FDA says No to Congress on food supplement bill

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 Daniel Fabricant of the FDA on January 26 to request that the FDA withdraw its NDI draft guidance altogether—a meeting that ANH-USA, together with some trade groups, helped set up.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.

The 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 The FDA’s Draft Guidance for New Dietary Ingredients was supposed to fulfill that requirement.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 is trying to turn a simple notification system for new supplements into a totally arbitrary approval system. which allows FDA to arbitrarily deny the sale of any supplement created (or said to be created) in the past 17 years!

FDA’s proposed regulations are 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 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.

It seems that the 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. The 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.

For years the FDA has attempted to treat food supplements as if they were drugs.Meaning that you would need a prescription to purchase any food supplement (including vitamin C. This action has been prevented by Congress. Now it looks as if the rogue agency is using Congress' own law to implement the agency's  power grab.