Amazon is pulling some eye drop products after the U.S. Food and Drug Administration (FDA) warned the e-commerce platform about the significant risks posed by the items to consumers.
Drug products intended for administration to the eyes generally pose “a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses,” the agency added.
The FDA said that failure to address concerns expressed in the letter “may result in legal action including, without limitation, seizure and/or injunction.”
Safety is a “top priority” at the company, the spokesperson said, adding, “We require all products offered in our store to comply with applicable laws and regulations.”
Amazon has 15 days from the receipt of the letter to notify the agency about the “specific steps you have taken to correct any violations.”
“Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce, deliver, or cause the introduction or delivery into interstate commerce of, ophthalmic unapproved new drug products, as well as copies of related documentation.”
The letter cited seven eye drop products: 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.
These products are “not generally recognized as safe and effective” for their labeled uses. As such, they are classified as “new drugs” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
“With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect.”
However, the FDA was able to buy the products through Amazon, the letter states. These drugs “were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.”
Some of the items are categorized as homeopathic drugs and are subject to the same statutory requirements as other medications. They enjoy no exemption under the FD&C Act when it comes to adulteration, misbranding, or FDA approval.
The FDA insisted that Mr. Jassy is responsible for ensuring that “your firm complies with all requirements of federal law, including FDA regulations.” Amazon is obliged to investigate and determine the cause of any violation of FDA rules and prevent such violations from recurring, the letter stated.
Eye Drop Infections
The FDA’s letter to Amazon comes weeks after the agency issued a warning to consumers not to purchase and use 26 over-the-counter eye drop products “due to the potential risk of eye infections that could result in partial vision loss or blindness.”The products were marketed under six brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma. The list has now been updated to 28 items.
“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.”
A few days earlier, the FDA asked customers not to buy two products that contained methylsulfonylmethane (MSM) as an active ingredient. “There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient,” the agency said at the time.
“And assuming that the drops that we have at home are not on any recall list, are from reputable companies that are producing eyedrops at the highest level of quality and with the oversight of the F.D.A. and other companies that monitor manufacturing, then it is 100 percent perfectly safe to continue using those drops.”
Amniotic fluid is the substance that surrounds the embryo and fetus. Some researchers have stated that the fluid could help heal eye issues. However, a clinical trial that analyzed eye drops containing amniotic fluid found it did not offer any healing properties.
In an interview with MedPage Today, Paul Knoepfler, a professor at the University of California, Davis, said that amniotic fluid eye drops could contain substances harmful to the eyes.
“The drops likely contain hundreds of different fetal proteins and other substances, which don’t necessary just do helpful things, so there are definite risks,” he said.
“For example, I could imagine a risk of abnormal blood vessel or other undesired tissue growth in the eye after using such drops due to growth factors in the drops.”
