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On the eve of tomorrow’s close of the new dietary ingredient (NDI) draft guidance comment period, Nutritional Outlook is keeping updated on comments submitted.
On the eve of tomorrow’s close of the new dietary ingredient (NDI) draft guidance comment period, Nutritional Outlook is keeping updated on the nature of comments industry members tell us they have submitted to the agency.
The Natural Products Association (NPA; Washington, DC) says it has submitted extensive comments asking FDA to rewrite the guidance. “NPA takes serious issue with the overstepping by FDA in this draft guidance….Safety is, of course, of the utmost importance but there are ways to protect safety without doing unnecessary economic harm. DSHEA was designed to ensure consumer access to safe supplements, and the FDA is obligated to implement this law based on that principle,” the association stated in its comments. (For a full look at the association’s comments, click here.)
Below are some highlights, as well as quotes, from NPA’s submitted comments:
NPA’s comments reflect many of the main points industry have taken issue with regarding the draft guidance.
Meanwhile, nonprofit health advocacy Citizens for Health says that tomorrow, it will deliver a petition signed by 10,320 Americans calling for FDA to withdraw the draft guidance entirely. The petition is being sent to the U.S. House of Representatives, the U.S. Senate, FDA, and President Barack Obama.
“The history-making petition drive, one which generated over 10,000 signatures in under 10 days, received support and inspiration from many sources,” the organization states.
Of the draft guidance, it says, “FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law…If this guidance is not withdrawn and its misinterpretation of law is backed by the FDA’s own policy review and enforcement powers, it would cause major disruption in the dietary supplement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.”
Read the Citizen’s for Health petition here: http://tinyurl.com/ndi-petition