The eye drops listed in the warning letter are defined as drugs because they are intended to use for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure of any function of the body.
The FDA’s Center for Drug Evaluation and Research (CDER) issued a warning letter regarding the sale and distribution of eye drop products sold by Amazon.com. The letter, issued on November 13, 2023, to Amazon CEO Andrew Jassy, addresses seven ophthalmic products sold through the company’s 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.
“These products which are drugs defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service,” the FDA wrote in the letter to Jassy. “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 eye drops listed in the warning letter are defined as drugs by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are intended to use for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure of any function of the body.1
The FDA stated that the following claims on product labels for these products is evidence of their intended use as medications:
“You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations," the FDA stated in the letter to Jassy. "It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.”
Because the products have not been recognized as safe and effective for the listed uses, the FDA stated these products are classified in the “new drug” category under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Outside of certain exceptions, the FDA mandates that a new drug cannot be introduced or delivered for introduction into interstate commerce without an approved application from the agency.
The FDA noted that the eye drops were labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. Under FDA guidelines, homeopathic drugs are subject to the same statutory requirements as other drugs and there are no exemptions for homeopathic products from the requirements addressing the adulteration, misbranding, or FDA approval in the FD&C Act.
The FDA will provide Amazon with an opportunity to address the concerns listed in the letter, but failing to take action could lead to legal action.
“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 stated in the letter. “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.”
Center for Drug Evaluation and Research. Amazon.com, inc. - 665460 - 11/13/2023. U.S. Food and Drug Administration. November 13, 2023. Accessed November 14, 2023. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-665460-11132023.