CGMP Storm Troopers CGMP
Makes War on
he glorious victory that many have claimed for the passage
of the Dietary Supplement Health and Education Act (DSHEA) of 1994 was never
true. In its favor, DSHEA held the regulatory hounds of war at bay for a few
years. But to its detriment, it seeded the mechanism that may end up eventually
controlling every aspect of the nutritional industry. DSHEA did this by
authorizing the FDA to develop and impose full pharmaceutical Current Good
Manufacturing Practice (CGMP) standards for dietary supplements. As could have
been expected—given the sinister nature of political interference in the
marketplace—it was just a matter of time until the full force of rampant
bureaucracy collided with our industry.
On March 7 the hammer came down with a 547-page proposed
rule, “Current Good Manufacturing Practice in Manufacturing, Packing, or
Holding Dietary Ingredients and Dietary Supplements.” The “standards” put forth
in this document are so severe that they exceed those imposed upon the
pharmaceutical companies, which are Goliaths with virtually unlimited resources
in comparison to nutritional companies. With the cost of taking a drug to
market now approaching one billion dollars, it is outrageous to establish
equality of “standards” between the two industries. Yet, as proposed, CGMP for
nutritional companies is harsher.
For starters, the proposed CGMP would require manufacturers
to evaluate the identity, purity, quality, strength, and composition of their
dietary ingredients and dietary supplements for every batch. This would be
particularly onerous and expensive for small companies that manufacture complex
formulations. For a multivitamin containing 45 ingredients, the cost of
analysis, by the proposal’s estimates (undoubtedly low) would be $30,000 or
more per batch! For batches of 1000 bottles or less—a good-size run for a small
company—the added burden of evaluation alone would at least triple the price.
Thus, if this requirement holds, the result would be a skewing of production
toward the simplest formulations and a scarcity of quality multivitamin
formulations. When only the largest companies are left making multivitamins,
chances are they will be more likely to comply with 100% of the recommended daily
values. They will toe the correct political line.
CGMP would ensure not only a rollback of complex products,
but also hinder or halt the development of new products, thus severely
diminishing the spirit of creativity that characterizes our industry and makes
us the envy of the world.
However, batch evaluation is but one small part of the onus
of CGMP. Whole divisions of “qualified” and “certified” personnel, the red tape
of endless protocols, functional codes such as an “adequate” number of
lavatories, and mounds and mounds of paperwork would cleave the bottom line
from all but the largest companies. There can be little doubt that the proposed
rule would level most small businesses (which comprise most of the industry),
like a daisy-cutter can level a city. Far fewer companies would survive, and
these would tend to be the largest and most conservative, resulting in
significantly less competition and far less innovation.
Worst of all, the FDA would have the right to conduct
unrestricted inspections of nutritional companies at their discretion and
could, for subjective reasons (a substantial portion of the proposed code is
difficult to quantify—the word “adequate” is used 111 times in the proposal),
shut down companies that are in their political beacon.
As things stand, the industry and all who would respond to
this proposal have until June 7 to file their critiques. When these are
answered, as it is the FDA’s task to do, it will be patently clear that the
FDA’s solution to “good manufacturing” is nothing less than the imposition of
arbitrary and undefined powers enabling it to exercise repression of all with
whom it disagrees.
The proposed regulations would force a jackboot into the
door of every nutritional concern, big or small, giving the FDA entry and discretionary
overwhelming powers to shut down businesses for a tidal wave of codes that can
be followed only at enormous expense, at best, and by halting and reversing the
progress of nutritional science, at worst.
Make no mistake: CGMP is not really about quality control.
This proposal hands the FDA the powers to do everything that they’ve ever
wanted, to run around the Constitution—they have said that they don’t believe
the First Amendment applies to themselves!—and to find a rationale to
dramatically increase their budget, not to mention protecting the
pharmaceutical industry, the triumph of which has always been regarded as in
the best interest of the regulatory profession (fees by the pharmaceuticals for
“fast-track” approval swell the FDA larders by a significant percentage of its
In the face of all this mayhem, is there a positive note?
Under the Administrative Procedures Act, the FDA is required by law to conduct
impact studies to determine how their proposed regulations would impact small businesses—but
will they? It may be necessary to sue the FDA to force the issue, and by the
way, it will take at least four years to implement the proposal. A lot can
happen during that time. And, of course, there’s the United States
Constitution, which, while not perfect, is a hell of a lot better than what we