Drug Spiked Warning Letters

FDA sent three warning letters this week to companies selling drug-spiked ingredients like diclofenac and methocarbamol.

This is a short Warning Letter Wednesday as I am writing this from holiday on the Sea of Corinth in Greece. Follow previous WLWs here.

This continues the trend of FDA testing products for drugs like these. I thought it would be interesting to explore what we can learn from these types of products.

Disease claims, especially in the joint health category, can trigger FDA to examine the product and company more closely. 

From warning letter:  “Artritis” (English translation: Arthritis)”

Recalls signal manufacturing and quality issues and allow the FDA to look deeper at the company’s QA/QC processes. Here is FDA’s Health Fraud Database, which links to drug-spiked product notifications and recalls. This is a good resource to help you identify what potential contaminants to test for in your products.

FDA follows the “breadcrumbs” of non-compliance. When FDA inspects a facility, issues a public notification, investigates a recall, or finds a brand with issues, it will “follow the trail” to see what other similar violations it can find. For example, when a recall is reported for a drug-spiked ingredient, the FDA will look to other places where this brand may be sold, such as marketplace sites.

Many of the previous diclofenac spiked products included Spanish language supplement labels. This set of letters included both Chinese and Spanish language labels. This may be because, in some cases, there may be less quality control for products manufactured for the Spanish language community.

DATE ORIGINALLY POSTED: 9/4/24

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.