Many supplements contain unapproved, dangerous ingredients: study

Many supplements contain unapproved, dangerous ingredients: study

(HealthDay)—U.S. health officials have issued more than 700 warnings during the last decade about the sale of dietary supplements that contain unapproved and potentially dangerous drug ingredients, new research reveals.

In nearly all cases (98 percent), the presence of such ingredients was not noted anywhere on supplement labeling, the U.S. Food and Drug Administration found.

From 2007 to 2016, the lion's share of FDA warnings—46 percent—concerned supplements that touted enhanced sexual pleasure, while weight-loss products were cited in 41 percent of the warnings. Most of the remaining warnings (12 percent) concerned supplements marketed as muscle-builders, the findings showed.

The tainted-supplement problem appears to have grown in scope in recent years, with 57 percent of all warnings having been issued since 2012, the researchers said.

"Over the past decade, ever since I first began tracking the problem, I have only seen the number of supplements adulterated with drugs increase rapidly," said Dr. Pieter Cohen. He is a general internist with the Cambridge Health Alliance, and an associate professor at Harvard Medical School in Boston.

"Back in 2009, it appeared that there might be less than 150 brands of supplements that contain drugs," he added. "Now it's clear that there are well over 1,000 brands of supplements that contain active drugs."

Cohen is the author an editorial that accompanies the new analysis, which was published online Oct. 12 in JAMA Network Open. The study was led by Madhur Kumar, of the California Department of Public Health's Food and Drug Branch.

Kumar's team noted that more than half of all American adults routinely take some form of dietary supplement, with estimated annual sales of $35 billion.

The FDA explicitly warns that supplements aren't a replacement for either over-the-counter or , and should not be viewed as a way to treat or prevent disease.

The agency classifies —including vitamins, minerals, botanicals, amino acids and enzymes—under the category of food, rather than drugs.

That distinction is important.

"Supplements are handled completely different than either prescription medications or over-the-counter drugs," Cohen explained. "Those two categories are carefully vetted by the FDA. Supplements are not vetted by the FDA, and do not require that any evidence of safety or efficacy is presented to the agency before they are sold to consumers."

The FDA's Dietary Supplement Health and Education Act of 1994 essentially places the burden for evaluating supplement safety, content and labeling primarily on the shoulders of the manufacturers, he said.

Experts point out that this arrangement means that, while the FDA has the authority to remove from the market any supplement reported as causing harm, as a practical matter it does so only after the fact. This raises the risk for a wide range of "serious adverse events" involving tainted supplements—including stroke, kidney failure, liver injuries, blood clots and even death—critics of the arrangement contend.

The study team said prior estimates suggest that such events result in roughly 23,000 emergency department visits and 2,000 hospitalizations in the United States every year.

The new analysis reviewed a decade's worth of information contained in an FDA database titled "Tainted Products Marketed as Dietary Supplements."

Almost 800 tainted warnings were issued during the review period for supplements manufactured by 147 different companies, though some involved multiple warnings about the same supplement, the study authors said.

About 20 percent of the warnings identified products containing more than one unapproved ingredient, the investigators found. Sildenafil (commonly known as Viagra) was the ingredient in nearly half of the warnings concerning sexual enhancement supplements.

Sibutramine—an appetite suppressant taken off the market in 2010 due to cardiovascular risks—was cited in nearly 85 percent of weight-loss supplements, according to the report.

And among muscle-building supplements, synthetic steroids or steroid-like ingredients were the cause for concern nearly 90 percent of the time, the researchers said.

Cohen said any meaningful solution will require a change in the laws that govern the way the FDA monitors supplements. Barring that, you should "ask your doctor if you need to take supplements," he advised.

"If your doctor doesn't advise supplements for your health, then they will likely not help you," Cohen stressed. "However, for my patients who still want to use supplements, I advise them to purchase supplements that list only one ingredient on the label and to avoid any that has a health claim on the label, such as improving immunity or strengthening muscles."


Explore further

New study finds concurrent use of prescription drugs and dietary supplements could pose health risks

More information: Pieter A. Cohen, M.D., general internist, Cambridge Health Alliance, and associate professor, Harvard Medical School, Boston; Oct. 12, 2018, JAMA Network Open, online

There's more on supplement regulations at the U.S. Food and Drug Administration.

Journal information: JAMA Network Open

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Oct 13, 2018
There are already laws against fraud. Why are these manufacturers not in prison? If they are manufacturing overseas and immune to US prosecution, why are they not forbidden any access to the US market? We don't need new laws. Enforce the ones we have.

Oct 13, 2018
My thoughts exactly. If you add a drug to a product without mentioning it on the label, you should face jail time and have your business torn down immediately, some fraud we cannot tolerate.

Now, if the market for this kind of supplements is big and people buy it knowing it might harm them, legalize it while asking the sellers to state that their product has side effects.

I really don't understand what the f*ck the agencies and politics are doing, it's unbelievable that a right as simple as having transparent ingredient lists can be disregarded while it asks absolutely zero work from the manufacturer. It's either about corruption or stupidity...

Oct 14, 2018
If you're buying supplements instead of looking to your diet then there's already something wrong.
Humans have evolved to get all their nutrients out of their food. There is an abundance of food and food avriety available.
Taking supplements should never be necessary.

Oct 14, 2018
Watch your intake of vitamin D! Too much can maybe kill you! Medical folks say daily dose is about 600mg/day for average person. This will vary by weight. Somewhat!? Some quack docktors on the internet are hawking 6000mg/day plans that WILL land YOU in the local morgue some really dizzy day if you persist in taking to much too quick' Have your blood tested to see if you actually need it in the first place. Your family sawbones usually can handle it. I almost got into trouble on 4000mg/day that I was taking. Fortunately I wised up in time. Please Read, Listen, and LIVE.

Oct 14, 2018
Or active ingredients no one needs to actually supplement

Oct 14, 2018
There are already laws against fraud. Why are these manufacturers not in prison? If they are manufacturing overseas and immune to US prosecution, why are they not forbidden any access to the US market? We don't need new laws. Enforce the ones we have.


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KBK
Oct 14, 2018
so they are talking about supplements for the workout and exercise industry and PURPOSELY CONFLATING it with the vitamin and health supplements industry.

read that again.

This is quite obviously agenda driven drivel.

They don't care about the exercise/workout industry, it is just a "casus belli" to get at the vitamin/ supplements industry.

This is big pharma, the BIGGEST INDUSTRY IN THE USA, doing what it can to get rid of vitamins and supplements.

They've been after people who try to take car of themselves, for as long as anyone can remember. They want their hundreds of billions in profit and will do whatever it takes to keep those profits in play.

Including flipping relative nickels (all day long, relentlessly) at this sort of distracting and trojan horseshit article.

Who paid for this article? where did it come from? Who owns those offices and companies? Who wrote this misdirecting garbage?

http://www.health...les.html

Oct 14, 2018
Who paid for this article? where did it come from? Who owns those offices and companies? Who wrote this misdirecting garbage?

http://www.health...les.html


More information: Pieter A. Cohen, M.D., general internist, Cambridge Health Alliance, and associate professor, Harvard Medical School, Boston; Oct. 12, 2018, JAMA Network Open, online

Oct 15, 2018
it's unbelievable that a right as simple as having transparent ingredient lists can be disregarded while it asks absolutely zero work from the manufacturer

Humans have evolved to get all their nutrients out of their food.

Well, there you have it: Humans evolved.
So if there is no God then there is no absolute standard of what is right or wrong or good or evil.
Hence in the absence of such a standard, anything goes - after all who gets the right to say what is good or bad? That is just your "truth". So if someone wants to profit off someone else's danger, sickness or death then that is just fine in the evolutionary world. Laws just means squat. If you can cheat, lie and steal in the evolutionary world and get away with it then all the best to you. You cannot deny God and then suddenly want to claim a right to His rules of life when the going gets bad. You made the bed, so sleep in it.

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