GMP Labeling Lessons
Small issues signify deeper noncompliance
Small issues signify deeper noncompliance
Dietary supplement labeling can be confusing, but ensuring that the “small things” like line thickness are compliant is important. When FDA looks at a label that is not quite right, it can signify greater compliance concerns and trigger them to look deeper, as the adage “Where there’s smoke, there’s fire” is often true.
Let’s look at this warning letter to see what we can learn.
Address or phone number: This is an important part of GMPs and safety and is considered a major violation if missing. This is how consumers report adverse events to the company, which can help the company identify quality issues and, if necessary, serious adverse events that must be reported to the FDA. Learn more here. Also, if the company named is not the manufacturer, the label must clearly disclose this fact using a statement like “Manufactured for” or “Distributed by.”
From warning letter: “The labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement.”
- The correct order of ingredients is important. Learn more here.
- “Supplement Facts” should be set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i)
- The correct nomenclature should be used for items with a percent daily value.
From warning letter. “The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words “as” or “from”, e.g., “Calcium (as calcium pyruvate)”. When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement.”
Formatting is important.
From warning letter. “The Supplement Facts label format requirements including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e).”
From warning letter. “The statement “**Daily Value not Established” must be within the Supplements Facts label.”
Common ingredient name must be listed.
From warning letter. “”Aquamin™” is not the common or usual name for Lithothamnion spp.”
There are lots of GMP violations in this letter, which is likely the primary reason for this letter.
DATE ORIGINALLY POSTED: 2/5/25
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.
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