In July the FDA issued its “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (what is called the "NDI Draft Guidance").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, mandated by the food “safety” law passed earlier this year, 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 If this guidance is not withdrawn and its misinterpretation of law is backed by the FDA's own policy, review and enforcement powers, it would cause major disruption in the dietary supplement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 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 should 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is why Citizens for Health is calling on Congress and the President to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the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.
|I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to demand that the U.S. FDA not use appropriated funding in enforcement of new dietary ingredients (NDIs) until this NDI Draft Guidance is summarily withdrawn or drastically modified to comply with Congressional intent. Congress must insist that the FDA summarily withdraws its NDI Draft Guidance and go on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the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 the current NDI Draft Guidance, but, instead, will swear to honor the law that the American people gave to the agency to uphold via regulation according to both the spirit and letter of DSHEA.|
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