Reject US Government Attempt to Ban Nutritional Supplements

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March 23rd, 2010 Leave a comment Go to comments

I was recently alerted to the actions of Senator John McCain who is sponsoring the misleadingly named Dietary Supplement Safety Act (DSSA). This flawed legislation should concern anybody who wants to be able to manage their own healthcare free from unreasonable prohibitions and cost-inflation caused by the United States government. It should also concern anybody alarmed by the out of control healthcare costs in the county. While McCain’s primary intent appears to be to assist the US sports industry from stomping out illegal steroid use, his legislation is irresponsible, destructive, and won’t fix the problem. This article explains why DSSA is flawed and if passed would be harmful yet not solve any real problems. It also explains how you can easily contact your legislators via two web sites to relay your disapproval of DSSA.

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Shackle the Supplement Industry With FDA Chains?

McCain has backed the DSSA that would put the entire supplement industry under tight regulation of the FDA. Although the name of the bill implies that it will somehow improve safety of supplements, it is only likely to have any effect in this area simply because it will result in the wholesale banning of large numbers of safe supplements. The lives saved by such bans will be essentially zero. Banning both many proven supplements and new supplements from the market will likely kill far many more Americans than it will save by causing some to be unable to afford treatment for health problems and others to resort to expensive prescription drugs and risky surgeries when supplements could have been as effective at lower cost and risk.

The FDA is not an agency that can even do its current job well. Consider the long litany of drugs such as Vioxx that the FDA has approved which later turned out to kill patients using them. In many cases safer but not as profitable alternatives were available, but the FDA tried to suppress them because it couldn’t earn revenues and justify its budget if those alternatives were used widely.

Why Do FDA Drugs Kill People?

If you’d like to read more about how the FDA has manipulated US healthcare for the benefit of pharmaceutical vendors and detriment of patients, this quote below describes a book and freely available excerpts from it. Life Extension Foundation has contributed many of its articles on FDA abuses over the years to a new book on the corrupt and reprehensible conduct of the agency and how it has harmed the American public.

Take action now on FDA failure, deception and abuse!

Hunter Lewis and Gretchen Dubeau run an organization called the Alliance for Natural Health-USA (ANH-USA). (The name reflects a merger of the American Association for Health Freedom (AAHF) and the Alliance for Natural Health in the UK.) The merged organization will redouble its efforts to radically reform the FDA.

Hunter and others compiled a collection of articles written by William Faloon over the years concerning the United States Food and Drug Administration. The book, entitled FDA: Failure, Deception, Abuse represents a compilation of FDA atrocities that have never appeared together in one publication. The objective is to disseminate this book, published by Praktikos Books (Praktikosbooks.com), far and wide in order to enlighten this country about the urgent need for radical FDA reform. Until April 14, 2010, order this book from Life Extension for only $10!

Life Extension encourages its members to obtain a copy of FDA: Failure, Deception, Abuse for themselves and to loan it out to others. The publisher will also provide a PDF highlights version of the book on a special website www.fdafailuredeceptionabuse.com that may be downloaded and either emailed or mailed to everyone you know, including your Representative and two Senators.

There may be no more efficient way to initiate a revolution against FDA tyranny while unshackling legitimate scientists whose discoveries could save countless numbers of human lives.

Illegal Drug Users Drive McCain’s Vision of Healthcare Policy

The impetus for McCain’s purported concern about supplements is the sports industry having illegal drug users unsafely pumping steroids into their bodies. The FDA can’t seem to stop that even though it is already illegal. So McCain apparently thinks the answer is to clamp down on legal supplements because some of them contain trace amounts of steroids or are hormones that the body can convert into steroids.

For instance, the popular supplements pregnenolone and DHEA are both precursors to testosterone. Yet these supplements have long established track records of safety and efficacy. They are very inexpensive means to deal with the common health problems of aging men and women having declining levels of these hormones that lead to increased rates of diabetes, obesity, and cardiovascular disease.

No Need for DSSA

GMP Enforcement and FDA Inspections Already Apply to Supplement Manufacturers

The FDA already regulates manufacturers of dietary supplements by requiring them to comply with Good Manufacturing Principles (GMP) and inspecting their manufacturing plants to verify that supplements are being manufactured with listed ingredients and are free from unacceptable impurities. What the FDA does not do today but would love to do is to require drug testing studies (typically costing $1 billion or more for each drug) for dietary supplements. But unless we as a society want to turn dietary supplements with decades or even centuries of usage experience into high-priced prescription medicines, slapping prescription pharmaceutical type regulations on natural substances found in foods makes no sense.

Nutritional Supplements Not Involved in Fatal Poisonings

Nutritional supplements are not a significant cause of death in the United States, even when consumed in large quantities. According to the American Association of Poison Control Centers, its 2008 annual report on poisoning statistics shows there wasn’t been a single documented death from dietary supplements in 2008. While it is true that there are cases of people being poisoned by vitamins as shown on pages 19 to 21 of that report , there are no documented fatalities. Most “poisonings” involving vitamins require no treatment although they may have elicited a call to a poison control center.

It is interesting to note that vitamin poisoning is statistical noise for adults and is really only a problem for children ages 5 and under. Even in that group, vitamin poisoning at 3.9% of cases of poisoning in young children is a minor player compared to 13.5% being due to cosmetics and personal care products, 9.7% due to painkillers, 9.7% due to household cleaners, 7.5% due to ingestion of toys or other foreign bodies, 6.9% due to topical preparations, and 4.1% due to cold and cough preparations.

Compared poisonings with vitamins to poisonings with prescription medicines including many common medications such as benzodiazepines, antidepressants, corticosteroids (such as those used for skin irritations), insulin, birth control pills, and even antacids. These all appear significantly more dangerous than vitamins.

Critical to understanding this report is that any time somebody mentions taking a vitamin in a report to a poison control center, that is recorded and affects the statistics even if it wasn’t particularly relevant. For instance, if you were to pop a multivitamin in the morning, pop 10 antidepressants in the evening, and then shoot up some heroin at night and finally end up in the hospital, the multivitamin would be mentioned as a suspected cause of your poisoning even though common sense says that it was not the problem. Case 707 on page 71 of the report illustrates this well. The person died after taking codeine (a painkiller), amphetamines, carisoprodol (a muscle relaxant), cimetidine (an antacid with many other uses), and multivitamins. The report classifies the multivitamins as the least significant cause of the poisoning fatality, yet still lists it.

If the DSSA were to require safety caps on bottles of vitamins containing iron, vitamin A, and the few other substances common in nutritional supplements that could be poisonous to children when several or more capsules or softgels are consumed, I could understand how that might be a useful precaution with a relatively low cost. But DSSA doesn’t even mention that problem.

When you look at overall poisoning incidents involving vitamins and compare them to nonprescription medicines and personal care products, you see that aspirin, acetaminophen (Tylenol), cosmetics, antihistamines, cough and cold remedies, and even nonprescription digestive remedies are all more dangerous than vitamins.

Singling out supplements for increase regulation flies against all reason and consistency. Instead, it seems far more likely the drive to tightly control supplements is being driven by pharmaceutical companies that wish to eliminate as much competition as possible so their high-priced drugs will be the only option for many conditions. That will drive up the cost of medical care, but of course big pharma is only too happy for that to occur.

Please Let Your Legislators Know You Oppose DSSA

Below is an example of a letter sent to US Senators via the call to action site of the American Association for Health Freedom:

Please do not co-sponsor Senator McCain’s Dietary Supplement Safety Act (DSSA). Please instead oppose it!

DSSA would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.

If this bill passes, the FDA would have full discretion and power to compile a discreet list of supplements allowed to remain on the market. Supplements drawn entirely from food and long established supplements or supplement potencies could be arbitrarily banned.

McCain’s Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.

The problem here is of course one of illegal sale and use of steroids. So why dismantle the supplement industry in order to control already illegal substances?

The FDA currently has complete and total authority to stop illegal steroids and, more broadly, to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give FDA more power; we should instead demand that the FDA do its job.

Why would a bill be offered to solve an illegal steroid problem that does not really address the steroid problem but instead gives the FDA complete and arbitrary control over all supplements?

One possible explanation is that the bill’s sponsor buys into the often heard argument that supplements and drugs should be treated identically, that both should be brought through the FDA’s drug approval process in the same way. This is a completely false argument. The FDA drug approval process costs as much as a billion dollars. It is not economically feasible to spend such vast sums on substances that are not protected by patent, and natural substances cannot legally be patented.

This is the great “Catch 22” of American medicine. The FDA is unfriendly to supplements because they do not come through the drug approval process. But the drug approval process only makes sense for patentable substances that will sell at very high prices. This leaves the FDA, which is supposed to guard and promote our health, hostile to the kind of natural medicine–based on diet, supplements, and exercise–that represents the real future of healthcare.

If McCain’s bill passes, we can look to Europe for a snapshot of what we may be in for: EFSA, the European Food Safety Authority, has sharply reduced the list of available supplements and is in process of reducing potencies to ridiculous levels, such as less beta carotene than can be found in half of a large carrot.

My personal health has been greatly helped by the ability to buy and use supplements. My sex hormones, thyroid hormones, cholesterol levels, and cardiovascular disease risk indicators were all seriously out of whack. Many conventional doctors are not aware of the problems or solutions in these areas and ignore the problems until they cause heart attacks, strokes, or other potentially lethal crises. But I was able to vastly improve my health as shown by changes in test results before and after using supplements. There is plenty of medical and scientific research to back the safety and efficacy of these supplements. They are safer and less expensive than many of the drugs that the FDA approves. And they work.

Blocking access to supplements like these is going to hurt a lot of people who depend upon them to improve their health instead of resorting to expensive medicines with lethal side effects that often don’t work as well as the safer and less expensive supplements. Take statin drugs for instance. These drugs are widely prescribed by conventional doctors to control cholesterol levels, but they come with a wide range of very serious side effects such as muscle weakness, long-term muscle damage, neurological problems, and severely diminished CoQ10 levels that impair the muscles and brain from functioning properly. There are safer supplements such as niacin, beta-sitosterols, red yeast rice, guggulipid, policosanol, and others that can lower harmful LDL cholesterol safely within the serious side effects of statins. Some of them also boost beneficial HDL cholesterol, something statins cannot do.

Do you want to be known as a legislator responsible for the premature deaths of many thousands, perhaps even millions, of Americans? Speaking as somebody with seriously impaired CoQ10 levels and problems with high cholesterol that have been helped dramatically by supplements, if you pass legislation like this bill you are likely to significantly shorten my life. I liken it to murder by legislation.

You should instead be looking for ways to encourage doctors and the public to learn how to use supplements appropriately and effectively. They can lower the cost of medical care for the public by making preventive health care less expensive than having to treat severe illnesses in crisis mode as is currently the common practice. There are many supplements with extremely strong research records that should be used by the public far more widely.

If you want to be passing legislation regarding supplements to save people’s health, you should instead be looking to provide tax deductions for critical supplements such as vitamin D3 that could vastly decrease the numbers of Americans suffering from cardiovascular disease, diabetes, autoimmune disorders such as multiple sclerosis and arthritis, and other chronic conditions causing huge medical care expenditures. The small loss in tax revenues from widespread use of such inexpensive, safe, and effective supplements would be far more than offset by the billions of dollars per year in savings in expensive medical interventions and medicines. Further, by reducing the burden on the overworked medical system that is short of doctors and nurses, the quality of care may be improved for those patients who still require such care. Costs of care for those patients may also come down as the shortage in medical staff becomes less critical because of reduced demand for intensive interventions.

As an example, consider that there are about 300 million Americans. Unlike our ancestors who were running around naked in equatorial climates allowing their skin to generate sufficient vitamin D from sun exposure, the majority of Americans today are deficient in vitamin D unless they are taking supplements. Current research is suggesting that 5000 IU of vitamin D3 per day is a typical level needed for an adult to have sufficient vitamin D. Some people (children, lifeguards, etc.) need less, some people need more. Studies show that vitamin D is free from toxicity risks in adults at until dosages exceed 10,000 IU per day.

Let’s use that 5000 IU number for a back-of-the-envelope calcuation to estimate cost-benefit tradeoff. The cost of 5000 IU daily supplementation for the approximately 200 million Americans who are deficient in vitamin D is approximately $21.28 per year using a readily available vitamin D3 supplement from Costco that is sold at $13.99 for a bottle of 600 softgels of 2000 IU each. There are many other vendors of similar supplements with similar prices. An annual test to verify vitamin D levels are appropriate is about $45 to $50 today when a patient shops around to get a reasonable price. Add it up and that is about $70 per year per person. That’s $14 billion per year in costs for vitamin D supplements and testing.

That may sound like a lot of extra expense until you see the research that shows people who have healthy levels of vitamin D have vastly reduced risks for chronic diseases. Estimates are that incidence reductions of 20% to 50% for epidemic diseases such as diabetes, high blood pressure, obesity, and cardiovascular diseases could be achieved via the population being sufficient in vitamin D. Based upon this, scientists and doctors active in vitamin D research estimate that $100 to $200 billion per year could be saved by spending that $14 billion to ensure that everybody has sufficient vitamin D. While the exact numbers are obviously open to debate, even if the savings are only 15% of that estimate it would still be enough to attain breakeven.

Please see the following web pages for more information on vitamin D and its impact on health:

The Vitamin D Deficiency Epidemic
Disease Incidence Prevention by Serum 25(OH)D Level
Is Vitamin D Supplementation Helpful or Hazardous?

From the perspective of the federal government, the savings are even greater as making tax deductible critical supplements such as vitamin D3 and tests related to vitamin D, the $14 billion in costs translate to around $3 to $4 billion in reduced tax revenues due to deductions assuming an average marginal tax rate of 20% to 30%. Compare this to the multiple tens of billions in potential savings achieved by reducing Medicare expenditures for expensive chronic and critical illness treatments for senior citizens.

Furthermore, you can even sell such policies as being particularly helpful to minorities. Research on vitamin D levels in humans makes it very clear that dark-skinned people are at higher risk for deficient vitamin D.

In summary, please oppose the Dietary Supplement Safety Act and instead focus your energy on supplements towards ensuring inexpensive access to supplements for all Americans to help solve our health care crisis.

Sincerely,

signature

name, city, state

Here is a second example letter, this one to US Senators and Representatives sent via the Life Extension Foundation Legislative Action Center:

Please do not co-sponsor Senator McCain’s Dietary Supplement Safety Act of 2010 (DSSA). I ask you instead to vehemently oppose it!

DSSA seeks to repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.

If this bill passes, the FDA would have full discretion and power to compile a discrete list of supplements allowed to remain on the market. Supplements drawn entirely from food and long-established supplements or supplement potencies could be arbitrarily banned.

McCain’s Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.

The problem here is, of course, one of illegal sale and use of steroids. So why dismantle the supplement industry in order to control already illegal substances?

The FDA currently has complete and total authority to stop illegal steroids and, more broadly, to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give FDA more power; we should instead demand that the FDA do its job.

Why would a bill be offered to solve an illegal steroid problem that does not really address the steroid problem but instead gives the FDA complete and arbitrary control over all supplements?

One possible explanation is that the bill’s sponsor buys into the often heard argument that supplements and drugs should be treated identically, that both should be brought through the FDA’s drug approval process in the same way. This is a completely false argument. The FDA drug approval process costs as much as a billion dollars. It is not economically feasible to spend such vast sums on substances that are not protected by patent, and natural substances cannot legally be patented.

This is the great “Catch-22” of American medicine. The FDA is unfriendly to supplements because they do not come through the drug approval process. But the drug approval process only makes sense for patentable substances that will sell at very high prices. This leaves the FDA, which is supposed to guard and promote our health, hostile to the kind of natural medicine — based on diet, supplements, and exercise — that represents the real future of healthcare.

If McCain’s bill passes, we can look to Europe for a snapshot of what we may be in for: EFSA, the European Food Safety Authority, has sharply reduced the list of available supplements and is in the process of reducing potencies to ridiculous levels, such as less beta carotene than can be found in half of a large carrot.

The federal deficit-debt is at obscene levels, while government actuaries mathematically project future financial insolvency.

Why then is any legislation being proposed that creates more federal debt, saddles the private sector with needless but costly new regulations, and denies Americans free access to better dietary supplements that reduce their need for expensive medical care?

The Dietary Supplement Safety Act of 2010 is a blatant example of oppressive legislation that undermines free markets, decimates private sector innovation, and hastens the federal government’s plunge into a financial abyss. It is likely to cause damage not only to the pocketbooks but also to the health of millions of Americans.

If you support DSSA, will you pose for a photo with the Americans you are consigning to poor health or even death?

Will you explain to them and to the public why you believe it is important to deny affordable and effective supplements that help many with health issues poorly addressed by mainstream medicine?

Can you explain how it is appropriate to deal with problems of illegal drug abusing athletes by oppressing law-abiding citizens who depend upon supplements to improve their health and keep them out of expensive chronic illness and urgent and emergency care treatment?

Instead of having to dream up elaborate spin-jobs to explain away a vote for oppression, please refuse to co-sponsor the Dietary Supplement Safety Act and any other legislation that adds to the already outrageously high fiscal deficit. If the legislation reaches a vote, please vote against it.

Sincerely,

signature

name, city, state

angiEmedia