Federal Action
FDA is Attempting to Quash the Dietary Supplement Industry! Send your comments immediately to the FDA regarding the dangerous Draft Guidance document on New Dietary Ingredients.

Click Here to Take Action and Submit
Your Comment to the FDA and feel free to cut
and past the folllowing points to tell the FDA!

Don’t Let the FDA Regulate Your Supplements Out of Existence! The new FDA Draft Guidance for Industry; “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” if adopted, could result in loss of access by consumers to thousands of dietary supplements already on the market. Tell the FDA to please withdraw and do not finalize the “new dietary ingredient” FDA Draft Guidance! Click Here and then Click on View Document to Read the Complete Draft Guidance

The Draft Guidance goes against Congress’s specific intent in the 1994 Dietary Supplement Act (DSHEA) that: “the [FDA] should not take any actions to impose regulatory barriers limiting or slowing the flow of safe products … to consumers;”. Yet the proposed Draft Guidance imposes onerous reporting, safety testing, and evidentiary burdens, and even in some cases animal and human studies, on manufacturers of dietary supplements with new dietary ingredients that go way beyond the current industry standards. If finalized, this guidance will force thousands of supplement manufacturers out of business.

The Draft Guidance goes against Congress’s specific intent in DSHEA that: “dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare;”. Yet this guidance would give the overarching presumption that dietary supplements and new dietary ingredients (NDIs) are inherently dangerous and extensive safety and compliance measures must be required.

Despite DSHEA’s clearly stated law that: “dietary supplements shall be deemed food” and despite U.S. Senate findings that: “nearly all consumers indicate that dietary supplements should not be regulated as drugs,” the proposed evidentiary requirements essentially treat food supplements with new ingredients as if they were toxic drugs, presumed dangerous, when really any new dietary ingredient, even if not marketed before 1994, is still a food: an herb, an amino acid, a vitamin, a mineral, or other ingredient defined in DSHEA.

The FDA’s understanding of what is an NDI is much broader than what DSHEA intended and, if adopted, the FDA’s Draft Guidance will cause the loss of up to 239,347 jobs and result in a total economic loss to the U.S. economy of up to $39.8 billion annually, according to Dr. Shepherd-Bailey, Ph.D., of Emory University School of Law. And most importantly, this guidance if adopted, would cause the loss to consumers of their most treasured asset … their health!

Don’t let dietary supplements be regulated out of existence! Tell the FDA to withdraw the NDI Draft Guidance immediately so that consumers may access the dietary supplements and NDIs on which millions of citizens thrive!

Click Here to Take Action and Submit
Your Comment to the FDA and feel free to cut
and past the folllowing points to tell the FDA!