FDA Issues Warning to Amazon Over Unapproved Ophthalmic Products

Credit: US Food and Drug Administration

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

• _{“Pink Eye Relief”}
• _{Drug Facts label under “uses”: “the active ingredients in this product temporarily relieve minor eye symptoms such as excessive watery (clear) discharge, sensation of grittiness, redness and burning”}

The Goodbye Company Pink Eye

• _{“Pink Eye”}
• _{“New – Pink Eye Relief…Conjunctivitis (15 ML)"}

Can-C Eye Drops

• _{“Lubricant Eye Drops”}
• _{Indications: “As a soothing eye drop, for temporary relief of minor irritations to the eye and exposure to sun and wind etc.”}

Optique 1 Eye Drops

• _{“Multi-symptom eye irritation relief - Dry Eyes, Allergies, Eyestrain”}
• _{Drug Facts label under use – “temporarily relieves minor eye irritation such as dry, red, itchy, and burning eyes due to: eyestrain and fatigue, light and glare, digital displays, airborne irritants (pollen and dust)}

OcluMed Eye Drops

• _{“Nutritional/Lubricant Eye Drops – formulated with 6 active antioxidants including Nacetylcarnosine for ocular health and clarity”}
• _{“OcluMed Nutrition Eye Dr…for Cataracts & Dry Eyes”}
• _{Product Insert – “OcluMed is a unique patented formula of specially blended eye nutrients including anti-oxidants and amino-acids that are designed to replace nutrients that diminish with age, disease, or trauma.”}

TRP Natural Eyes Floaters Relief

• _{“Floaters Relief”}
• _{“Floaters/Squiggly lines/Dark dots/Dust particles”}
• _{Drug Facts label under use: “These ingredients provide temporary relief from symptoms such as: floaters, squiggly lines in vision, irritation, dark dots in vision, shapes in vision, dust particles in vision”}

Manzanilla Sophia Chamomile Herbal Eye Drops

• _{“Refresh Your Eyes,” “Cleanses,” “Soothes”}
• _{Drug Facts label under use: “to refresh and replenish moisture to the eyes”}
• _{Product Insert: “Active Ingredient: Chamomile (Matricaria chamomilla L.) 3X HPUS with ‘Purpose: Eye moisturizer” and “Use: to refresh and replenish moisture to the eyes”}

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.

References

1. _{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.}
2. _{Iapoce C. FDA warns against eye drops from major brands due to infection risk. HCP Live. October 30, 2023. Accessed November 14, 2023. https://www.hcplive.com/view/fda-warns-against-eye-drops-major-brands-infection-risk.}