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The FDA sent a warning letter to Amazon on November 13, stating that the seven eyedrops products were “unapproved new drugs”under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).The FDA said that the eyedrops had not been approved by the agency because they had not been shown to be safe and effective.
The seven eyedrops products that Amazon has removed from its website 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
- Manzanilla Sophia Chamomile Herbal Eye Drops
The FDA said that it was concerned about the safety of the eyedrops because they could potentially cause serious side effects, such as infection, vision loss, and allergic reactions. The agency said that it was especially concerned about the safety of the eyedrops because they were being sold online, where consumers may not be aware of the risks associated with using unapproved drugs. “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 defences,” the agency told Amazon in the letter
What Amazon has to say
Amazon said that it was taking the FDA’s warning seriously and that it was removing the seven eyedrops products from its website. The company said that it was working with the FDA to resolve the issue. “We require all products offered in our store to comply with applicable laws and regulations,” an Amazon spokesperson was quoted in online reports. “The products in question have been investigated and are in the process of being removed.”
The FDA is continuing to investigate the safety of the seven eyedrops products and is taking steps to ensure that they are no longer being sold online.
This is not the first time that Amazon has been warned by the FDA about selling unapproved drugs. In 2019, the FDA warned Amazon about selling a number of dietary supplements that were being falsely advertised as being able to treat or cure serious diseases.
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