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February 1, 2023 By: Asa Waldstein

FDA Crackdown on Monkeypox Claims

Takeaway -

Learning from other’s mistakes is a good strategy

FDA sent five warning letters this week to companies selling products for Monkeypox. This is a clear violation, but there are some critical learning lessons here.

Sign up for the weekly Warning Letter Wednesday post here.

One company is a wallpaper website with a few herbal tinctures containing uncompliant product descriptions. They probably just posted whatever content the tincture company provided, which shows that companies distributing supplements are on the hook for claims made on their platforms. Find my video and post about the distributors Amazon and Walmart here.

Implied claims are marketing claims. In this blog post titled “What is Monkeypox,” the company says the product may help Monkeypox and then states, “we don’t know enough to be sure.” Suggestive words and phrases do not protect companies from implying their product will help diseases.

From warning letter: “What Can I Do To Protect My Family From Monkeypox?… products like Vitamin A, Vitamin D, Zinc, Mother’s Immunity, and Immunity Boost [each of these product names links to your page selling the product] . . . help to prevent viral infections in general and *MAY* help prevent Monkeypox (we simply do not know enough to say for sure if they will offer protection).”

This company needs a lot of compliance help. I found 161 occurrences of “depression” and 2930 references to “infection” on their website. I offer website and social compliance cleanup services. Let’s talk about how I can help you avoid a warning letter.

Another company has DSHEA disclaimers all over their disease-containing posts. This is not a “get out of warning letter jail free” card that allows companies to say whatever they want. The dietary supplement industry is nuanced and requires knowledge and care when marketing supplements. This is why I always suggest hiring dietary supplement experts to help grow your company. I write in detail 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.

Written by

Asa Waldstein
Asa Waldstein
Asa Waldstein is a 24-year veteran of the dietary supplement industry, with experience spanning manufacturing, marketing, and regulatory compliance. He is the principal of Apex Compliance, a software company dedicated to streamlining regulatory marketing compliance for the dietary supplement and natural products sectors. Asa also leads Supplement Advisory Group, a boutique consultancy focused on marketing risk analysis, labeling, and practical compliance strategies for websites and social media. Asa has helped oversee three FDA GMP inspections with no 483s and was honored with the 2023 AHPA Herbal Hero Award and the 2024 What's Up Supps Policy and Change Agent Award. He currently serves as Chair of the American Herbal Products Association’s (AHPA) Cannabis Committee, helping shape policy and industry best practices