Health policy and practice is out of step with the everyday health practices of millions of Americans. According to The Natural Marketing Institute's 2003 study on health and wellness trends, more than 85 percent of the general population use some type of nutritional supplement, and more than 59 percent use them on a daily basis.
Why in the world then, would the Federal Food and Drug Administration (FDA)—a dogmatic agency responsible for overseeing the health guidelines of a nation—be blind to scientific evidence indicating that regular use of dietary supplements and eating a balanced, whole foods diet, can and do improve one's quality of life? Especially when their mission is "to promote and protect the public health by helping safe and effective products reach the market in a timely way."
Recent study contradicts The Food and Nutrition Board's findings
In 2003, The Food and Nutrition Board of the National Academy of Sciences—the main authority in the U.S. for nutritional recommendations (which, by the way, gets funding from the FDA)—published a major report on antioxidant nutrients, including vitamins C and E. The study concluded that taking antioxidant supplements serves no purpose.
But, not surprisingly, a recent study conducted by two Oregon State University researchers at the Linus Pauling Institute refuted that conclusion.
The study, co-authored by Angela Mastaloudis, a researcher at the Linus Pauling Institute, and Maret Traber, one of the nation's leading experts on vitamin E, shows that a group of runners who participated in a 50-mile ultramarathon showed metabolic damage and lipid oxidation similar to the damage commonly found in heart attack victims. On the other hand, a group of runners who supplemented their diets with daily doses of vitamins C and E prevented the increase in lipid oxidation.3
Interestingly, the male runners who did not receive supplements continued their unusually high levels of oxidized lipids for almost a week, while the metabolism of females returned to normal in a day.
"This study clearly showed that supplementation with these antioxidant vitamins could help prevent the significant levels of lipid oxidation that are associated with intense exercise," said Mastaloudis. "And it's worth noting that the people who did not take supplements, but did have a vitamin E intake that would be about the amount suggested by the federal RDA, did not gain those protective benefits."4
According to the co-authors, the findings of this study may have ramifications far beyond just people who undergo unusual exercise regimens. Oxidative stress and higher levels of lipid oxidation are seen in a wide range of health problems, ranging from diabetes to heart disease, stroke, Alzheimer's disease, smoking and even obesity, the researchers said.4
"Everyone can benefit from a diet rich in fruits and vegetables which contain these antioxidants," Mastaloudis said. "But for people with oxidative stress, such as runners or people with heart disease, it is more beneficial to take supplements."4
Vitamin E was discovered 80 years ago and is best known as an antioxidant that may reduce oxidative stress associated with the development of coronary heart disease. The dietary source of vitamin E is fats and oils, yet only about 20 percent of Americans are getting even the recommended daily allowance of the vitamin, to say nothing of the extra dosage that is recommended by this study.4
"This study clearly showed that supplementation with these antioxidant vitamins could help prevent the significant levels of lipid oxidation that are associated with intense exercise," Mastaloudis said.4
According to Mastaloudis, the Food and Nutrition Board have yet to change their standpoint on the use of antioxidants, even when directly contradicted by evidence found in this study as well as many others.4
The most recent RDA recommendation, Traber said, is based largely on data that is decades old, and does not really explore the optimal intake for people who have depressed levels of micronutrients for various reasons, such as athletic exertion, heart disease, other degenerative diseases, or simple lack of physical activity.4
Some members of Congress have yet to be convinced of the benefits of supplements. What's going on here? Do we simply have a case of "David versus Goliath"? Is it a case of conflict of interest between the consumer and the pharmaceutical industry that stands to gain from the ever-increasing cost of pharmaceuticals, and the proliferation of modern-day diseases? Is it sheer ignorance and poor education that are to blame for the pressure that doctors, politicians and some scientists put on the FDA to restrict our access to alternative health options, and information we should be getting from reputable scientists?
Whatever the answer, the health climate in the U.S. is complicated and dangerous. But we can tell you this, if medical organizations continue to use heavily conflicted experts to make clinical recommendations, public confidence will erode. And if politicians and policy makers continue to try to restrict our access to dietary supplements, our personal efforts and freedom to choose how we take care of our health will become a thing of the past.
The bottom line is this: most members of Congress do not understand what dietary supplements are, how they keep people healthy or how they actually reduce health care costs. Despite the fact that dietary supplements are an integral part of most Americans' lives, the dietary supplement industry faces political and regulatory challenges which are almost as imposing as those prior to the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA)—which is why we need your help!
How much can the nutrition industry save the country in healthcare costs?
After the economy and the war in Iraq, health care ranks as the issue that most concerns Americans. When asked to name the most important problem for the government to address, respondents to a Kaiser Health Poll Report in August 2003 ranked health care third, in a tie with terrorism at 13% and higher than national tax and budget issues, education and crime.5
At the forefront of health care concerns is cost. In an ABC News/Washington Post Poll in October 2003, 78% of respondents said they are dissatisfied and 54% very dissatisfied with the cost of the nation's health care system. Additionally, 54% are dissatisfied with the overall quality of health care, and 62% would prefer a universal health insurance program.5
Instead of responding to those concerns, our senators are trying to derail free access to dietary supplements
The hard-won natural health freedoms ensured by the Dietary Supplement Health and Education Act (DSHEA) of 1994 could be overturned!
Reacting to the hysteria over ephedra, Richard J. Durbin (D-IL) brought forth Senate Bill 722, cosponsored by Hillary Clinton (D-NY), Dianne Feinstein (D-CA) and Charles Schumer (D-NY), which gives unprecedented power to the FDA to remove nutritional supplements from the market. Here's how:
Senate Bill 722 calls for a reporting system for adverse reactions to nutritional supplements. The FDA is empowered to act on a single adverse reaction report and immediately take the product off the market while it is being investigated. In addition, it could force the manufacturer to undergo prohibitively costly safety analyses of the product, similar to what is required for new drugs.
Imagine this scenario: A child is taking a supplement containing vitamin C. One day at school he has some diarrhea, gets dehydrated and faints on the playground. He hits his head, and is rushed to the emergency room, where he is diagnosed with a brain injury. Believe it or not, just one incident like this could be blamed on vitamin C. And based on this isolated incident, the FDA could, at its discretion, restrict sales of vitamin C until an investigation proved that vitamin C did not cause the boy's problems.
If the forces backing this measure are successful, DSHEA may be amended so that any and all dietary supplements can be banned!
Where Do We Go From Here?
Oppose Senate Bill 722
SB722, the so-called Dietary Supplement Safety Act, would greatly expand the FDA's authority over dietary supplements and undermine the hard-fought victory the Nutritional Supplement Industry achieved with DSHEA, which sought to restrain the FDA's historical abuse of discretionary authority over dietary supplements. And, despite its title—The Dietary Supplement "Safety" Act—this Bill will provide the consumer with no more protection than current law provides.
If passed into law, however, this bill will:
- increase health care costs and decrease consumer choices
- single out dietary supplements and hold them to a higher standard of scrutiny than many over-the-counter medications and food additives that have already proven less safe than supplements
- provide unnecessary additional regulatory authority to the FDA, which has not enforced DSHEA in a timely manner. The overall result would be fueling the healthcare cost crisis and seriously undermining DSHEA and consumer's right to choose health products.
What can you do?
A unified industry effort is needed! We must inform the public of this legislation and how it affects us all. Please urge everyone you know who values the health freedoms we now have, to contact their state senators nationwide to oppose SB722. We need your help!
Send a letter to your State Senator to oppose S-722. Without your opposition, this bill stands a good chance of passing into law and affecting the health freedoms we take for granted now.
The only way to stop this bill is for us to flood our elected representatives with so many emails, faxes and phone calls that they will be forced to say no to the powerful interests that are behind this movement.
Oh, and one more thing...
We have to support Senate Bill 1538, the DSHEA Full Implementation and Enforcement Act of 2003.
Don't Let Congress Overturn the Dietary Supplement Health and Education Act of 1994!
Because the Food and Drug Administration has failed to fully uphold the law, Congress is looking into making changes that will undermine many of the freedoms that American consumers of dietary supplements hold dear.
The FDA has fallen short when it comes to enforcing the law. Let's give the FDA the resources it needs to implement DSHEA! This bill will eliminate the Food and Drug Administration's favorite excuses that it doesn't have enough staff, money or power to regulate supplements.
Support research that validates the safety, effectiveness and quality of dietary supplements.
Because dietary supplements come from natural ingredients, they can't be patented. While this insures that these products are readily—and affordably—available, it takes away the ability of manufacturers to recoup research costs. The bill doubles the funding given to the Office of Dietary Supplements to expand research and consumer information about these products.
Hold the government accountable for its actions.
SB1538 will require the FDA to file annual reports to Congress about how they're regulating dietary supplements. If they fail in their responsibilities to fully implement the law, they'll be held accountable.
The Better Health Action Center, part of the Campaign for Better Health, has given us permission to print their letters for your use. You may log onto their site— http://www.healthactioncenter.org/
action/index.asp?step=2&item=14239—and send it automatically to your State Senators.
And ... we like to ask just one small favor: After you click the "Send" button and you get to the "Tell Your Friends" Page, please put our email address in there:
So often political work feels thankless and we'd be very pleased to get thousands of emails back so we know you took action.
As an alternative to using the web site above you can print out the abbreviated versions below, to send them by postal mail.
I urge you to oppose any efforts by your fellow Senators to enact S-722, which has been erroneously named the Dietary Supplement "Safety" Act by its sponsor Senator Durbin.
This bill would allow the FDA to take away my dietary supplements.
Under existing law, the FDA has been given broad, legal authority to regulate all aspects of manufacturing, marketing and distributing dietary supplements. Rather than encouraging the FDA to start aggressively enforcing existing law, Senator Durbin's bill would grant the FDA new enforcement powers without any corresponding increase in the protections accorded to consumers under the existing law. These new enforcement powers would include wide discretionary authority that would enable the FDA to remove from the market safe and healthful dietary supplements. This would completely undermine the primary goal of the Dietary Supplement Health and Education Act of 1994 ("DSHEA") to restrain the FDA's historical abuse of discretionary authority over dietary supplements.
If adopted, this Bill would unjustifiably subject vitamins, minerals, herbal products and other supplements to an unwarranted level of government scrutiny. Beneficial products that have been used safely for hundreds--and in some cases, thousands--of years would be subjected to clinical evaluation using ambiguous standards. This would permit the FDA to fabricate safety concerns and remove safe, nutritious dietary supplements from the market.
Under the Durbin Bill, if a single report of an adverse experience occurring while taking a dietary supplement is received, even though it is not known to be causally related to the dietary supplement, the FDA can initiate procedures resulting in the termination of the marketing of the ingredient. All of these procedures are left entirely to the unbridled discretion and whim of the FDA.
Already, adverse experiences have been filed for Vitamin C; Echinacea; Multivitamins; Glucosamine; Calcium and more.
I encourage you to oppose this extreme and unnecessary legislation and use your authority to encourage and support the FDA in fully exercising its already adequate enforcement powers.
Respectfully yours, --
I support the full implementation of DSHEA and believe the recent FDA action banning ephedra demonstrates that this regulation works. This action clearly demonstrates that the FDA has the ability to take actions it determines are necessary to promote consumer safety, including removing products it deems harmful from the marketplace. Please support Senate Bill 1538. This bill aims to provide full enforcement of DSHEA by authorizing sufficient implementation appropriations for the FDA and provides additional funding to the Office of Dietary Supplements to expand research and develop better consumer information on dietary supplements. Doesn't it make more sense to mandate that FDA to enforce the existing law, which it has not done in the past 10 years?
Respectfully yours, --
How to Contact Your Senators
You may also call your senators' offices. You will likely speak with staff members, but your message will still be heard. Let them know who you are, ask them to vote against SB722, and be prepared to tell them why.
The US Capitol switchboard number is (202) 224-3121. Look in the phone book for your senators' local office numbers. Staffers can give you your senators' fax numbers, as well as other contact information.
We can shake our heads at the blatant misuse of our tax dollars. However it would be better to send a barrage of letters and e-mails to our policy makers. This will let them know that we will not sit by and watch as our nation's health standards fall due to Federal bias and indifference.
Please act now! The timing is critical.
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This article is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a physician before embarking on a dietary supplement program.
Starfield, Barbara, MD, MPH, "Is US Health Really the Best in the World?" JAMA, Volume 284, No. 4, July 26, 2000.
Edmonds, Bryce. Consumers' Confidence In Supplements Rises. January 1, 2004. The Natural Foods Merchandiser. September 1, 2004. http://www.naturalfoodsmerchandiser.com/asp/
Maret, Traber, Angela, Mastaloudis, et al. Antioxidant supplementation prevents exercise-induced lipid peroxidation, but not inflammation, in ultramarathon runners. Free Radical Biology and Medicine. (36(10), pp1329-41), May 15, 2003.
Stauth, David. "Study shows vitamin E can prevent metabolic damage." Oregon State University Press Release, 6/17/04
Consumer Research III, Nutrition Business Journal, Nov. 2003.