Oct. 24, 2023 – Certain products marketed for arthritis and pain management could contain hidden ingredients that could harm consumers, according to an FDA warning.
Some of these products have active ingredients found in prescription drugs.
“These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking,” the FDA said in a statement. “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers.”
Over 10 years of testing, the FDA identified 22 arthritis and pain products with ingredients not disclosed on the product label. These hidden ingredients can be active, meaning they have a direct effect on the body, or inactive, said Candy Tsourounis, PharmD, a professor in the Department of Clinical Pharmacy at the University of California, San Francisco. Ibuprofen, for example, is the active ingredient in Advil. Inactive ingredients are things like preservatives, flavoring, and dyes.
Unlike prescription medication and over-the-counter drugs such as loratadine (Claritin) or acetaminophen (Tylenol), supplements do not need FDA approval before they can be sold. The FDA can get involved only after a complaint is made or FDA testing reveals illegal or unsafe ingredients.
In this investigation, the FDA found prescription-only drugs, including steroids, nonsteroidal anti-inflammatory drugs, and muscle relaxants, in certain supplements, Tsourounis said.
Kuka Flex Forte and Reumo Flex — both promoted for joint pain and arthritis — both contain the NSAID diclofenac. Tapee Tea — a product promoted for pain relief—contains the steroid dexamethasone and the NSAID piroxicam. Diclofenac, dexamethasone, and piroxicam are all prescription drugs.
“It is interesting that these products have hidden ingredients that are used to reduce swelling and inflammation,” Tsourounis said. “I don’t know if this was intentional, but it seems suspicious that a product marketed to reduce joint pain and inflammation contains prescription-only ingredients that are used for this purpose.”
These types of medications can have serious side effects. Steroids can make the body less able to fight off infections. And in some patients, NSAIDs can lead to a higher risk of stroke or heart attack. Muscle relaxants can cause dizziness and drowsiness, and might make someone less able to do certain tasks, like driving or operating heavy machinery, Tsourounis said. These medications can also interact with other medications someone is taking or may cause allergic reactions.
These types of products likely target underserved and immigrant communities, said Pieter Cohen, MD, a primary care doctor and an assistant professor of medicine at Harvard University in Cambridge, MA, who studies dietary supplements. They might be sold in mom-and-pop shops or gas stations to people with limited access to health care or insurance, he said.
Tsourounis advises anyone taking any of the listed products to stop right away and contact their care team. They can provide safer recommendations for managing symptoms and may suggest testing, like checking kidney function. Any side effects or adverse events that could be related to the use of these products can be reported to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
The FDA warned that this list included “only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of arthritis and pain management products.”
To make sure supplements and other over-the-counter products are safe to use, Tsourounis recommended buying products from well-known retailers like Target or large pharmacies like CVS or Walgreens. Avoid buying products with labels in another language that you cannot read, and be wary of any product that offers miracle cures or relies on personal testimonies without evidence.
In general, do not make purchases based on any health claims on a product label, as companies selling supplements making these claims “don’t have to have any clinical data to back them up,” Cohen said.
Cohen also said you should stick with individual ingredients. “If you want echinacea, buy echinacea. Don’t buy a complicated mix that is supposed to be good for arthritis with 10 different botanical [ingredients]. That’s more likely to run into trouble,” he said.
Lastly, Cohen recommended buying supplements that are certified by the NSF or USP, both respected third-party testing organizations. “If it has an NSF or USP stamp, that gives us more certainty that what’s in the bottle is going to be what’s listed on label,” he said.
Tsourounis noted that if you are skeptical of a product, you can search the FDA’s health fraud database to see if that product shows up. You can also try calling the phone number on the product label.
“I always encourage people to call that number to see if somebody answers,” she said. “Sometimes, you can tell a lot about that company just by calling that number.”
