What is a new dietary ingredient (NDI)?
What is aegeline?
Per the 1994 Dietary Supplement and Health Education Act (DSHEA) and amendments since a NDI is any dietary ingredient not marketed in the US before 15 Oct. 1994. Conversely, any product marketed as a dietary supplement before that date was grandfathered per DSHEA. The FDA requires a 75 day pre-marketing notification to the FDA for any NDI. In amendments to DSHEA, as well as FDA guidance to industry, the FDA may not consider a synthetic, identical version of a botanical ingredient as an allowed, grandfathered, dietary ingredient. A case in point is aegeline. This chemical was an implicated hepatotoxin in the updated version of OxyElite Pro that was withdrawn from the market in 2013 due to hepatotoxicity. Although the manufacturer argued that aegeline had been found in food products going back over a millennia the FDA concluded there was no evidence that aegeline had appeared as a dietary ingredient in the US before 1994 nor that it had been used as a food ingredient. (The fact that aegeline in this product was likely synthetic may also have disqualified it as a grandfathered substance.)
Submitted by M. Hodgman, MD on behalf of the Herbs and Dietary Supplements Section