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FDA Warning Letter: Regulatory Concerns for Eye Health Products on

Date: 11/22/2023

amazon fda warning letter

In the realm of regulatory scrutiny, our attention is drawn to a recent development where Amazon is a central figure—the issuance of FDA warning letter about specific eye health products. Noteworthy among these are '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 gravity of the situation lies in the FDA's classification of these products as new, unapproved drugs, predicated on their intended use for diagnosing, treating, mitigating, or preventing diseases. Even those products labeled as homeopathic are not exempt from the purview of standard FDA regulations.

The crux of the matter:

Beyond the classification, there are substantial concerns regarding potential health risks associated with these products. Ophthalmic drugs, designed for direct ocular administration, are under heightened scrutiny due to their potential to circumvent the body's natural defense mechanisms.

For entities affiliated with these products on, a measured and expeditious response is imperative. The FDA advocates for immediate corrective action, emphasizing that overlooking these concerns may culminate in serious legal repercussions. What does this mean for stakeholders?

A swift and well-articulated response is paramount. Regardless of alignment with or dissent from the FDA's findings, a judicious and timely reply is indispensable. Given the potential implications for businesses intertwined with these products, navigating this situation with diligence is crucial.

This case serves as a stark reminder that strict adherence to FDA regulations is imperative for those selling medical devices, pharmaceuticals, cosmetics, dietary supplements, and other health-related products within the United States. It underscores the significant legal implications associated with non-compliance.

Industries seeking to export and sell products in the U.S. must diligently prepare by conducting comprehensive, specific, and professional research on FDA standards. This includes understanding the categorization of each product, identifying the applicable regulations, and navigating the intricate procedures and approvals mandated by the FDA.

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