FDA Issues Warning Letter to Amazon Over Sale of Unapproved Ophthalmic Products

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.

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“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:

• Similasan Pink Eye Relief
  • In the name of the product – “Pink Eye Relief”
  • On the Drug Facts label under “Uses” - “[T]he 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
  • In the name of the product – “Pink Eye”
  • “New – Pink Eye Relief…Conjunctivitis (15 mL)”
• Can-C Eye Drops
  • “Lubricant Eye Drops”
  • Under “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”
  • On the Drug Facts label under “Uses” – “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 six active antioxidants including Nacetylcarnosine for ocular health and clarity”
  • “Oclumed Nutritional Eye Dr…for Cataracts & Dry Eyes”
  • On the 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
  • In the name of the product – “Floaters Relief”
  • “Floaters/squiggly lines/dark dots/dust particles”
  • On the Drug Facts label under “Uses” – “[T]hese 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”
  • On the Drug Facts label under “Use” – “to refresh and replenish moisture to the eyes.”
  • On the product insert:
  • “Active Ingredient: Chamomile (Matricaria chamomilla L.) 3X HPUS” with “Purpose: Eye moisturizer”
  • Use: to refresh and replenish moisture to the eyes.”

“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.”

Reference

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.