Amazon warned by FDA over unlicensed medicines

The FDA has sent a warning letter to Amazon, taking the retail giant to task for distributing ophthalmology products that it says are new, unlicensed medicines.

The products in question are sold under a range of brand names, including Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief and Manzanilla Sophia Chamomile Herbal Eye Drops, says the letter, which is addressed to Amazon chief executive Andrew Jassy.

“These products are not generally recognised as safe and effective for their claimed uses, including temporary relief of minor eye symptoms such as excessive watery (clear) discharge, sensation of grittiness, redness and burning, or pink eye,” according to the regulator.

“These products are categorised as ‘new drugs’ under the Federal Food, Drug & Cosmetic Act,” it continues, adding: “Your firm is responsible for introducing or delivering for introduction into interstate commerce these products,” including via its Fulfilled By Amazon channel.

Ophthalmic drug products are especially concerning from a public health perspective, says the latter, as products intended for use in the eyes generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defences.

It’s the second letter sent to Amazon about unapproved new drugs, coming after the company was warned about products claiming to treat viral skin infection molluscum contagiosum on its platform. It also received two letters last year regarding dietary supplements containing non-steroidal anti-inflammatory drug (NSAID) diclofenac and mole and skin tag remover products.