Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims
Distributors are responsible for the products they sell
Amazon and Walmart were cited for selling a product with disease claims and adulterated with NSAIDs.
The product is a nutraceutical and omega-3 product that contains undeclared diclofenac, a non-steroidal anti-inflammatory drug (NSAID).
Both warning letters include comments where FDA highlights that the company (Amazon or Walmart) is the party that fulfills and distributes the product. According to supplement regulations, companies that distribute products have a level of GMP and regulatory responsibility. Essentially if a company markets, distributes, and sells a product, they are responsible, even on a marketplace site. This webinar with Nathalie Bougenies and Steven Yeager shows many items companies need to comply with these regulations.
From Amazon warning letter. “These products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.”
There were also examples of claims on both the Amazon and Walmart sites, such as “arthritis.” This is the most common “itis” referenced in warning letters and is an important reminder to scan for higher-risk words like “arthritis.”
I expect this action to possibly lead to these companies asking for more adulterant testing and a deeper look at disease claims. For example, if the word “arthritis” is on your Amazon page, I expect it to be flagged.
This product was recalled in June 2022. It is unclear if the products in these warning letters are from the same recalled lot or a different batch.
From warning letter. “Combate la artritis.”” (English translation: Fights arthritis.)”
Interestingly, the disease claims were in Spanish, a good reminder that the FDA also pays attention to claims made in other languages.
I welcome your thoughts on these notable warning letters.
Read the Amazon warning letter.
Read the Walmart warning letter.
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.