If You See This on Your Supplement Label, Stop Taking It Now, FDA Warns
The agency is warning the products contain potentially dangerous hidden ingredients.
Thanks to their self-purported benefits, taking a daily supplement can feel like an easy way to help you stay on top of your health. But whether you're looking for an immune system boost or a way to keep your heart in good shape, there's a chance you may not be getting what you're paying for at best—or putting your health at risk at worst. Now, the Food and Drug Administration (FDA) is warning that customers should stop taking any supplement with specific words on their label. Read on to see which products could be putting you in harm's way.
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Supplements are not always guaranteed to be effective or safe.
It can be easy to assume that the dietary supplement bottles you see on shelves and advertised online contain a trustworthy product based on the industry's sheer size alone. According to data from the Centers for Disease Control and Prevention (CDC), 57.6 percent of adults aged 20 and over reported taking one within the past 30 days in 2017-2018. But despite their wide use, research has shown that the quality of the allegedly beneficial pills can be wildly inconsistent. One study published in the Journal of Clinical Sleep Medicine in 2017 found that out of 31 melatonin supplements tested, 71 percent of them differed from their advertised amounts, ranging from 478 percent more to 83 percent less than their label claims.
This may be because the process by which dietary supplements eventually end up on the market is also quite different from the path that prescription and over-the-counter (OTC) medicines have to take. Unlike approved drugs, the FDA only tests supplements for safety after they're released and is "not authorized to review dietary supplement products for safety and effectiveness before they are marketed."
Fortunately, there are some simple ways to tell when a specific supplement has been verified, including a seal of approval from the United States Pharmacopeial Convention posted on a product's label. The small green and yellow "USP Verified" seal indicates that the item has been independently vetted and determined to be free of harmful levels of contaminants or ingredients and "has been made according to FDA current Good Manufacturing Practices using sanitary and well-controlled procedures."
The FDA is warning to stop taking supplements from one company that uses these two words on their label.
Now, it appears there are still some products on the market that could potentially create health risks. On April 20, the FDA released a warning that any dietary supplements using variations of the words "Artri" or "Ortiga" in their names printed on labels should not be purchased or used.
The products, which are marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions, are sold on websites including Amazon and certain retail stores in the U.S.
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The supplements could contain dangerous unlisted ingredients that pose a serious health risk.
According to the warning, lab testing conducted by the FDA has found the supplements contain active drug ingredients not listed on their labels. The list includes dexamethasone, a corticosteroid that can cause changes in blood pressure, psychiatric problems, and damage to bones, especially when long-term use is suddenly stopped; methocarbamol, a muscle relaxant that can cause low blood pressure, dizziness, and sedation; and diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) that the agency warns can "cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines."
Besides the risks presented by the undeclared drugs themselves, they also pose a serious risk of interaction with other medications or OTC drugs that could have significant health consequences. The agency specifies the list of products that were found to contain the unlisted ingredients during testing so far includes Artri Ajo King, Artri King, Ortiga Mas Ajo Rey, and Ortiga Mas Ajo Rey Extra Forte. However, this likely means that other items produced by the company could also be contaminated.
"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 warns. "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."
Here's what you should do if you bought or have been taking the supplements.
Unfortunately, the FDA says it has received reports of adverse health effects potentially linked to the use of the supplements—including liver toxicity and death—since it first issued a warning about a product from the company on Jan. 5, 2022. The agency says its investigation of the product's distribution is ongoing, saying that it has warned certain companies against selling the supplements and that it "may take additional enforcement steps that may include warning letters, seizure, injunction, or criminal charges" against the producer.
The agency advises that anyone who may be experiencing adverse health effects from taking the supplements should report it to their healthcare provider or doctor immediately. They should also report it to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting a form online. Report forms can also be downloaded, completed by hand, and submitted by fax to 1-800-FDA-0178.
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