GMP Inspection Leads to Online Scrutiny

This is another example of a GMP inspection leading to a website and social media review. The initial FDA inspection was in April this year, but the website was not reviewed until September and October! This trend is common in warning letters, and FDA does not appear to critique online marketing until months after the initial inspection. This is a reminder for companies inspected in the past year to re-review online marketing to ensure there are no compliance concerns. This includes blog posts that cross the line from education to marketing.

Study citations are marketing. There have been several letters where companies highlight research about ingredients like elderberry. This is considered marketing if those ingredients are in products sold on the site, and I talk more about this here. Now is a good time to review your elderberry and other ingredient marketing to ensure there are no “forgotten” ingredient claims.

From warning letter. “The Study showed that Elderberry extract is effective in treatment of flu.”

Testimonials are becoming more common in warning letters. This company copied a customer testimonial onto a social media image, which is considered “endorsing the testimonial.”

From warning letter. “Facebook image post: Joint Support Capsules … Amazing. Really works. Muscle pain and nerve pain.”

Several blog claims are cited in this warning letter. A common blog writer trap is to use sensational titles such as “Can Turmeric Help Reduce the Risk of Strokes”? As discussed above, this is a marketing claim if turmeric is sold on the site. Here are some best practices for reducing blog risk.

There are several GMP violations cited in this warning letter. They probably wouldn’t have elevated to a warning letter if adequately addressed and if there were no online disease claims present.

Companies continue to be cited for not demonstrating the identity of the finished herbal product blend, even if the individual ingredients have been tested and the blending has been validated. To show the finished product identity, a specific method needs to be developed. Does a small company need to spend valuable resources to develop a specific method just to confirm the identity of an herbal blend? I find this rigid interpretation of the regulations puzzling and a potential burden on industry.

Setting herbal specifications too rigidly can lead to issues. This company was cited for not properly handling an ingredient that exceeded its lead limit of 1.45ppm, which is not a high level for an herbal ingredient. This would not have been an issue if the company had set a realistic lead level. This demonstrates the importance of setting up a practical Quality Management System (QMS). A QMS developed with GMPs but also operational efficiency in mind is essential to any growing business. Having a properly functioning QMS is critical, but an overburdensome approach to quality is restrictive. Some companies hire exquisite pharmaceutical managers to develop their QMS, and they get what they pay for, a rock-solid system that is pharma-level, but is this needed in a small to midsize company?

Some citations went to quality concerns from 2016, showing that even several-year-old decisions regarding quality can come back to bite a company. The FDA did not feel the company’s 483 responses were sufficient. I write about how improper 483 responses can turn into a warning letter here.

Read the full warning 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.