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FDA needs stronger rules to ensure the safety of dietary supplements

February 2, 2012
  • By Patrick J. Skerrett, Former Executive Editor, Harvard Health

About the Author

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Patrick J. Skerrett, Former Executive Editor, Harvard Health

Pat Skerrett is the editor of STAT's First Opinion and host of the First Opinion podcast. He is the former editor of the Harvard Health blog and former Executive Editor of Harvard Health Publishing. Before that, he was editor of … See Full Bio
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Louis Edwards
March 31, 2012

We the public need more information to protect ourselves. Regulators can only do so much.

March 23, 2012

Considering the sizable number of patients who take dietary supplements and the widespread availability of these products, this topic is immensely important.

Natural Standard features an excellent webinar on this topic on its website:

March 21, 2012

I have been around weight loss supplements for years now and I’ve never had an issue where someone was in a life threatening situation using them.

March 5, 2012

Thank you for bringing this up! I know someone who was poisoned by a tainted supplement. (Not only was the supplement tainted, but the active ingredient was also proven dangerous in clinical trials.) Unfortunately this “supplement” is still on the market today. There need to be more regulations to protect people from scammers and unqualified people making health claims. There are many safe and helpful supplements out there, but there are also quite a few dangerous ones. People need protection from these scams, so fewer people fall victim. Thanks for writing this article. People need to be aware. 🙂

March 22, 2012

I was diagnosed with aienxty 16 years ago.0.5 mg of Xanax three times daily.Side effects = none for me, unless you count not experiencing aienxty as a side effect.Don’t get me wrong, I tend to be the first one to avoid western medicine and hate having to take these pills daily, but after hearing the bullshit you have to go through just to cope with aienxty I think you might wanna consider Xanax.Taken it exactly as prescribed while on Entheogens and other substances.Always mixes great.

February 21, 2012

good job for having written this article

February 20, 2012

Unfortunately the FDA is only interested in furthering the wealth of the big pharmaceutical companies. There are many good treatments that are affordable (cheap) that don’t cause all the side effects of most drugs that they approved for the big pharma companies. Natural health treatments could probably take the place of most, if not all, of the drugs presently pushed on American citizens. Something needs to be done.

Chandler Chiropractor

George W Kukurin DC DACAN
February 20, 2012

Reports of adverse events related to nutritional supplements are rare, so one has to question the expense of increasing FDA oversight. However, many nutritional supplements bind to or otherwise effect the Cytochrome system of the liver. This could lead to abnormal drug metabolism rending prescription medications either ineffective or potentially toxic. Perhaps warnings on supplement labels is a reasonable compromise.

February 15, 2012

An interesting article. I myself make many herbal remedies from a variety of herbs.

February 12, 2012

FDA needs stronger rules to ensure the safety of drugs. Far, far more people die from the side effects of drugs each year than vitamins. Vitamins are essential nutrients yet the FDA won’t even allow manufactures to print on the bottle what each vitamin does. The U.S. uses more drugs than any other nation yet falls behind many others in the average life expectancy of it’s citizens, that shows these drugs are not miracle cures they claim to be. Big Pharma cares about profits not helping people and it see vitamins a competition which needs to be down away with.

Which Pharma Company are you being paid to be a “consultant” by?

February 10, 2012

I began using diet pills when I was 20. Eventually I went to a psychiatrist who prescribed me Adderall for my “ADD”. Not only did I become dependent on the drug, at least psychologically – I lost an incredible amount of weight in a short period of time. What a mess I found myself in. I eventually went to treatment at a program that specialized in Adderall addiction

Luckily, I’m off Adderall now, but I have to say who anyone who is considering taking diet pills – don’t start. It only gets worse and eventually you might find yourself needing treatment like I did…

Don Dehmlow
February 8, 2012

this is one way of framing this topic. Another possibility is to look at how many deaths or even serious adverse reactions are attributed to any supplements (unregulated) over the past 1,2,3 or even 4 decades,(you pick the time frame) and then compare that to deaths alone from prescription drugs (highly regulated). I would argue that money would be better spent making sure prescription drugs are being prescribed properly.

February 12, 2012

You are 100% corrupt, more people die from perspiration drugs each year than die in traffic accidents. If medial drugs where really the miracle cures they claim to be then the U.S. would have the highest life expectancy in the world, since we consumer way more than any other nation on the planet, but we don’t even come close to have the highest life expectancy, that shows they are not the cure all they claim to be and in many causes are just used to make profit for the drug companies.

juliea blondo
February 7, 2012

wow…. I’ve read many of your articles, and HAD formed the impression that you were well spoken, and fairly bright, Congratulations on the snoiw job! Give this man an Emmy! You have just revealed yourself to be a shallow, Sellout: just like your heros in the FDA!

Alliance for Natural Health
February 7, 2012

First, supplements are regulated:  Opposition to the FDA’s new supplement guidance isn’t from industry only.  Our organization, along with other natural health, health practitioner, and health freedom groups, submitted over 100,000 consumer comments to the FDA opposing their anti-supplement guidance.  There is a strong and rapidly growing grassroots movement to preserve our access to vitamins, minerals, and herbs that should not be ignored by media. The drafters of DSHEA, Sens. Hatch (R) and Harkin (D), recently wrote in a letter to the FDA that the agency had misinterpreted their legislation and should withdraw the guidance.  If an illegal product (like a pharmaceutical drug) is put into a supplement, it’s no longer a supplement, it’s a drug, and FDA has all the authority needed to seize that product and prosecute the offenders. Creating a pre-market approval system for supplements is counter to the intent of the law, which sought to -preserve the public’s access to vitamins and minerals. The current FDA guidance is a heavy handed and misguided attempt at a solution in search of a problem. 

February 12, 2012

The FDA is controlled by Big Pharma who see supplements as competition and a problem to be gotten rid of, since they can’t paten them.

February 6, 2012

What about all of us eliminate damaged businesses like the FDA. Possibly after that businesses may have much more morals simply because the actual large pharmaceutical drug businesses along with plenty of lobbying energy might suffer from the actual legal responsibility associated with promoting the harmful medicines rather than using a federal government back-up. The actual free of charge marketplace works much better in the event that all of us let it.

Elliot Feldman
February 5, 2012

“Compare this hands-off approach with the strict rules and regulations for drugs. No drug can be sold until the FDA has proof clear proof that it is safe and effective. And every FDA-approved drug must be made to strict specifications”. Funny how with these so-called strict rules that by their own admission, JAMA, has said that roughly 100,000 people are killed each year from properly prescribed prescriptions! Now that’s what I call safe.

March 23, 2012

NO!!! It doesnt BURN it, you ot it wrong!!!!! It ateivacts the metabolism, then by having a good diet and nice exercise routine, it will HELP the weight loss procress!it’s not the same thing, you guys want miracles there’s no such thing, you have to change ALL YOUR BAD HABBITS. No deal, only that. Or else, you will be a fat motherfucker your entire life.Sorry to say, THERE IS NOT MAGICAL STUFF THAT MAKES YOU LOSS WEIGHT.

Frank Lampe
February 3, 2012

Both the editor of Harvard Health and Dr. Cohen seem to conveniently not including some important information here: if a supplement is adulterated with an unapproved drug, it is, by definition, not a supplement. It is misleading for them to state otherwise. Additionally, Mr. Skerrett knows well that there are no patents on most supplements and thus no incentive for the type of research required by the incredibly high-profit drugs on the market. The safety record of supplements over the last 25 years speaks for itself. He also conveniently forgets to mention the reams of positive, well-designed research studies about the health benefits of supplements. This is just bad journalism and leads one to wonder what unmentioned biases the authors and Harvard might have and who might be paying the bills at the school. It certainly isn’t the dietary supplement industry.

John M
February 2, 2012

I’d also like to add that the pharmaceutical industry puts more money into lobbying than any other industry. Their lobbying power is incredible.

John M
February 2, 2012

Look up the amount of deaths from dietary supplements in the past 5 years. Compare to deaths from pharmaceuticals within the last year (not a fair comparison, I know).

How about we abolish corrupt organizations such as the FDA. Perhaps then companies will have more morals because the big pharmaceutical companies with lots of lobbying power would have to deal with the liability of selling a dangerous drugs instead of having a government safety net. The free market will work better if we allow it to.

February 7, 2012

I agree with you. Government agencies are full of not only political hacks but people who stand to benefit by approving or disapproving certain laws and regulations. The FDA hasn’t had a good record on keeping food safe and I don’t trust it. I don’t know what the answer is though since too many people are totally biased and not looking out for the common good but what’s good for their career or pocket.

February 2, 2012

Does the author mean the regulation should be handled by the same FDA that allowed Vioxx to kill 60,000+ people AFTER it had been subjects to the safety tests of all drugs? The FDA is not out for the public’s best interest with all the conflict of interests that panel experts have.
I agree with Steve above that we should have a body count of drug related deaths and supplement related deaths. It wouldn’t even be close!

February 22, 2012

Simply wish to say your post is snurpisirg. The clarity in your post is nice and i can assume you are an specialist on this subject. Thanks a million and please carry on the great work.

Marc Ullman
February 2, 2012

Today, without any need for new regulations or legislation, it is a federal crime to market any dietary supplement (or any other FDA regulated product)that contains an ingredient that is not listed on the label, contains a “new” ingredient that has not been properly presented to FDA, is not manufactured in accordance with Good Manufacturing Practices, or makes claims that it cannot support.

These violations all make the product misbranded, adulterated or both. The Federal Food Drug and Cosmetic Act classify misbranding and adulteration as criminal offenses. There is even strict criminal liability for misdemeanor offenses.

Perhaps enforcement of the law as written in a way that removes illegal products from the marketplace would be a preferable approach to creation of even more rules and regulations that would have zero impact on scofflaws who ignore what is already on the books.

February 2, 2012

Also, I think it would be wise to compare the amount of deaths from over-the-counter unregulated supplements vs deaths caused by highly regulated prescription drugs.
Not a very good argument for regulation.

February 2, 2012

I think you’d be sabotaging the market in the name of big business. There’s hardly any clinical trials on natural ingredients (there are an abundance of in-vitro data, but even these, it may take you awhile to find) and instead research is mainly directed at profitable drugs. To suggest that every supplement maker have to succumb to the fees of having their product tested is to annihilate the market, especially for lesser used compounds for which people have the right to buy.
In my opinion, it comes down to personal responsibility, not a monolithic pharmaceutical-friendly apparatus.

Commenting has been closed for this post.

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