CGMP Makes War on Nutritional Supplements - May 2003

[Guest guest]

http://www.life-enhancement.com/article_template.asp?ID=833 CGMP Makes War on

Nutritional Supplements - May 2003

Cometh the CGMP Storm Troopers CGMP Makes War on

Nutritional Supplements

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 budget).

 

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

have now.

 

 

 

 

Gettingwell- / Vitamins, Herbs, Aminos, etc.

 

To , e-mail to: Gettingwell-

Or, go to our group site: Gettingwell

 

 

 

The New Search - Faster. Easier. Bingo.