Discussing Ingredient Benefits Leads to a Warning Letter

No such thing as “too small to be on FDA’s radar”

Discussing Ingredient Benefits Leads to a Warning Letter

Small herb company cited for elderberry-oriented disease claims. This is a good reminder there is no such thing as “too small to be on the FDA’s radar.”

Claims in the letter provide some good learning opportunities.

Discussing ingredient benefits on a commercial website where those ingredients are sold is a marketing claim, even if there is no cross-linking to a product page. In this letter, the company made statements about elderberry in their “Elderberry 101” FAQs. Here is another post about this. 


From warning letter: “In 2004, a study on elderberry extract in flu patients revealed that symptoms were relieved 4 days sooner than patients who didn’t receive elderberry.”

Claims made on social media are also cited. It seems like the majority of warning letters involve social media claims. The front and last line of defense is the company’s social media manager. Unfortunately, it’s common for these team members not to understand the nuances of supplement marketing. This is one of the reasons I make helpful hints regulatory videos such as this.

From warning letter: “Benefits of Elderberry .. From Facebook “Another 2020 review of five elderberry studies concluded that, when taken within 48 hours of initial symptoms, elderberry supplements may reduce the length and severity of fever, headache, runny nose, and congestion associated with cold and flu.”

Copying literature or “research” about an ingredient onto a commercial website or social media post is a common trap new supplement marketers fall into. I talk about this here


This is another example of a well-intentioned cottage herb company that didn’t understand the rules of marketing supplements, thus resulting in a warning letter. Once product marketing is posted online or on socials the risks of FDA/FTC scrutiny increase. Unfortunately, marketing compliance is not commonly taught at herb or natural medicine schools. Helping to educate this community is one of my missions, so please help me spread the good word of compliance.

Read the full warning letter.

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