Patrick J. Skerrett

FDA needs stronger rules to ensure the safety of dietary supplements

Walk into a pharmacy, grocery store, or vitamin shop and you’re likely to see dozens, if not hundreds, of vitamins, herbal remedies, and other so-called dietary supplements. You might think that someone, somewhere, tests these pills and potions to make sure they contain what they say, improve health as advertised, and are safe. But that isn’t happening.

Under the terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (meaning those that had been sold in the United States before 1994) can be marketed without any evidence that they are effective or safe. For new supplement ingredients, the DSHEA requires manufacturers to give the FDA evidence that a new ingredient should be safe. “Regrettably, this aspect of DSHEA has thus far not been enforced,” writes Dr. Pieter A. Cohen in a commentary in today’s New England Journal of Medicine.

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.

From the safety, effectiveness, and truth in advertising standpoint, DSHEA hasn’t been a good watchdog for public health. Take “natural supplements” for erectile dysfunction. Since 2004, the FDA has pulled off the shelves more than two dozen of these products, with names like Stiff Nights and True Man, because they contained sildenafil (the active ingredient in Viagra), or a chemical cousin of it. Sildenafil in a dietary supplement is a problem because 1) sildenafil isn’t a naturally occurring compound, 2) it is an FDA-regulated drug, and 3) when taken with heart drugs called nitrates, it can lower blood pressure to unsafe levels—but the supplements don’t carry a warning about this, as sildenafil does.

Last July, the FDA proposed some rules to help it test new ingredients. This is a good first step, but the FDA’s plan doesn’t go far enough, argues Dr. Cohen, an assistant professor of medicine at Harvard Medical School whose research has explored the use of dietary supplements. Under the FDA’s plan, companies can give the FDA historical data to support the safety of an ingredient. Data from clinical trials would be better, and easier to evaluate. The plan also doesn’t require companies to give the FDA unfavorable data (as is required for new drug applications).

Americans spend more than $25 billion a year on dietary supplements. Many people take supplements because they believe they are safer than drugs (since they are “natural”), or work better. The safer part has been challenged numerous times. Remember ephedra, a widely used weight-loss supplement that was banned after it was linked to deaths and adverse side effects? And solid clinical trials routinely knock down the effectiveness of dietary supplements for stopping the common cold (vitamin C), shrinking an enlarged prostate (saw palmetto), and preventing heart disease (beta carotene and vitamin E). In fact, high daily doses of vitamin E have been linked with an increased risk of prostate cancer, respiratory infection, and heart failure.

The dietary supplement industry is fighting the new FDA guidelines, saying they will be bad for business. I think they’ll be good for the health of anyone who chooses to take dietary supplements. What do you think?

Comments:

  1. Louis Edwards

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

  2. Jennelle

    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: http://www.naturalstandard.com/webinars.asp

  3. James

    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.

  4. Lizzy

    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. :)

    • Mhine

      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.

  5. namasaya

    good job for having written this article

  6. Stan

    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

  7. George W Kukurin DC DACAN

    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.

  8. Grace

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

  9. Anonymous

    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?

  10. Tiffany

    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…

  11. Don Dehmlow

    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.

    • Anonymous

      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.

  12. juliea blondo

    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!

  13. Alliance for Natural Health

    First, supplements are regulated: http://www.anh-usa.org/dietary-supplement-regulation-facts.  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. 

  14. Anonymous

    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.

  15. Elliot Feldman

    “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.

    • Carmen

      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.

  16. Frank Lampe

    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.

  17. John M

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

    http://www.opensecrets.org/lobby/top.php?indexType=i

  18. John M

    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.

    • Elaine

      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.

  19. Ed

    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!

    • Irina

      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.

  20. Marc Ullman

    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.

  21. Steve

    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.

  22. Steve

    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.