Discussing ingredient benefits is a marketing claim

Replace high-risk words on a commercial website

Discussing ingredient benefits is a marketing claim

#WarningLetterWednesday

Discussing ingredient benefits on a commercial website can easily cross into product disease claims.


This is a common marketing mistake, and I suggest fighting the urge to explain ingredient benefits with high-risk language.

👉Here is a video about replacing high-risk words with lower-risk alternatives. 


➡️From warning letter: Persimmon leaves have anti-hypertensive, anti-carcinogenic, and anti-mutagen properties."

👉These are common "claims" mistakes. Here is a video about tips for knowing if a claim is being made. 


🔷Read my post about ingredient benefits from a few months ago here


➡️From warning letter: "Chamomile's mildly sedating and muscle-relaxing effects can help those who suffer from insomnia . . . ."

👉Insomnia claims are high risk. I write about this here


🔷This warning letter is interesting as there was first an in-person inspection in August 2021, then the FDA reviewed the company's website in November 2021 and recently in February 2022. This is a good reminder for companies to clean up their websites before/during/after GMP inspections, as it seems a few website edits could have prevented this letter.


Citing studies can be looked as product marketing claims.

➡️From warning letter: Examples of some of the claims on your website's "TEA AND CANCER PREVENTION – NATIONAL CANCER INSTITUTE" page that provide evidence that your product is intended for use as a drug include: "More than 50 epidemiologic studies of the association between tea consumption and cancer risk have been published since 2006.....


Full warning letter here.

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