http://www.lef.org/featured-articles/Dietary-Supplement-Safety-Act-of-2010.htm
New Bill Seeks to Ban Consumer Access to Dietary Supplements
By William Faloon
Senator John McCain has introduced a bill that if passed will drive up the cost of dietary supplements and restrict your access to them.
This bill seeks to give the FDA complete and arbitrary control over what supplements you are allowed to have. I am writing you about this and a far more important matter.
If you believe in the science of mathematics, you may have noticed that this country is descending into financial oblivion. There is a debate as to whether this is the fault of the private or governmental sector.
My position is simple. If it were not for the technological advances made possible by private enterprise, the adverse effects of governmental ineptitude would have rendered this nation insolvent decades ago. Said differently, if it were not for the increases in productivity and reductions in costs made possible by free enterprise, government waste and fraud would have already destroyed us.
By way of example, Life Extension has approximately 300 employees today. We develop dietary supplement formulations and make them available at lower relative prices each year. If it were not for our private enterprise-invented computers, it would require several thousand employees to do the same work. That would mean higher prices and inferior products for you, assuming we remained solvent.
Senator John McCain (and others) is proposing to squander tax-debt dollars by mandating more government waste, while sticking the private sector with oppressive laws that will hinder scientific advances and increase costs. The net effect will be to take away your free access to dietary supplements.
Pharmaceutical interests are obviously behind this latest effort to legislatively force more Americans towards expensive prescription drugs and away from natural ways of preventing degenerative disease.
In normal times, I would ask each of you to e-mail Congress to demand that they refuse to co-sponsor the bill that John McCain introduced in the Senate. But these are far from normal times.
You should instead use John McCain’s bill as an example of the rampant tax-debt fraud being perpetrated by Washington, D.C., politicians and bureaucrats. Please use our convenient legislative action center to e-mail your Senators and Representative to not only protest against this corrupt piece of legislation, but every government project that contributes to an impossible-to-pay-back federal debt.
(Note: This communication is not an attack on John McCain or any other elected official. Many Senators would have been deceived by pharmaceutical lobbyists as you will soon read.)
The bill being spearheaded by Senators John McCain and Byron Dorgan represents the kind of federal regulation that is not only ineffective, but also suffocates innovation in ways that inflict permanent damage to this nation’s economic vitality.
The bill supposedly originates from the controversy surrounding the use of steroids by Major League Baseball players. Since some unethical companies illegally sold steroid drugs as “dietary supplements,” certain members of the Senate (i.e., John McCain and Byron Dorgan) appear to have been deceived into believing that the FDA needs to be given additional power to ban dietary supplements across the board.
The fact is that the FDA has all the legal authority it needs to remove supplements that contain illegal drugs from the market. The FDA has failed to do its job, and there are companies selling dietary supplements that contain prescription drugs. If the FDA continues to fail to do its job, then these companies will continue to sell drug-tainted supplements no matter what new laws are “created” by Congress.
The outrage over this bill expressed by so many supplement consumers is that it gives the FDA broad and arbitrary new powers to remove natural products from the marketplace. Since the FDA (and Congress) is dominated by large pharmaceutical interests, this bill will effectively enable drug companies to control which supplements you have access to.
You may recall the FDA’s ban last year of a more effective form of vitamin B6 (pyridoxamine) because a pharmaceutical company wants to have it approved as an expensive new prescription drug to treat diabetic kidney failure.
If McCain’s bill is passed, it will make it far easier for pharmaceutical companies to file use patents on what are now inexpensive dietary supplements and convert them into outrageously priced “drugs”. Just look at the cost of prescription drug fish oil that so many cardiologists are prescribing to their patients. It costs about seven times more than the same amount of EPA/DHA fish oil you can buy as a dietary supplement. Just imagine if the FDA was given arbitrary power to ban omega-3 dietary supplements!
In order to mislead the public about the true nature of this bill, it has been named the Dietary Supplement Safety Act of 2010 (DSSA). It purports to protect consumers, but the question arises, from what?
According to a published report by the American Association of Poison Control Centers, no one died in the year 2008 as a result of taking a dietary supplement.1 The facts are that legitimate reports of deaths caused by dietary supplements this century are virtually non-existent.
Despite this safety track record, John McCain’s bill would give the FDA authority to draw up a list of allowed and disallowed supplements (and supplement potencies). This alone would destroy your free access to supplements. But there is more.
There is no real world rationale for this legislation. Yet this bill would automatically cause any dietary supplement to be classified as “adulterated” if it is “manufactured, packaged, held, distributed, labeled or licensed by a dietary supplement company not registered with the Secretary.” The “Secretary” in this case is the Secretary of Health and Human Services, the department of the federal government that oversees the FDA.
The registration requirements would add layers of overhead costs to manufacturers who are already fully compliant with current Good Manufacturing Practices (cGMP) and are inspected by the FDA. It would also create an entire new category of taxpayer-funded bureaucrats who would oversee this hideous expansion of federal control over dietary supplement access.
The registration process would require paperwork to be submitted to the federal government for every new formulation, re-formulation, new ingredient, etc. The effect will be to take what are now low-cost natural supplements and force the paperwork requirements to be more closely aligned with those of unaffordable prescription drugs.
Burdensome registration requirements also mandate voluminous paperwork submissions for new ingredients that give the FDA more power to DENY the “approval” of a natural ingredient. This clause of the bill would further reduce the availability of new dietary supplements coming to the market…effectively giving pharmaceutical companies a monopoly over what new health products you are allowed to use. Any new products that make it to market will carry the higher cost associated with complying with this bill’s new obstructive mandates.
The FDA already requires manufacturers to maintain records of serious adverse reaction reports. This bill would require that all “non-serious adverse events” be submitted to the federal government. The problem is that when a large group of people take any product, there are always coincidental adverse reactions. This means that for any given product, the FDA can arbitrarily take the list of adverse reports submitted to it and use it as a basis to remove the product, even if there was not a single valid adverse reaction!
Once again, pharmaceutical companies would be able, under the Freedom of Information Act, to gain access to coincidental reports of adverse reactions, and petition the FDA to REMOVE the supplement from the market. (There are of course millions of cases of serious adverse reactions — [including many deaths] — on file with the FDA about the drugs they approve, but of course these drugs are virtually never withdrawn from the marketplace.)
The FDA already has broad powers to remove dangerous products. This legislation would enable the FDA to ban anything if they have only “reasonable probability” that there is a serious problem with a product. This kind of discretionary authority gives the FDA tyrannical power to ban supplements, a power they have not hesitated to use when they’ve had it.
Recall that in the early 1990s, the FDA declared that many of the supplements used today, including CoQ10, selenium and chromium, were inherently dangerous. The public’s revolt against the FDA’s absurd proclamation led to passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994. This is the law that protects consumers’ rights to access low-cost dietary supplements. The Dietary Supplement Safety Act (DSSA) bill introduced by John McCain would largely eviscerate the protections afforded by DSHEA.
Just imagine owning a pharmaceutical company and hearing from physicians that patients are refusing to take your expensive side effect-prone drugs. Instead you learn they are switching to low-cost dietary supplements that you cannot patent.
Since you control a large percentage of Congress, the logical solution is to have legislation enacted that will enable the FDA (that you also control) to remove supplements that compete with your drugs. That is exactly what the Dietary Supplement Safety Act of 2010 (DSSA) will accomplish if Big Pharma has its way.
The greatest economic challenge this country faces is how to deal with runaway disease care costs (they call it “health care” when it isn’t). What few understand is that there is no real medical cost crisis. Medical care is so expensive today because it has been so corruptly over-regulated. Disease care costs, in other words, are egregiously hyper-inflated compared to what their free market price would be.
FDA Failure, Deception and Abuse is the title of a new book that documents that disease care costs are a result of endless legislation passed by Congress that enables those in conventional medicine to earn obscene profits, while the nation’s economy collapses under the burden of outlandish prices for dangerous and minimally effective therapies.
The proposed Dietary Supplement Safety Act of 2010 is an egregious example of how this kind of insidious legislation comes into being, and how the public is deceived into thinking that Congress is seeking to “protect” them (in this case from nothing), when the real purpose of the legislation is to further enrich the entrenched drug cartel that long ago bought and paid for most of Congress and the FDA.
In addition to drug companies who want the Dietary Supplement Safety Act enacted into law, professional sports teams are also behind McCain’s legislation. This is because they want to blame somebody other than their players and themselves for illegal steroid use in sports. See the following statement by the Baseball Commissioner Allan H. Selig made on February 4, 2010:
“On behalf of Major League Baseball, I would like to thank Senators John McCain and Byron Dorgan for their efforts to broaden the Food and Drug Administration’s regulatory authority over dietary supplements. We fully support the proposed legislation designed to protect athletes and consumers from dangerous, mislabeled and tainted over-the-counter supplements. The continued leadership of Senators McCain and Dorgan has made an impact on this important issue.” By conspiring with what has been long viewed as a wholesome American sport, pharmaceutical interests are seeking to deceptively portray this insidious legislation as being beneficial to consumers — the exact opposite of what its effects will be.
In the face of unconscionable levels of governmental waste and abuse, the federal deficit-debt is at obscene levels, while government actuaries mathematically project financial insolvency in the not-too-distant future.
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 how Congress undermines free markets to enrich campaign contributors, decimates private sector innovation, and hastens the federal government’s plunge into a financial abyss.
The only encouraging news is that the numbers of dedicated supplement users are enormous. I ask each and every one of you to click here to conveniently alert your two Senators and Representative about this oppressive legislation that should not be co-sponsored and should instead be vigorously opposed.
As in the 1980s and 1990s, the majority of the public is strongly on our side. Your voice needs to be heard to usurp the predatory financial influence pharmaceutical companies wield over Congress.
