EDITORIAL

Market Science vs. FDA Religion

T here is no such thing as consensus science. This is because the dominance of a collective judgment, position, and opinion—no matter how many scientists (or bureaucrats) say it is true—is not a scientific argument. More to the point, popularity is not part of the scientific method and science is not a democratic process. Yet while the marketplace is not an ultimate arbiter of science, it is more in keeping with the spirit of science than bureaucratic dictates. That’s because one involves choice and the other coercion (force), which has no role in science (except perhaps in the old USSR).

Not surprisingly, authorities often claim to have a monopoly on scientific truth, which is amazingly similar to the worst claims of religion, which by one definition is an attempt to establish contact with a perceived higher power (or authority). This is done for protection and guidance, and also to engender a certain degree of fear. (Think hurricanes, thunderbolts, and earthquakes for example; only the authorities can save you.)

Speaking of bureaucrats, we supplement users are faced with the FDA’s recent plan, called the New Dietary Ingredient (NDI) Guidance,* the goal of which appears to be the death of the supplement industry from a thousand paper cuts. If the FDA has its hopes fulfilled, hundreds of thousands of NDI notification applications will need to be filed when the “Guidance” is adopted. The costs will be monstrous; probably in the billions of dollars. Worse yet, nearly all supplements that have had any changes since 1994 must be removed from the market for 75 days, while they await approval which may never come. Changes that require supplement notifications include things as small as altering the level of a nutrient intake or changing the copy on a label. With the NDI Guidance, the FDA has massively expanded what was DHSEA’s original definition of a new dietary ingredient, so that far more ingredients must be the subject of advance FDA approval to be lawful to market. And that must be done by every company, independent of whether the ingredient has been approved. Indeed, the entire supplement must be approved.


* See “New FDA Directive to Outlaw Most Supplements” in the September issue.


Drop Dead, Says the FDA

“Drop dead” the FDA says, according to attorney Jonathan Emord, “culling from [the industry’s] ranks many small, innovative producers to pave the way for an ultimate assumption of market control over basic vitamins and minerals by pharmaceutical companies.”1 Since the 1960s, the FDA has initiated one scheme of tactics after another to hoodwink the public into believing that supplements are drugs, or worse than drugs, and that they must be controlled lest a holocaust of horror, death, and suffering ensue. That is wildly far from the truth, with the safety of supplements overwhelmingly established, while even with the extreme oversight of the FDA, pharmaceutical drugs are extremely dangerous. According to US National Poison Data System figures, the last two years of available data show that pharmaceutical drugs caused 80% and 81% of fatalities respectively (the rest are caused by contaminated or spoiled foods), while supplements have not caused one single undisputable death.


Giordano Bruno (1548 – February 17, 1600), an Italian Dominican friar, philosopher, mathematician, and astronomer who after proposing that the Sun was essentially a star was burned at the stake by civil authorities in 1600 after the Roman Inquisition found him guilty of heresy.
Freedom to Make Up One’s Mind and to Choose Freely

But the public hasn’t bought culpability, or anything like it, and the Dietary Supplement and Health Act (DHSEA), brought into existence by popular demand, came to the rescue when enacted in 1994. Until now it has kept the market for supplements relatively safe, although politicians and bureaucrats have continued to hack away at the tree of liberty that it represents for the most part. These are the freedoms to make up one’s own mind, to individually respond to the multitude of opinions about efficacy and safety, and take responsibility to choose wisely.

Turn Supplement Company Founders into Wanted Criminals

Also note: All products made with ingredients that are not APPROVED by the FDA under these new rules will be called ADULTERATED, and continuing to market an unapproved supplement, even if not doing so means the bankruptcy of a company, will be met with possible criminal proceedings. Or perhaps, they should be tortured or burned at the stake. (Just joking.)

It’s For Your Own Good

This whole gambit is coming at us under the guise of safety, so public sentiment is not offended, As Emord writes, this “... approach is causing the supplement company carcasses to form heaps along the regulatory road.” That was the guise of the current Good Manufacturing Practice guidelines too, which it is estimated will lop off at least 25% of the smaller concerns in the industry because compliance is enormously costly, adversely affecting all companies, small and big, to the great benefit of the latter, the pharmaceutical companies

There is more. According to Emord, “[FDA] Commissioner Margaret Hamburg … has changed its enforcement priorities and policies to be far more aggressive, protecting the agency’s favored regulatee, the drug industry, from all but nominal actions while slamming supplement companies even for minor infractions of the rules.”

In the preparation of a public comment, filed in response to the NDI Guidance, Emord’s law firm commissioned an expert to assess the impact of regulation and it was determined that full implementation by supplement companies would cause as many as 50% of the dietary supplements currently on the market to be unlawful to sell. Plus, the Guidance would cause over 100,000 people in the industry to lose their jobs, with revenue losses in the billions.

In total, the aggressive regulatory enforcement, including the Guidance will only succeed in the destruction of businesses, the sacrificing of jobs, and denying consumers access to health-enhancing nutrients. In conclusion, again writes Emord, “The beneficiaries of the FDA’s supplement wrecking ball are the large pharmaceutical companies who, like Cheshire cats, sit on the fence, eyeing the developments with smiles, waiting to pounce and fill the void once the supplement companies have been sufficiently culled by big pharma’s help mate.”

The New Inquisition

The FDA in its “wisdom” is not to be trusted to decide what constitutes science, or safety for that matter, especially given its bad track record which is the consequence of combining politics and a religious-like attitude, one that represents itself as a “higher authority”. By fighting those who would prefer to think for themselves, not settle for revealed “science,” and make up their own minds—the new “heretics—the FDA is creating the equivalence of a new Inquisition. This must come to an end, or we will all face the consequences. Some time may still remain. If you have not done so already, please send your message to Congress through the Action Alerts at the Alliance for Natural Health Website (www.anh-usa.org) in opposition to the FDA’s NDI Guidance.

Reference

  1. Emord J. FDA to supplements: drop dead. http://newswithviews.com/Emord/jonathan206.htm. Updated Aug. 22, 2011. Accessed Aug. 29, 2011.

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