FDA sends warning letter to Amazon

Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means the agency has identified what it calls “breaches of regulatory significanceand that you (as the recipient) must take corrective action or risk inviting actual enforcement under the Food, Drug and Cosmetic Act (FD&C Act), which could include injunctions, seizures and criminal penalties.Because they are advisory in nature and otherwise releasable under the Freedom of Information Act, with appropriate redactions, the FDA proactively posts warning letters on its website. here. Therefore, even when a company can quickly correct cited violations and otherwise avoid more serious enforcement under the law, warning letters can damage reputation and trigger breach of contract or other forms of harm. commercial for the recipient.

Historically, the FDA sends warning letters regarding the production, sale, and distribution of unapproved drug products to the manufacturer or labeler of those products, asking them to take immediate action to remove those products from the market. But a recent letter sent by the FDA to online retail giant Amazon.com warns that the agency may be adding new tools to its arsenal in the perpetual fight to protect American consumers from adulterated, mislabeled and potentially dangerous. He also points to the fact that FD&C law broadly prohibits any action that places unapproved products into the stream of commerce, reminding online fulfillment services and retailers that they have independent responsibilities to ensure that regulated products by the FDA that they offer comply with all applicable federal laws. .

The August 4, 2022 Warning Letter to Amazon states that the FDA may have purchased unapproved mole and skin tag pharmaceutical products from the online platform, and that these products were subsequently “introduced or delivered for introduction into interstate commerce by Amazon through your service Fulfillment by Amazon”. The agency’s Press release related to this recent action – which also included two warning letters to marketers of these unapproved mole removal and skin tag products – emphasized that the FDA is “working to identify threats to public health and prevent these products from to reach our communities [including] where online retailers like Amazon are involved in the interstate sale of unapproved pharmaceuticals.

Some of you may be wondering how Amazon could be responsible for unapproved pharmaceutical products sold by independent companies that simply use the online platform to market their products. The main facts that led to this missive from the FDA were not that the products could be purchased through the Amazon.com site, but rather that Amazon stores the products on behalf of the sellers and then packages and ships them directly to the consumer buyer after an order is placed. These actions mean that Amazon – and not the independent seller – is the entity “responsible for the introduction, delivery or introduction or delivery into interstate commerce” of products that are considered under the FD&C law as unapproved new drugs.

Consider, however, whether the sellers in question would not be able to market these products to consumers using other channels, even if Amazon cracked down on their ability to offer unapproved products through the Amazon.com marketplace. We also wonder what kinds of controls and systems the FDA would consider sufficient for an fulfillment service like the one made available by Amazon to prevent such products from entering commerce. Would written certificates of compliance with the laws registered by each seller suffice? We know that Amazon employs people who perform informal regulatory reviews of certain device products and require assurances that those products comply with applicable FDA regulations, but should Amazon assure the FDA that all products potentially regulated would be subject to such a review?

These will no doubt be major topics for negotiation and discussion between the retail giant and the FDA following the recent warning letter, which ends with the request that Amazon include in its response “a explanation of each action taken to prevent recurrence”. of offences. If additional news emerges regarding the FDA’s expectations for this type of company, we’ll let you know!

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC All rights reserved.National Law Review, Volume XII, Number 234

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