Under the guise of consumer protection...

Or -is something more sinister at work with the FDA?

Under the Food Safety Modernization Act (FSMA) signed into law January 2011, the New Dietary Ingredient (NDI) notifications requirements to the FDA will force supplement manufactures to prove new methods of formulation are safe - sounds reasonable right? There is more. This new law will also remove many of the previously grandfathered in "safe" ingredients.

The FDA breaks down the nutritional components into ODI's and NDIs. Old dietary ingredients (ODIs) are nutritional ingredients(herbal extracts and nutrients), that were sold prior to 1994. NDI's are supposed to be completely new compounds.

NDI's are often hybrids of nutrients – never before seen in nature in exactly that form. FYI - many "safe nutrients" are often combined with other safe, natural substances that help the mineral or vitamin’s absorption. These benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.

This means that if a new manufacturing process, extraction method or plant part is used, then it will now be considered a new dietary ingredient and thus required for testing.

Why would this pose any problem you ask?

Because this added regulation point to the real intent of the FDA - to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.

If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards ( outdated, nferior and less safe in many instances. Future development of innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

What can you do? File a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.

You can read the entire op-ed by By James Gormley, Senior Policy Advisor, Citizens for Health at this link:

What’s old is new again? The FDA takes aim at modern science and innovation