Amazon says it will stop selling seven brands of eye drops after its 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 Amazon CEO Andrew Jesse on Monday detailing sales of products claiming to help with pink eye, dry eyes and eye strain on Amazon that the FDA says violate federal regulations.
“Security is a top priority at Amazon.” We require that all products offered in our store 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.
News of the letter to Amazon was first reported by the New York Times.
The seven eye drops distributed by Amazon included: Similasan Pink Eye Relief, The Goodbie Company Pink Eye, Can-C Eye Drops, Optikue 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief and Manzanilla Sophia Herbal Eye Drops chamomile eyes.
“These products are of particular concern from a public health standpoint.” Ophthalmic drugs, which are intended for administration to the eyes, generally pose a higher risk of harm to users because the route of administration of these products bypasses some of the body’s natural defenses. “, the FDA said in the letter.
The agency also said Amazon is “responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs,” alleging violations of the Federal Food, Drug, and Cosmetic Act (FDAct of &C).
All seven products belong to FD&C Act “because they are intended for use in the diagnosis, treatment, mitigation, treatment, or prevention of disease, and/or are intended to affect the structure or any function of the body,” the FDA explained.
The FDA also shared examples of label claims “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 claims under “uses” on the drug facts label that “the active ingredients in this product temporarily relieve minor eye symptoms,” including excessive watery (clear) discharge , feeling of grittiness, redness and burning sensation.
Similasan USA did not immediately respond to ABC News’ request for comment, and neither did the other brands.
Click here to read the full letter and more about the claims for each product.
The FDA stated that all seven products in question “are not generally recognized as safe and effective for their above uses and therefore these products are ‘new drugs.’
According to the agency, “a new unapproved ophthalmic drug may not be introduced or supplied for introduction into interstate commerce without a valid FDA application.”
“No FDA-approved application under the section is in effect for ‘Similasan Pink Eye Relief,’ ‘The Goodbie Company Pink Eie,’ ‘Can-C Eye Drops, ‘Optikue 1 Eye Drops,’ ‘OcluMed Eye Drops eyes’, ‘TRP Natural Eye Floaters Relief’ and ‘Manzanilla Sophia Chamomile Herbal Drops’.”
FDA again pointed to FDThe &C Act for the use of the term “medicine”, which is stated “includes articles recognized in the Official Homeopathic Pharmacopoeia of the United States (HPUS), or any supplement thereof. Homeopathic medicines are subject to the same legal requirements as other medicines; nothing in FDThe &C Act exempts homeopathic medicines from any of the requirements related to adulteration, misbranding, or FDA approval.”
The violations the FDA outlined in the letter “were not intended to be an all-inclusive statement of past or present violations that may exist in connection with products that Amazon distributes.”
According to the FDA, Amazon is “responsible for investigating and determining the cause 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 injunctive relief,” the FDA warned.
Within fifteen business days of receiving the FDA’s letter, Amazon must notify the agency in writing of the “specific steps” the firm has taken to correct any violations, including steps to ensure that Amazon no longer makes those products available and copies of related documentation.
The letter was signed by Jill Furman, director of compliance for the FDA’s Center for Drug Evaluation and Research.
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