Amazon has announced the discontinuation of sales for seven brands of eyedrops following a warning letter received by the CEO regarding the retail of “unapproved new drugs” on the popular e-commerce platform.
On Monday, the U.S. Food and Drug Administration (FDA) sent a letter to Andrew Jassy, Amazon’s CEO, outlining the sale of products claiming to address pink eye, dry eyes, and eyestrain on Amazon, which the FDA asserts violate federal regulations.
In response, an Amazon spokesperson conveyed, “Safety is a paramount concern at Amazon. We mandate that all products available in our store adhere to relevant laws and regulations. The identified products are under scrutiny and are in the process of being removed,” as stated in an email to ABC News.
The New York Times initially reported the FDA’s letter to Amazon. The seven eyedrop products affected by Amazon’s decision include 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.
“The FDA emphasized the heightened public health risk associated with these products. According to the letter, ophthalmic drug products designed for eye administration present an elevated potential for harm to users, as the route of administration bypasses certain natural defenses within the body.”
The agency asserted that Amazon is accountable for introducing or facilitating the introduction of these products into interstate commerce, labeling them as “unapproved new drugs” and citing a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
All seven products are deemed to fall under 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,” clarified the FDA.
Furthermore, the FDA provided instances of claims from the product labels that serve as evidence of their intended use as drugs.
For instance, Similasan Pink Eye Relief, with “pink eye relief” in its name and stating 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 and the other brands did not respond immediately to ABC News’ request for comment.
The FDA declared that the seven products under scrutiny “lack general recognition as safe and effective for their mentioned purposes, making them categorized as ‘new drugs.'”
As per the agency, “an ophthalmic unapproved new drug cannot be introduced or distributed in interstate commerce without a valid FDA-approved application in place.”
“‘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’ do not have an FDA-approved application in effect pursuant to the relevant section.”
Once again, the FDA referred to the FD&C Act in relation to the use of the term “drug,” emphasizing that it encompasses items acknowledged in the official Homeopathic Pharmacopeia of the United States (HPUS) or any of its supplements. Homeopathic drug products, the FDA clarified, are subject to the same statutory requirements as other drugs, with no exemption from FD&C Act provisions pertaining to adulteration, misbranding, or FDA approval.
The enumerated violations in the FDA’s letter were clarified as “not intended to be an exhaustive account of past or current infractions associated with the products” distributed by Amazon.
The FDA holds Amazon accountable, stating that the company is “obligated to investigate and ascertain the causes of any violations and to prevent their recurrence or the occurrence of other violations.”
A cautionary note from the FDA warned that the failure to adequately address the matter might lead to legal action, encompassing seizure and/or injunction.
Amazon is given a window of fifteen working days from receiving the FDA letter to inform the agency in writing of the “specific steps” taken to rectify any violations. This includes measures to ensure the unavailability of the mentioned products on Amazon and the submission of relevant documentation.
Jill Furman, the Director of Compliance for the Center for Drug Evaluation and Research within the FDA, endorsed the letter.
