WASHINGTON UPDATE*

Vanishing Innovation?

Potential NDI guidelines punish forward-thinking supplement manufacturers.

April 2013

The Food and Drug Administration’s New Dietary Ingre­dient Draft Guid­ance (NDI) has continued to cast a cloud of unease over the entire natural products industry. NDI was proposed and rescinded for an apparent complete overhaul. Next, the FDA appeared to reverse its stance, with statements suggesting NDI would return in a form closer to its destructive first draft.

The uncertainty of NDI is a threat to anyone who takes supplements. It is critical that we maintain steady pressure on our elected officials to ensure that NDI, which now hangs in the balance, is vanquished once and for all.

NDI Might Ban Krill

Let’s explore how NDI might affect krill oil, one of today’s popular nutritional supplements. Tiny deep-sea creatures, krill supplies healthy omega-3 fatty acids. But under potential NDI rules, krill might be among the many nutrients that are pulled from store shelves. That’s because krill also supplies a nutrient called astaxanthin. A potent antioxidant with inflammation-modulating properties, astaxanthin possesses anti-aging properties and promotes healthy skin, immune system, eyes and more.

But according to the FDA’s initial NDI draft guidance astaxanthin should be considered as a “new” ingredient—even though it is present in shrimp, lobster, salmon and other foods we’ve been consuming for eons. Under that first, problematic version of NDI, astaxanthin products—including krill oil—would therefore be removed from the market pending completion of an extensive FDA “notification process.”

How long this bureaucratic process would take is anybody’s guess. But while manufacturers and consumers waited for it to be completed, millions of Americans would be denied access to an intriguing natural compound that may hold the potential to have a tremendous positive impact on the nation’s health.

Innovation Under Attack

Astaxanthin is just one example of supplements potentially lost to bureaucracy. A “worst-case scenario” NDI Draft Guidance would also decimate newer strains of probiotics, newly discovered amino acids, cutting-edge synthetic vitamins and game-changing bio-identical nutrients that arrived on the scene after 1994 (when DSHEA, the law that treats supplements as natural foods instead of synthetic drugs, was passed). This might amount to thousands of different health-enhancing supplements being swept off store shelves.

As bad as that would be, loss of these supplements might be just one part of a much larger problem. In the big picture, those same potential NDI rules would cripple innovation. Nutritional supplementation is a dynamic and promising area of modern wellness. So many people are optimizing their well-being with supplements, achieving and maintaining a state of exhilarating good health. Each nutritional breakthrough brings us closer to vibrant natural health for everyone.

But under possible NDI scenarios, there would be no more nutritional breakthroughs. Manufacturers who even attempted to make a supplement better, easier to absorb or more effective would be punished. Under early NDI guidelines, it seems the FDA wants the dietary supplement industry to spend all its time and money on filling out hundreds of pages of forms—rather than dedicating resources to creating new ways to keep America healthy.

Since when is innovation punished in America? The spirit of discovery is a core American value! But potential NDI rules may flip the script and discourage health innovation. While the FDA has put NDI on the back burner for now, we must let our elected officials know that it is still on our minds. Go to www.NHA2013.com to write your elected officials today. Tell them you vehemently disagree with the FDA’s NDI Draft Guidance, and that you want nutritional innovation to be encouraged, not quashed.

For the sake of health freedom, join the NHA today!

 

*This editorial is a public service announcement sponsored by the Nutritional Health Alliance (NHA).

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