Herbal Pain Relief Tea Recalled for Having Undeclared Drugs
/By Pat Anson, PNN Editor
“Alleviates Pain & Inflammation Within 10 Minutes”
“Drug-Free All Natural Herbal Pain Relief”
As the saying goes, if the ads sound too good to be true, they probably are. Especially the part about being “drug-free.”
An herbal tea being marketed as a pain reliever for arthritis, gout, fibromyalgia and migraine is being voluntarily recalled after the Food and Drug Administration found that it contained “undeclared drugs.”
WS Global, a New York-based distribution company, is recalling all packages of Himalayan Pain Relief Tea after being informed by the FDA that the tea contains diclofenac, a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone, a corticosteroid.
The company said it had not received any reports of adverse events involving the tea, but urged consumers to “immediately consult their health care professional” if they consumed it.
In a news release, the FDA said diclofenac may raise the risk of cardiovascular events, such as a heart attack or stroke, and could interact with other medications.
Dexamethasone can suppress the adrenal gland, impair a person’s ability to fight infections, and cause high blood sugar, muscle injuries and psychiatric problems. It may also have serious side effects when combined with other medications.
Neither diclofenac or dexamethasone are mentioned on the tea’s product label or advertising. The company claims the tea was “formulated by a traditional comprehensive recipe from the Himalayan monks.”
Himalayan Pain Relief Tea was being sold online, primarily through Amazon.
This is not the first time that an herbal or dietary supplement sold by Amazon was recalled due to undeclared drugs, contamination or other health concerns. In recent months, recalls were also ordered for a male sexual enhancement product, a glucose supplement, apple sauce, and an anti-cavity mouthwash for kids. All were being sold on Amazon.
In a recent warning letter to Amazon’s CEO about selling several brands of unapproved eye drops, the FDA said the company should take more responsibility for the products it sells.
“The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” said Jill Furman, Director of the FDA Office of Compliance, Center for Drug Evaluation and Research.
Amazon complied with that request by removing the eye drops from its online marketplace.
“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations,” the company said in a statement.
Amazon received a similar warning letter in 2022, for selling a “misbranded” dietary supplement for arthritis that was linked to liver toxicity and at least one death. That product also contained diclofenac and dexamethasone.
You can still find Himalayan Pain Relief Tea on Amazon, with a notation that it is “currently unavailable.”
“We don't know when or if this item will be back in stock,” Amazon cautions potential buyers.
