Nearly 100 severe hepatitis and liver failure illnesses — nearly half requiring hospitalization, including three transplants and one death — are raising new questions about the nation’s $32-billion-a-year supplements industry.
This comes only three months after the prestigious Annals of Internal Medicine found that all those vitamin and mineral supplements peddled by the industry are worthless if taken for preventing the occurrence or progression of chronic diseases.
All the recent liver damage was caused by a supplement called “OxyELITE Pro” sold by Texas-based USPlabs LLC, according to the U.S. Centers for Diseases Control and Prevention (CDC).
The supplement was recalled after it started crashing livers last May. While the U.S. Food and Drug Administration (FDA) was then able to get two substances, aegeline and 1,3-dimethylamylamine (DMAA), that were linked both to the illnesses and the fatality removed from the market, that’s about all FDA could do.
“The dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death,” Dr. Pieter Cohen writes in the New England Journal of Medicine. “Nor have any changes been made to improve the FDA’s ability to detect dangerous supplements.”
Cohen says FDA’s action on the liver-damaging supplement was a “delayed response” with “life-threatening consequences” because of “woefully inadequate” monitoring of the supplements.
Indeed, the most effective regulation of the supplements industry often comes not from FDA, but from the Federal Trade Commission (FTC) for the claims supplement companies make that cannot be justified by science. FTC, with jurisdiction over marketing, often forces supplement marketers to stop making outrageous claims about diet miracles or easy muscle building. FTC settlements often entirely remove brands from the market, but typically they come back in short order under another name.
Cohen says that, unlike drugs, which require FDA approval before they can be sold, “anything labeled as a dietary supplement is assumed to be safe until proven otherwise.” He says there are currently 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics and other supplement ingredients out there, and that the 20-year old federal law on supplements shields the industry from more effective oversight.
“The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm,” Cohen says.
And he claims FDA has its work cut out for it because dangerous supplements are widely available. More than 500 supplements have already been found to be adulterated with drugs, stimulants, steroids, banned weight-loss medication and other harmful substances.
Cohen calls for a pre-market approval system to protect Americans from dangerous supplements and a better adverse event reporting system. He says FDA’s “Med Watch” reporting system for incidents involving drugs, medical devices and supplements is inadequate.
The supplements industry responded by saying that existing law is sufficient. Steve Mister, spokesman for the Council for Responsible Nutrition, said FDA requires 75 days notice for new supplement ingredients.
But Cohen says supplements with chemical compounds close to methamphetamine and amphetamine are being sold as “natural” by the supplements industry. His claim is backed up by recent news reports such as one this past October when a panel of international scientists found the body-building supplement called “Craze” contained a compound chemically similar to the illegal drug methamphetamine.
Craze was sold in candy grape, berry lemonade and piña colada flavors over the Internet and in retail stores like those that sell supplements and organic groceries.
U.S. Sens. Dick Durbin (D-IL) and Richard Blumenthal (D-CT) have introduced legislation to require supplement manufacturers to register products and provide FDA with more information about their potential adverse affects. Cohen says that, while the bill is an improvement, it would not improve FDA’s ability to detect and remove dangerous supplements from the market.© Food Safety News