Study warns of tainted dietary supplements in US market – UPI News | Region & Cash

New research suggests consumers need to exercise caution when purchasing herbal supplements because the Food and Drug Administration’s warnings may go unheeded by manufacturers who bring tainted products to the U.S. market. Photo by Creative Commons

July 26 (UPI) — The warning letters from the Food and Drug Administration are doing little to stem the flow of dangerous dietary supplements contaminated with unapproved stimulants into the US market, new research suggests.

After the FDA warned dietary supplement manufacturers about certain products and called for corrective action, researchers found that 29% of tainted products were still available for purchase years later, with most containing a banned ingredient.

Those findings are included in an article published Tuesday in the Journal of the American Medical Association, which analyzed some dietary supplements labeled with “analogues of amphetamine, ephedrine, and other drugs…associated with serious health risks, including hemorrhagic stroke and sudden death.” have been falsified. “

According to the latest data from the Centers for Disease Control and Prevention, 57.6% of US adults age 20 and older nationwide have used a dietary supplement in the past 30 days, the researchers said. Consumption was higher among women at 63.8% than among men at 50.8%.

In the new study, the researchers said they didn’t know whether FDA warning letters prompted manufacturers to recall or reformulate products. Therefore, they assessed the frequency of product recalls and the presence of FDA-banned drugs in dietary supplements after the agency issued warning letters.

FDA spokeswoman Courtney Rhodes told UPI in a statement, “The FDA is committed to advancing our strategic priorities for dietary supplements: safety, product integrity, and informed decision-making.”

She added: “We appreciate studies like this one to raise awareness and bring needed attention to these matters. In general, however, the FDA does not comment on specific studies, but instead evaluates them as part of the body of evidence to enhance our understanding of a particular issue and assist in our mission to protect public health.”

Warning letters are posted by the FDA on its website, Rhodes said, and product recalls are posted publicly online in the agency’s enforcement reports.

The study included dietary supplements that were previously the subject of an FDA warning letter for containing the amphetamine analog known as BMPEA, the ephedrine analog methylsynephrine, or the dimethylamylamine analog octodine known as DMHA.

The FDA issued warning letters targeting the presence of these three stimulants found in 31 dietary supplements in 2015, 2016, and 2019, respectively, according to the research paper.

The researchers found that only one product was recalled by the manufacturer, while nine, or 29% on average, were still available online six years after FDA warning letters were issued.

In its warning, the FDA requires manufacturers to promptly notify the agency of steps to take to correct the violation and prevent similar violations in the future.

“This is really an alarming result because what we have seen over the years is that dietary supplement manufacturers use lax laws” to introduce illegal, experimental foreign drugs into the market [U.S.] market, said Dr. Pieter A. Cohen, the study’s lead author, told UPI in a phone interview on Tuesday.

“By not following up on their warning letters, the FDA continues to put people at risk,” he said.

Cohen said manufacturers “can’t just buy powder from China and put it in a dietary supplement,” but he claimed they often don’t test products to make sure all the ingredients are known and safe.

He said he’s concerned the risks almost certainly extend beyond the three stimulants analyzed in his small study.

“This is just the tip of the iceberg,” Cohen said, describing the study as a “careful look at a small subset” of “well over 1,000” dietary supplements on the U.S. market that are known to be laced with experimental drugs .

“We have only purchased dietary supplements that the FDA has recalled and that should be recalled immediately,” said Cohen, an associate professor at Harvard Medical School and an internist at the Cambridge Health Alliance, a Harvard-affiliated safety-net health system.

Typically, the FDA can issue voluntary product recalls, or manufacturers can quietly remove problematic ingredients without publicizing the issue, Cohen said. “But a lot of the companies obviously didn’t do that because we were able to buy the products years later.”

He cited the FDA’s mandatory recall a few years ago of a dietary supplement containing pharmaceutical stimulants that was sold on military bases and harmed soldiers. But, he said, the FDA took this enforcement action because of outside pressure from the Department of Defense and the media.

He said his research into contaminated dietary supplements began about 15 years ago after some of his patients were harmed by weight-loss products and subsequent analysis found they were contaminated by “alien experimental drugs”.

Cohen said his advice to the many people who take supplements is to try to avoid potentially contaminated products by purchasing supplements with individual ingredients, such as: B. a bottle of echinacea.

He also suggested avoiding mixed-ingredient supplements and those that make “structure/function” claims of improved brain function, among other benefits.

For their latest study, the researchers searched the Internet for evidence of product recalls. They used the Google search engine to find products that were still for sale in January 2022 and bought them online.

Next, the scientists reconstituted powders of the supplements in question in methanol and performed chemical analysis for the presence and amount of FDA-banned ingredients.

After chemical analysis, it was determined that five of the nine products still available for purchase, or 56%, contained at least one FDA banned ingredient: four products contained one banned ingredient, and one product had three different banned ingredients.

Two products contained the same banned ingredient for which the FDA issued the warning letter, the researchers found.

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