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Article: Supplements Need Review Before They Can Do Damage, Not Afterward

New England Journal of Medicine examines liver cases

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
  • catcan221

    Sounds like another big power grab for Pharma. I have never known anyone who has gotten ill from normal vitamin, mineral supplements. Yet I have had life-threatening reactions to vaccines, FDA approved Avelox – a fluoroquinolone, and others. In fact, the toxciity of Motrin/Ibuprofen and Tylenol/Acetaminophen are very serious, should not even be given to children and yet they still have most every dangerous drug on the market, even though hundreds of thousands of deaths from these “approved drugs”, taken as directed, happen every year. PATHETIC.

    • juliusaugustus

      The lack of safety of pharmaceuticals doesn’t justify the lack of safety of dietary supplements. Both need to be regulated more strictly.

    • bigboss302

      I’ve never known anyone who has had ebola or overdosed on heroin, but I don’t deny it happens based on that fact.

  • Gertrude “Trudy”

    Power grab by FDA, as well as Pharma, FDA’s “sugar daddy” (if the shoe fits…) FDA made two previous attempts to grab control over supplements. The first time, in the mid-1950s, Congress passed a bill telling FDA to back off because supplements are nutrients not medicines. FDA backed off a few decades…and made another attempt, and again Congress said supplements were nutrients not pharmaceuticals, and FDA again backed off–for a little while this time. Then FDA made its third attempt to grab power over supplements…coincidentally around the time that a lot of Pharma’s products were due to lose their patents. Only this time Congress no longer felt it had power to tell FDA what to do. Instead, two congressmen at different times pleaded with FDA to pretty-please consider backing off…and FDA ignored them. Then Orrin Hatch negotiated with FDA to back off..and since Hatch had partial control over FDA’s purse strings (per somebody’s article), FDA agreed to back off temporarily–for 6 months, which coincided with the patents ending.
    FDA’s head also refused to appear before Congress when required to do so, saying basically “you aren’t the boss of FDA, if my boss says appear, I will, but otherwise I won’t.” And FDA didn’t. Interestingly, the head of the Congressional committee resigned right before the set date for FDA to appear, and the new committee head was quoted as saying that if FDA did not appear there would be further action. Well, FDA didn’t appear and there was no further action.
    FDA in the same time frame tried to grab power over smart phones with semi-medical apps. While this went nowhere, at least it showed there are no limits on an agency with no set boundaries and no penalties for transgressing the few boundaries Congress did set in the 50s.
    FDA scares me.
    Supplements are the only real market competitors that Pharma has. FDA is Pharma’s bully boy to sweep away Pharma’s competition for the health industry. FDA even made fruits and vegetables into “unapproved drugs” when doctors in one city were handing out city-funded certificates for obese children to buy fruits and vegetables locally. FDA warned it would shut down sale of such “unapproved drugs.”
    Who gave FDA such power? Well, Congress, for one. Pharma for another (monetarily). Did I miss any others?
    Who can tell FDA to stop? Nobody any more. Not even Congress. FDA is bringing in too much Pharma money for the government. Fee for submission. Fee for approval after submission. And it is at FDA’s sole discretion when if ever FDA responds with approval to anything. Non-drug submissions have to spend the whole 12 months in trials, then wait years to see if FDA will approve or deny them. Meanwhile drug submissions are speeded to approval, some with only
    a 3-week drug trial instead of a whole year.
    Can supplements pass FDA protocols? Never. Because FDA protocols require taking the substance at a 1,000 times dosage each day for 365 days. You can’t even drink 1,000 glasses of water a day and survive even two days. Supplement take-over is a front for market monopoly of drugs…all issues of quality aside, FDA isn’t playing for fairness or safety–look at all the dangerous drugs that cost 100,000 lives a year which FDA passed and then refused to take off the market–FDA is doing Pharma’s dirty work so don’t assume the sudden media-fed interest in supplement quality is due to FDA’s kind heart. It’s due to FDA’s heartless pursuit of Pharma’s heartless goals…Take the Sick and Make them Sicker…laughing all the way to the bank…!