Researchers found unapproved and sometimes dangerous drugs in 746 dietary supplements, almost all marketed for sexual enhancement, weight loss or muscle growth, a new analysis published on Friday shows.
The evaluation of a database of nutritional and drug administration of contaminated supplements for the years 2007 to 2016 mostly produced sildenafil – the medicine sold as Viagra – and other medicines with erectile dysfunction in sex improvement products; sibutramine and the laxative phenolphthalein, both banned by the FDA, in supplements for weight loss; and steroids or their analogues in muscle building products.
Approximately 80 percent of the supplements were contaminated with a pharmaceutical product that should not have been in the product. Twenty percent contained at least two such drugs and two of the supplements contained six unapproved drugs. One product contained a medication that increases blood pressure and another medication that lowers it. Despite these contaminations, less than half of the products were recalled.
The presence of unknown drugs in supplements "poses a serious risk to public health," the researchers wrote. More than 50 percent of the US population consumes dietary supplements and many consumers mistakenly believe that the products are carefully regulated and accurately labeled.
The drugs in the supplements have "the potential to cause serious adverse health effects due to accidental abuse, overuse or interaction with other medications, underlying health problems or other drugs," the researchers wrote.
The controversy about counterfeit supplements extends for decades. Under a 1994 law, the Health and Supplement Health Supplement, the products are regulated as food and therefore not subject to premarket safety and efficacy tests imposed on pharmaceutical products. The $ 35 billion supplement market includes multivitamins, minerals, plant and other products.
The new article, written by a team from the California Department of Public Health, was published online in JAMA Network Open on Friday.
In an interview, Daniel Fabricant, chairman of the Natural Products Association, said a trade group in the supplement industry, that it is unfair to consider sex enhancement, weight loss and muscle building products in the same category as traditional dietary supplements such as vitamins. He said that these are edge products, often made by manufacturers who fly-by-night & # 39; are sold on the internet or in convenience stores.
"We are completely on the FDA side here," said Fabricant, who worked for the federal agency for supplements that this year. "This is someone who puts the product in. They say it's a supplement, it's not a supplement in any way, form or shape."
Fabricant said that his organization supports the FDA with its authority to file charges against companies that falsify drug addicts.
But Pieter Cohen, who wrote an editorial
Cohen, an associate professor at Harvard Medical School who investigates the safety of dietary supplements, called on the FDA to act more aggressively against companies that produce counterfeit supplements and insisted on a revision of the 1994 law. required to register the products with the FDA before the sale.
In a statement released late Friday afternoon, an FDA spokesman said the FDA was analyzing the findings of the study.
"The FDA is determined to do everything within its means and authorities to identify and remove unsafe products from the market" and "to ensure that products sold as dietary supplements are safe, well-manufactured and accurately labeled."
The spokesperson, Jeremy Kahn, said that when the FDA takes action against one distributor, others may still market the product and supplements are sometimes labeled to bypass detection.
The new analysis of the Tainted Products from the FDA, which is being sold as a database with nutritional supplements, contained some alarming findings about the three types of products. For example, the prescription antidepressant fluoxetine, or Prozac, was found in about 5 percent of the slimming products. Sibutramine, which is commonly found in weight loss products, can significantly increase blood pressure and heart rate. The FDA removed it from the market in 2010 because of the potential to cause strokes.
The active ingredients in Viagra, Cialis and Levitra – frequently found in supplements for sexuation – may interact with nitrates found in medications prescribed for diabetes, high blood pressure and high cholesterol levels and may cause dangerously lower blood pressure, the researchers said.
Men excluded from taking erectile dysfunction medications can turn to these supplements, not realizing that they are receiving the same drugs, they said. Others can choose them because they are less expensive or because they are easily available at petrol stations and convenience stores, Cohen said.
"As the food supplement industry in the United States continues to grow, it is essential to further address this important public health problem," the researchers wrote.