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Sent on November 13, 2023, the FDA letter warns Amazon on the introduction of unapproved new eye drop products into interstate commerce on their website.
The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a warning letter to Amazon.com, Inc. regarding unapproved new ophthalmic drug products introduced into interstate commerce.1
Released on November 13, 2023, the letter, addressed to Andrew Jassy, chief executive officer of Amazon, warned against 7 eye drop products fulfilled by the website, 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.
The warning letter noted Amazon is responsible for the introduction or delivering for introduction into commerce these unapproved products under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a).
“You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations," wrote the FDA. "It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.”
Each of the 7 ophthalmic products indicated in the letter are drugs defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), as they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure of any function of the body.1
According to the agency, the claims on the labels and labeling provide evidence of the intended use of these products as drugs:
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
As these products are not recognized as safe and effective for their referenced uses, the letter noted these products fall into the “new drug” category under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Barring certain exceptions, the FDA indicated a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from the agency.
The letter recognized these products were labeled as homeopathic drugs with active ingredient(s) measured in homeopathic strengths. Citing section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the agency indicated homeopathic drug products are subject to the same statutory requirements as other drugs. They noted no exemption in the FD&C Act for homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.
The FDA indicated the letter serves as a notification for Amazon and will provide the company an opportunity to address these concerns. However, failure to do so could result in legal action including, without limitation, seizure and/or injunction.
“Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations,” the FDA wrote. “Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon 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.”
Previously, on October 27, 2023, the FDA released a warning for consumers to avoid purchase and to immediately stop the use of 26 over-the-counter eye drop products, including from CVS, Target, and Rite Aid, due to the potential risk of eye infection leading to partial vision loss or blindness.2
The FDA has emphasized the potential impact of hazardous eye drops on public health. Ophthalmic drug products intended for administration into the eye can pose a greater risk of harm to users as they bypass many of the human body’s natural defenses.