Supplement Labeling Errors lead to Warning Letter

This warning letter has numerous labeling teaching opportunities, which is really exciting! I don’t think any of these violations would attract a warning letter on their own, but altogether they paint a picture of non-compliance.

This letter cites a product that does not have the designation “dietary supplement” on the main label panel. This is called the statement of identity and is a core aspect of supplement labels.

This is interesting! The company was cited for adding the “percent daily value” statement when it was not necessary.

From warning letter. “product labels each bear the following statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein”

The lack of a heavy bar separating % DV from non-% DV ingredients in the supplement fact panel is cited. Formatting is important, and here are some FDA supplement fact panel examples.

One of the most fascinating aspects of this warning letter is the comment that vitamin K2 does not qualify as vitamin K, which has a % DV. This is a relatively obscure regulation, and I don’t recall seeing this in a warning letter before.

From warning letter. “Supplement Facts label incorrectly declares as a (b)(2)-dietary ingredient, “Vitamin K (as menaquinone-7)”. 21 CFR 101.9(c)(8)(iv) lists an RDI for vitamin K of 120 mcg based on the AI (adequate intake) that pertains only to phylloquinone.

It’s “% DV,” not “DV %.” Yes, folks, we can learn a lot from warning letters. This is a minor but commonly overlooked item in supplement fact panels.

From warning letter. “ the listing of “DV%” is incorrect but may be listed as “% DV”. Finally, the “%” symbol must follow each numerical value listed as a DV.”

Oh my goodness, so many great learning lessons! Here is one about formatting. The FDA prefers the format list the supplement fact panel, then “Other Ingredients,” then the contact information.

From warning letter. “product label fails to place the “Other Ingredients” list below the Supplement Facts label.”

This label also does not include a domestic street address or phone number, which is required for adverse event reporting, and this is essential to a compliant supplement label.

Here is a previous Warning Letter Wednesday post with more labeling lessons that include items called out in this letter, such as improper serving size  

Here is FDA’s labeling information. If you have additional labeling questions, I would be happy to try to be of help.

As a resource, I get carried away with this “GMP Pitfalls and Best Practices” blog. I hope you find this useful.

There are so many more lessons in this warning letter, including improper specifications. Read it 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.