Amazon receives FDA warning for selling 7 unapproved eye drops

The FDA has issued a warning to Amazon.com, Inc. regarding the online platform’s “introduction into interstate commerce” of seven unapproved eye drop products for sale to consumers.

Let’s start with this warning.

Dated November 13, 2023, and addressed to Amazon CEO Andrew Jassy, the warning letter cautions against the use of these specific topical ophthalmic formulations (see below).

The reasoning: Significant concerns from a public health standpoint.

Now these products.

They include:

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
Manzanilla Sophia Chamomile Herbal Eye Drops

To note, Amazon distributed each of these products directly to U.S. consumers on behalf of third parties (described as being “fulfilled” by Amazon), according to the agency.

And the concerns?

According to the FDA’s Center for Drug Evaluation and Research (CDER), the category these ophthalmic products fall under indicates they are intended to be applied directly to the eye for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases, “and/or intended to affect the structure or any function of the body.”

However…?

However, given their unapproved—and, as a result, unverified status by the FDA—the seven eye drops have “a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”

So what do these products claim to treat?

Here's a brief rundown on each eye drop’s intention for use:

Similasan Pink Eye Relief
- Temporarily relieve minor eye symptoms like:
  - Excessive watery (clear) discharge
  - Sensation of grittiness
  - Redness and burning
The Goodbye Company Pink Eye
- Pink eye relief (conjunctivitis)
Can-C Eye Drops
- Lubricant for temporary relief of minor irritations to the eye and exposure to the sun and wind, etc.
Optique 1 Eye Drops
- Multi-symptom eye irritation relief (dry eye, allergies, eyestrain)
- Temporary relief of:
  - Minor eye irritation
    - Dry, red, itchy, and burning eyes due to:
      - Eyestrain and fatigue
      - Light and glare
      - Digital displays
      - Airborne irritants (pollen and dust)
OcluMed Eye Drops
- Formulated with six active antioxidants including N-acetyl-carnosine for “comprehensive ocular health nutrition” and clarity
- Active ingredients: N-Acetyl-Carnosine, L-Carnosine, L-Glutathione, L-Cysteine, L-Taurine, Riboflavin Monophosphate
TRP Natural Eye Floaters Relief
- Temporary relief for floaters and:
  - “Squiggly lines” in vision
  - Irritation
  - Dark dots in vision
  - Shapes in vision
  - Dust particles in vision

Manzanilla Sophia Chamomile Herbal Eye Drops

Refresh and replenish moisture to the eyes
Active ingredient: matricaria chamomilla L. (3X HPUS*)

*HPUS stands for Homeopathic Pharmacopoeia of the United States

And how are they currently classified by the FDA?

Important to know: Per the agency: none of the eye drops are not generally recognized as safe and effective (GRASE) for each of their claimed indications for use.

As such, the FDA considers them to be “new drugs”.

Meaning… ?

As a new drug, each product,”may not be introduced or delivered for introduction into interstate commerce without an approved application from (the) FDA in effect.”

In other words: no FDA-approved application for any of these products, which would allow for them to be commercially sold through platforms such as Amazon, is or has ever been in effect.

Aren’t four of these drugs considered homeopathic?

Yup they are! Those include:

Similasan Pink Eye Relief
Optique 1 Eye Drops
TRP Natural Eye Floaters Relief
Manzanilla Sophia Chamomile Herbal Eye Drops

However, the agency noted that homeopathic drugs are not exempted from any of the federal guidelines.

So what happens next?

In the warning letter, the FDA stated that Amazon is responsible for “investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.”

Further, the company is required to ensure it is complying with all federal law requirements—including FDA regulations.

Any deadline?

Yup! Amazon has 15 working days (from November 13, 2023) to respond to the agency’s requests with the following:

Specific steps for correcting any violations.
Details of steps taken to prevent a recurrence of these violations, including:
- Steps for no longer introducing, delivering, or causing the introduction or delivery into interstate commerce of the unapproved new drug products
  - Copies of related documentation

And if they don’t?

The FDA advised that if the company believes it’s not in federal violation with these drug products, it must include proper reasoning and any supporting information.

If the company is unable to respond within the 15-day period, it must also provide the reason for the delay and the new time period for a response.

Which leads me to my follow-up: has the company responded yet?

Funny you should ask: in response to a request for comment regarding this, an Amazon spokesperson told Glance that the products in question have been investigated and are in the process of being removed.“Safety is a top priority at Amazon,” the spokesperson stated. “We require all products offered in our store to comply with applicable laws and regulations.”

I could’ve sworn we just had eye drop recall and warning reports…

I know, right? Seems like just…. last month. In fact, just two weeks ago.

On October 31, the FDA warned consumers to immediately stop the purchase and use of 27 over-the-counter (OTC) eye drop products due to a potential risk for eye infections.

See here for our coverage on that, including details on the plethora of recalls and warnings that have ensued over the course of 2023.

*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.