It has been revealed the fact that a new FDA warning forces Amazon to withdraw eye drop products. Check out the latest reports below.
FDA warning about eye drop products is out
Amazon has decided to remove some of its eye drop products from its platform after the US Food and Drug Administration (FDA) warned the company about the significant risks that these products pose to consumers.
On November 13, the FDA sent a “warning letter” to Amazon CEO Andrew Jassy, stating that certain eye drop products sold on the platform are “unapproved new drugs” and that selling them is prohibited for such items that are engaged in interstate commerce.
The agency pointed out that drug products intended for administration to the eyes pose a greater risk of harm to users, as the route of administration for these products bypasses some of the body’s natural defenses.
The FDA has warned that if the concerns expressed in the letter are not addressed, it may take legal action, including seizures and injunctions.
Amazon has confirmed that the products in question are being investigated and removed from their store. The company has stated that safety is their top priority, and they require all products to comply with laws and regulations. Amazon has 15 days to inform the agency of the specific steps taken to address 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.
According to a letter, the FDA was able to purchase certain products from Amazon. The products in question were introduced or delivered into interstate commerce by Amazon via its Fulfillment by Amazon service.
Some of these items are categorized as homeopathic drugs, and as such, are subject to the same statutory requirements as other medications.
This means that they are not exempt from FDA approval, and must comply with regulations regarding adulteration and misbranding.
