Labeling Lessons
Minor label issues signal deeper compliance issues
This warning letter has numerous examples of what not to do when labeling supplements.
Here’s what we can learn.
Incorrect statement of identity: The statement of identity is one of core required elements on supplement labels. “Dietary Supplement” is most common but if accurate terms like “Vitamin Supplement” or “Herbal Supplement” are allowed. In this warning letter, FDA cited “Nutritional Supplement” as not being a compliant statement of identity. You can see how “vitamin” is descriptive, whereas “nutritional” is not specific enough.
Serving sizes: This product’s serving size is listed as 1 to 3 teaspoons twice a day, but the supplement fact panel lists the serving size as one teaspoon. A serving is the “maximum amount consumed per eating occasion,” which is three teaspoons in this example. The company could have kept the one-teaspoon serving size on the label by updating it to “one teaspoon up the 3x daily.” I review a lot of labels with my work at Supplement Advisory Group, and this issue is more common than you may think.
Adverse event reporting: A full domestic address or domestic phone number is needed for adverse event reporting requirements.
Supplement fact panel layout:
- From warning letter. “The statement “Daily Value Not Established” is not linked to a symbol linking it to the heading “%DV heading,” which is not in accordance with 21 CFR 101.36(b)(2)(iii)(F).”
- Servings per container: Did you know that the servings per container may be omitted when stated in the net quantity of contents declaration?
Missing DSHEA disclaimer: From warning letter. “The labels make structure/function claims but fail to bear the required FDA disclaimer, in accordance with 21 CFR 101.93(b)-(e).”
Are you interested in learning more about nutrient content claims? Here is my write-up.
Here are more labeling citations from previous warning letters.
Do you need support with labeling compliance? I love this stuff!
Read the full warning letter.
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