claims, as this is considered an endorsement and turns a product review into a marketing claim. Here’s an example from the warning letter where the company engaged with reviewed on its Trustpilot site. Claims in product reviews typically appear in warning letters when they appear on a company website, but I’ve not seen this cited when hosted on platforms like Trustpilot, which reinforces the “Don’t engage with product reviews when they are risky words” rule.

• From warning letter showing how the company engaged with a review. “Trustpilot Web Site: “We're really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.”

Complaints on Trustpilot not investigated. Product complaints and safety issues need to be adequately investigated. Typically, customer complaints are emailed or called into the company, and once the company is aware of potential issues, it is its obligation to investigate. Interestingly, in the example, FDA requires the company to investigate third-party reviews on the Trustpilot site since they engaged with these reviews. As I discussed above, engaging with third-party reviews is an endorsement and makes them marketing. In this example, it also shows FDA that the company is aware of the issues and triggers the investigation requirement. This is the first time I’ve seen FDA mention this for third party reviews and companies should take note. We can also extrapolate that the FDA will want companies engaging with customer complaints on social media to properly investigate the issues as well.

• From warning letter. “Complaints related to the addition of CBD to … Tampons that were listed in Trustpilot or third party systems were given responses by your firm, but not logged and evaluated appropriately in your complaint handling system. The complaints indicate CBD … Tampons may have an impact on the patients’ health (e.g. CBD drug interactions) that exceed the expected risks associated with regular (non-CBD) tampons.”

The company was also cited for selling a vaginal microbiome screening kit which FDA does not consider a general wellness kit. They determined this by reviewing the product’s claims like “Detect bacteria that cause vaginal infections like yeast infections” from their Amazon store, Trustpilot page, and website. I had never read the “General Wellness: Policy for Low Risk Devices” document before and it worth knowing about.

• From warning letter. “Your firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document “General Wellness: Policy for Low Risk Devices” at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices; and therefore, your device would need to be submitted for premarket review by the FDA.”

Read the full warning letter here.

This Warning Letter Wednesday post marks 52 weekly posts this year and over 150 since I started writing WLW. Thank you for all of your support! You are appreciated!

DATE ORIGINALLY POSTED: 1/1/25

 
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.