ibusinesslines.com November 14, 2018

Weight loss & sex supplements are hiding risky substances inside

18 October 2018, 07:45 | Melissa Porter

Nearly 800 dietary supplements contained unapproved drug ingredients study finds

Nearly 800 dietary supplements contained unapproved drug ingredients study finds

So, what did the FDA do about these supplements?

With an estimated 50 percent of Americans consuming some type of supplement, researchers note that the $35 billion industry is a big business. However, despite the agency's warnings, in 19 of the 28 cases, the products even contained new unapproved ingredients by the second or third warning instead of having the original unapproved ingredient removed. "Now it's clear that there are well over 1,000 brands of supplements that contain active drugs".

"The FDA is committed to doing everything within its resources and authorities to identify and remove unsafe products from the market, and we continue to work collaboratively with all of our stakeholders to help ensure that products marketed as dietary supplements are safe, well-manufactured, and accurately labeled", reads their public statement.

Most of the adulterated products, about 45%, were marketed for sexual enhancement, weight loss (about 41%) or muscle-building (12%).

Among them were dapoxetine, an antidepressant that is not approved in the USA, and sibutramine, an appetite suppressant that was banned from the U.S. market in 2010 because of cardiovascular risks. They are not meant to treat or prevent disease and are not subject to premarket safety and efficacy testing.

The FDA has identified the tainted over-the-counter products, but according to new research published Friday in JAMA Network Open, over half the time, the study found, the FDA doesn't enforce recalls of supplements that knowingly include unapproved prescription drug ingredients.

In almost all cases (98 percent), the presence of such ingredients was not noted anywhere on supplement labeling, the U.S. Food and Drug Administration found. And nearly all of the muscle-building supps contained synthetic steroids or steroid-like ingredients - the long-term side effects of overuse include liver, kidney, and mental health issues to name just three. Of the 776 adulterated supplements identified, the FDA requested a voluntary recall of fewer than half (46.4 percent).

"Only 360 of 746 (48 per cent) were recalled, leaving the majority of adulterated supplements, more than 350 products, available for sale", Cohen said. One would require manufacturers to register products with the FDA before they go on the market. The database contains supplements that the FDA has purchased, tested and found to be adulterated.

"It's mind-boggling to imagine what's happening here", said Dr. Pieter Cohen, an associate professor of medicine at the Cambridge Health Alliance in MA.

"The agency's failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers' health at risk", Dr. Pieter Cohen, a general internist at Cambridge Health Alliance in Somerville, Massachusetts, wrote in a commentary accompanying the study.

The study goes on to explain that some of the supplements that received warnings from the FDA were found to still contain unapproved prescription drugs long after the discovery was made.

Because consumers don't know if these products contain illicit substances, they "have the potential to cause adverse health effects both on their own and also in combination with other medications an individual may be taking", the authors write.

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