Rock Creek Pharmaceuticals Inc. (fka RCPIQ)

[thefamilyman]

While this law has been on the books for awhile, the FDA has not been enforcing it. The FDA has apparently not even implemented (or written?) the regulations necessary to enforce it. Further there has been a years long effort to overturn the law and/or stop the FDA from implementing this section of the law. Several years ago when I was participating in the letter writing campaign to congress, Anatabloc did not even exist. As I recall, the law impacts any supplement brought to market since 1994 and CoQ10 was the primary supplement I was concerned about at the time.

The fear of those in the supplement industry is that any new supplement brought to market since 1994 would be required to go thru drug like testing. This would drive the price so high as to make those supplements unaffordable. Or worse, since it is very hard (many times impossible) to acquire patent protection for a supplement, why would any company fund efficacy studies that their competitors could then use for free. This would mean that new supplements would never make it to the US market. The other factor was the concern that every new combination of supplements formulated since 1994 would be required to also go through such testing. The "new" FDA has the potential to cripple the vitamin and supplement industry thru disincentives and substantially increased cost.

If all he FDA was trying to do was quality control of the ingredients and final product, I would support that effort. But I fear that this is the opening shot in a whole new arena of bureaucracy and regulation.

The current negative publicity environment created by AF and his minions along with the political fiasco, apparently made anatabine the low hanging fruit the bureaucrats at the FDA were looking for to begin this long planned expansion of their authority.

Dynarod said...

Can someone please answer this question? I though we had FDA savy guys on our team. What bright spark in our companywas completely unaware of the fact that new supplements need to be preapproved by the FDA?