FDA issues warning letter to Amazon for selling unapproved eye care products

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In a letter addressed to Andrew Jassy, President and CEO of Amazon, the US Food and Drug Administration (FDA) issued a warning to the company regarding the sale of unapproved ophthalmic drugs.

Recently, the FDA urged customers to avoid a slew of eyedrops due to the possible risk of eye infections that could result in vision loss or blindness. This is just one of many times the FDA has issued a warning on unapproved ophthalmic products in 2023.

The letter specifies 7 drugs that Amazon is “responsible for introducing or delivering for introduction into interstate commerce” which are “unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a).” Furthermore, the letter states that the introduction of these products into interstate commerce is “prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).”

The list of ophthalmic drops included in the letter are:

• 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
• Manzanilla Sophia Chamomile Herbal Eye Drops

In the letter, the FDA warns Amazon that these products are especially concerning because “ophthalmic drug products, which are intended for administration into the eyes, in general, pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”

The listed drops are not generally recognized as safe and effective (GRASE) for their listed uses, says the FDA. The FDA defines these drugs as “new drugs,” and new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from the FDA (with certain exceptions).

The FDA warned Amazon that action must be taken within 15 working days of receiving the letter at risk of legal action. The FDA also requested “an explanation of each step being taken to prevent the recurrence of violations, including steps [Amazon] will take to ensure that [it] will no longer introduce, deliver, or cause the introduction or delivery into interstate commerce of, ophthalmic unapproved new drug products, as well as copies of related documentation.”¹

As of writing all of the products listed in the warning letter have been removed from Amazon and are unable to purchase.

References:

1. Warning letter to Amazon. Released November 13, 2023. Accessed November 16, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-665460-11132023