10,000 Americans Tell FDA: Withdraw the “NDI Draft Guidance”!!

By James J. Gormley


WASHINGTON, DC – On December 2nd, representatives from Citizens for Health (a non-profit health advocacy group with over 100,000 supporters) will deliver a petition to The United States House of Representatives, The United States Senate, the U.S. Food and Drug Administration (FDA) and President Barack Obama signed by 10,320 Americans, calling for the FDA’s outrageously anti-supplement and anti-consumer NDI Draft Guidance to be summarily withdrawn.

This history-making petition drive, one which generated well over 10,000 signatures in under 10 days, received support and inspiration from many sources, including New Zealand truth rapper and activist Jody Lloyd, aka “Trillion,” whose re-mastering of CFH’s “10,000 Signatures” video for YouTube helped inspire and activate thousands of health-freedom-conscious Americans to “Sign the Petition” (watch the video here: http://youtu.be/3knIwX09d9Y).

In July the FDA issued its “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (what is called the “NDI Draft Guidance”). The agency issued the guidance purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.

However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present. If this guidance is not withdrawn and its misinterpretation of law is backed by the FDA’s own policy, review and enforcement powers, it would cause major disruption in the dietary supplement market; force a significant number of products off the shelves; and, say estimates from Emory University, result in revenue losses of over a billion dollars and the unemployment of over 100,000 Americans.

Neither American consumers nor the dietary supplement industry will stand for this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.

That is why Citizens for Health supporters are calling on Congress and the President to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Citizens for Health and its army of supporters were aided by, and would like to thank, many liberty-loving people and organizations, including (but not limited to): Suzanne Somers (Actress); Michael Schoor and William Schoor (Essential Formulas); Bob Barrows, Jr. (Bluebonnet Nutrition); Charles Brown (Consumers for Dental Choice); Dr. Betty Martini (Mission Possible World Health International); Alliance for Natural Health; Living Naturally; Gary Null; “The Power Hour With Joyce Riley”; “Tunies Friday Health Line Show”; Michael Ostrolenk (The Liberty Coalition and Campaign for Liberty); Bill Sardi; Martie Whittekin (Healthy By Nature radio show); Wayne Gorsek; and Mary F. Christopher.

 To read the petition go to: http://tinyurl.com/ndi-petition.

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About Citizens for Health: Citizens for Health, one of the nation’s oldest and most respected consumer action groups. Citizens for Health is a non-profit organization that provides over 100,000 supporters with consumer news, action alerts, and ways to demand access to healthy food, non-toxic products, and truthful, non-misleading health information.  More information is available at www.citizens.org.

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Comments (5)

[…] businesses especially hard,” the NPA wrote.Indeed, the non-profit Citizens for Health, which just dropped an anti-NDI guidance petition of 10,000-plus signatures on Washington’s doorstep, cited a study […]

[…] made it clear that 10,000 petition signatures in 10 days was only the beginning salvo in American consumers’ call for Congress to demand that the FDA […]

[…] as opposed to ingredient-specific. This means that the agency would have required a new NDI notification for each specific supplement, formula, or blend in which the NDI is used, instead of simply the NDI itself. […]

[…] as opposed to ingredient-specific. This means that the agency would have required a new NDI notification for each specific supplement, formula, or blend in which the NDI is used, instead of simply the NDI itself. […]

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