First Seven FDA Warning Letters for Supplement Labels in 2015

By Curtis Walcker, M.S.
March 29, 2015

fda-warningOnly three months into 2015, the FDA has already issued 19 Warning Letters to dietary supplement companies, seven of which cited product label violations. This is the same number of Warning Letters citing cGMP violations. Five companies were cited for both label and cGMP problems. It is not only clear that the FDA is gathering and reviewing labels during facility inspections, but also that companies continue to struggle to label their products compliantly.

In the seven Warning Letters citing label violations, the FDA managed to find problems with every mandatory label component:

Statement of identity: One company did not identify their product with the term “dietary supplement” as part of a statement of identity.

Net quantity of contents statement: One company neglected to include one. Another stated their net quantity of contents in U.S. Customary terms only.

Supplement Facts panel (SFP): All seven companies had issues with their SFPs. These violations included: no SFP, missing or incorrect Serving Sizes and Servings Per Container, zero amount claims, missing dietary ingredients, missing plant parts for botanical ingredients, and declaring (b)(2)-dietary ingredients out of order.

Ingredient statement: One company was missing ingredients in their statement.

Name and place of business: One company failed to include their name and/or place of business on their label as required.

Other: Two companies neglected to include a domestic address and/or domestic telephone number through which serious adverse events associated with the products could be reported. One company was using two languages on their label, but did not repeat all of the required label information in both languages.

In all of 2013 and 2014, the two most common label violations cited in Warning Letters involved inadequate statements of identity and missing plant parts for botanical ingredients. In 2015, the most common one (three of seven companies had this problem) is having the wrong Serving Size in the SFP. Take notice and review this aspect of your own labels. Here is what you need to know:

  • One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or in the absence of recommendations, one unit (e.g., tablet, capsule, packet, teaspoonful, etc).
  • If you recommend one capsule with a meal up to three times per day, your Serving Size is one capsule.
  • If you recommend one to three capsules per day with a meal, your Serving Size is three capsules.
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