Labeling Violations & Web Claims

This company received several observations for minor labeling issues, but the GMP-related observations and the website disease claims likely tipped the scale into a warning letter. This warning letter is filled with important reminders about labeling format, and I review some key points here.

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🔷Structure-function claims and the DSHEA disclaimer are required to link to each other with a symbol. This is rarely referenced in warning letters but may be a more common plaintiff lawsuit.
👉From warning letter. “Your … product labels each fail to bear a symbol next to all structure/function claims linking the claim to the disclaimer, in accordance with 21 CFR 101.93 and (d). For example, we note use of the term “wellness” is a structure function claim.”

🔷“Supplement Facts” should stretch the top length of the supplement fact panel. This is a minor but common label oversight.
👉From warning letter. “Your… products fail to set the “Supplement Facts” full width of the nutrition label.”

🔷Vitamins or minerals with less than 2% daily value must be listed in “Other Ingredients.” Admittedly, this is a new one for me.
👉From warning letter. “Any dietary … that is present in an amount that can be declared as zero in section 21 CFR 101.9(c), must not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). The source of the ingredient, i.e., potassium citrate must be listed in the Other Ingredients list. “

🔷Items without a percent daily values must be disclosed in grams rather than milligrams if over 1000mg. Again, this is a minor but common oversight.
👉From warning letter. “Your … products fail to declare the quantitative amount by weight of each dietary ingredient per serving using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100mg must be expressed as 1.1 g)”

🔷“Dietary Supplement” should be in bold and in a large font size.
👉From warning letter. “The statement of identity “dietary supplement” on your … products must be presented in bold type on the principal display panel, in a size reasonably related to the most prominent printed matter on the panel”

🔷This warning letter is another example of an FDA inspection that led to a website review six months after the initial inspection. This is an important reminder that a compliance re-review of online marketing is essential if the FDA has recently visited your facility. I ran ApexCompliance on their website and found many risky statements. Learn more about this compliance program.

There are many more learning lessons in this letter.

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.