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TCM Company Cited for Claims & GMP Violations

Re-review online marketing if inspected by FDA

TCM Company Cited for Claims & GMP Violations

This Traditional Chinese Medicine (TCM) product company was cited for GMP violations and disease claims. This warning letter contains critical GMP and marketing lessons such as labeling, testing, and marketing essentials. Here, we unpack some critical takeaways as a learning opportunity to help keep you out of trouble.

This company was inspected by FDA and received some 483s, which led to their website being reviewed for disease claims months after the inspection. As we've spoken about many times here on Warning Letter Wednesday, it is imperative for companies that are inspected by FDA to ensure their websites are "clear" of risky claims. This is one of the reasons I developed Apex Compliance. To learn more about Apex Compliance, contact me.

Here are some key labeling takeaways.

  • The botanical ingredients are not in the standardized common name as noted in AHPA's Herbs of Commerce. They appear to be the TCM names, which is fine, but the common or Latin names are also required.

  • If a label lists information in another language than English, all required information must also be listed in that secondary language. Admittedly, I've never thought about this, but it makes sense from a consumer protection standpoint.

  • The plant parts were missing from a label.

Many of the GMP violations cited here have to do with specifications. Specifications are integral to GMPs, and each raw material and finished product must have specifications for identity, purity, strength, and composition. I suggest reading through the warning letter to review FDA's comments.

Master Manufacturing Records (MMRs) are the recipe telling the staff how to make a product. Here are several missing items that were cited in this letter.

  • Description of packaging and a representative label.

  • A complete list of components.

  • The weight or measure of each component.

  • Any intentional overage amount. This is to accommodate for shelf life testing and manufacturing variance.

  • A statement of theoretical yield. This is so the company can find problems before the product gets to the next stage of production. For example, if too much of an ingredient was added, the weight should potentially be over the theoretical yield. In the past, my team accidentally added one kilo rather than 0.1 kilo, and calculating the yield caught the error.

  • Specifications are needed for each point, step, or stage in the manufacturing process where control is necessary

  • One person weighs or measures a component, and another person verifies the weight or measure. This is known as the doer/checker system to ensure weighing issues are prevented. This can be difficult to achieve in small companies.

  •  And many more items.

Unqualified reference standards continue to be called out in warning letters. This company was cited for not using a validated reference standard for FT-IR identity tests. This essentially means if you are testing for something like chamomile powder, you must purchase a qualified sample and test against this standard. Yes, I know GMPs can be burdensome. There has never been a more challenging time than now to be a supplement manufacturer. I feel your pain.

From warning letter. "You do not have an adequate identity specification because you are not conducting identity testing against a qualified reference standard."

An Out Of Specification (OOS) was cited in this letter. An ingredient or product was OOS for zinc, but the company retested using a different method. FDA took issue with this, which is a learning lesson to ensure retests use the same method. This seems obvious, but in the heat of the pressure to release products, these items can sometimes be inadvertently overlooked.

From warning letter. "The investigation testing was performed using a different methodology and by a different laboratory than the laboratory which conducted the original analysis, thus making it difficult to compare the results and to verify accuracy."

The website states that products can only be purchased by a practitioner and that no retail sale is available. This is very interesting from a "material connection" point of view. If there is a material connection (e.g., commerce on the website), this is what FDA uses to connect marketing disease claims to commerce. If there is no commerce on the website or linked websites, FDA seems to rarely call out disease claims, which makes this example a rarity. Full disclosure: I have no way to verify if this was a recent change since the warning letter. If anyone knows, please let me know.

There are so many GMP learning opportunities here.

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.

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