Discussing ingredient benefits is a marketing claim
Replace high-risk words on a commercial website
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.
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.