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#ORTIGA MAS AJO REY SIDE EFFECTS SKIN#

Both letters containing the following language: “As discussed below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce.

FDA is again referencing a similar line of reasoning in its Warning Letters to Amazon and Walmart: Even though the companies don’t directly sell the products, they are intrinsically involved through their fulfillment services.

FDA’s argument in the August 2022 letter was that the introduction or delivery of unapproved new drugs into interstate commerce is a prohibited act, and Amazon is “responsible for introducing, delivering or causing the introduction or delivery” of such products into interstate commerce. That places a far more serious duty on fulfillment services to closely police their platforms. Rather, it’s that the FDA could potentially take future action against platforms for the introduction or delivery of products that violate federal law.

#ORTIGA MAS AJO REY SIDE EFFECTS SKIN#

As AgencyIQ noted in August 2022 when Amazon first received a similar letter warning the company about the sale of products intended for mole and skin tag removal, the risk to the company isn’t the sale of any one product.

Rather, they’re part of the third-party marketplace that both companies support which permits other companies to list their products for sale, and then Amazon or Walmart will fulfill the sale through their logistics network.

These products aren’t sold by Amazon or Walmart directly.

There are a few reasons these letters are especially interesting

The products were marketed as dietary supplements, meaning they could not legally contain an approved drug ingredient since diclofenac had first been approved in 1988 – before the marketing of this product. Referring back to its prior public warnings, the regulator explained that its concerns were related to the undeclared drug ingredients found in the purchased samples, which were confirmed by FDA to contain diclofenac. As FDA’s letter explains, FDA officials were able to purchase all three products from Amazon’s website, and one of the products from WalMart’s website.These ingredients can cause serious metabolic, cardiovascular, renal, and gastrointestinal side effects when not used properly. FDA warnings about all three cite undeclared drug ingredients, including diclofenac, a prescription non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid. The products, “ Artri Ajo King Reforzado con Ortiga y Omega 3,” “ Artri King Reforzado con Ortiga y Omega 3,” and “ Ortiga Mas Ajo Rey,” have previously been flagged by the FDA as being dangerous.

As is FDA’s tradition, both letters were sent to the companies’ respective CEOs, Doug McMillon (Walmart) and Andy Jassy (Amazon). Both letters were sent by the FDA on Octoand refer to similar products sold on both companies’ websites.The letters are the latest – and highest-profile – efforts by the FDA to encourage online retailers to better police their web platforms to prohibit the illegal sale of products known to contain prohibited drug ingredients or make improper claims. The FDA last week sent two Warning Letters to Amazon and Walmart, respectively, regarding products that are sold on the companies’ online platforms.