Senators Orrin Hatch and Tom Harkin met with Dr. Daniel Fabricant of the FDA on January 26 to request that the FDA withdraw its NDI draft guidance altogether—a meeting that ANH-USA, together with some trade groups, helped set up. They were following up on their recent letter to FDA Commissioner Margaret Hamburg asking the FDA to stop the process altogether, withdraw the guidance, and start again after meeting with interested parties to address the list of significant concerns expressed by consumers and industry.
You may recall that the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA) required that guidelines be established for supplement manufacturers to notify FDA when a new dietary ingredient was introduced into the marketplace. The FDA’s Draft Guidance for New Dietary Ingredients was supposed to fulfill that requirement.
Unfortunately, the FDA’s proposed regulations are in fact completely contrary to the intent of Congress when DSHEA was passed, and Sens. Harkin and Hatch wanted to make that clear to FDA. They should know—they were the two principal authors of the legislation!
According to our sources, FDA has turned down the senators’ request. FDA in effect said that it is refusing to reconsider its interpretation of what the NDI section of DSHEA means, regardless of what Sens. Hatch and Harkin say they meant when they wrote the law.
Does this mean FDA intends to use the NDI process as a de facto pre-market approval system—something which regulatory observers believe was specifically excluded by DSHEA? In a word, yes. We have been told that FDA claims the NDI process is the only “preventive control” for dietary supplements in federal law. Whatever “preventive control” means, it is completely untrue that supplements are uncontrolled under federal law or that the FDA lacks the power presently to regulate them.
In refusing to follow the intent of the law as clearly stated by the law’s authors, the FDA is acting as a rogue agency. If you haven’t done so already, please ask your legislators to make a one-minute floor speech opposing the FDA’s guidance document. FDA’s plan would sweep many supplements off the shelf and make the ones that survive much more expensive.