The Food and Drug Administration (FDA) is turning a deaf ear to consumers and their health by pushing forward its agenda to remove thousands of safe supplements from the American marketplace.

Daniel Fabricant, Ph.D., the director of the Division of Dietary Supplement Programs at the FDA, has stated that the Agency has no intention of withdrawing its proposed Draft Guidance for New Dietary Supplement Ingredients (NDIs) that it published last July. The FDA has not changed its position despite receiving over 7,000 comments on the draft industry guidance, which would subject many thousands of supplements to very expensive, drug-like testing and approval requirements in order to stay on store shelves.
    
Fabricant says “alternative approaches” by the FDA to satisfy the FDA’s proposed requirements in the NDI Guidance might be reviewed. However, there was no clarification on whether the requirements imposing prescription-drug-like clinical testing and scientific testing to gain FDA approval for supplements sold since 1986 and in the future would be subject to amendment, or dropped from the Guidance. He had previously implied that it could take 3-4 years to resolve these issues but now says the timeline “is really up in the air.” Interestingly enough, before joining the FDA in February 2011, Fabricant was a vice president with the Natural Products Association (NPA), which makes it very clear that Fabricant has abandoned his obviously sparse roots along with whatever understanding he ever had of the industry.

The FDA’s strategy for more heavy-handed regulation is the statement that “If you look at the numbers of NDI submissions versus the number of supplements introduced to the market since 1994, it would appear there is a significant lag in compliance.” On its face, the marketplace has changed over the last seventeen years. But who is responsible for this 17-year lag in compliance?

The Dietary Supplement Health and Education Act of 1994 (DSHEA) required manufacturers to submit pre-market notification applications for supplements and new ingredients when there is a history of use or other evidence establishing that an ingredient is safe when used as directed. The FDA has 75 days to accept or reject the application. A non-decision by the FDA means that the Agency accepts the evidence and that the product has complied, is approved, and can be marketed to the consuming public.  Alternatively, a formal petition for a review and FDA issuance of an order prescribing the conditions under which a new dietary ingredient can be used and reasonably be expected to be safe, with the FDA having to respond within 180 days, can be filed.

Apparently, the FDA believes that manufacturers and suppliers have not met the FDA’s own self-interpreted DSHEA burden of proof standard to show to the FDA that there is reasonable evidence that supplements and new ingredients in supplements are safe. The NHF believes, based upon the DSHEA law language, that this is a total misapplication of the DSHEA burden-of-proof standard. The burden of proof has been, and is on, the FDA to prove that supplements, which they have de facto approved through the pre-marketing notification process, are unsafe in the post-marketing stage of consumer use.

Since DSHEA, there have been seventeen years of additional historical use-safety experience conducted by many millions of Americans. The FDA is choosing to ignore evidence and is attempting to paint this as non-compliance. In other words, it has not done its job but instead claims that it is not the FDA’s fault – instead, supplement consumers and industry should pay the price.

Take Action now and contact your representatives and urge them to co-sponsor, the Dietary Supplement Protection Act (DSPA), H.R.3380. We need the same consumer outrage that was seen pre-DSHEA to make this legislation a reality.  Be bold and be persistent.
 
Both companies and consumers must support H.R.3380, especially when Congress gets back to work in mid-January 2012. The bill changes a key date in the DSHEA law that will save thousands of our supplements.  It does this by acknowledging and using in our favor the new regulatory environment for supplements as well as supplements’ incredible safety record. It will put FDA bureaucrat’s feet to the fire and an end to their seventeen-year efforts to salami-slice the DSHEA law to fit their own public-policy agenda for dietary supplements.

Excerpts from an article published by the National Health Federation website, written by Lee Bechtel, NHF lobbyist.

Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals' rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions.