Unsafe Supplements And The Revolving Door Between The Supplement Industry And FDA

Are you taking a multivitamin that contains selenium? How do you know that the amount stated on the label is what is in the pill? Do you just trust? No government body, including the FDA, tests that supplements are safe and effective. And in 2008, more than 200 people suffered selenium poisoning from a brand of multivitamin that was subsequently recalled by the manufacturer.

From: Selenium Toxicity from a Misformulated Dietary Supplement, Adverse Health Effects, and the Temporal Response in the Nail Biologic Monitor, Nutrients, April 2013:

“The median selenium (Se) exposure … ranged from 669,570 to 965,520 μg over an approximate 30 day period, which exceeds the RDA for Se by a factor of 300 to 585 leading to selenosis symptoms and adverse health effects, some debilitating, that persist 2.5 years.”

“Let the Buyer Beware” is no longer an adequate national policy to regulate the booming dietary supplement enterprise.”

There was a great commentary by Dr. Pieter Cohen a few weeks ago on just this topic:

Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements, New England Journal of Medicine (NEJM), 4 April 2014

Cohen tells of a popular supplement, OxyElite Pro, that caused 97 cases of severe hepatitis, 47 hospitalizations, three liver transplants, and one death. FDA didn’t even know about the hepatitis cases until 4 months after they came to light.

“Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.”

Cohen notes that a bill in a Senate committee, the Dietary Supplement Labeling Act, would require supplement manufacturers to provide a bit more safety information, such as listing a supplement’s known side effects. That could happen.  Here’s an example:

SupplementSideEffects

Note that prostate cancer is listed as a side effect of taking vitamin E, which I discussed here.

But he really wants to see:

“Every supplement ingredient should undergo rigorous safety testing before marketing. Until that happens, consumers and physicians cannot be assured that the pills, powders, and potions labeled as dietary supplements are safe for human consumption.”

I doubt that will happen. This is why…

The New York Times covered Cohen’s article this morning: Why Dangerous Supplements Linger on Store Shelves

Now, watch this. Are you ready?

Cohen said, in a prestigious, peer-reviewed journal, on April 4, that the FDA wasn’t banning bad products in a timely fashion, if at all. FDA’s Director of Dietary Supplements, Daniel Fabricant, said:

“I certainly understand and share Dr. Cohen’s concern, but I do think the system has been useful and successful and instrumental in the agency taking action against products that were unsafe.”

Four days after Cohen’s critical article, the FDA announced that Fabricant was leaving the agency. No replacement was named.  Fabricant was a top executive for a dietary supplement trade group, the Natural Products Association, before he joined FDA in 2011. He will be returning to that trade group as its CEO.

This is called a revolving door between industry and government. It is how industry manipulates government. While at the FDA, industry-friendly Fabricant was involved in drafting guidance for “New Dietary Ingredients” and “Good Manufacturing Practices.”  And Fabricant will return to his industry with a deeper understanding of how government operates, thanks to his stint as an FDA director.

As long as a revolving door is in place, we will probably never see premarket safety and efficacy testing of dietary supplements.

This is an example of how the United States is earning its oligarchy badge.

3 thoughts on “Unsafe Supplements And The Revolving Door Between The Supplement Industry And FDA

  1. RB

    John Oliver on his HBO show “Last Week Tonight” provides the best and funniest (satirical) commentaries on nutritional supplements, Dr. Oz and Congress’s role in the matter and why we have the lax regulations we have. I think Oliver get the message across better than anyone. See the You Tube video: https://www.youtube.com/watch?v=WA0wKeokWUU

    Reply
  2. Pingback: Vitamin And Energy Drinks: More Risk Than Benefit | Fanatic Cook

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