“First and foremost”, says Citizens for Health senior policy advisor James Gormley, the Food and Drug Administration’s (FDA’s) draft guidance on new dietary ingredients (NDIs) must be “withdrawn or otherwise mothballed”.
And in its place, he says, CfH will be “looking at drafting de novo legislation that would create strengthened consumer access to high-quality, innovative dietary supplements, ensuring that nutritional supplements continue to be regulated as a class of foods rather than as drugs or food additives.”
But other challenges emerged in 2011 and will need tackling in 2012, adds Gormley, citing “Sen. Durbin’s Dietary Supplement Labeling Act; a blurring of regulatory and enforcement lines between the FDA and Federal Trade Commission; the ever-building mountain of Prop 65 claims; and proposed changes to Daily Value calculations.”
Misguided attempts at regulation
The Alliance for Natural Health USA is also on a mission to derail the NDI draft guidance, but says the defeat of “anti-supplement legislation” in Congress (he cites Durbin’s labeling bill and Sen Leahy’s Food Safety Accountability Act 2011), is also on its priority list.
And at the state level, says a spokesman, the ANH-USA will continue to challenge proposals that would make the American Dietetic Association the primary credentialing organization for registering nutritional therapists as well as dieticians, plus proposals that would require the former to complete a dietitian program in order to practice their trade.
Finally, he says: “We should prepare for more of the same inaccurate big media coverage of supplements, questionable studies, and misguided attempts at regulation by Congress and federal agencies in 2012.”