5-7 December 2023
On 01 November 2022, the U.S. Food and Drug Administration (FDA) has published two Warning Letters, both dated 28 October 2022.
In the Warning Letter to Amazon.com, Inc. the agency writes that it purchased three products, “Artri Ajo King”, “Artri King Reforzado con Ortiga y Omega 3”, and “Ortiga Mas Ajo Rey”, via the amazon.com website. All products were introduced or delivered for introduction into interstate commerce by Amazon via the Fulfillment by Amazon service. The FDA then conducted laboratory analysis of these products. It came out that they contained the active pharmaceutical ingredient (API) diclofenac. This API was not listed on the product labels.
The FDA sees this as a potential health risk for consumers. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which may cause increased risk of cardiovascular events. According to the FDA, "the undeclared diclofenac ingredient in “Artri Ajo King,” “Ortiga Mas Ajo Rey,” and “Artri King Reforzado con Ortiga y Omega 3” may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products."
For Amazon, by the way, this was not the first Warning Letter. In August 2022, the FDA has issued another Warning Letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality.
The Warning Letter to Walmart Inc. also focuses on the product “Artri King Reforzado con Ortiga y Omega 3”. The FDA ordered it through the website www.walmart.com. The product was introduced or delivered for introduction into interstate commerce by Walmart via the Walmart Fulfillment Services.
Also in this case, laboratory analyses showed that the product contains diclofenac.
From a legal point of view, the FDA classifies the products as so-called “new drugs”, which may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA. In addition, the products are misbranded, because the labeling is false or misleading. Both aspects are explained in detail in the Warning Letters, with reference to the applicable legal provisions.
The FDA points out that Amazon and Walmart are responsible to ensure that they comply with all requirements of federal law, including FDA regulations. The FDA expects a written response from both companies within fifteen working days. Both firms were requested to include an explanation and documentation of each step being taken to prevent the recurrence of violations.