Members of Congress Unhappy with FDA Draft Guidance entitled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”
As we previously reported, the Food and Drug Administration (“FDA”) released a Draft Guidance for Industry entitled, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (“the NDI Draft Guidance”), on July 5, 2011. The NDI Draft Guidance is highly controversial and, as we previously reported, many industry associations have been petitioning Congress to take action. In response, on February 29, 2012, 17 members of Congress sent a letter to Dr. Margaret Hamburg, Commissioner of the FDA, “strongly urging FDA to withdraw this guidance and begin work on a new draft that does not undermine the balance Congress struck in [the Dietary Supplement Health and Education Act of 1994 (DSHEA)] to provide consumers with access to safe, affordable dietary supplement products.”
According to the letter, the NDI Draft Guidance “seems to run counter to the will of Congress by: erecting new extra-legal barriers to market entry of dietary supplements; imposing food additive type evaluative criteria; requiring multiple New Dietary Ingredient (NDI) notifications for dietary supplements beyond those required by law; and transforming the legal requirements for marketing of dietary supplements that contain NDIs from the notification process described under law to an FDA approval process.” FDA has no statutory basis for these requirements.
As two examples of how FDA has overreached, the signatories of the letter point to FDAs rejection of the industry associations prepared lists of “grandfathered” ingredients and FDAs view that each manufacturer of a finished dietary supplement must provide a separate NDI notification. The Congressmen stated, Ëœ[i]f implemented as written, we believe that the draft guidance would overturn the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no apparent benefit for consumers.”
This letter comes on the heels of FDAs dismissal of Senator Hatchs and Senator Harkins December 22, 2011 request that FDA withdraw the NDI Draft Guidance. In their letter, Senators Harkin and Hatch, the principle authors of the DSHEA, “urge[d] FDA to withdraw this guidance and begin work on a new draft that will provide needed clarification on what constitutes a New Dietary Ingredient (NDI), but does not undermine the balance Congress struck in DSHEA to provide consumers with access to safe, affordable dietary supplement products.”
Fuerst Ittleman will continue to monitor the status of the NDI Draft Guidance. For more information on how the NDI Draft Guidance may affect your company, please contact us at (305) 350-5690 or firstname.lastname@example.org.