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     Last July, the FDA stunned supplement manufacturers with its proposed Guidance that would require all dietary ingredients introduced into the marketplace since 1994 to undergo drug-like safety testing prior to marketing. The tests could cost millions of dollars per each new ingredient, and that includes each variation on that ingredient too. These requirements would not make supplements any safer than they are today and would require supplement makers to lay aside 20 years of profits to conduct the tests. To make matters worse, tens of thousands of workers could lose their jobs as the supplement industry would be forced to remove products from store shelves.

     While many of these dietary supplements have been on the market for over a decade without reported deaths or significant side effects, the FDA’s proposed new dietary ingredient guideline appears to be nothing more than an expensive paperwork exercise intended to eradicate many safe products from the marketplace.

     Besides, we do not have to compromise with a document that has no basis in law, thwarts the clearly stated intent of Congress when it passed DSHEA and is absolutely unnecessary, even counterproductive.

     This Guidance directly threatens your supplements and your health business, if you have one. By requiring very-expensive safety testing for many of the supplements that you manufacture, distribute, sell and stock on store shelves, it will guarantee that a high percentage of those products will not survive the process. They will either be priced beyond the reach of your customers or else be removed from store shelves and the marketplace in general because they were not “safety tested” to the FDA’s satisfaction.  The FDA has a reputation for harshly applying safety rules to “dangerous” supplements while blissfully looking the other way as its drug-company overlords’ pharmaceuticals kill hundreds of thousands of Americans year in and year out.


     The National Health Federation (NHF) ( , through its lobbyist Lee Bechtel in Washington, D.C., has come up with the idea for a new bill to attack the FDA Guidance problem.  This bill was introduced in November 2011 in the House of Representatives by industry-friend Rep. Dan Burton (R-IN). Called the Dietary Supplement Protection Act (DSPA), it has been given bill number H.R.3380. In a nutshell, the DSPA moves the defining date of October 15, 1994, to a more realistic and recent date in early 2007. By doing so, it will encompass within that previous grandfathering clause all of the “new” dietary-supplement ingredients that have appeared in that 13-year interval and that would otherwise be subject to the onerous requirements of the FDA Guidance.


     The reasons to support this Bill and move the grandfathering date forward from 1994 to 2007 are simple and to the point:

  • As demonstrated above, supplements are safe; and new ingredients have continued that same track record of safety. There is no risk.
  • The regulatory environment for dietary supplements is different today than it was in 1994, as now there are GMPs, adverse event reporting, and even the FDA Food Safety Modernization Act in place that regulate from the beginning supplement manufacturing in a way not done pre-1994. Ironically, the very legislative and regulatory measures put in place to burden the industry can now be used to justify lightening its regulatory burden.
  • There is no cost to the Government in enacting this Bill. Indeed, it will save the Government many millions of dollars in unnecessary regulatory costs.
  • It will preserve jobs in America that would otherwise be lost were the FDA Guidance to be put into effect.
  • The Bill will ensure that the intent of Congress when passing DSHEA—that ”the right of access of consumers to safe dietary supplements is necessary in order to promote wellness”—is honored.
  • In a time of economic crisis, this Bill will ensure that supplements remain affordable and within the reach of ordinary Americans, thereby lowering our national health-care costs as more citizens remain healthy and disease-free.
  • It will also ensure that the innovation in dietary supplements unleashed by DSHEA in 1994 will continue and not be stifled.




                  Read the bill here:  [H.R.3380 Dietary Supplement Protection Act (DSPA)]

                  Spread the Word!  Get your friends, family, and organizations to support this Bill.

                  Contact your Congressional Representative  TODAY!



                  Thank you!!!



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