Do Not Buy Supplements Under These Brand Names, FDA Says in New Warning

The FDA regularly warns consumers about potential risks with supplements.

The FDA does not authorize the safety and effectiveness of dietary supplements before they are marketed to consumers. In fact, the agency has warned that companies can legally start selling most supplements without even notifying them. Once these supplements are on the market, however, the FDA is responsible for enforcing regulations to ensure consumer safety, which it does through things like inspections and marketplace monitoring.

This delayed inspection does make it possible for unsafe products to make it into the hands of consumers. "Dietary supplements can be beneficial to your health, but they can also involve health risks," the FDA warns.

Now, the agency is reaching out to the public and retailers alike to warn about specific supplements that could put you at risk.

The agency is calling out major retailers for selling certain supplements.

On Oct. 28, the FDA sent warning letters to two major retailers about their supplement supply. The notices were addressed to Walmart CEO Doug McMillon and Amazon CEO Andy Jassy, warning both executives about their retailers' distribution of the supplement product Artri King Reforzado con Ortiga y Omega 3. (Amazon was also notified about the company's distribution of Artri Ajo King Reforzado con Ortiga y Omega 3 and Ortiga Mas Ajo Rey products).

According to the FDA, these products are misbranded drugs that violate the Federal Food, Drug, and Cosmetic (FD&C) Act. And the supplements are "not generally recognized as safe and effective" as a result of these violations, per the agency. Despite that, the FDA said it was able to purchase the products from both Walmart and Amazon's websites, with both retailers distributing the products "directly to individual U.S. consumers on behalf of third parties."

You should not purchase or use any of these products.

Supplements with variations of the names "Artri" or "Ortiga" are generally promoted as treatments for arthritis, muscle pain, osteoporosis, and bone cancer, according to the FDA. But the agency warns that products marketed under these two brand names could potentially contain "dangerous hidden active drug ingredients" that are not listed on the product label. Laboratory analysis revealed that certain Artri and Ortiga products contained the following undeclared drug ingredients: dexamethasone, diclofenac sodium, and methocarbamol.

These ingredients can cause serious adverse events, such as infections, heart attack, stroke, sedation, and changes in blood pressure. The FDA said it has received multiple adverse event reports as a result of undeclared drug ingredients in these supplement. This has included reports of liver toxicity and death associated with the use of Artri King products.

Consumers are being warned not to purchase or use products marketed under any variation of the name Artri or Ortiga due to these problems. "FDA urges consumers taking these products to immediately talk to their health care professional (e.g., doctor) to safely discontinue use of the product because suddenly stopping these drugs may be dangerous," the agency adds.

The FDA says Artri and Ortiga supplements might still be on the market despite recalls.

Another smaller retailer, Latin Foods Market, was also sent a warning letter for its distribution of these brands' unapproved and misbranded drug products. But according to the FDA, two of the retailers have already issued voluntary recalls for these supplements. Walmart voluntarily recalled all lots of Artri Ajo King Joint Supplements sold by Innovacion Naturals and PDX Supply Warehouse LLC on its website in late May. And Latin Foods Market voluntarily recalled one lot of Artri King Reforzado con Ortiga y Omega 3 tablets in June.

The FDA has been warning consumers about the dangers of Artri and Ortiga supplements since Jan. 2022. But in its newest update, the agency said it issued warning letters to Amazon and Walmart on Oct. 28 "in support of public safety and because some of these products may still be available on the market."

"Products marketed as dietary supplements that are found to have hidden drug ingredients generally fail to comply with most current good manufacturing practices designed to ensure product quality and safety," the FDA said. "Therefore, consumers should expect the manufacturing processes for Artri and Ortiga products are unreliable in providing consistent amounts of active ingredients or to prevent the introduction of unknown chemicals or other impurities."

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