The U.S. Food and Drug Administration this week warned Amazon.com Inc.
AMZN,
about the sale of unapproved eye drops marketed for the treatment of redness, pink eye, floaters and other conditions.
In a warning letter dated Monday, the agency told Amazon that seven eye products sold on its website, including Similasan Pink Eye Relief and OcluMed Eye Drops, are unapproved new drugs that are “especially concerning from a public health perspective.” Drug products that are put in the eyes “in general pose a greater risk of harm to users” because they can bypass some of the body’s natural defenses, the FDA wrote.
The other unapproved products cited in the FDA’s letter are Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops and TRP Natural Eyes Floater Relief.
The Amazon warning comes two weeks after the FDA said that over-the-counter eye-drop products marketed under brands including CVS Health Corp.
CVS,
Target Corp.
TGT,
and Rite Aid Corp.
RADCQ,
pose a risk of dangerous eye infections.
The FDA in September also warned CVS, Walgreens Boots Alliance Inc.
WBA,
and several smaller consumer-products companies about marketing unapproved eye products, including drops for allergies and pink eye.
Amazon must notify the agency within 15 working days of the steps it is taking to correct the violations, the FDA’s Nov. 13 letter said.
“Safety is a top priority at Amazon,” an Amazon spokesperson said in a statement to MarketWatch. “We require all products offered in our store to comply with applicable laws and regulations. The products in question have been investigated and are in the process of being removed.”
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