The Publisher's Desk: New Hope for Health Freedom

We have been keeping you informed about the FDA’s flawed NDI draft guidance—and now we can share with you good news. The Alliance for Natural Health—USA (ANH-USA) and nutritional supplement trade organizations met with two longtime supporters of natural health—Senator Tom Harkin (D-IA) and Senator Orrin Hatch (R-UT). These senators were the principal authors of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

The organizations explained to the Senators that if the NDI draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. The result: many supplements would cost as much as drugs.

The senators agreed and wrote to FDA Commissioner Margaret Hamburg, formally asking the FDA to withdraw its guidance document. They urged the FDA to create a new draft that clarifies what constitutes a New Dietary Ingredient (NDI) while not undermining Congress’s desire to provide consumers with access to safe, affordable nutritional supplements.

“When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” the senators wrote. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”

The senators asked the FDA to work with interested parties to resolve the issues that have been raised. The good news? FDA must respond to the senators’ request, because the agency must work within legislative intent. If the FDA ignores the senators’ request and implements the draft guidance as it stands now, the agency would be breaking the law by attempting to create new law. The fact that the FDA is making new law with the draft guidance is one of the arguments against it that opponents have made all along. And now Congress agrees—and is calling FDA on it!

It’s not a done deal yet. But thanks to Senators Harkin and Hatch, this is a step in the right direction.