Earlier this month, on August 4th, the FDA issued Amazon a warning letter beginning, “This letter concerns your firm’s distribution of products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”) … If you operate a third-party fulfillment service, fulfillment center or offer products on your website that come under FDA jurisdiction, you may want to take special note of the Food and Drug Administration’s recent warning letter it sent to online retail giant, Amazon.

 

“…Your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a).”

The FDA issued this warning after having purchased, via Amazon’s website, two mole and skin tag removal products, which were delivered by the company. But, because the products in question are not available for over the counter (OTC) sale or purchase, Amazon became complicit (however unwittingly) in a potentially unlawful act.

What makes this warning letter so unique, besides Amazon having never received an FDA warning letter before, is that Amazon does not manufacture or own these products. It simply fulfills delivery of them into interstate commerce.

Keep in mind, Amazon has perhaps hundreds of non-FDA compliant products all over its website, which it fulfills delivery for…

So, this may be just the beginnings of enforcement actions against the company.

What it could mean for you and your business:

If you are a distributor, manufacturer, third party fulfillment company or own a website that offers any products that fall under FDA jurisdiction, you must be fully aware of all the rules and regulations regarding these products.

As shown with the Amazon FDA warning letter, even if you simply offer delivery or fulfillment services of non-compliant products, you too may be issued an FDA warning letter.

Of course, you may not know all the rules and regulations regarding FDA regulated industries like food, dietary supplements, cosmetics, medical devices, and OTC drugs. That’s why it’s highly advised you consult with and FDA compliance attorney.

FDA compliance attorneys, like Bustos Law Group, can assist in all your compliance issue needs, including product review, label review, marketing material review, website review FDA warning letters and more.

We do this for manufacturers, distributors, fulfillment centers and entrepreneurs looking to enter markets regulated and overseen by the FDA; and companies already operating in the space looking for counsel.

Our expert FDA compliance attorneys specialize in dealing directly with the Food and Drug Administration on your behalf so you can continue building your business.

Now, even if you believe you are fully in FDA compliance with all your products and services, it’s always important to be certain of it.

Contact Bustos Law Group today for a free, 30-minute consultation and we’ll discuss any, and all concerns you may have about your FDA regulated products.

You can call 1-832-592-7851 or book an appointment online, HERE