Amazon Gets an FDA Warning Letter for Distributing of Unapproved Injectable Drug Products
The letter was sent directly to CEO Andy Jassy.
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The FDA has increasingly cracked down on online retailers for selling unapproved products, and a March 3 warning letter to Amazon highlights familiar concerns.
Read the full warning letter here.
According to the letter, the agency was able to purchase multiple “injectable lipolytic drug products” through Amazon’s platform, which were then distributed in interstate commerce. Since these products are classified as drugs under federal law, they require FDA approval—and, in this case, a prescription—to be legally sold.
More specifically, the letter stems from an investigation in which the FDA purchased three products through Amazon's website:
"LemonBottle Ampoule Solution"
"L-Carnitine Body Serum Ampoule"
"Matrigen PPC Ampoule"
These products were distributed through Amazon's Fulfillment by Amazon (FBA) service, where Amazon handles storage, packaging, shipping, and customer service for third-party sellers.
According to the warning letter, these products qualify as drugs under federal law because they are marketed with claims to affect the structure or function of the body—specifically, to dissolve, remove, or eliminate fat tissues. The FDA provides detailed evidence of these claims from product labels, linked websites, and social media accounts.
For instance, the LemonBottle product is marketed on Instagram as a "non-surgical alternative to liposuction," while the Matrigen PPC Ampoule claims to offer "permanent fat removal treatment" through a multi-step process.
The agency’s letter expresses particular concern about these products because they are injectable, bypassing the body's natural defenses against toxins and microorganisms. This delivery method significantly increases the risk of serious and potentially life-threatening conditions for consumers.
The FDA explains that these products violate Sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act because they are "new drugs" without FDA-approved applications. And under federal law, new drugs require proper approval before they can be legally introduced into interstate commerce.
What makes this case notable is the FDA's position on Amazon's central role in the distribution chain. Rather than treating Amazon merely as a neutral marketplace, the agency holds Amazon directly responsible for introducing these unapproved drugs into interstate commerce through its fulfillment services. The letter quotes Amazon's own description of the FBA program: "we'll pick, pack, and ship orders, as well as handle customer service and returns."
A few thoughts
We see this enforcement approach possibly extending well beyond just injectable products to platforms fulfilling uncleared medical devices, cosmetics making drug claims, supplements promising to treat diseases, unauthorized prescription medications, and even digital health products.
The important shift here is treating fulfillment services as active participants in distribution, not just neutral intermediaries. By storing, packing and shipping products, these platforms are now being held accountable for what they're actually putting into commerce.
Perhaps what's most telling is the FDA targeting a major platform rather than just the countless small manufacturers. They’re pursuing arguably the biggest choke point in the supply chain for maximum impact. This could fundamentally change how e-commerce platforms approach product screening and compliance.
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