Amazon to stop selling 7 brands of eyedrops following FDA warning

The Center for Drug Evaluation and Research sent a letter to Amazon's CEO.

November 16, 2023, 11:52 AM

Amazon says it will stop selling seven brands of eyedrops after the CEO received a warning letter for selling "unapproved new drugs" on the popular shopping website.

The U.S. Food and Drug Administration (FDA) sent a letter to Andrew Jassy, Amazon’s chief executive officer, on Monday, detailing the sale of products with claims to help pink eye, dry eyes and eyestrain on Amazon that the FDA says violate federal regulations.

"Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and are in the process of being removed," an Amazon spokesperson told ABC News in an emailed statement.

The news of the letter to Amazon was first reported by the New York Times.

The seven eyedrops products distributed by Amazon included: 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.

"These products are especially concerning from a public health perspective. 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 FDA stated in the letter.

PHOTO: A woman puts an eye drop in to her eye in this undated stock photo.
A woman puts an eye drop in to her eye in this undated stock photo.
STOCK PHOTO/Getty Images

The agency also said that Amazon "is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs" citing the violation of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”).

All seven products fall into the FD&C Act "because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body," the FDA explained.

The FDA also went on to share examples of claims from the labels "that provide evidence of the intended use of these products as drugs."

Similasan Pink Eye Relief, for example has "pink eye relief" in the name and under "uses" on the drug facts label claims that the "active ingredients in this product temporarily relieve minor eye symptoms" including excessive watery (clear) discharge, sensation of grittiness, redness and burning.

Similasan USA did not immediately respond to ABC News' request for comment, nor did the other brands.

Click here to read the full letter and more about the claims on each product.

The FDA stated that all seven of the products in question "are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are 'new drugs.'"

According to the agency, "an ophthalmic unapproved new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect."

"No FDA-approved application pursuant to section is in effect for 'Similasan Pink Eye Relief,' 'The Goodbye Company Pink Eye,' 'Can-C Eye Drops, 'Optique 1 Eye Drops,' 'OcluMed Eye Drops,' 'TRP Natural Eye Floaters Relief,' and 'Manzanilla Sophia Chamomile Herbal Eye Drops.'"

The FDA again pointed to the FD&C Act for use of the term "drug," which it said "includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval."

The violations laid out by the FDA in the letter were "not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products" Amazon distributes.

Amazon, according to the FDA, is "responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations."

"Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction," the FDA warned.

Amazon has within fifteen working days of receipt of the FDA letter to notify the agency in writing of "specific steps" the firm has taken to correct any violations, including steps to ensure Amazon no longer makes those products available and copies of related documentation.

The letter was signed by Jill Furman, director of compliance for the Center for Drug Evaluation and Research within the FDA.

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