GMP Labeling Lessons
Incomplete 483 responses turn into warning letters
Labeling is an important part of dietary supplement compliance, and here we review a warning letter to help you learn from other's labeling mistakes.
This company was inspected by FDA and received at least one 483 violation for labeling and manufacturing violations. In today's WLW, I will focus on the labeling issues, but I suggest everyone read the full warning letter. I may also write a WLW about the manufacturing issues because there are a lot of nuggets of wisdom to glean from it.
Here are some of the labeling lessons from this warning letter.
Branded ingredient names are not sufficient in the supplement fact panel. This reminds us that branded ingredient names in the fact panel are okay, but they must also be common or accompanied by a usual name.
From warning letter. "Aquamin™" is not the common or usual name for Lithothamnion spp."
Formatting. I review many labels, and companies sometimes put statements like the %DV statement in odd places.
From warning letter. "For the Calcium Pyruvate product, the statement "**Daily Value not Established" must be within the Supplements Facts label."
Items with a %DV must be listed in a specific format and order. Here's the eCFR link, which is challenging to understand. If you are an AHPA member, they provide an excellent free resource. I also use Marian Boardley's SFP and NFP program, which is reasonably priced. Thanks, Marian!
From warning letter. "The label lists calcium pyruvate, which is not the nomenclature specified for calcium in 21 CFR 101.9(c)(8) or 21 CFR 101.36(b)(2). The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", e.g., "Calcium (as calcium pyruvate)". When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement [21 CFR 101.36(d)]."
From warning letter. "The presentation of the (b)(2)-dietary ingredients is not in the order as set forth in 21 CFR 101.36(b)(2)(i)(B). For example, the declaration of calcium must appear before the declaration of phosphorus."
No intervening material. One of the reasons I love writing Warning Letter Wednesday is that it gives me an opportunity to dig deep into enforcement trends, which I often learn from, which in turn makes me a better consultant and entrepreneur. This allergen comment is a new one for me. The FDA has labeling regulations that state no intervening material is allowed between the supplement fact panel, other ingredients list, and the allergen statement. In this warning letter FDA cited the company for listing "allergen warning" before the required "contains" statement. This is not high risk at all and is unlikely to lead to a 483 or warning letter unless larger issues are present. It is, however, important to understand that even minor issues like this can add up and may help tip the scale into warning letter territory.
·From warning letter. "the statement "Allergen Warning" appears before the Contains statement, which is considered intervening material."
Supplement Facts stretching the top width of the fact panel. There are some exceptions if "unpractical," but generally, it is a good idea to try to comply with it. Helpful link.
From warning letter. " The title, "Supplement Facts", is not set at full width of the nutrition label, in accordance with 21 CFR 101.36(b)(1)(i)."
No partial percentages for items with a %DV.
From warning letter, The Supplement Facts label must list the % Daily Value for (b)(2)-dietary ingredients by calculating the dietary ingredient's quantitative amount by weight per serving divided by the established RDI noted in 21 CFR 101.9(c)(8)(iv), and expressed to the nearest whole percent, in accordance with 21 CFR 101.36(b)(2)(iii)(B).
FDA will investigate. I've never noticed the FDA look at a supplier's website to correct the ingredient listing in the supplement fact panel, especially one that lists the ingredient as collagen. They must have irritated the inspector, and there may be more to this story.
From warning letter. "We note that the xxxx product declares "Naticol Marine Collagen." Xxxx website describes their ingredients as "a range of bioactive and bioavailable marine collagen peptides of natural origin." If the dietary ingredient used in this product is marine peptides, that ingredient must be declared by its common or usual name."
Supplement fact panel formatting. Here's a helpful FDA resource that shows images of fact panels.
From warning letter. The Supplement Facts label format requirements, including the use of bolded text, hairlines, and/or light and heavy bars are not in accordance with 21 CFR 101.36(e)"
Address for Adverse Event Reporting
From warning letter. "the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761 of the Act [21 U.S.C. 379aa-1] may receive a report of a serious adverse event with such dietary supplement."
Read the full warning letter here.
DATE ORIGINALLY POSTED: 7/24/24
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.