The Ruling Class Have you ever wondered if the "threats to our health care freedoms" are just a little bit exaggerated? If so, you should know that the FDA has put the question to rest with a recently issued rule titled "Final Rule for Current Good Manufacturing Practices (CGMPs) for Dietary Supplements." With this rule, our health care freedoms have suddenly changed course and headed south. BFF!!! Most supplement manufacturers already test their ingredients to ensure potency and purity. Under the new FDA rule, tests and testing reports will be mandatory. And while that may sound reasonable on the surface (as long as you're comfortable with increased government meddling, of course), FDA officials know full well that the rule will drive many supplement makers out of business, while having only a negligible effect on the largest manufacturers. As you may be aware, many of the largest supplement manufacturers are owned by pharmaceutical companies whose executives will be delighted to have fewer competitors. A recent column written by Certified Clinical Nutritionist Byron J. Richards highlights these four revealing quotes that are actually contained within the FDA publication of the new rule: 1) "We find that this final rule will have a significant economic impact on a substantial number of small entities." 2) "Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate." 3) "The regulatory costs of this final rule will also discourage new small businesses from entering the industry." And I saved the absolute worst for last: 4) "We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption." That's one big, beautiful gift for drug company executives, with lots'n'lots of love, from their Best Friends Forever at the FDA. You and me and other U.S. supplement consumers? Too bad for us. All-time high As you might expect, many "experts" and academics in the mainstream see this new rule as the beginning of a regulatory paradise. But it's only the first step. The problem, in their view, is that the FDA still hasn't done enough. Over at ABC News, Keith Ayoob, an associate professor of pediatrics at Albert Einstein College of Medicine, offered this insight: "The big pharm companies that do supplements will be compliant. The ones I'm more worried about are the fringe companies that produce nothing but supplements." Apparently Prof. Ayoob didn't spot the fine print about those worrisome fringe operations being driven out of business. Meanwhile, his naïve faith in the compliant nature of big pharm companies is charming. I think it's safe to say he doesn't read the e-Alert. Janell Mayo Duncan, the senior counsel for Consumers Union (which publishes Consumer Reports), told the Associated Press: "Consumers still have no idea if a given product works, or whether it is dangerous." I'm guessing Ms. Duncan is blithely unaware of the irony that the very same can be said of a wide range of prescription drugs, which are regulated in exactly the way she apparently would like to see supplements regulated. And finally, David Katz of Yale told ABC: "In many countries - Germany, in particular - nutrient supplements are regulated like drugs. The U.S. has lagged behind in that area." Unfortunately, it looks like the U.S. is finally beginning to catch up with a ridiculous system that doesn't recognize the huge and obvious differences between fish oil and Lipitor. The new rule goes into effect in late August, and smaller supplement companies will have about three years to fully comply. So by summer 2010 we should see supplement prices reach an all-time high - right alongside an all-time high of anger from U.S. supplement consumers. | 
