Regulation trends in 2011 with Loren IsraelsenRegulation trends in 2011 with Loren Israelsen
January 4, 2011
By Loren Israelsen
The storyline on the delay of the New Dietary Ingredients (NDIs) guidance goes like this: Wait, wait, we're thinking about it. We'll have something out by the end of the year. No wait, we're not sure when it's going to come out. What's the hang-up?
I believe it becomes a Talmudic exercise to figure out when a plant extract went from being old and became new. What solvents are used, what type of extraction process, the strength of the extraction, what part of the plant, etc. – all of these things need to be considered.
I think the most current iteration of thinking is to look at NDIs more broadly, essentially as the premarket review gateway.
As far as Congress is concerned, I would expect to see a less-active agenda than we have seen over the past four years with the change of majority in the House and committee control changes.
As for the FDA and FTC, I expect them to continue to ramp up the level of enforcement. With respect to the FDA, I hope that they will continue to aggressively go out and conduct GMP inspections and aggressively go after spiked products. The caveat here is that the FTC is certainly expanding its scope of interest. There is some danger that it may go too far.
My daily supps: Omega-3s, probiotic blend, niacin, CoQ10, seaweed extract, ribose, red salvia root extract, carnitine, green superfood mix, and anti-inflammatory medical food.
Loren Israelsen is executive director of the United Natural Products Alliance.
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