FDA AND THE DRUG INDUSTRY OUT TO DESTROY THE SUPPLEMENT INDUSTRY
By Attorney Jonathan Emord
Author of "The Rise of Tyranny" and
"Global Censorship of Health Information" and
"Restore The Republic"
February 25, 2013
NewsWithViews.com
A decade ago advisors to the leading dietary supplement companies and to
their principal trade association came to the remarkable conclusion that
they could not build a workable relationship with the FDA unless the FDA
came to regulate every aspect of the production, holding and distribution of
dietary supplements. For decades FDA had endeavored to restrict what could
be said about supplements and remove supplements from the market. After much
discussion, many leading supplement companies and their trade association
followed the advice given them and drafted proposed regulations that would
permit FDA to impose process controls governing every aspect of sourcing,
production, holding, and distribution of dietary supplements. The proposal
was breathtaking in its grant of discretionary power, enabling the FDA to
regulate everything from the location of hand washing stations to the
qualifications of quality control personnel. The proposal subsumed local
health and safety and zoning laws. The promise made by the industry to its
members was simple: Join us in granting FDA these powers and FDA will change
its view of the industry and embrace us rather than destroy us.
At that time I was a lone critic of the proposal. I explained that the
proposal was based on a fundamental misunderstanding of the relative
bargaining power of the supplement industry in the FDA's regulatory
universe. I explained that the proposal would not change FDA's negative view
of the supplement industry, would redound to the detriment of the industry
(in costs and loss of freedom) and would ultimately inure to the benefit of
the FDA's most favored regulatee, the drug industry. The metaphor I used in
speeches at the time (and since) was that of a rogue elephant (the drug
industry), ridden by a blind mahout or elephant driver (the FDA), equipped
with a riding crop (regulation). A pesky flea on the flank of the elephant
represented the dietary supplement industry. Ridden by a blind driver, the
elephant could go wherever it wanted; the blind mahout was dependent on the
elephant for guidance. The mahout's only concern was to help the elephant
avoid distress; so long as the flea took no action that would irritate the
elephant, the flea could abide in peace but, whenever the flea annoyed the
elephant, the mahout would use his riding crop to hammer the flea into
quiescence.
On the black day when the industry finally presented the proposed cradle to
grave GMP regulations to the FDA, the FDA seized the day, recognizing that
in fact it had received the industry's head on a silver platter. The
industry continued to operate on a surreal plane, predicting that adoption
of the GMPs signaled a new day for the dietary supplement industry where
those who complied would buy themselves peace with the FDA. Not so. For
decades FDA had endeavored to break down the supplement industry, the
arguments about supplement safety were but a pretext (by and large dietary
supplements have been safer than even foods). Science concerning dietary
supplements had revealed them variously to have therapeutic effects,
associating them with disease treatment and prevention. The FDA's statutory
mandate (a gift of drug industry lobbying of Congress in the 1960s)--and its
predisposition in light of the lucrative post-government employment offered
by the drug industry--reinforced an agency role antagonistic to the food and
supplement industries.
To ensure that the drug industry would enjoy a monopoly over the use of
therapeutic claims, it endeavored to tame the supplement market (censoring
its speech and endeavoring to remove specific products). To that end,
whenever the food or supplement market included claims that a food or
supplement could treat or prevent disease, the FDA was quick to stamp out
those claims, sending in agents and sometimes U.S. Marshals to shut down the
operations with broad search and seizure warrants (on the legal fiction that
the products had been transformed into drugs by the claims made for them).
For decades, FDA has endeavored to assert greater control over what had
historically been a robust free market in supplements. The agency tried to
reclassify supplements as unapproved food additives but the courts shot down
that effort, to coerce and cajole the market into dropping claims of health
benefits but the courts demanded that truthful disease prevention claims be
allowed, to reclassify supplements with certain dose levels of vitamins and
minerals as drugs but Congress adopted legislation forbidding that move, and
to ban supplement ingredients altogether.
As Congress found in the 1980s, the FDA's history reveals a bias against
dietary supplements. That bias complements its bias in favor of drugs. At
the same time that FDA expended millions annually cracking down on dietary
supplement companies, it relished in a cozy relationship with the drug
industry. Repeatedly FDA's Commissioner approved drugs over the safety
objections of the agency's medical reviewers. FDA's Center for Drug
Evaluation and Research director engaged in direct ex parte communications
with drug company executives assuring them that medical reviewers who
objected to drugs then under review would be punished, ostracized, and
removed from cases or that public relations efforts of those drug firms
would be complemented by favorable statements from FDA.
So it was that a decade ago in speech after speech I urged the dietary
supplement industry to reject the notion of going to FDA with cradle to
grave regulations (the cGMPs) but to no avail. The industry went to the FDA
with the regulations already drafted and obtained the support of Senators
Hatch and Harkin along the way. The agency received the proposed regulations
and then proceeded to ratchet them up several notches. After they were
published in the federal register and available for comment, I filed
comments on behalf of the Alliance for Natural Health-USA. Those comments
included an economic analysis by regulatory economist Joanna
Shepherd-Bailey, Professor of Law and Economics at Emory University. Her
assessment revealed that upwards of 50% of the dietary supplement industry
would be eliminated by enforcement of the regulations and that all players
would incur several hundred thousand dollars of new costs annually, all
without any demonstrable increase in the relative safety of an already very
safe dietary supplement market. Suddenly those who favored the regulations
began to have doubts.
Several filed comparable comments in which they explained that the impact of
the regulations would be profoundly negative on the dietary supplement
industry, resulting in increased supplement costs, decreased supplement
availability, and increased incidence of supplement company closures and
consequential unemployment. But alas it was too late, FDA had what it wanted
and proceeded to adopt final rules. We filed duplicate comments concerning
the regulations with the Office of Management and Budget, which assesses
whether the economic impact statements associated with proposed regulations
are accurate reflections of cost. Apparently OMB chimed in, withholding
allowance of the regulations and telling FDA that its rosy economic
projections conflicted with likely costs, as expressed in the economic
assessments provided the agency. To the surprise of many observers, in its
final rule FDA essentially adopted the predictions of adverse economic
impact, rejecting its earlier rosy prognostications, agreeing that adoption
of the rule would result in the closure of many firms, increased costs for
supplements, and decreased availability of products.
As predicted, the regulations have been taming the dietary supplement
industry, forcing the closure of several firms and costing even the biggest
players huge sums annually in a futile effort to satisfy the ever changing
regulatory demands of the FDA. The extraordinary discretion given FDA's
investigators under the GMPs ensures that they may lord over companies,
making companies change all manner of operations to satisfy an agent's whim
or caprice. Failure to do so results in issuance of "observations" in a Form
483, which must be satisfied immediately or enforcement will follow.
The regulations have so intimidated supplement companies that they have been
transformed from robust market players to timid, largely impotent actors who
labor under the constant fear that an investigator will show up and find
something remiss, no matter how minor, which will under the GMPs be deemed
adulteration even if products produced are perfectly safe. The authority FDA
always sought over the industry to cabin it, consolidate it, and intimidate
it into subservience to the dictates of the agency has been achieved.
This objective is but a part of a much bigger picture, apparently
misunderstood by those who advocated the GMPs. As science has revealed
therapeutic effects of supplements, they have become of greater interest to
the agency's most favored regulatees, the drug industry. So long as the
market for supplements is robust with many players and products, competition
keeps prices and profits relatively low (by drug company standards).
However, if the market is honed down to a few actors, prices will rise and
the opportunity to market supplements as the equivalent of over-the-counter
drugs becomes more promising. At present the drug industry sits like hyenas
on the edge of the supplement market. As FDA beats up that market and
reduces the number of players in it, the hyenas continue to gather and
prepare to seize the prey. Once enforcement under the GMPs and the new Food
Safety Modernization Act provisions result in significant market
consolidation, the drug industry will increasingly enter the market, buy the
concerns, and establish a major presence.
Once FDA's favored regulatee, the drug industry, has taken over much of the
supplement market, the agency will—under drug industry lobbying—warm to the
idea of reducing the effective barriers now present on supplement claims,
permitting supplements to be marketed with therapeutic claims more akin to
over-the-counter drugs. In exchange for those changes, the drug industry
will be required to give up more control over aspects of production and
content of products, resulting in even more market concentration.
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That bargain the drug industry will embrace because the right to make claims
for specific products will enhance their marketability and because further
lessening in what may be sold will invite increased prices. Many other
changes are predictable once the FDA's favored regulatee takes control over
most of the supplement market.
Ironically, those who favored the GMPs because they thought they would
remove small players and build a better relationship with FDA were right;
they just misunderstood who would receive those oligopolistic benefits (it
was not the leaders of the dietary supplement industry who advocated the
GMPs, it was the drug industry).
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Jonathan W. Emord is an attorney who practices constitutional and
administrative law before the federal courts and agencies. Congressman Ron
Paul calls Jonathan "a hero of the health freedom revolution" and says "all
freedom-loving Americans are in [his] debt . . . for his courtroom
[victories] on behalf of health freedom." He has defeated the FDA in federal
court a remarkable eight times, six on First Amendment grounds, and is the
author of Amazon bestsellers The Rise of Tyranny, Global Censorship of
Health Information, and Restore the Republic. He is also the American
Justice columnist for U.S.A. Today Magazine. For more info visit Emord.com.
Website: Emord.com
E-Mail:
jwemord@gmail.com-
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