How Should FDA Regulate Diet Supplements?

(CBS)  Supplement companies promising "skinny" are now being slapped with fat fines for false advertising, CBS News correspondent Sharyn Alfonsi reports. So how did they get away with it in the fisrt place?

In 1993, the FDA was on the verge of enforcing a "truth in labeling regulation" for dietary supplements. The industry struck back with commercials that urged consumers to write to their congressmen or else they might have to kiss their Vitamin C goodbye.

"More people wrote to Congress about the supplement bill than wrote about the Vietnam War," says science and medical writer Dan Hurley.

Hurley says Congress caved and passed the Dietary Supplement Health and Education Act of 1994 instead.

Does it protect the consumer? "I would say it protects the manufacturers. It frees them of any requirement to prove that their product is safe or effective before it's sold," Hurley says.

Hurley — who investigated the supplement industry for his book "Natural Causes" — says the supplement industry then convinced lawmakers to spend millions of taxpayer dollars on studies, looking at everything from treating colds with echinacea to treating cancer with mistletoe and shark cartilage.

"We learned that most of of the products tested have not worked," Hurley says.

But not everyone agrees. David Seckman, the head of the Natural Products Association, says supplements have been proven to work and are safe. But if they're safe, what's the problem with regulating them?

"They are regulated," Seckman says. "That's just it; as a food, not a drug."

The difference? Drugs have to be approved by the FDA before they hit the market. Supplements don't. So when it comes to protecting people before there's a problem, the FDA has its hands tied.

[daniel hobbs]

tricky question. lots of views.

[kpunger]

I used to hold CBS news with some kind of high regard. I always felt that if they did a commentary on a controversial subject they would do so with some integrity and balance. Unhappily I can no longer say that. I have been smoking for over 40 years and have no doubt that if I had never started that today, at the age of 61, I would not be able to out on a basketball court and outrun at least half the people on it who are half my age. But I knew smoking was potentially bad for ones health before I ever started. I also discovered that when I started it was something I enjoyed doing. After about ten years when I realized that if I was going to continue to smoke because I enjoyed it, even though I knew it was bad for me, that perhaps I should try and figure out why it was bad for me and see if I couldn%u2019t do something to mitigate some of that badness. That focus has led to a lot of amazing discoveries that I%u2019m quite sure I never would have made otherwise. I am not saying supplements are the total answer to good health, but they can surely be an important part it. The truth is that you do get what you pay for provided you also invest a bit of intelligence and research. It%u2019s obvious CBS didn%u2019t do either before they decided to do their thing on supplements. Is CBS going to become the same type of %u201CFair and Balanced%u201D propaganda machine as their buddies over at Fox? Where is Walter Cronkite when we need him?

Ken Ungerecht
Baltimore, MD

[mirtocap]

Post by ccschm11 at 03:08 PM : Jan 19, 2007:

My response.
Their they go again with the clinical study. Sounds like a Pharma person.

Foods are macronutrients and supplements are usually micronutrients. Suggest you apply your clinical study to all nutrients. Where is the clinical study for water, fruits, vegetables, meats, etc?

Suggest you review what clinical studies are.

In medicine, a clinical trial (synonyms: clinical studies, research protocols, medical research) is a type of research study. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority (in the USA, the Food and Drug Administration; in Canada, Health Canada; in the EU, the European Medicines Agency; in Japan, the Ministry of Health, Labour and Welfare (Japan)) approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a clinical trial protocol.

Hope that helps and your question on asking supplement companies for a clinical study is Irrelevant. Go back and see definition of clinical study.

[ccschm11]

I have read through all the comments concerning supplements. The 'drug companies conspiracy' seems to always be the justification for any negative about supplements that comes out in the media.

The claims for supplements are the responsibility of the FDA; however the FTC is responsible for false advertising rather than the FDA. The FDA is primarily responsible for determining safety of supplements and that they not not make treatment claims for diseases. Only products that have followed the guidelines set by the FDA for proving that a product is effective, safe and provides more benefit rather than risk for treatment of a specific disease can make claims for treating a disease or condition.

Most supplements come to market with little if any testing concerning their purity, content or safety. Most do not have any type of clinical studies to prove they work. Most of the evidence used to justify their effectiveness is based on laboratory experiments and not in testing with patients.

I suggest that consumers interested in using any supplement ask the manufacturer to supply any clinical study of their specific product(not just the ingredient) has been tested in humans. I think that many will find that most products have never been tested in a human patient prior to coming to market.

If the supplement users are so convinced of the efficacy of the products they use, then clinical studies to support their widespread should be conducted.

[pm555--2008]

as a professions nurse, with many years of experience in public health, i have and taught a philosophy of self responsibility for one's health; a better philosphy than the one promoted by big pharma which is "pop a pill" to solve your health problem. as a senior citizen, who is approaching 75 yrs of age, i take no prescription medications regularly and avoid them unless absolutely necessary. i use herbs, supplements and essential oils instead. far more people die from prescription drugs than from the use of herbs and supplements. as usual, it is the bottom dollar that pushed for passage of this bill; money for big pharma (whose skewed studies that hide adverse effects and subsidize researchers and MDs to get desired study results) who pursued legislation for regulation of these products. we also deal with harmful cosmetics and polluted foods for the same reason.

[rayk469]

I was just wondering if Rupert Murdock had bought CBS. This story represents tabloid journalism at its best: no truth, exaggeration of fact, and outright scare tactics. Most disappointing. What happened to the CBS of the 1950s and 60s. We could trust you then. How sad.

[kugi1-2009]

I was very disappointed with the CBS News report on nutritional supplements. The book referenced in the report was clearly biased and with very little scientific credibility. Herbs have been used to treat ailments for thousands of years.

How about balancing your report with a discussion about the thousands of Americans that die from pharmaceuticals? You can also mention how the FDA approves drugs that harm people based only on testing performed by the drug industry itself?

[kugi1-2009]

I was very disappointed with the CBS News report on nutritional supplements. The book referenced in the report was clearly biased and with very little scientific credibility. Herbs have been used to treat ailments for thousands of years.

How about balancing your report with a discussion about the thousands of Americans that die from pharmaceuticals? You can also mention how the FDA approves drugs that harm people based only on testing performed by the drug industry itself?

[deannem1]

As a pharmacist working in integrative medicine, I am very disappointed with CBS's one-sided view of supplements. I see patients daily who benefit more from the supplements they take than their prescribed medications. This is just another reason to watch ABC and Charlie Gibson!

[charlesarno]

What fools we citizens be! Rep. Joe Barton (R; TX)manipulated Congressional vote counting at 3:08 A.M., Jan. 4, to overcome the NAY votes against S.3546.

Thus, as one of its closing acts, the 109th Congress passed the Dietary Supplements and Nonprescription Drug Consumer Protection Act, S.3546. If the President signs this bill into law, manufacturers of dietary supplements will be forced to comply with AER (Adverse Event Reporting). AER implements "guilt by association" that will enable any American who experiences a serious adverse event like a heart attack or stroke to blame their nutritional supplements--even if supplements had nothing to do with, and did not cause, these adverse events. There are 72 million serious adverse events that occur each year. Under S.3546, 42 million of these events will be associated with dietary supplements. (Source: An editorial sponsored by the Nutritional Health Alliance (NHA; January 2007)

Visit www.nha2007.com.