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Consumers take dietary supplements with illegal – and potentially harmful – ingredients, reveals a growing body of evidence.
A new study published online in JAMA Internal Medicine this week revealed experimental stimulants in dietary supplements before and after the US Food and Drug Administration issues warnings about these stimulants.
Pieter Cohen, associate professor at Harvard Medical School and general internist at Cambridge Health Alliance, conducted the study with researchers from the University of California. , San Francisco. "They do things that we think could have serious health effects, such as heart attacks and strokes," he says.
One of the stimulants, DMAA, was used in nasal decongestants in the 1940s but was removed from the market several decades later. Another drug, oxilofrin, has been approved in some European countries for patients with low blood pressure, but has never been approved in the United States. Two others, BMPEA and DMBA, have never been approved for human use, but are thought to function as animal-based stimulants. studies.
The researchers examined nine weight loss supplements, two sports supplements and a cognitive function substitute and tested them for stimulants in 2014 and 2017. Supplements were purchased online, but can also be found in stores, explains Dr. Cohen. The study does not disclose the brands or companies that make the supplements.
Once the FDA has issued a public warning, it is expected that supplements containing prohibited ingredients will be removed from the market and new products will not be added, Dr. Cohen said. But, he adds, in practice this does not always happen and the measures to be taken and their consequences are unclear.
Growing set of pieces of evidence
The JAMA internal medicine study follows another JAMA study released earlier this month by the California Department of Public Health. He analyzed the FDA's warnings for supplements from 2007 to 2016 and found that 776 food supplements were in pharmaceutical ingredients, even after the FDA issued public product warnings. There were 157 products containing more than one ingredient not approved.
The majority of products have been marketed for sexual enhancement, weight loss or bodybuilding. Examples include sildenafil, sold as Viagra, in sexual enhancement supplements, steroids in muscle building supplements and sibutramine, removed from the market due to potential risks, in weight loss supplements.
The analysis revealed that the FDA had recalled the products less than half the time.
More than 50% of American adults take dietary supplements such as vitamins, herbs and enzymes. Supplements are in the food category and are not regulated as prescription drugs. Supplement manufacturers do not have to demonstrate the safety or efficacy of the FDA before their products are marketed.
"Medicated ingredients can potentially have serious health effects due to improper use, overuse or interaction with other medications, health problems underlying or pharmaceutical products contained in the supplement ", Madhur Kumar, lead author of the previous JAMA study and research scientist. at the California Department of Public Health, wrote in an email.
Jeremy Kahn, a spokesman for the agency, is reviewing the findings of the FDA.
"The FDA is committed to doing everything in its power to identify and remove dangerous products from the market, and we continue to work with all our stakeholders to ensure that products marketed as complements are safe, well-made and accurately labeled, "he said in a statement sent by e-mail.
When the FDA issues a public warning, as in the case of stimulants, consumers are informed that the products in question may contain an undeclared ingredient and that they should not buy or use them, says Kahn.
Even when the FDA issues a recall or takes enforcement action against a distributor, other distributors often continue to sell the recalled product, or distributors re-label the products to evade to any detection, says Mr. Kahn.
Dr. Cohen, who wrote an accompanying editorial for the analysis of the California Department of Public Health, said the FDA needed to do more.
His previous research focused on what happens after the FDA's recall of prescription drug supplements illegally, and found that, years after the recall, two-thirds of the available-for-sale supplements still contained drugs.
Another study found that Boston consumers buying a brand of weight loss supplement were unaware of a booster and were still able to purchase the supplements.
New discoveries
In 2014, the FDA announced that DMAA was not allowed in supplements. In 2017, he announced separately that supplements are not allowed for all four stimulants.
Researchers in the new study released Monday conducted a chemical analysis of the supplements. He found that in 2014, despite the announcement made by the FDA about DMAA, it was present in half of the supplements tested. Two other stimulants, BMPEA and oxilofrin, have been found in many supplements.
In 2017, researchers found DMAA in two supplements, oxilofrin in nine, BMPEA in one and DMBA, which were previously found in none, in four.
"Whatever the FDA does to try to eliminate these experimental stimulants from supplements does not work and consumers will continue to be exposed to this if the FDA does not intervene and becomes much more aggressive in its application," said Dr. Cohen. said.
A group specializing in dietary supplements and functional food manufacturers, based in Washington, alongside researchers. Duffy MacKay, Executive Vice President for Scientific and Regulatory Affairs at the Council for Responsible Nutrition, says the examples cited in the studies are "threat" products.
"We share the disdain for this type of behavior," said MacKay. "A responsible manufacturer with a big brand, none of this ever happens."
Sreek Cherukuri, an ear, nose and throat surgeon in Indiana, said that in recent years, more patients have been asking questions about dietary supplements. Many are not properly informed.
Before surgery, he asks patients what supplements, vitamins and herbal products they take, as these can interfere with surgery and cause blood thinning, he says. To educate consumers about supplements, he created a website about a year ago.
"The vast majority of supplements lack solid scientific data to validate their use," says Dr. Cherukuri. "At best, they may not be doing what we think. In the worst case, they can be fraudulent or dirty and take you to hospital or emergencies. "
Expert advice for the purchase of supplements
Avoid supplements marketed for sexual health, weight loss and bodybuilding, which are most often tainted with illegal ingredients, says Dr. Cherukuri.
Do your due diligence on finding potential supplements. Most products are unproven. Even if they are not dangerous, they could be a waste of money, says Dr. Cherukuri. Be wary of bold claims or products claiming to treat a disease.
Talk to your health care professional before starting any type of supplement.
Check the products in the Council for Responsible Nutritions' voluntary online product registry, which includes approximately 12,000 labels.
Look for third-party certified and sealed products to certify that what's on the label is what's in the bottle, says Council of Responsible Nutrition's Dr. MacKay. The United States Pharmacopoeia certifies supplements with the USP seal. Other third-party seals include UL of Underwriter Labs and NSF of NSF International.
Write to Sumathi Reddy at [email protected]
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