FDA Issues Warning to Amazon Over Sale of 7 Unapproved Eye Drops
The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a warning letter to e-commerce giant Amazon.com regarding the introduction of unapproved ophthalmic drug products into interstate commerce.
The FDA's warning, delivered in a letter released on November 13, 2023, was specifically addressed to Amazon's Chief Executive Officer, Andrew Jassy. The letter explicitly cautioned against seven eye drop products available on the platform.
These include 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 raise significant concerns from a public health standpoint. Ophthalmic drug items, designed for application directly into the eyes, present an elevated risk of potential harm to users due to the administration route bypassing some of the body's inherent defense mechanisms.
Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eye Floaters Relief, and Manzanilla Sophia Chamomile Herbal Eye Drops fall under the category of drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1). This categorization stems from their intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or their intended impact on the structure or any function of the body.
Examples of claims discerned on the labels and accompanying materials of these products, such as Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops,c OcluMed Eye Drops, TRP Natural Eyes Floaters Relief, and Manzanilla Sophia Chamomile Herbal Eye Drops, provide clear indications of their intended use as drugs. These claims, though not exhaustive, include:
1. 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”
2. The Goodbye Company Pink Eye
● In the name of the product – “Pink Eye”
● “New – Pink Eye Relief . . . Conjunctivitis (15 mL)”
3. 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.”
4. 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)”
5. 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.”
6. 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”
7. 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.”
“This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may 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. 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,” the FDA concluded.
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