EDITORIAL

Stop the Dietary Supplement
Safety Act of 2010

B ack in the early 1990s, it appeared as if the Food and Drug Administration would ban nutritional supplements. They argued that only they were qualified to protect the American public from the alleged rampant dangers inherent in supplementary foods. But then the public roared in opposition to FDA usurpation, sending more mail to Congress than it had received on any other subject since the misbegotten Vietnam war. Along with this, supplement retailers started to cover their product in black cloaks, to demonstrate how vast the ban would be if the FDA were allowed to proceed. Ultimately, the point was driven home, and Congress drafted and passed by unanimous consent the Dietary Safety Health and Education Act (DSHEA) of 1994. This piece of legislation wasn’t perfect, but at least it said to the bureaucrats, “Keep your hands off our supplements.”

Now again, in 2010, another dangerous threat looms and is poised to severely limit our right to choose supplements that we individually determine will give us better health and support our well-being. This threat is called the Dietary Supplement Safety Act of 2010 (S. 3002), sponsored by Senators John McCain (R-AZ) and Byron Dorgan (D-ND), and make no mistake, under the guise of safety, they are trying to gut DSHEA. Quoting the Health Freedom Federation, “This bill has as much to do with safety as pigs [have to do] with space travel.”

This is a truly bad bill. It gives the FDA near-dictatorial control over the manufacturing and availability of supplements. A list would be created by the FDA, and if a company’s products don’t appear on the list they are “unaccepted” products, the result of which would be punitive fines for companies selling or distributing what is not preapproved.

At the FDA’s own arbitrary discretion, the bill would allow the removal of perfectly legitimate nutritional supplements from the marketplace. The FDA could also file complaints against legitimate supplements at their sole whim, and impose what constitutes drug testing standards on each supplement. If you don’t already know, meeting FDA standards for the marketing of a new drug can cost as much as $600 million. What’s certain is that no supplement company has the resources to legally combat or financially meet such regulatory and legal impositions. The result would be the arbitrary closure of many ethical supplement companies; they would simply be forced to close their doors and shut down. This is exactly what DSHEA was intended to avoid.

What is the rationale for such a horrendous piece of legislation? Senator McCain appears to be motivated by recent scandals involving the doping of athletes with illegal steroids and has been approached by various professional athletic organizations such as Major League Baseball. Given that a lot of these outfits contributed to his Presidential campaign, he may be beholden, to say the least. Yet, don’t you seem to recall that these organizations were blamed for pushing athletes to the point of breaking, to get in shape too rapidly, and meet draconian schedules? How much easier to shift the blame to the supplement industry?

The FDA already has all the power it needs to investigate and punish companies that market and sell steroids improperly and requires no added authority to pursue what is really part of the drug market. Many steroids are sold legally, via prescription. Nor does the FDA need additional control over supplements that are properly manufactured and marketed, or over ingredient companies that provide the materials that comprise supplements. Not, at least, in order to regulate steroid spiking.

This bill is not an innocent overstepping of the existing limitations imposed on the FDA. Current Good Manufacturing Practices have already gone an additional distance by requiring supplement companies to provide proof of ingredient integrity and quality. Furthermore, S. 3002 appears to play into what many of us know is the FDA’s dislike of the supplement industry at large. After all, the supplement industry does not provide Fast Tracking money, as do pharmaceutical companies, and which now total a significant percentage of the entire FDA budget.

Despite DSHEA’s mandate that the FDA allow health claims—and the Pearson v. Shalala decision compelling them to do so—after several years of moving begrudgingly forward, things have now gone into reverse motion, with the FDA disallowing claims it had granted. This show of antagonism, even against ethically manufactured supplements, undoubtedly results from playing too much footsie with Big Pharma, who along with the FDA have shared a desire to remove supplements from over-the-counter availability and make them into prescription drugs, completely under their control. Pricing could then ascend to the enormous prices of drugs.

But enough is enough! Perfect safety is impossible in a conditional world, and people tend to be safest where they are most free. In summary, this bill is written in Napoleonic Code and all supplements are guilty until they appear on the approved list. That is backwards! What about the Constitution? As one who should have known about issues of the trade off, Benjamin Franklin wrote, “They who can give up essential liberty to obtain a little temporary safety, deserve neither liberty nor safety.”* Call your Congressional Representatives, and insist they say “no” to S. 3002.


* Franklin B. Memoirs of the Life and Writings of Benjamin Franklin. London: Henry Colburn. 1818.


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