The “Final Rule” creates Mordor for a large segment of
CGMP Will Rule Us . . . Find Us . . .
the nutritional supplement industry
and in the Darkness, Bind Us
hirteen years after Congress delegated the creation of “current good manufacturing practices” (CGMP) for the nutritional supplement industry to the Secretary of the Department of Health and Human Services, the FDA has delivered its “Final Rule.” But this rule is not in accordance with the provisions of the Dietary Supplement Health and Education Act (DSHEA) or the intent of Congress. Section 9 of DSHEA reads, “The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology.” [Emphasis added] Yet the Final Rule is modeled after drugs and is, in fact, more severe in many ways than pharmaceutical GMPs.
Politics Rather Than Science
Just the size of the ruling alone—815 pages, not including an interim ruling of 100+ pages—is strong indication of the complexity of the many rules encompassed by CGMP. Draconian, redundant, and poorly edited, the Final Rule uses the imprecise word “adequate” hundreds of times for matters of judgment concerning compliance. This bespeaks a failure to set objective standards that can be readily understood, making interpretation a matter of politics rather than of science.
The central concern of any food manufacturing standard should be the issue of adulteration. Yet the focus of CGMP is on extraneous matters that will entail enormous costs. If you happen to be a large company, you are more likely to be able to finance the avalanche of recordkeeping that it requires. Will the public be any better off for this gargantuan effort, or will concern for adulteration be buried by bureaucratic deadweight? If we see what runaway paperwork has done to the practice of medicine, devouring time that physicians could spend with their patients, the future of the supplement industry looks bleak.
How CGMP Came to Be
It is clear that CGMP is not the result of popular clamor by a majority or even a plurality of the companies that constitute the supplement industry. On the contrary, the model for its drug-like rules originated with the industry’s trade organizations. Indeed, these organizations (which charge huge membership fees starting in the tens of thousands of dollars per year) represent only the largest members of the industry—just a few percent of the total. Their alleged goal has been to clean up the industry, but by cozying up to their counterparts in the pharmaceutical industry, it is clear that they want to see far fewer competitors—and CGMP will do just that.
The Prognosis for the Industry
As the FDA admits in the Final Rule itself, the price for its “high” standards will necessitate the bankruptcy of 172 small companies. But regulatory attorney Jonathan Emord thinks that the estimate is off by at least a factor of 10 and that the upshot will be sayonara for up to 2000 or more companies. This represents a significant part of the nutritional supplement industry, about 30%. If this occurs, many of the more innovative companies will disappear, and the industry will never be the same.
Only Mercedes Will Drive the Highways
What will the ultimate costs be for the consumer of nutritional supplements? Per the FDA, prices will go higher. Variety will also contract. By how much? Jonathan Emord has said that if the same kind of GMPs were applied to the automobile industry, only the Mercedes-Benz-type vehicles would survive, and of course the prices would be far higher. Who could afford them?