How Should FDA Regulate Diet Supplements?

Dietary Supplement Health And Education Act Regulates Supplements As Foods, Not Drugs

(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.

[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.

[luckybean2]

Whose payroll are Hurley and Alfonsi on? My family has been taking supplements for over 50 years and I don't think its time for the FDA to tell me I don't know the dose of Vitamin C to put in my mouth. If you want to show a few examples of people that don't educate themselves before they use or overuse something, then tell Katie I'm turning the channel. This form of journalism is appalling. Maybe Alfonsi needs to walk-in KMART to see One-A-Day now makes vitamins with herbs for weight loss, joints, memory, etc. It's BIG BUSINESS. Herbs are given to us in the Bible and since the FDA can't even regulate prescription drugs well, I don't plan on paying a dietician or Doctor to tell me what natural thing I can put in my mouth. The FDA is too busy cloning meat for me to eat. I guess I need to get my pen ready for a letter writing campaign and to Alfonsi's boss about her one-sided journalism style.

[euthman]

The FDA claims that the Dietary Supplement Health and Education Act of 1994 (DSHEA '94) limits its jurisdiction over food supplements. While the Act did in fact remove the requirement for pre-market approval, the FDA is still called on to enforce the veracity of claims made by the manufacturers. Thus, from the FDA's own Web site:

"In addition, manufacturers may describe the supplement's effects on 'structure or function' of the body or the 'well-being' achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading..." (ref: http://www.cfsan.fda.gov/~dms/dietsupp.html )

I defy the FDA to prove it has held the manufacturers to substantiate the claims that their products can "remove toxins," "promote prostate health," "enhance immune function," or possess any health-giving properties at all. The FDA is clearly not doing its job in protecting the consumer, and I urge CBS News to expose this derogation of responsibility by a Federal agency.

[euthman]

The FDA claims that the Dietary Supplement Health and Education Act of 1994 (DSHEA '94) limits its jurisdiction over food supplements. While the Act did in fact remove the requirement for pre-market approval, the FDA is still called on to enforce the veracity of claims made by the manufacturers. Thus, from the FDA's own Web site:

"In addition, manufacturers may describe the supplement's effects on 'structure or function' of the body or the 'well-being' achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading..." (ref: http://www.cfsan.fda.gov/~dms/dietsupp.html )

I defy the FDA to prove it has held the manufacturers to substantiate the claims that their products can "remove toxins," "promote prostate health," "enhance immune function," or possess any health-giving properties at all. The FDA is clearly not doing its job in protecting the consumer, and I urge CBS News to expose this derogation of responsibility by a Federal agency.

[kirk1639]

It is obvious that this report is influenced by the BIG drug companies. They are already making huge profits and spend huge dollars advertising on your network .Why don't you have some experts in eastern medicine and natural medicine have a chance to respond so the audience could here both sides of the story.if this keeps up,soon we will be so regulated that we will have no choice in any matter.I know many people who have had great results using natural products who have been able to avoid the many side effects of the prescription drugs which are handed out like candy to the public. It is a shame that young children are also being prescrbibed drugs wityout trying safer non addictive methods first.

thoroughly disgusted,

Al Bosco

[natmedlaw]

The readers of Natural Medicine Law Newsletter know all about what is required to comply with the law as well as what happens when someone gets in trouble. We are in our 10th year of publication and its all free except the current hard copy issue on out website. Just use my name with a dot com and take a look.

[mirtocap]

Did Dan Hurley and CBS not know how to read about the accusations they made against supplements. Suggest they go into a supplements store, probably never have, and pick up a bottle of Vitamins,Minerals, Amino Acids and read the following on most items that make any clain: (It's on almost every bottle.)

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Suggest they bring this back to the people's payroll they are on and prepare a new game plan. While they are at it share this with them: "So are the ways of everyone who is greedy for gain, it takes away the life of the owner".
The following is the truth and I challenge you to let me prove this anyplace you want. **Just one more reason in the line of many on why "Prescription Drugs are the largest Orchestrated Fraud in human history when it comes to infective and degenerative diseases".**

And let us not forget the VIOXX SCAM.

[epearson65]

I%u2019m disappointed with CBS. They didn%u2019t provide compelling evidence of a problem and seemed biased. It is already illegal for a dietary supplement to make claims to cure or treat any illness or medical condition, and obesity is recognized as a medical condition. Enforce it!

I believe it should also be up to consumers to research myth and truth, especially since these products aren%u2019t dangerous except when misused (the same way household items such as toothpaste and hairspray can be harmful). Consumers already use judgment when buying products from wrinkle cream to junk food. They should talk to doctors before trying products that may not produce results, or may exacerbate existing conditions. Dietary supplements are already required to display this warning even though foods with hydrogenated oils, MSG and nitrates are not.

I also believe the government should facilitate the flow of TRUTHFUL information so that consumers aren%u2019t misled and don%u2019t have decisions made for them by entities with more interest in the state of the economy or profit than the health of the consumer. The government has historically made policies detrimental to consumer health in order to preserve industries that contribute to the economic health of the nation (beef, tobacco, pesticides, health insurance and petroleum just to name a few). Economic health is important, but I hope everyone understands that there will be a price to pay for putting profit first.

[sewbusy-2009]

CBS, when are you going to learn? You have only angered those of us who know that supplements are effective, needed and safe.
Like duh%u2026%u2026why do you think more people wrote letters to Congress for supplements than for the entire Vietnam War? WAKE UP!! Smell the green tea!! I was one of those people. Those of us who wrote, know that supplements work. We have the right to make our own decisions on our health. Government needs to keep their dirty little hands away from my good health!

[rampagesr]

Many of the supplement companies sell their products through Multilevel Marketing (MLM) pyramid schemes. This allows the companies to recruit distributors to sell their products. However, the distributor's cost is inflated and is very unlikely to sell the product. So instead, the distributors recruit more distributors into the pyramid so they can collect commissions from required monthly minimum purchases to qualify as a distributor.

These distributors make health claims like how products containing grape seed extract can reverse the affects of certain cancers (Dr. Ladd McNamara, a USANA Gold distributor and on USANA's Medical Advisory Board, made this claim during a USANA distributor meeting). When asked how USANA can make such claims. He said USANA doesn't make any health claims and since he is a doctor he can make any health claim he wants. So many of these nutritional supplement companies hire people to make the health claims for them. Distributors also make verbal health claims that are not permitted by law, but little is ever done about it.

Many commenting on here repeat the same slogans that are taught during MLM training material. On many MLM forums selling nutritional supplements, distributors are urged to comment on the CBS website regarding this segment. So most of the comments on here are from distributors selling supplements. These individuals insinuating greed amongst drug companies, only have to look in the mirror (from recruiting members into pyramid schemes).

[missval973]

Is CBS even remotely interested in the truth about supplement?... OR perhaps they are in the pocket of "big pharma!" There are many good studies, legit studies, not the "Kitchen quacks" that the media consistantly use to tout their ridiculous big pharm campaign, but good studies that prove over and over again that supplements and herbal remedies, when used correctly, work. I believe that that this type of shoddy journalism has an agenda. Why are there still pain medicines available that have been proven to cause heart attacks, if not for the money that is generated for the FDA and big pharma? Explain to me how the regulation by FDA has helped us there? Yet you want to outlaw B12 or vitamin C? C'mon cbs! Transparent as cling wrap! Your in someone's back pocket!

Missval

[charlesarno]

What an irresponsible use of broadcasting power! You have a 'burn' against the $20 billion supplements industry, so you open with an entrepreneur......who prepares herbal concoctions in her home kitchen!?

You cite an 'unknown', Dan Hurley, because he published a book? There are thousands of books, pro- and anti- , in circulation on this subject, many written by better credentialed researchers. Why did you elevate Dan Hurley "to the purple"? How is he, suddenly, an "authority"? How much does he, or you, know about "biochemical individuality"?

Seems that CBS News has jumped on the bandwagon, to put strangling regulations on the inexpensive availability of herbal supplements, at the behest of the $400 billion Pharma industry. Humankind has been using herbal remedies for millennia, without suffering the devastation wrought by Pharma's pantheon of 'harmless' side effects. But, then, since CBS, et al, derive so much revenue from tooting Pharma's horn, what else are we to expect from broadcast "journalism"?

When the revolving-door FDA tries to sellout to the complete control of Pharma again, they'll have their hands full (again). Maybe, the FDA will even lose its license to (unscientifically) practice! Take this 'trial balloon', and burst it!