Small Herbal Company in Big Trouble for Disease Claims

This is yet another example of a well-intentioned herbalist-owned, very small company being cited for disease claims. I write about how no company is “too small to be off FDA radar” here.

This company is a farm that makes small-batch products, but unfortunately, they don’t seem to know the rules of dietary supplement marketing. All the claims cited in the FDA warning letter have been removed, but there is still a cancer treatment herbal kit for sale on their website. Unfortunately, the basics of DSHEA and marketing compliance are not taught in herb and acupuncture schools. One of my missions is to educate these communities about the basics of the dos and don’ts of supplement marketing. Here is my speaking schedule; please let me know if I can extend free education to your school.

Also interesting in this warning letter is the second mention of “brain fog” in FDA letters. Do you consider this to be a disease claim? According to HHS, brain fog can be a symptom of long-haul Covid, a recognized disability under the Americans for Disabilities Act (ADA). My take is brain fog related to Covid symptoms is undoubtedly a disease claim, but brain fog not related to Covid isn't high risk. I feel “occasional brain fog” from time to time. Due to the hashtags in this post, the correlation to Covid is undeniable. This is a good reminder that hashtags can be considered disease claims and tip the scale into the warning letter category. Here’s a video about this.

From warning letter. “Plants geared towards cardiac and mental health, brain fog, respiratory issues, and fatigue . . . # postcovid, # postcovidsyndrome, # longcovidrecovery, # longcovidsymptoms

This is a joint FDA and FTC warning letter, which is common when Covid claims are cited. This is very serious, and it also involves a cease and desist barring the company from making Covid-related claims or face injunction, a civil penalty of up to $46,517 per violation requirements to refund customers.
Full warning letter

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.