Hofseth BioCare (HBC) has successfully achieved New Dietary Ingredient (NDI) status from the US Food and Drug Administration for its ProGo bioactive peptides, having already achieved this for its CalGo and OmeGo ingredients.
The FDA appears to be moving ahead with a proposed rule to allow NAC (N-acetyl cysteine) as a dietary ingredient for use in supplements, according to a newly published guidance.
The high prevalence of dietary supplementation use in the athletic population means there is a risk of inadvertent doping for those users who don’t do their research or get their information from reliable sources.
A research report by a group led by prominent supplement industry critic Dr Pieter Cohen MD, found DMAA and three similar stimulant-like compounds in dietary supplement-like products purchased on the open market.
The Council for Responsible Nutrition (CRN) has submitted comments to the FDA via international law firm Steptoe & Johnson, LLP, to address when an ingredient is chemically altered such that it would require a separate NDI notification.
They’ve had the sword of Damocles hanging over their heads for months. So when 10 firms selling DMAA supplements were finally told to put up or shut up by the FDA last week, it looked like the game might finally be up for the controversial stimulant.
It’s official, says the FDA. “Synthetically-produced DMAA (1,3-Dimethylamylamine) is not a dietary ingredient and is not, therefore, eligible to be used as an active ingredient in dietary supplements”.
