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New Bill Seeks to Ban Consumer Access to Dietary Supplements

By William Faloon

A bill has been introduced to the Senate that would drive up the cost of dietary supplements and restrict your access to them. This bill seeks to give the FDA arbitrary control over what supplements you are allowed to have.

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 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.

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 this 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 in this century are virtually non-existent.

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.

These 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 by the FDA.)

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.

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.

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.

The Dietary Supplement Safety Act of 2010 is a blatant example of how Congress undermines free markets and decimates private sector innovation.

The encouraging news is that the numbers of dedicated supplement users are enormous.

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.

1. Bronstein AC, Spyker DA, Cantilena LR Jr, Green JL, Rumack BH, Giffin SL. 2008 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 26th Annual Report. Clinical Toxicology. 2009. 47, 911-1084.