At the request of the NHF, Congressman Dan Burton has introduced H.R.3380, the Dietary Supplement Protection Act (DSPA). At the time of this writing, the Bill has two sponsors and the NHF is working to increase this number. In addition, the Council for Responsible Nutrition (CRN), the trade group for the largest nutritional food-and-supplement manufacturers has indicated its tentative support through its Congressional lobbyist. The ever-alert National Health Freedom Coalition is on board in supporting the Bill, but the Institute for Health Freedom (IHF) and Alliance for Natural Health (ANH) have noticeably been absent on Capitol Hill with any support for this important legislation.
Some within the industry and the health-freedom community have raised concerns with the legislation, which concerns are really based upon misunderstandings. The two misunderstandings are: (1) Questioning the selection of January 1, 2007 as the new date for moving the existing DSHEA “grandfathering” date forward from the current one of October 15, 1994 date; and (2) Thinking that amending DSHEA may open the law up and could make things worse for the regulation of supplements in the future. As discussed below, neither of these concerns are a reason to withhold support.
The July 2011 FDA-proposed Draft Industry Guidance for New Dietary Ingredients (NDIs) is the culprit, and the reason for H.R.3380. This Guidance outlines the FDA’s intentions to enforce rigorous “safety” standards” on all supplements sold since 1986 (and into the future) and the imposition of prescription drug-like testing in order for a “new” supplement to be marketed to American consumers. This would affect many as recent government data estimates that 53% of Americans over the age of 18 consume at least one dietary supplement daily. The NHF opposes this Draft Industry Guidance (more information is available on the NHF website at http://www.thenhf.com/page.php?id=124).
There has been almost universal opposition from health-freedom advocates, dietary supplement consumers, and industry groups to the proposed NDI requirements. Industry groups have taken the position that at least the FDA has finally published its proposal, seventeen years after DSHEA, and that the negotiation process with the Agency should be followed. Post-release of the Guidance, the head of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) publicly has already stated that the FDA would not withdraw the Guidance and that it would take three to four years to potentially negotiate compromises on what the Agency wants and what the industry can live with. Unlike others in the health-freedom community, the NHF has raised the bar with the introduction of H.R.3380. In other words, absent passage of H.R.3380, the FDA would once again with the NDI Guidance “salami slice” its interpretations of the DSHEA law to better fits its own agenda, rather than what Congress actually intended when it passed the law in 1994. We have been down this road before, but this time the path can and should be different.
H.R.3380 seeks to roll back FDA authority and limit future regulatory and Guidance actions by exempting many thousands of the estimated 25,000 new supplements introduced and sold since 1994. Almost all of these already have been reviewed and approved by the FDA under the existing requirements of DSHEA. Under current law, “grandfathered” supplements that already were being sold prior to 1994 were DSHEA-exempted. Moving the date forward would exempt supplements being sold and already approved by the FDA between 1994 and 2007. These many thousands of supplements would also be classified as being “Generally Recognized As Safe” (GRAS) under the Food, Drug, and Cosmetic Act (FDC&A). Moving the “grandfathering” date forward would limit the Federal statutory law and administrative reach, and limit the impact of the FDA’s July 2011 Industry Guidance for New Dietary Ingredients if and when it is published in the future. Eligible products would not be subject to FDA regulatory misinterpretations and “double jeopardy” for proving the safety of supplements that is already being consumed.
Moving the “grandfathering” date forward to 2007 would not exempt these newer grandfathered products nor their manufacturers from the regulatory requirements for the manufacture and production of dietary supplements (Good Manufacturing Practices), nor exempt these supplements from the requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA), the adverse event reporting law already on the books. Products entering the marketplace after January 1, 2007, would have to comply with DSHEA, as intended by Congress, and future FDA actions and misinterpretations of the law could only go back to 2007, and not 1986. If H.R.3380 is enacted, the FDA could still ignore the revised exemption date, just as was done to the 1994 date in the proposed Draft Guidance. However, there is one critical difference against this happening. The 1994-to-2007 exempted supplements were already reviewed and approved as being safe. The adverse event reporting system for supplements ensures that in these supplements are safe in the post-marketing and consumption by the public. The 1994-to-2007 grandfathered supplements would be GRAS exempted and be exempt from further regulatory actions. Unlike the pre-1994 supplements, there is a track record of safety, and a stronger argument against FDA action.
Why the 2007 date? The existing law October 15, 1994 grandfather date was a purely compromise date that was selected on the basis of the DSHEA enactment date because there were no benchmark dates prior to a new structure for regulation by making supplements a new category within the framework of foods. The January 1, 2007 date, on the other hand, is based upon the FDA’s issuance of a final rule establishing the requirements for the manufacture and production of dietary supplements and the enactment of the dietary supplement adverse event reporting for consumers and manufacturers. The 2007 date establishes a firm public policy anchor date that is not arbitrary by design. Moving the “grandfathering” date forward closes the window and rolls back the FDA’s authority to continue to “salami slice” its interpretations of DSHEA to fits its own agenda.
As to the concern with “opening up DSHEA” and potentially making it worse for industry players and consumers, quite frankly, this concern is the voice of fear, weakness, and cowardice. Health-freedom advocates and others need only recall the history of FDA actions in attempting to circumvent Congressional intent via intentional regulatory actions during these years. The anti-freedom forces continue to chop away at our health freedoms year by year. What are we to do? Sit quietly by the wayside, quivering in fear that if we dare speak, then something worse might happen? Without resolution, this will continue and only to the benefit of those opposed to freer access to safe supplement products. Without firm resolution on our part, our health freedoms will continue to be taken away from us. Whether we take action or not, they are going to continue “opening up DSHEA” to diminish our freedoms. So, we have nothing to lose and everything to gain by firm action here and now on our part. H.R.3380 is finally a step towards more freedom and not less.
Since DSHEA’s enactment there have been seventeen years of additional historical use-safety experience for supplements, all conducted by millions of Americans. During this time, newer regulations for industry practices and consumer post-market safety have replaced the arbitrary 1994 supplement product grandfathering date so it should logically be moved forward to reflect the safety record of supplements. If the FDA chooses not to recognize these facts, then Congress should do so by limiting its regulatory reach. If a supplement on the market before 1994, and a supplement approved by the FDA and sold to the public between 1994 and 2007, is, under the GRAS section of the FDCA law, recognized as safe for human consumption then there is no need for further regulation, nor would there be application to them in future industry Guidance requirements. There must be an end to the FDA’s continued usurpation of Congressional authority and the bureaucratic public-policy misinterpretations of the DSHEA law. H.R.3380 provides the vehicle to accomplish these goals in a simple and straightforward manner.