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August 7, 2024 By: Asa Waldstein

Website & Social Claims Lead To Warning Letter

Takeaway -

Flu & virus claims are enough for regulatory action

This company was making claims about virus and flu prevention on its website and social media accounts, which led to a warning letter.

Here are some of the high-risk claims from the warning letter:

  • “Support the immune system against virus and germs”
  • “Vitamin C stimulates antibody production to aid the immune system in reducing the severity and duration of colds”

Many may not know that I have a certified clinical herbalist background, and I love plant medicine. Some botanicals do have antiviral properties, such as the wonderful osha plant here in the Rocky Mountains, and herbal texts and people talk about the benefits of plants. This is OK, but it crosses the compliance line when companies use these descriptors to market their products. It seems this is what happened here: a potentially unaware company copying and pasting product benefits from herbal texts, scientific journals, or ChatGPT. 

Here are a few basic rules for avoiding this issue:

  • Avoid words ending in “itis,” which means “inflammation of.”
  • Avoid most words with “anti” such as “antiviral.”
  • Avoid comparing products to drugs, especially those in the mental health, blood sugar, or heart health categories.
  • Use caution in the immune category. For example, “immune support” may be allowed with substantiation, but “use when sick” is going too far.
  • Search Warning Letter Wednesday for what others have been cited for. I’ve written this for ~3 years, and old posts are searchable by keyword.

There are also several mid-risk claims in this warning letter. Even though they should be avoided in dietary supplement marketing, they are not typically enough for a warning letter. Here are some examples of mid-risk claims.

From warning letter:

  • “Helps…and pain of the throat”
  • “DIMINISHES PHLEGM: …. contains a generous dose of ginger, which has been used for centuries as a natural decongestant and antihistamine.”
  • “ALLEVIATES SORE THROATS: …. has a generous amount of honey which will quickly reduce inflammation and soothe your respiratory system.”

Read the full warning letter 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