The FDA's Road Map to End Dietary Supplements

07/03/07

By Nurse Mark

Last week I commented briefly on the new FDA rules - and suggested that it was possible, just possible, that they might be a good thing for the supplement industry and for consumers. I was basing that upon the FDA's news releases and informational releases. I included as a reference to that article, though I had not yet closely read it, a link to the new rules in their entirety as that are posted in the Federal Register.

Silly me! How Naive!

There are some 800-odd pages of incredibly dry, boring, mind-numbingly stupefyingly boring, legalese and bureaucratese in this document, and I have just managed to chew my way through it superficially so far.

This document frightens me for the future of America's access to nutritional supplements.

In this document the FDA has laid out a very precise 3-year plan to decimate the nutritional supplement industry, reduce the availability of nutritional supplements to Americans, and to radically increase the price of those nutritional supplements that remain.

This is not what I think, or assume, or conjecture. After reading the FDA document this is what I know, for this is what the FDA has said in their own document.

Here, then, are some excerpts from that 800 page document:

No-One Is To Be Spared:

The final rule, then, will be phased-in over 36 months, with firms with 500 or more employees
complying after 12 months, firms with under 500 but 20 or more employees after 24 months, and firms with fewer than 20 employees after 36 months.

The Goal Is Clear:

[The model] predicts that, as a result of the final rule, 140 very small and 32 small dietary
supplement manufacturers will be at risk of going out of business. The model estimates the number of workers in those firms to be about 2,250. The regulatory costs of this final rule will also discourage new small businesses from entering the industry. The dietary supplement has been characterized by substantial entry of small businesses. Although we cannot quantify how much that will change, we expect that the rate of entry of very small and small businesses will decrease.

And Clarified Still Further:

In response to comments on the number of firms likely to go out of business, we have used our small business model to estimate that 172 small and very small firms will be at risk of going out of business. Many other small firms--some of them already experiencing financial difficulties-may see their financial condition worsen as a result of this final rule.

The Math Just Doesn't Add Up:

We estimate that, once it is fully implemented, the annual benefits, able to be quantified, from the final rule will be $8 million to $64 million; the annual costs will be $104 million to $322 million.

The Intention Is Clear - Drive Costs Up, Drive Consumers Away From Dietary Supplements And Into The Waiting Arms Of Big Pharma:

We agree with the comment that part of the costs of this final rule will be passed on to consumers as higher prices for dietary supplements. The annual costs of this final rule are less than 1 percent of total spending on dietary supplements. We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption.

So there we have it, explained to us in the FDA's own words.

The goal is clear - decimate the dietary supplement industry in 3 years. At least 172 businesses and 2250 jobs gone - with the stroke of a bureaucratic pen.

The rational makes no sense- the math just doesn't add up - for every dollar of annual "benefit" that these rules are claimed to bring the cost will range from at best $1.62 and in the worst case $40. No business or household would last long spending $1.62 to save $1.00 - our government bureaucrats can do this because they have access to a bottomless well of money - your money.

There can be no doubt that the FDA understands and endorses the effects of these rules - which will be to drive the costs of dietary supplements beyond the reach of Americans. Unable to obtain or afford dietary supplements with which to maintain their health, Americans will be forced to turn to Big Pharma for the drugs that will ease the symptoms of the diseases they will increasingly suffer.

These rules will drown the dietary supplement industry with massive amounts of paperwork in reporting and record-keeping as they will require detailed documentation of every step of every phase of manufacturing. Any error in this paper-trail, a form filled out incorrectly, a record misplaced, even spelling mistakes - could be used by FDA inspectors as an excuse to label a product as "adulterated," resulting in the product lot being seized, the manufacturing facility shut down, and of course, the company forced out of business.

These rules can leave no doubt to anyone - even the most ardent supporters of the FDA - that the FDA is truly the representative and the bully-protector of the pharmaceutical industry.

Compliance with these rules is to begin within a year - so there may yet be time to create enough of an outcry to make our politicians sit up and take notice. It is just possible that Congressional Hearings might be able to rein in this out-of-control bureaucracy before it can complete it's industry-appointed task of removing any and all competition to it's masters, Big Pharma.

But it will be up to you, readers, to barrage your elected representatives: tell them in no uncertain terms of your displeasure, and that such displeasure can and will cost them dearly at the polls. When a politician hears "I voted for you" he just smiles and nods. When he hears "I'm not going to vote for you" he just smiles and nods. When he hears "I'm not going to vote for you - and I'm going to make sure that everyone I know, and everyone they know, knows why and doesn't vote for you - and not only that, but if you don't change your ways I and all my friends are going to actively work against your re-election." then he really sits up and takes notice! That is the kind of anger he cannot ignore for it leads to the kind of action that threatens his job security.

Tell your politicians - "The FDA is out of control and you must stop them before they destroy my access to dietary supplements!"

Here is the link to the FDA Final Rules - please read them for yourself!

http://www.cfsan.fda.gov/~lrd/fr07625a.html