TCM Company GMP & Marketing Violations

FDA inspected this TCM manufacturing and product company earlier in the year, including looking at its product catalog and website. This led to GMP and disease claim citations.

Let’s start with the disease claims. Some of these may be considered TCM verbiage, but this is an important reminder that using common Traditional Chinese Medicine (TCM) or herbal language doesn’t necessarily translate into compliant marketing.

From warning letter.

• “Staunches bleeding, disperses swellings, and relieves pain”

• “Expels pathogens, resolves depression”

Product catalog: This is a reminder that anything FDA sees during inspection can be reviewed, including shipping inserts. I remember years ago almost forgetting to discard old “potentially non-compliant” product brochures that were collecting dust on a shipping shelf. If FDA found these during an inspection, they would have been “fair game” for them to collect and review.

Now for the GMP issues. There are a lot of learning opportunities here.

Identity specifications. In most cases, organoleptic (e.g., color, taste, smell, feel) testing is not sufficient to determine botanical identity. However, if the plant came in whole leaf (rather than powder), for example, I think a case can be made that organoleptic testing may be sufficient.

• From warning letter. “Analysis of organoleptic factors does not provide unique information that is specific to each of these ingredients and thus cannot confirm the identity of each ingredient.”

Metal detection. This is one we don’t see very often.

• From warning letter. “You failed to use effective measures to protect against the inclusion of metal or other foreign material in components and dietary supplements, as required by 21 CFR 111.365(i).”

Incomplete MMR instructions. I like to think of the MMR and BPR as recipes. If a new team manufactures the product, does the MMR/BPR have all the needed instructions? This is to maintain consistency in product manufacturing.

• From warning letter. “Your master manufacturing records (MMR) failed to include written instructions and specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement products and that the dietary supplement is packaged and labeled.”

Product specifications. Not having complete specifications is one of the most common GMP violations. Here FDA states that the provided microbial and heavy metal specifications are not enough to justify the product’s identity, purity, strength, and composition. I ask, if the product contained only botanicals, what else is needed to verify this? One answer is that a finished product composition test is needed, which is an expensive method to develop and test.

• From warning letter. “The physical and chemical factors do not constitute unique criteria that can confirm the identity of these products and do not evaluate the purity, strength, or composition of these finished products.”

Here are some labeling citations.

Structure function claims on labels not linked to FDA disclaimer. This is showing up in more warning letters.

Plant parts should be listed on the label. I personally think that “herb” is descriptive, but according to FDA, it is not sufficient.

• From warning letter. For example, “herb” does not identify the plant part used in the product. If the whole or entire plant is used, that information must be listed.

Listing the ingredient name common correctly.

• From warning letter.  “Citrus” which is not the common or usual name of an ingredient.

Solvents should be listed. This is not to be confused with processing aids, which, in most cases, do not need to be listed.

• From warning letter. “(the label) fail(s) to declare the solvent used in the extract within the ingredient list.

Other comments in the warning letter are important reminders of labeling and GMP compliance.

Expiration dates: The company did not have supporting data for its “best by” dates. Expiration or freshness dates are not required on supplements, but when they are used, the company must have supporting data. In my experience, this does not have to be super complicated and may include a time-zero and a 1 to 2-year-old product tested for organoleptic, microbial, and line item assay tests.

Facility registration: It looks like the company did not update its facility registration within 60 days of important changes.

Read the full warning letter here.

DATE ORIGINALLY POSTED: 10/2/24

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.