AK Forte recall highlights growing problem of drug-spiked joint pain products

A recall of AK Forte, a joint pain product flagged by the U.S. Food and Drug Administration for containing illegal drug ingredients, highlights a growing problem facing the dietary supplement industry: heightened prevalence of drug-tainted products that target joint pain.

On Oct. 8, C&A Naturistics, an online distributor of personal care and supplement products, issued a voluntary recall of AK Forte after FDA determined the products contained undeclared pharmaceutical drugs, including diclofenac, dexamethasone and methocarbamol.

“Products containing diclofenac, dexamethasone and methocarbamol cannot be marketed as dietary supplements,” per the recall. “AK Forte tablets is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.”

The affected products were being sold through the distributor’s online Etsy and eBay stores, according to the recall. C&A Naturistics told SupplySide Supplement Journal that it discontinued sale of AK Forte. Per the recall announcement, the product is marketed as a dietary supplement for arthritis and joint pain.

“We are taking all safety precautions and working closely with the FDA to keep our customers safe,” the company said in a statement. “I encourage all my colleagues in this industry to remove this item from the market for our consumers’ safety.”

According to the recall, C&A Naturistics has not received any reports of adverse events related to AK Forte.

FDA first targeted AK Forte in April 2023, when the agency issued a public notification alerting consumers to avoid the drug-laced joint pain product. In June 2023, more than a year before C&A Naturistics’ recall of AK Forte, FDA issued a warning letter to a California-based distributor, Suprimo Imports, for the sale of AK Forte and another product, Bob Marley Cannabis King, which purported to treat such conditions as arthritis, cancer and “Parkinson.”

An investigation by SupplySide Supplement Journal (formerly known as Natural Products Insider) revealed that Suprimo Imports continued sale of AK Forte until May 2024, nearly a year after FDA’s warning letter to the distributor.

Despite FDA’s efforts to remove AK Forte from the market, the product remains available for sale online. At the time of publication, Botanical-Be, an online distributor of dietary supplements and personal care products, includes AK Forte among its items for sale.

Botanical-Be, which did not immediately respond to a request for comment, voluntarily recalled a crop of products tainted with diclofenac in October 2023. The affected products, Artri King, Kuka Flex and Reumo Flex, were being sold as dietary supplements for relief of pain and inflammation associated with arthritis, according to Botanical-Be’s recall.

Dan Fabricant, Ph.D., CEO and president of the Natural Products Association (NPA), called the problem of illegal products like AK Forte popping up for sale by various distributors a “registration issue.”

“The problem with AK Forte is, where is it that they exist?” he said. “The product doesn’t matter. It’s the same offender — it’s the brands. The websites pop up [and] they go away.”

AK Forte in July 2023 was added to the red list of an FDA import alert and tied to a manufacturer in Santa Ana, Mexico. The manufacturer, Plantas Herbolarias de Mexico, had products refused at import on Nov. 23 and Nov. 28, 2022, and July 11, 2023, according to FDA’s Data Dashboard.

Trending: Drug-spiked joint pain products

According to James Kababick, founder and director of Flora Research Laboratories LLC, pharmaceutical adulteration of products targeting joint pain is a “big issue” and becoming more prevalent.

“We're seeing a lot more products that contain NSAIDs [nonsteroidal anti-inflammatory drugs], steroids and things like that marketed toward joint pain management,” he said.

Flora Research Laboratories has nearly 30 years’ experience in dietary supplement testing and, specifically, the detection of “clandestine” adulterants like pharmaceutical drugs and unapproved new drugs.

Diclofenac and dexamethasone — two of the drugs detected in AK Forte — are “very common” among the pharmaceuticals increasingly popping up in joint products, Kababick said.

As an NSAID, diclofenac may increase risk of cardiovascular events and gastrointestinal (GI) damage. In June, FDA detected undeclared diclofenac in two products marketed as dietary supplements, Infla-650 and Umary.

Methocarbamol and proton pump inhibitor drugs are other drugs common in joint products marketed as dietary supplements, Kababick added. Methocarbamol is a muscle relaxant and was also found in AK Forte. Proton pump inhibitor drugs are used to treat acid reflux and, per Kababick, may be used in joint products “with the idea of controlling side effects of the pharmaceuticals.”

Trinity Gold, a product promoted and sold for joint and muscle pain, was recently flagged by FDA for its contents of undeclared drugs, including diclofenac, acetaminophen and phenylbutazone. On Oct. 7, FDA issued a health fraud advisory warning consumers to avoid using or purchasing the product, which is available for sale on Trinity Gold’s website and possibly in some retail stores.

According to FDA’s advisory, phenylbutazone, an NSAID, was discontinued for human use in the U.S. due to the high risk potential.

“The most serious and life-threatening injury associated with phenylbutazone treatment is bone marrow toxicity, which occurs when the body does not produce enough red blood cells, white blood cells and/or platelets,” the advisory stated. “Certain types of bone marrow toxicity are reversible; however, in rare circumstances it can lead to death.”

The advisory went on to call Trinity Gold a “serious threat to consumers” that could lead to unintentional acetaminophen overdose, especially for consumers who use the product in combination with other acetaminophen-containing products.

Kababick said “misbranded products masquerading as all-natural” that contain undeclared drugs “really are concerning for consumers.”

On its website, Trinity Gold describes its product as “a blend of all-natural, hand-picked herbs that is formulated to naturally help your immune and skeletomuscular system function.” It goes on to state “the ONLY ingredients” in the product are nine natural ingredients, including herbs like shilajit (Asphaltum punjabianum) and ashwagandha (Withania somnifera).

Trinity Gold did not immediately respond to a request for comment.

“If a consumer thinks they're supplementing their health treatment with products that are designed to help support joint health, that's one thing, but then to receive very potent pharmaceuticals that could have life-threatening side effects is another,” Kababick said, “and not knowing you're taking that is quite alarming.”