Common Labeling Errors Lead to Warning Letter

#WarningLetterWednesday focuses on label violations that helped lead to a warning letter. These are basic but important reminders.

This company was inspected by the FDA when they collected product labels and issued 483s for common violations such as not correctly setting specifications. I talk more about these common violations and improper 483 responses here.

Here are some label lessons from this warning letter.

The serving size must match the suggested use. For example, a suggested use of “take 1-2 capsules” requires a two-capsule serving size, and FDA defines this as the “maximum amount consumed per eating occasion.”

From FDA warning letter. “The (b)(4) label’s directions state to “Take 1-2 chewable tablets daily as needed, at bedtime.”, but the serving size listed in the Supplement Facts label is 1 tablet.”

Items with a daily value percentage must be listed in the correct format. For example, listing “Vitamin B5” is incorrect, but “Pantothenic acid” is correct.

The FDA also has a strict order that items with a DV% must be listed. I refer to AHPA’s labeling guidance for this, but I believe this document is now only available for members. Here is a decent FDA resource.

From FDA warning letter. “Facts label fails to place pantothenic acid before biotin”

I see companies posting labels online that have the incorrect layout and format. I’m not sure if these labeling violations would lead to a warning letter on their own, but they signal the FDA that more significant GMP violations may be occurring and likely triggers them to look deeper. “Where there’s smoke, there’s fire” is often true in GMP and label compliance. In my consulting practice, when I review labels that are way off in terms of compliance, I usually suggest that the brand owner look elsewhere for a manufacturing partner.

Read the full warning 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.