Amazon and Walmart Receive Another Round of FDA Warning Letters

FDA just posted a group of ten warning letters about homeopathics and other unapproved products marketed for sexually transmitted infections (STIs) or their symptoms. Amazon and Walmart are among the recipients, along with eight product-company letters. There are several useful learning opportunities here, even for companies selling very different types of products.

As I’ve discussed in previous Amazon WLWs, distributors have responsibility for the products they handle. FDA points to Amazon’s and Walmart’s fulfillment services, noting that both companies handled the products FDA purchased, which helps explain their responsibility as distributors.

What I find interesting is the crossover. Several of the same products appear in both the Amazon or Walmart warning letters and the letters sent to the other companies marketing them.

We’ve seen this approach before, and it reinforces the lesson that a product’s compliance issues can affect the companies that sell and distribute it. The key point here is that just becuase products are available on a major marketplace doesn’t mean they are compliant.

One letter in this group references a website’s “Shop by Condition” section, and FDA describes how selecting “Herpes” to direct shoppers to the company’s Amazon storefront may be considered intended-use marketing.  

From warning letter: “consumers can ‘Shop by Condition’ and select ‘Herpes,’ which redirects to your Amazon storefront page…”

Asa comments: This is easy to overlook when reviewing marketing, as companies may spend time reviewing the product description but give less attention to the category where the product appears Placing a product under a disease category or “tagging it” helps communicate intended use. These product category claims sometimes appear in warning letters, but they are somewhat uncommon.

As a side comment, I do a lot of research for WLW, but I also share an Amazon with my daughter and wife. I wonder what they will think about my extensive herpes and STI product viewing (haha)!

Several products in this group were labeled as homeopathics, which brings us back to a theme from my previous homeopathic WLWs. FDA pays attention to serious disease claims and potential safety concerns, and homeopathics do not exempt a product from drug requirements. In these letters, FDA is concerned that consumers relying on the products may delay appropriate medical care or believe an infection has been adequately treated.

Older social posts are still being cited. One letter includes a Facebook post from 2024 and FDA also reviewed the company’s website, Instagram, and a customer testimonial describing disease-related results. This is why I continue to encourage companies to review their older content. These are many of the marketing issues Apex Compliance can help identify, explain, and replace with lower-risk language. Companies can review websites, Facebook, Instagram, and Amazon content, understand why a statement may be a concern, and work through alternative wording using their approved claims and internal guidance. It is also useful for reviewing new content before publishing, so teams can apply what they learn to the next campaign.

If you’d like to see how this could work for your company, schedule an Apex Compliance demo here. I’d love to show it to you!

Also, I looked on Amazon and found another homeopathic product making out-of-bounds claims, and put it into Apex. See how it did.

Read the Amazon warning letter and Walmart warning letter.