The FDA conducted an inspection of Amazon’s website and found several violations regarding claims, branding, and illegal products in the marketplace, all of which is discussed in the Warning Letter released.
Typically, Nutrition Label Review focuses on conventional foods when highlighting Warning Letters released, however this one has many significant implications that could be seen in other sectors which are regulated by the FDA.
So now let’s dive into the violations listed.
Amazon was found to be introducing and distributing unapproved drugs into interstate commerce, which is against the Code of Regulations. There were two items in immediate question, both of which were to help with mole and skin-tag removal. Deisana and Skincell were the two companies found to be violating and determined to be unapproved drugs being sold. The FDA stated that there are no OTC drugs which are approved to be sold for mole or skin-tag removal. The primary concern is that by someone self-diagnosing there could be the potential that proper checks and a potential diagnosis for things such as cancer could be delayed by use of these products.
Why is this so substantial for a Warning Letter?
Normally the brand owner or the product is the only one found liable in Warning Letter infractions, Amazon does not manufacture or produce in any way the items discussed in the letter, they only distribute the product from the brand owner to the consumer. This may seem trivial to some, but by the FDA making this letter public they are sending a message that even distributors can be held liable. They are asking that Amazon takes the responsibility and investigates all of the products sold through their site for compliance. They are responsible to investigate and prevent any violations from being promoted on their site. Now this has only been observed with online-retail, however by the FDA issuing this it opens the question could grocery stores, for example, as well receive these types of letters?
No one wants to receive a Warning Letter, and most definitely no brand wants to be the cause of a large well-known distributor being hit with one. In the foreseeable future, because of this, there are several things that will probably be seen across the industry to prevent something like this from happening again.
- Brand owners first and foremost will be needing to take more preventative steps to ensure that they are meeting compliance, be that with their labels, marketing literature, and claims. By focusing on investing in the compliance upfront they will be able to prevent issues down the road, but it is just that and upfront investment that a company will need to deem necessary.
- You will also see businesses like Amazon, and you could argue all distributing companies, becoming stricter on its requirements to sell through their channels. This will mean a tougher approval process and more time before being able to enter the marketplace.
Many companies believe that their regulatory risk is minimal enough to avoid any issues if they are under the umbrella of a large distributor, but that is not so. In recent years we are seeing the FDA come down harder and harder on companies and those connected to them. Your websites, branding, and social media accounts are all reviewed for compliance and now it is clear the distributor can be held liable so make no mistake that they will protect themselves which could keep you from utilizing that path into the marketplace.
To read the letter in full, click HERE.
If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.