Congress NDI Intent

SALT LAKE CITYThe New Dietary Ingredients (NDI) section of the Dietary Supplement Health and Education Act of 1994 (DSHEA) is short; yet 17 years after it became law, it could be the most important thing affecting the supplement industry. Understanding the atmosphere that led to DHSEA can help industry and current regulators grasp Congress intent and interpret the meaning of the NDI notifications, according to Patricia Knight, senior political adviser for the United Natural Products Alliance (UNPA), at UNPAs two-day conference on the FDAs NDI Draft Guidance.

Knight was health policy director and chief of staff to Rep. Orrin G. Hatch (R-UT) and a staff negotiator for DSHEA when it was passed, giving her great insight; yet she said she had no idea how it would affect the dietary supplement market.

In the years leading up to DSHEA, FDA was stepping up enforcement regarding dietary supplements, which many in the industry thought was overreaching, Knight said. FDA released reports suggesting supplements follow the strict rules of food additives, and the agency was raiding doctors offices that sold vitamins.

Through the work of industry, consumers and Congress members, DSHEA was passed on the last day of Congress in 1994. Knight said she and the rest of Hatchs staff thought the law was dead, but gave it one last-ditch effort by sending it on to Rep. Henry A. Waxman (D-CA) for review. She said it surprised her when he decided to propose it to Congress. She also noted the NDI section was almost the last part of the bill included, with Rep. Waxman including the idea of old dietary ingredients (ODI) that would be grandfathered in on the last day.

It was a big win for the industry and set up several principles that has allowed industry to thrive to this day, including supplements being regulated as foods rather than drugs, the burden of proof for supplement safety lying with FDA rather than the manufacturer, and supplements not requiring FDA preapproval.

NDI notifications were also laid out in DSHEA, but Knight said it was proposed by Rep. Waxman in 1994 without being subjected to public discussion. In the law, NDI concepts were not fully explained, which is why industry is grappling with the requirements for the history of safe use and how the 75-day pre-notification timeframe is supposed to operate.

After 17 years without guidance from FDA, the industry finds itself confused, but Knight said FDA, with the Draft Guidance, has now given industry a change to be a part of the interpretation. She said it should be a joint effort between industry, FDA and Congress. We should work with agency," she said. FDA has devoted a lot of time to [the Draft Guidance], and we should read it carefully."

For more background on the passing of DSHEA, download INSIDERs report, The Incredible Story of DSHEA."