Labeling Errors Lead to Warning Letter

This warning letter resulted from a GMP inspection and label review. Several labeling errors are cited in this letter, which are excellent learning lessons.

FDA has clear requirements for nutrient content claims such as “good source,” “high in,” and “high potency.”
From warning letter. Your …product label displays the following claim “Canary Seed … is high in protein content.” In the context of this label, FDA considers the claim “Canary Seed . . . is high in protein content.”

Botanicals must be listed in the supplement fact panel according to AHPA’s Herbs of Commerce. Learn more about this book here.
From warning letter. “the Supplement Facts label lists “guanabana” which is not a standardized common name listed in the reference Herbs of Commerce; soursop is the standardized common name for guanabana.”

The words “Dietary Supplement” are not in bold and prominent font size. This is rarely cited in warning letters but is a friendly reminder of this regulation.
From warning letter. “Your …. product label’s dietary supplement statement of identity is not presented in bold type on the principal display panel and in a size reasonably related to the most prominent printed matter on the principal display panel. (see 21 CFR 101.3(d))”

There are so many lessons; read 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.