The FDA's Broad Discretionary Powers over Dietary Supplements

Adapted from the story by Lauran Neergaard, Associated Press; Washington, April 2, 2004.

According to an advisory panel for the Food & Drug Administration (comprised of members of the Institute of Medicine and the National Research Council), the FDA doesn't need direct evidence of human harm before it removes a dietary supplement from the market.  Data gathered from animal and test-tube studies, or similar products, can suffice.

Additionally, this advisory panel urged the need for Congress to require that manufacturers of dietary supplements report customer side effects, making it easier for the FDA to "protect the public from dangerous supplements." 

[Update: S.3546, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the Adverse Event Report bill) now before Congress would address this.  It essentially removes the protections we've enjoyed under DSHEA, moving dietary supplements closer to be re-classified as OTC drugs.  This is a serious threat to health freedom.]

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA, pronounced du-shay), it was assumed that the FDA was required to prove that an ingredient was unsafe before removing it from the market.  The conclusion of this panel is that this is not true.  "You don't have to have proof of harm," stressed Barbara Schneeman, vice provost and a nutritionist at the University of California, Davis, who headed the panel.

The Standard for Action

While the law requires that the FDA demonstrate a significant or unreasonable risk of harm from a supplement before it can remove that product from the market, this panel insisted that this burden can be met with less strict evidence.  It provided a step-by-step protocol for the evaluation of a supplement's safety when there isn't clear-cut human data.

The intent of this scientific framework is to allow the FDA to be "more effective in identifying substances that could pose a risk for harm to human health," Schneeman explained.

Why this is needed

Contrary to frequent claims by supplement proponents, neither the absence of reports of side effects, nor a product's long history of use automatically means that it is safe, the panel's report cautioned.

Indeed, legal "constraints imposed on the FDA make it difficult for the health of the American public to be adequately protected," the report concluded.  It called on Congress to better fund the FDA's oversight of supplement safety, and to mandate that manufacturers report side effects experienced by their customers, just as required of the pharmaceutical industry.

Why this poses such a potential threat to your health freedom

First of all, the "constraints imposed on the FDA" that "make it difficult for the health of the American public to be adequately protected," are a precious part of DSHEA's safeguards to our health freedom.  They were won after a long, hard battle against the tyrannical actions of the FDA, which threatened your freedom to choose an alternative to the toxic healthcare options offered by the pharmaceutical industry.

Since the passage of DSHEA, there has been an uneasy truce, of sorts, between the FDA and the dietary supplement industry.  Still, the despotic tenancies of the FDA have not been entirely quieted.  Time and again, courts have ruled that FDA policies have violated the spirit — if not the letter — of DSHEA.  The same is true of Congressional hearings.  Still, the FDA battles to regain the powers it had "constrained" by DSHEA.

The goal is not the public health.  It is control; it is money.

Let's face it, more and more Americans are turning to alternative healthcare options.  I need to look up the details on this, but the amount spent on alternative therapies — most out-of-pocket expenditures — is challenging the role of medicine in the hearts and minds of the American public.  This was noted in the New England Journal of Medicine almost a decade ago, and the trend has grown considerably since then.  What was a concern then is becoming fear now, if the actions of the big medicine cartel are any indication.

A question of public health

The FDA and various medical/scientific groups like to speak of concerns for public health and safety.  That's really ironic when you consider that the American (medical) healthcare system is the leading cause of death for Americans.

• Medical doctors, working within the modern healthcare system, kill more people than cancer or heart disease, and sicken thousands more.
• You have a seven times greater chance of dying walking into your doctor's office than you do getting behind the wheel of your car?  Prescription drug adverse reactions are the third leading cause of death in America.

When are the FDA and these scientific groups going to start protecting us from them?

The question of a long history of use

I think it's fairly obvious that, just because something has been in use for years and there is an absence of reported side effects, doesn't mean the product is safe or effective.  However, the same standard needs to be applied to things standard to modern medicine.

• Chlorine as a water purifier creates many health problems; but, even though it's known to be toxic, it's use continues on the basis of it's long history of use.
• Dental amalgam fillings are highly toxic, but are allowed to remain in use because of their long history of use.

In both of these instances, history of use precludes them from the necessity of proving their safety and effectiveness.

The point is, if you removed chlorine (and fluoride) from the water, and eliminated the use of amalgam fillings, you would practically destroy that part of the pharmaceutical industry that produces antacids, acid suppressors, anti-diarrheals and allergy medications.  That's big business; and the FDA doesn't want to mess with that.  Too much of their money comes from there.

What scares me most

The part of this "no direct link" policy that scares me the most is that all products containing an ingredient can be banned based on research or anecdotal reports related to that ingredient, either by itself or as part of another product.  This can apply even if the findings are in a test-tube, under artificial circumstances, or in animal studies.  It also applies to to natural forms of a substance, even if the adverse event was to a synthetic form — which reacts very differently in the body.

There are some really disturbing elements to this policy:

• Things don't always work the same in a test-tube or an animal as they do in people.
• Product ingredients, taken by themselves, can have extremely different effects in people than if they are found in their natural state.  For example, certain essential oils contain chemical constituents that are, in themselves, quite toxic; but as part of the whole oil, contribute important properties to the therapeutic effect of the oil.
• Ingredients can have very different effects in people, depending on the source of the ingredient and how it was produced.  For example, several studies have shown that vitamin E has little impact on heart health; but, those studies used synthetic vitamin E, which reacts in the body as a toxic waste, not a nutrient.

Therefore, to ban any dietary supplement with a specific ingredient, based on indirect evidence that it might be harmful in humans, is ludicrous.  But the FDA can be counted on to try to apply this standard.

The bias factor

What makes all of this especially troubling is the history of bias — and outright hostility — against things natural on the part of the FDA and the medical establishment.

• When people started getting sick and dying from reactions to MSG (monosodium glutinate), and the public began actively trying to avoid it, instead of banning the poison, the FDA allowed food producers to conceal its presence in foods by calling it a natural flavoring or hydrolyzed protein.
• Although it's known to cause all sorts of health problems, aspartame (NutriSweet^®) is allowed to stay on the market, but if a safe and truly natural product (stevia) is called a non-sugar sweetener, instead of merely a food additive, it can get pulled from the market.
• When a batch of L-tryptophan was contaminated during manufacturing in 1983 and a few people died (approximately the same number as died from the tainted Tylenol at about the same time), the FDA pulled all tryptophan from the market, and wouldn't allow it back on the shelves, even after the cause of the problem was identified and corrected.  [Update: L-tryptophan has recentely been allowed back on the market.]  On the other hand, when SSRI medications, which have something of the same action, but in a totally alien way, are known to have caused thousands of severe adverse reactions — including deaths, and impulsive murder/suicides — the FDA allows these medications to be used for an ever-widening group of complaints.
• Although the safety and effectiveness of dietary supplements — supported by thousands of years of use, in some cases, and hundreds of documented clinical studies in others — are dismissed by the FDA as merely anecdotal, this panel's report accepts purely anecdotal reports of possible harmful effects as grounds for removing any product with that ingredient from the market.  At the same time, pharmaceuticals with demonstrated adverse reactions are approved for the market, and their use is extended beyond those supported with by pre-approval studies on the basis of anecdotal reports.
• In all the history of the dietary supplement industry — and for thousands of years before — death or injury from taking dietary supplements in a responsible way have been a rarity.  Yet FDA-approved medications, taken as directed by doctors, kill hundreds of thousands of people each year.
• Although it is called the Dietary Supplement Health and Education Act of 1994, it seems that the intent of the FDA is to keep information on the safe and effective use of dietary supplements out of the hands of the public.  While pharmaceutical companies are allowed to tell the public almost anything about their products, and even define the nature of disease, those who produce dietary supplements aren't allowed to make anything but the most generalized statements about what their products are good for.  This effectively leaves the public uneducated, and puts the consumer at an unreasonable risk.
• Increasingly, doctors are relying on the information fed to them by pharmaceutical salesmen, rather than reading a drug's documentation for themselves; and they tend to work under the assumption that, if the FDA approved a drug, it must be safe.  On the other hand, the FDA approves dangerous pharamaceuticals with the belief that doctors will educate themselves about their use and dangers, and will monitor their patients to minimize the harmful effects of these drugs.  (The system is broken.)

I find the implications of this to be frightening.  There is a blindness here of monumental proportions.

Do you want people like this to have broad discretionary control over your choices in healthcare?  I sure don't want to surrender my freedom to choose to people of this mind-set.  It would be insanity itself.

Where is this going?

This past year (2004), there have been several attempt by Sen. Durbin (of S. 722 infamy) to pass legislation — often hidden in another bill — that would give the FDA greater power to control what you have access to.  The battles that led up to the Dietary Supplement Health and Education Act of 1994 appear to need fighting again.  Only this time, there is more subtlety and slight-of-hand involved.

We need to stay awake and vigilant, or our health freedom may become something completely of the past.