Publishing a final rule on "per day" labeling for dietary supplements is an "A" level priority for the Center for Food Safety & Applied Nutrition in the upcoming year.

The rule would amend supplement labeling to allow manufacturers to list the quantitative amount and the percent daily value of a product on a "per day" basis in addition to the "per serving" measurement.

A proposed rule on "per day" labeling was issued in January 1999 (¹ Also see "Supplement Labeling of "Per Day" Ingredient Amount Proposed by FDA" - Pink Sheet, 18 January, 1999., p. 12).

The final reg is one of several "A" priorities related to dietary supplements the center will aim to complete in 2005.

FDA is penning a proposed rule to amend the definition of new dietary ingredients (NDIs).

The documents "would lay out for the industry exactly what we mean and where the lines would be drawn" for NDI submissions, CFSAN Director Robert Brackett, PhD, said during a Dec. 1 teleconference announcing the center's plan.

Industry trade groups and company reps offered feedback on NDI definitions during a Nov. 15 public meeting (² Also see "Dietary Supplement Reps Ask FDA For Clarity Across The Board On NDIs" - Pink Sheet, 22 November, 2004., p. 3).

The NDI initiatives are part of FDA's "umbrella strategy" for implementing DSHEA. The three-part strategy entails the monitoring and evaluation of product labeling; ingredient safety; and assurance of product quality (³ Also see "FDA’s Crawford Outlines DSHEA “Umbrella Strategy” For Supplements" - Pink Sheet, 1 November, 2004., p. 14).

Development of a proposed rule on the ranking system for health claims and issuance of a draft guidance also rate as "A" goals. The current system outlines graded disclaimers to accompany health claims based on supporting scientific evidence (⁴ Also see "Qualified Health Claims Scientific Evidence To Be Assessed, Ranked By FDA" - Pink Sheet, 14 July, 2003., p. 3).

CFSAN has set 122 "A" list goals for this year. The center has added a new section labeled "Priority Ongoing Activities" to its priorities list this year; the section includes CFSAN's continuing responsibilities and serves "to communicate the breadth of action that [CFSAN does] on a daily basis," Brackett explained.

The center hopes to complete at least 90% of the "A" priorities by the end of the 2005 fiscal year.

CFSAN 2005 Priorities: “Per Day” Labeling, NDI Revised Definitions

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