GMP Labeling Lessons

This contract manufacturer was cited for several GMP issues, and today we'll explore some of the interesting violations. Learning from other's mistakes is a great way to adjust your labeling and manufacturing processes before they lead to a warning letter.

Here are some important labeling reminders. These labeling issues are red flags that show the authorities that the company may not understand the basics of manufacturing compliance.

🔷 A serving size is the maximum amount consumed in one sitting. For example, directions that state "Take 1-4 capsules daily" is a four-capsule serving size.

🔷 It seems they forgot to put a symbol like an asterisk in the proprietary blend linking to the DV Not Established statement. Formatting and items like this are why I use labeling software.

→From warning letter. "The …product does not have a footnote linking the proprietary blend to the statement "Daily Value not established", which is not in accordance with 21 CFR 101.36(b)(3)(iv)."

🔷 This "You forgot the DSHEA symbol next to your structure-function claim" has been a common citation in recent warning letters.

→From warning letter. "product labels do not bear a symbol next to the structure/function claim linking the claim to the disclaimer, in accordance with 21 CFR 101.93(d). Furthermore, the disclaimer fails to be enclosed in a box on the … product, in accordance with 21 CFR 101.93(d)."

🔷 I review a lot of labels for my consulting company, and I always mention that there should be no intervening material between the supplement fact panel, "other ingredient," and manufacturer information. It was cited here.

→From warning letter. "Information panels include nutrition, ingredient information, and manufacturer information intermingled with information that is considered intervening material. Examples of intervening material are "Contains no added sugar …""

🔷 Listing of stevia as sweeteners is also a recently common citation.

→From warning letter. "Stevia must be listed in the Supplement Facts label as a botanical with a plant part designated if it is used as a dietary ingredient. If being used as a sweetener, only a GRAS ingredient may be added to a dietary supplement, such as a purified stevia extract (e.g., "rebaudioside A")."

🔷 I can't remember seeing this one in a warning letter before. I admit I also made this mistake when I was a contract manufacturer.

→From warning letter. "FDA's view is that "evaporated cane juice" is not the common or usual name for sugar or cane sugar. For additional information, see: https://www.fda.gov/media/97827/download"

🔷 A domestic street address or phone number for adverse event reporting is essential.

→From warning letter. "the packet label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act) may receive a report of a serious adverse event with such dietary supplement."

🔷 It looks like the company used a nutrition fact layout for a supplement fact panel. Here are some callouts from the warning letter.

• Any … dietary ingredient not present, or in amounts that can be declared as zero in section 101.9(c), shall not be declared, in accordance with 21 CFR 101.36(b)(2)(i).

• A heavy bar is placed underneath the … ingredient "Calories", which is not in accordance with 21 CFR 101.36(e)(5).

• The type size of the (b)(2)-ingredient "Calories" in the … product's Supplement Facts label is not uniform with the other … ingredients, which is not in accordance with 21 CFR 101.36(e).

Admittedly, the primary reason for the warning letter was likely incomplete 483 responses related to specifications and batch production records (BPR). Here is one of FDA's comments to a 483 response, which shows that going the extra step to "show your work" can be the difference between a 483 and a warning letter.

→From warning letter. "You did not include any revised MMRs for review. Therefore, we are unable to assess the adequacy of your corrective action."

There are a lot of "juicy" learning lessons in the 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.