How Should FDA Regulate Diet Supplements?
Dietary Supplement Health And Education Act Regulates Supplements As Foods, Not Drugs
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How To Regulate Supplements?
Sharyn Alfonsi looks at the effects of the FDA's practice of regulating supplements as food, not as drugs - a decision it made in the 1990s after a major lobbying effort by the supplement makers.
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Do Herbal Supplements Work?
This year, Americans will spend around $20 billion on herbal supplements, but there is mounting evidence that many of these natural alternatives are unsafe or ineffective. Sharyn Alfonsi reports.
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Congress passed the Dietary Supplement Health and Education Act in 1994. (CBS)
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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.
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See all 53 CommentsA conservative estimate of the number of individuals killed by regulated medicine each year
(both error and "non-error" drugs, surgery is about 250,000 with many thinking that a higher estimate of three times that amount to be more accurate. How much has the FDA helped us in this matter? Look at Vioxx! The FDA appears to favor the Pharmaceutical corporations who would love to shut the herbal industry down. Few deaths can be attributed to the natural suppliment/herb business and most of these products are taken without supervision. Safe is an understatment of this business!
CBS you are barking up the wrong tree. You have the wrong **** treed.
I own a small supplement company. I was surprised at how little your story did to show the kind of FDA regulation that we in the industry actually do have to deal with. There are numerous rules concerning labeling and claims that can be made about products. For example you can make a structure function claim but not a health claim or disease claim concerning your products. This information is available from the FDA. Your story would seem to indicate that the supplement industry is unregulated and has no merit.
The top manufacturers of supplements in the country would never be able to afford the cost of FDA regulation if it was analogous to the way pharmaceuticals are treated. Drug companies have so much money at their disposal that they can afford the half billion dollars it takes to push something through the FDA.
I fear that stories like yours will harm companies like my own and have a deliterious affect on the health of many americans because of the way the supplement industry was negatively portrayed.
Sincerely,
Dr. Robert J. Gatto Jr.
Manager
Allegheny Nutritionals, LLC
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.
FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
*Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA.
http://www.cfsan.fda.gov/~dms/supplmnt.html
They have no scientific discipline or rigor for clincial trials to suggest, let alone prove safety and will sell you products that cure everything from erectile dysfuntion to micromastia ( small breasts) . Diet and weight loss products are still the main vehicle for their greed .Ephedrine was banned and will stay banned with unanimous suport of the medical community . These particular products play well on our youth and beauty receptors marketed by slick Madison Avenue folks. Most are defenseless against their label promises usually prominently placed in the vitamin aisle. Ask any doctor and you will find out they are not happy with the drug companies but they HATE the dietary supplement industry and have NO AXE TO GRIND.
Kudos to the FTC for recent crack down and fines since the new year. Hopefully the new democratic congress will change DSEHA and keep people safer and in doing so less separated from their dollars. Ms, Couric please keep reporting on this issue. Anne Andrews . Irvine California .
Also word of mouth covers suppliments better than the government. Most of the time a bad suppliment is known in the world of suppliment users. We care about our bodies more than the press or the government.
How about doing a story on the blatant false advertisement you are seeing every night on TV related to prescription drugs? Start with Vytorin by Merck. You probably won't because they spend too much money with you on advertising. Cholesterol is not even the main cause of the problem and related to family, what a joke. Maybe in extremely rare cases unlike they lead people to believe. And they brain wash the public every night with those lies. Come to the 21st Century of Cellular medicine by such people as Dr. Matthias Rath and learn the truth for a change. Conventional medicine and conventional doctors are still in the "dark ages" when it comes to infective and degenerative diseases and Prescription Drugs are The largest Orchestrated Fraud in human history.
"SAVE YOUR MONEY, PEOPLE... LISTEN TO YOUR PHYSCIAN AND PHARMACIST, NOT THE PEOPLE SELLING THE PRODUCT OR THE INDUSTRY THAT PROFITS FROM IT."
I listened to my physician and pharmacist and almost died. What he is saying is save your money and buy the pills he sells which are toxic to the body. The people who profit from the lies he promotes are Big Pharma, Doctors, Pharmacist, and a host of others in the field of iatrongenics. Emergency medicine yes, but when it comes to infective and degenerative diseases, these people are still in the "Dark Ages."
Today I eat right and take a lot of supplements. Unlike prescription drugs that were disastrous for my health, supplement have proven themselves many times over and I can dance again and live a life full of energy.
How far will this go? Will we attempt to alter Nature in an attempt to pacify Big Pharm? Burn all the herbal books to keep people from learning? Or take on another disaster like the drug war we are already losing? The government can't even stop the growth or importation of one illegal plant, let alone over 1000 species.
Herbs have helped me where prescriptions have failed. After watching CBS news for all of my 42 years, I am changing channels. That's the best way to win this war.
Karen Bergeron
Alternative Nature Online Herbal and Medicinal Plant Photo Gallery
http://altnature.com
Altnature is right. How far does CBS want us to take this? This same elitism in certain individuals, and the willingness of others to follow has driven our society through the ages. Why do we have to only feel safe if the FDA tells us it's ok? Why would we trust them over our grandma's home remedies? Why can't we just make our own informed decisions? Why couldn't CBS do a FYI series on remedies found in your yard? Because as altnature points out, the FDA can't regulate that!
I%u2019ve got three words for CBS News, Misleading, Misleading, Misleading.
It%u2019s not people like me and others (Chinese for thousands of years) who TRULY understand the value of Herbal Supplements but the individuals who have yet to become exposed to the benefits of Herbal Supplements. You could very easily have negatively affected hundreds of thousands of people. Is this what the CBS News organization stands for? Is money or should I say the %u201Clove of money%u201D (significant pharmaceutical commercials) is what your organization lives for? Although I understand profit is important to the success of any business or corporation, does it have to be at the expense of others?
I wasn%u2019t always a proponent of Herbal Supplements (so called Alternative Medicine) until 15 years ago when my %u201Cdoctors%u201D (eventually 18 in total) were unable to properly diagnose a serious health problem. In short, one visit to a %u201CNaturopathic %u201D (www.naturopathic.org I have no association with this organization) and recovery was almost immediate. As of today, at 57 years old, I%u2019m a world class athlete due to in large part because of Herbal Supplements and the like.
CBS News could have negatively influenced or helped to rob me of the %u201Csecond life%u201D I now so completely enjoy. Please think about the consequences when devoting such attention to something so very, very important.
So be prepared for more attempts to control your freedom to choose, with media companies like CBS playing along with their stockholders Big Pharma and their servants at the FDA.
Proof of their incestuous relationship with the "Drug Mafia" is their murderous refusal to to ban Aspartame, behaviour that can only be described as Genocide.
This month on behalf of the South African government a charge of Genocide as been lodged against those people who have poisoned thousands in that country with HIV and AIDS drugs. You can put all the money you have on the fact that CBS will not be repoting this prosecution.
Following intervention from South African President Thebo Mbeki, A person known as Zacki Achmat as been cited for Genocide at the International Criminal Court in the Hauge.
His crime was to implement the use of HIV and Aids drugs as approved by the FDA to thousands of poor South African People, who sadly passed away.
Full details www.tig.org.za
Hopefully retribution to ALL those responsible will be swift.
There are pharmaceutical grade supplements available, with guaranteed potencies. These are the highest quality supplements available, using the highest quality ingredients found from around the world. Cellular nutrition is a science, you shouldn't just trust it to any company trying to make money on the latest fad. Do your research before committing to any product.
Clearly CBS did not decide to just run a prime time story about supplements on a whim. Look at who advertises the most on CBS. Glaxo... I don't doubt for a second that the marketers at Glaxo demanded that CBS develop a story to discredit the supplement industry. Keep an eye out for Alli commercials on CBS in the coming months.
Dr Joe B
(Full name with held as I'm a practicing MD that does not need to be hassled by Big Pharma)
Should oranges, kale for their vitamin C is regulated? What if a company has the capability to extract the contents of natural fruits and vegetables and put them in a bioavailability and biocompatible form?
The supplements I take has help in choosing fresh vegetable for the value they may have. It is said, that some vegetables may loose some of their value from the field to the table.
Supplements are what they are, supplements, not substitutes for eating wholesome food.
All I hear about supplements are they may interfere with your meds. Well I am not on meds, pass 60 years old, so my supplements want interfere. Some say, herbs don%u2019t work. Where do medicine get their start? You know herb isn%u2019t just herb, they contain vitamins, minerals according to many authors of herbal books.
We talk about the cost of health care, who will pay, those who understand what they are doing may lower their cost by doing thing that support a good immune system.
I have not yet read Hurly's book Natural Causes so I quote Steve Mister, CRN president:
%u201CThe book includes more than 200 footnotes, but a cursory examination shows the author repeatedly footnotes his own inquiries, other people's opinions and people who spoke anonymously. This is not the bibliography of a serious piece of work. Hurley relies primarily on personal opinion and isolated incidents to falsely imply that these cases represent the experience of the more than 150 million Americans who take safe, beneficial dietary supplements as part of their healthy lifestyle choices. The book Natural Causes cannot be considered a credible, scientific work. This is an assortment of extreme anecdotes that exploit rare and tragic misfortunes in an agenda-driven attempt to sell books.%u201D
It is clear the real reasons you chose to do this story have nothing to do with facts related to the nutritional supplement industry. As has been detailed by many others posting here, one reason is your reliance on the pharmaceutical industry. Secondly, you chose this story and to get folks to watch your failed anchor Katie Couric. She and your nightly news are a failure, and by promoting this sensational story I again contend you will lose 20 times the number of viewers you could have ever gained by getting them to tune in.
I hoped, after the first part of your 2 part series, that you would give a separate persepctive on day 2. But your main source for both segments was only Dan Hurley.
You gave no credible information about legitimate concerns with supplements aside from diet pills, did no comparison of negative effects between supplements and other OTC medications or Rx alternatives. In fact you lump all supplements together - that is as silly as painting all RX meds as bad because of side effects with one.
You railed at teh fact that supplements are not FDA regulated, did not explore the ecnomic issues which drive drug companies to study Rx meds but give no economic incentive to study non-patentable herbal remedies.
Like many, you did not even look beyond our borders where many supplements and herbs have been studied extensively and used in Europe and Asia for centuries.
Responsible journalism would have included real facts, balanced perspective, interviews with medical personnel. You touted government results, but didn't even interview any official with responsibility for supplements studies.
Shame on you.
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!
Missval
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).
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!
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.
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.
thoroughly disgusted,
Al Bosco
"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.
"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.
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.
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?
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?
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