By Mike Montemarano, Associate Editor08.02.22
The U.S. Food and Drug Administration (FDA) sends warning letters to companies marketing supplements or ingredients that the agency deems to be illegal and/or fail to meet the definition of a dietary supplement.
In order to develop an estimate of how many companies follow through with removing illegal and potentially dangerous substances from the dietary supplements market, a team of researchers led by Pieter Cohen, MD, of Cambridge Health Alliance, writing in JAMA, tracked FDA warning letters for unapproved stimulants present in products on the market.
They assessed the frequency at which these products were removed following the receipt of an FDA warning letter, specifically with warning letters which addressed amphetamine, ephedrine, and some other drugs, which are known to carry serious health risks including hemorrhagic stroke and sudden death.
“Whether FDA warning letters lead manufacturers to recall or reformulate products is unknown. We assessed the frequency of product recalls and the presence of FDA-
In order to develop an estimate of how many companies follow through with removing illegal and potentially dangerous substances from the dietary supplements market, a team of researchers led by Pieter Cohen, MD, of Cambridge Health Alliance, writing in JAMA, tracked FDA warning letters for unapproved stimulants present in products on the market.
They assessed the frequency at which these products were removed following the receipt of an FDA warning letter, specifically with warning letters which addressed amphetamine, ephedrine, and some other drugs, which are known to carry serious health risks including hemorrhagic stroke and sudden death.
“Whether FDA warning letters lead manufacturers to recall or reformulate products is unknown. We assessed the frequency of product recalls and the presence of FDA-
Continue reading this story and get 24/7 access to Nutraceuticals World for FREE
FREE SUBSCRIPTION
