According to the letter, FDA officials purchased Similasan Pink Eye Relief, he 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, all of which are classified as unapproved new drugs by the FDA, on amazon.com
It is illegal for companies to introduce or deliver for introduction unapproved drugs into commerce, according to the Nov. 13 letter.
“These products are especially concerning from a public health perspective. 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 defenses,” officials wrote in the letter.
The unapproved eye drops are considered drugs by the FDA because they are intended to diagnose, cure, mitigate, treat or prevent disease.
The FDA claims that statements on the labels of the unapproved eye drops suggest that they are intended for use as drugs.
Statements include “pink eye relief,” “lubricant eye drops,” and “eye irritation relief.”
“The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” the letter reads.
If Amazon fails to notify the FDA of specific steps taken to address violations within 15 days, the FDA is approved to take legal action.
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