HerbalEGram: Volume 3

The US Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) released its annual Program Priorities Report Card in April, boasting completion of 78% (87 of 111) of the organization’s 2005 “A” List goals.¹ Of the 87 items completed, only 3 concerned dietary supplements.
 
CFSAN publishes a Program Priorities Report Card on its Web site at the end of each fiscal year to communicate the agency’s agendas and accomplishments with stakeholders, as required by the FDA Modernization Act of 1997 (FDAMA).² CFSAN also publishes mid-year progress reports and invites public comments on the establishment of new priorities at the beginning of each fiscal year.
 
With respect to dietary supplements, CFSAN succeeded in accomplishing the following goals in fiscal year 2005: (1) Hosted a public meeting on the pre-market notification program for New Dietary Ingredients in November of 2004; (2) Promoted a strategy for the further implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) in November of 2004; and (3) Published “A Dietary Supplement Labeling Guide” on the CFSAN Web site in April of 2005.¹
 
The center’s priority completion rate for 2005 represents a decline from completion rates of previous years. The percentage of CFSAN’s completed “A” List priorities steadily increased from 2000 to 2004; CFSAN completed 93% of its “A” List priorities in 2004. (“A” List priorities are those goals that CFSAN intends to complete within the fiscal year; “B” List priorities are those goals CFSAN plans to pursue but not necessarily finish before the end of the fiscal year.) According to a letter from CFSAN Director Robert E. Brackett, PhD, the center has been faced with decreased resources in recent years, including diminished funding and personnel.¹
 
CFSAN’s decrease in resources has led to a restructured list of Program Priorities for 2006, as well as a smaller number of goals for the new fiscal year.³ CFSAN has removed “A” List and “B” List priority classifications from its 2006 Program Priorities list and identified 62 priority items for the 2006 fiscal year. Dr. Brackett wrote that the center’s goal is to complete at least 90% of those items by the end of the fiscal year (September 30, 2006).
 
The 2006 Program Priorities document is divided into 5 sections, one of which is titled “Ensuring Dietary Supplement and Cosmetic Safety and Management Services.” CFSAN has identified 3 priority items concerning dietary supplements for 2006: (1) Publish a final rule for dietary supplement current Good Manufacturing Practices (GMPs); (2) Publish a final rule on “per day” labeling for dietary supplements; and (3) publish draft guidance on New Dietary Ingredient Notifications.³
 
The 2005 Program Priorities Report Card can be accessed at http://www.cfsan.fda.gov/~dms/cfsa406a.html. CFSAN’s 2006 Program Priorities can be found at http://www.cfsan.fda.gov/~dms/cfsan506.html.

- Courtney Cavaliere

References

1. CFSAN 2005 Program Priority Report Card [Center for Food Safety and Applied Nutrition Web site]. April 10, 2006. Available at: http://www.cfsan.fda.gov/~dms/cfsa406a.html. Accessed July 7, 2006.
2. Communicating with Our Stakeholders: FDA Modernization Act 1996-2006 Activities page. Center for Food Safety and Applied Nutrition Web site. Available at: http://www.cfsan.fda.gov/~dms/cfsan3.html. Accessed July 7, 2006.
3. CFSAN 2006 Program Priorities [Center for Food Safety and Applied Nutrition Web site]. May 3, 2006. Available at: http://www.cfsan.fda.gov/~dms/cfsan506.html. Accessed July 12, 2006.