New draft NDIN guidance – Timeline

Dietary Supplement Health and Education Act of 1994 (DSHEA) enacted on October 14, 1994 and signed into law on October 25, 1994

Dividing line between old and new dietary ingredients: October 15, 1994 (not marketed in the US prior to: “new” dietary ingredient)

Federal Register Final Rule (62 FR 49886) “Premarket Notification for a New Dietary Ingredient,” including FDA’s expectation of receiving 0-12 NDI notifications annually (one for each of the up to 12 new ingredients expected to enter the market each year), published September 23, 1997

FDA’s Good Guidance Practices Rule (delineates laws and regulations from guidance documents which represent only the agency’s thinking on a matter), finalized Sept 2000

First Federal Register notice soliciting public comment on interpretation of NDI provision of DSHEA: October, 2004

Public meeting re the above, November 2004

Food Safety and Modernization Act of 2010 (FSMA), signed into law on January 4, 2011.

FSMA Section 113(b) required publication of draft guidance within 180 days of passage, by July 5, 2011

Much awaited “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” published in the Federal Register on July 1, 2011, four days ahead of imposed deadline.

90-day public comment period initially scheduled to end October 3, 2011.

Due to the number of comments received, the public comment period was extended to December 2, 2011.

Letter from Sens. Orrin Hatch and Tom Harkin stating that FDA NDI draft guidance undermines DSHEA and should be withdrawn, December 22, 2011

Number of public comments reported: >146,000 pages of comments (from >7,000 unique entries, many of them harshly critical)

Usual period of time for FDA response:  Highly variable

Expected date of FDA response:  Uncertain – FDA has no obligation to respond within a certain time frame

Period waited thus far for guidance: Nearly 20 years (from passage of DSHEA in 1994)

Other numbers:

Number of supplement products on market when DSHEA was passed: ~4000

Number of supplement products currently on market: ~55,600

Number of new products added each year: ~1000

Number of days an NDIN to be filed prior to being marketed:  75 days minimum

Number of NDINs received by FDA over ~16-year period (to Sept 14, 2011):  715

Number of NDINs acknowledged by FDA with “no objection” (to Nov 2011):  162

FDA objection rate: ~70%,

Average number of NDI notifications received (2008-2010): 55

Expected number of NDI notifications received for 2011: ~50

Number of NDI notifications predicted by FDA in the 1997 Final Rule that would be filed annually: 12

Number of new ingredients predicted by FDA in the 1997 Final Rule to enter the market annually: 12