With as many as four out of five new dietary ingredient (NDI) submissions being rejected by the Food and Drug Administration, some say the agency is using the NDI process to quash product innovation while others claim it is making up for previous regulatory inaction in the cases of ephedra and andro.
NDIs require a 75-day pre-market safety notification of any ingredient not already on the market in the US by November 1994. But in some cases the FDA is saying that different botanical extraction methods — even of age-old herbs with stellar safety records — necessitate a new NDI filing.
?Ultimately, both sides need to ask and answer whether an ingredient presents a safety question,? said Loren Israelsen, president of consultancy LDI Group in Utah. ?Alkaloids, glycosides, and things known to be chemically and physiologically active should be on the FDA?s work list. But if it?s chamomile extract or echinacea, we know a lot about what?s in those things, so there?s not a real issue there.?
He said that if a company is intentionally emphasising a part of a botanical extract that has a clear biological effect, then it should err on the side of caution. ?FDA thinks this NDI process is a significant part of the safety net,? Israelsen said.
Some companies are gaining GRAS status for their ingredients. It is seen as being more rigorous and safer (and more expensive) than NDI notifications.
?GRAS is not part of supplements language, but that higher standard of safety demonstrated by a GRAS assessment can be a good marketing tool,? said James C Griffiths, PhD, director of toxicology at Burdock Group in Florida, a third-party safety assessor.
He said that while supplements must meet a ?reasonable expectation of safety,? GRAS and food additives must meet a higher threshold, of ?reasonable certainty of safety.?
?This clearly signifies FDA is becoming more rigorous,? said Israelsen. ?The question is, too rigorous? Are they applying food additive thinking to supplements??
Whether the FDA will find a middle ground after the comment process will take months to tell.