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Update on the Supplement Industry
Posted by: KidRaw ()
Date: December 19, 2013 02:50AM

The supplement industry is between a rock and a hard place what with the Drug Industry trying to take them over and the FDA and Obamacare forcing them out of existence. But, hey, what we need is more regulation of supplements.

Drug Industry Acquisition of the Supplement Marketplace


"Although market leaders in the supplement industry appear to be coping with the present recession, most are experiencing a downturn in sales and a few are doing better than in prior years. The bulk of small to mid-sized companies are struggling, caught in a squeeze between a dramatic reduction in demand and a dramatic increase in costly regulation. Moreover, all are trying to discover how they can accommodate the insurance requirements and tax burdens arising from Obamacare.

Ordinarily, when recession plagues an industry those with political power provide a temporary reprieve by reducing regulatory burdens. Not so with the current administration. If anything, the FDA is committed to more vigorous regulation of the dietary supplement industry, increasing the incidence and severity of cGMP inspections, warning letters, and enforcement regardless of the market effects. That course will drive many companies out of existence, force many more to reduce employment and product offerings, and reduce research, development and investment across the board.

The industry needs a good dose of deregulation brought about through removal of prior restraints in favor of after the fact sanctions already in the law but that prospect is dim. A regulatory roll back is essential for the survival of many firms and for the economic health of many more. The cost of compliance for companies already producing goods that are demonstrably safe is extraordinary. Companies are expending hundreds of thousands of dollars annually in an effort to stay ahead of regulators. Small concerns are lying low, hoping that FDA investigators do not land on their door steps. With small concerns that are unable to afford the cost of compliance, an FDA GMP investigation followed by a Form 483 ordinarily means that they must halt operations rather than expend resources that do not exist for the drafting and implementation of SOPs, the hiring of a QC manager, and finished product testing. While few would lament the demise of a company making adulterated products, most of these small firms make products for which there is no evidence of adulteration. They simply cannot afford the cost of complying with the enormous paperwork, risk management, and testing burdens imposed by the GMPs."

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Re: Update on the Supplement Industry
Posted by: KidRaw ()
Date: December 19, 2013 03:14AM

Is The FDA Out to Shut Down the Supplement Industry?


"This bill requires that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients (supplements) that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards.

Creating arbitrary lists of “bad” supplements or “bad” doses, especially with no scientific evidence whatsoever, is a dangerously slippery slope. This bill will give the FDA major new powers to curtail supplement sales, and neither the FDA nor the IOM will be subject to any clear standards. They can just make it all up as they go along! Even worse, once an ingredient or supplement is on the list, there is no clear process to challenge the FDA and IOM determination, not even if new or contradictory evidence comes to light.

This bill is a naked FDA power grab—an attempt to move us one step closer to a full FDA pre-approval system for supplements. That, of course, would just make supplements insanely expensive, like drugs—if you could get them at all. Since foods and supplements already occurring in nature are not generally patentable, producers faced with immense FDA approval costs (the average new drug costs $1 billion to get approved), most health foods and supplements would no longer be marketed at all."

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Re: Update on the Supplement Industry
Posted by: KidRaw ()
Date: December 19, 2013 03:26AM

Of course, everyone who believes in Health Freedom knows that the FDA is the enemy of True Health Seekers -

Whom Does the FDA Work For?


Use Food for Healing? Not if the FDA Can Stop It!


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