Citing Clinical Studies & Labeling Errors Lead To Warning Letter

Citing clinical studies, labeling, and formulation errors lead to a beverage warning letter. #WarningLetterWednesday

I'm sometimes asked if supplements can make disease claims with competent and reliable scientific evidence. Unfortunately not; even if a Randomized Controlled Clinical Study (RCT) was conducted on a supplement, the FDA does not allow disease claims in supplements or foods. Citing studies with disease claims on a commercial website is a common error that increases the chance of scrutiny, in my opinion.

From warning letter: “Green tea has been shown in studies to naturally lower blood pressure”

Nutrient content claims are cited in this warning letter. The company labeled their product “nitrogen enriched,” but because there is no DV% for nitrogen, it can’t comply with this regulation. Read more amount other nutrient content claims like “good source of” and “high potency” here.

This warning letter mentions the word “stevia,” which is an incomplete ingredient description, and this is a friendly reminder to add the plant part or other information to ingredient listings.

From warning letter: “stevia” does not meet the ingredient declaration requirements of 21 CFR 101.4 because it is not specific or descriptive enough to be a common or usual name. Simply declaring “stevia” does not identify whether the ingredient is stevia leaf, crude stevia extract, or purified steviol glycosides.”

Here is another interesting example of an inaccurate ingredient listing.

From warning letter: “hydrogen enriched RO water” are not common or usual names as required by 21 CFR 101.4 because “RO” is not a widely used abbreviation established by common usage. In addition, as explained above, hydrogen must be declared as a separate ingredient of these beverages, rather than as part of the name of the water ingredient.”

The FDA cites a different Nutritional Facts Panel listing on the website “label” and the product label. This is the first time I have seen this mentioned in a letter, and it is a great reminder to have continuity in marketing and labeling.

From warning letter: On your website, the product page … includes an image of its Nutrition Facts panel showing that the product contains 9 grams of sugar per serving. However, the physical label collected for this product during our inspection declares 0 grams of sugar per serving”

There are even more interesting aspects, and I suggest reading the full 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.