Expressing regret with the FDA’s dismissal of Senators Hatch and Harkin’s written request for the FDA to withdraw the draft Guidance for New Dietary Ingredients for supplements, Congressmen Dan Burton (R-IN) and Jason Chaffetz (R-UT) have sent a similar letter to FDA Commissioner Margaret Hamburg, M.D. Industry and consumers have been alarmed by this draft Guidance ever since last July when the FDA issued it amidst much fanfare but with the miserable intention of requiring thousands of “new” supplement ingredients to undergo expensive, drug-like safety testing.
The Burton-Chaffetz letter references numerous examples where the draft Guidance requirements clearly run counter to the will of Congress and the Dietary Supplement Health and Education Act of 1994 (DSHEA). A key feature of DSHEA is the watershed date of October 15, 1994, with all supplement ingredients marketed before that date being considered as safe. This “grandfather” date is the exact issue addressed by H.R.3380, the Dietary Supplement Protection Act. The bill would move the 1994 DSHEA grandfathering date forward from October 15, 1994 to January 1, 2007, so as to encompass and protect thousands of “new” dietary-supplement ingredients that are already safe but that the FDA would drive from the marketplace with its burdensome new testing requirements.
The Guidance explicitly rejects these supplements and instead requires each manufacturer to shoulder the burden of showing use of a supplement prior to 1994 to classify them as being exempted from the guidance. In fact, 1994 has even been changed by the FDA to 1986 for exemption purposes. If a manufacturer is unable to supply this data – a difficult burden some 17 years after the fact – the Guidance allows FDA bureaucrats to re-characterize old ingredients and supplements as being new and subject them to the new regulatory burdens set forth in the NDI Guidance.
For those companies that started manufacturing and selling supplements since 1994, these burdens would be cost-prohibitive and unnecessary because they have already been generally recognized as safe for human consumption. The NDI burdens illegally imposed by the FDA upon Americans will greatly increase the cost of supplements to the 53% percent of the US population who consume supplements, despite 17 years of historical use safety by millions of Americans for many of these “new” supplements. Just as importantly, it will also kill off innovation in the supplement industry.
The Burton/Chaffetz letter forewarns that if the FDA does not withdraw the guidance, legislation will be considered. That legislation is H.R.3380. This bill would exempt many thousands of supplements not just from this guidance but also from future burdensome and unnecessary FDA regulatory policies. In Federal statute, it drastically closes the window against which unjustifiable bureaucratic actions can be taken in the future. H.R.3380 does not impact any other post-marketing regulations for protecting consumer safety.
The Hatch-Harkin letter and the FDA’s blunt rejection of it – and the almost-certain rejection of the Burton-Chaffetz letter – are the start of an extended negotiation process with the FDA. The National Health Federation initiated the introduction of H.R.3380 with the intent not to engage in a process that will neither benefit the people nor the industry in the long term. As the most-experienced organization in the health-freedom community, we know all too well the history of what has happened and will not stand by to witness it again.
The Burton/Chaffetz letter can be downloaded from the NHF webpage at (Click Here)
Health-freedom advocates and supplement consumers need to proactively lobby their Congressional Representatives to cosponsor H.R.3380. This can be done at the NHF homepage atwww.thenhf.com.
CLICK HERE TO ACT NOW – http://www.thenhf.com/DSPA