Banned Eye Drops

FDA disallows Banned eye drops to sell on the E-commerce Platform

In a significant move to protect consumers, the U.S. Food and Drug Administration (FDA) has issued a stern warning to Amazon.com, urging the e-commerce giant to disallow the sale of seven banned eye drops on its platform.

The FDA’s action comes as part of ongoing efforts to ensure the safety and efficacy of over-the-counter medications, particularly those that pose a potential risk to US consumers.

The FDA’s Concerns:

In a letter dated November 13, 2023, the FDA highlighted its concerns over the sale of banned eye drops on Amazon that have not been recognized as safe and effective for providing temporary relief from common eye symptoms.

These symptoms include excessive watery discharge, redness, burning, or pink eye. The agency emphasized that products designed for ocular use pose an elevated risk of harm to consumers as they bypass some of the body’s natural defenses.

Previous Recommendations and Warnings:

This latest warning to Amazon follows the FDA’s recent recommendation to consumers to avoid using 26 over-the-counter eye drop products due to the risk of infection and potential cases of vision loss. The regulatory body has been actively addressing the sale of unapproved eye products, having previously warned eight companies, including major pharmacy chains CVS Health and Walgreens Boots Alliance, against manufacturing or marketing certain banned eye drops.

The Banned Eye Drops:

The FDA’s letter specifically mentions seven unapproved eye drops that are not allowed for sale on Amazon’s platform. These products include:

• Over-the-counter eye drop products marketed under the following brands:
  • CVS Health
  • Leader (Cardinal Health)
  • Rugby (Cardinal Health)
  • Rite Aid
  • Target Up & Up
  • Velocity Pharma

Examples of banned eye drops

1. Similasan Pink Eye Relief
2. Can-C Eye Drops
3. Optique 1 Eye Drops
4. OcluMed Eye Drops

The agency has deemed these products unsafe and ineffective for addressing eye symptoms, and their sale on Amazon poses a potential risk to the health and well-being of consumers.

Similasan’s Previous Compliance Issues:

Notably, Similasan, a privately held Swiss drugmaker, has been singled out in the FDA’s warning. The company had previously been instructed by the FDA to adhere to safety limits for levels of diethylene glycol or ethylene glycol, common contaminants in some medicines that could lead to lethal poisoning at higher concentrations.

Conclusion:

The FDA’s latest warning to Amazon underscores the agency’s commitment to safeguarding public health by ensuring that only approved and safe medications are available to consumers. As regulatory scrutiny intensifies on the sale of unapproved eye drops, both online platforms and pharmaceutical companies must adhere to established safety standards to protect the well-being of those seeking relief from common eye symptoms.