Online Marketing & GMP Lessons

Learning about compliance is fun, and today’s Warning Letter Wednesday has critical teaching opportunities for marketing and GMP compliance.

This is yet another example of a company being inspected by FDA; then, many months later, around the time of the inspection close out, FDA looked at the company’s online marketing and found a lot of no-nos. This is an enforcement trend that I write about in more detail here.

First, the marketing issues:

YouTube videos: Claims made in YouTube videos have been mentioned in three warning letters this year and I expect this trend to continue. Reviewing hours of YouTube videos for compliance concerns is painful, so I developed and patented a technology to help with this. In this warning letter FDA clearly shows the “material connection” or “commercial bridge” by referencing that the company placed its website on the screen.

From warning letter. “the URL for your website …  appears onscreen during the video and you state: “Very powerful anti-cancer properties…used in conjunction with chemotherapy and other cancer treatments, but not only does it have anti-cancer properties it also has a lot of other properties as well…the way that Taxane works in the body to fight cancer is it causes cell apoptosis in cancer cells.”

Biomarker claims continue to be mentioned in warning letters. I go into more detail about this here.

From warning letter. “Lowers LDL and Triglyceride Levels”

Words with “anti” are disease claims, except for antioxidant and perhaps anti-aging. Words like anti-inflammatory have a risk rating of three out of five (Asa risk scale) which means they are not likely to attract a warning letter on their own, but words like anti-viral are very risky.

From warning letter. Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and antibacterial ingredients with the intention of killing everything in the digestive tract.

Claims on product labels: We know that all marketing is an extension of the label, but I am still surprised by some of the “on-pack” claims companies put on the product label. No knowledgeable manufacturer would apply labels with these statements.

From warning letter. “Dr. Bob’s Parasite Killer is formulated with parasiticidal, anti-fungal, anti-viral, and anti-bacterial ingredients with the intention of killing everything in the digestive tract.”

Now the GMP learning opportunities:

Component specifications are integral to GMPs, and each raw material must have written specifications. This is to ensure ingredients do not make it into inventory unless they’ve been checked. For example, suppose an ingredient’s visual specification was green and the product came in yellow, or the ingredient did not pass identity testing. In that case, the specification sheet should help catch and document this.  

From warning letter. “Yuan Zhi is an ingredient in your … but you did not establish such component specifications for Yuan Zhi.”

Incomplete 483 responses are too common, and I write more about this here.

From warning letter.  “you did not provide any supporting documentation, such as copies of your specifications. We are unable to evaluate the adequacy of your corrective action, because you did not provide documentation to support that you have established component and finished product specifications.”

Batch Production Records (BPRs) are the “recipe” and should have all adequate information, including copies of labels and cleaning records. Here are some of the items cited in this letter.

The description and name of equipment used in producing the batch. This is important so cleaning can be documented.

🔷 The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch or a cross-reference to records where this information is retained.

🔷 The unique identifier, such as a lot number and item number for each component, packaging, and label used.

🔷 The identity and weight or measure of each component used [21 CFR 111.260(e)].
A statement of the actual yield or theoretical yield at appropriate phases of processing. This is important to ensure the weight is correct. For example, a high yield could signify an ingredient may have been incorrectly weighed, and this may pose a safety concern.
Documentation that the finished dietary supplement meets specifications.
Documentation at the time of manufacturing, such as real-time quality checks. This includes bottle weight and label verification.
Documentation that quality control personnel reviewed the batch production record and approved and released, or rejected, the batch for distribution. The job of quality is to review and release ingredients, in-process work, and finished products once it has been verified against its specification.

Labeling issues were also cited.

🔷 Not listing the capsule in the label’s ingredients

🔷 Not listing the plant part such as ginkgo leaf.

🔷 Not using the standardized common name as described in AHPA’s Herbs of Commerce. Thanks, AHPA, for this resource!

🔷 Incorrect serving size. If the label states, “take 5-8 capsules,” the supplement fact panel must reflect the higher number.

🔷 Listing nutrients with zero amounts, like cholesterol, is not allowed on supplements but is standard for conventional food labels.

🔷 The company was cited for not listing black walnut as a major allergen. I ask, is black walnut a tree nut allergen?

🔷 DSHEA disclaimer: I don’t remember seeing this in a warning letter. The company was cited for apparently not having the DSHEA disclaimer on the label.

From Warning Letter. Your … are each misbranded within the meaning of section 403(r)(6) [21 U.S.C. § 343(r)(6)] in that the products make structure-function claims but fail to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).

There are many more labeling items cited. Read the full letter 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.