FDA's Center for Food Safety & Applied Nutrition will send a completed cost analysis of its 10-year dietary supplements strategic plan to Capitol Hill within the next few weeks, CFSAN's John Ford said at the Food & Drug Law Institute annual education conference in Washington, D.C. April 19.

"If we get the money that we envision for our 10-year plan over these next three years, we expect to be in full operation level by year three of our plan," said Ford, leader of CFSAN's planning and formulation team within the Office of Management Systems.

The House Appropriations Committee requested FDA provide an estimate for implementing the 10-year strategic plan for supplement regulation within six months after passage of the fiscal 2000 appropriations bill (¹ Also see "Supplement Labeling Safety One Of Six Guidance Topics Raised By GAO" - Pink Sheet, 17 July, 2000.).

CFSAN's 10-year plan was designed to produce a "science-based" regulatory scheme that "fully implements" the Dietary Supplement Health & Education Act. The plan was released in January 2000 (² Also see "CFSAN 10-Year Dietary Supplement Strategy Comprises Six Core Areas" - Pink Sheet, 10 January, 2000.).

The six core categories that comprise the decade-long strategy are: safety; labeling; boundaries; enforcement activities; science-base; and outreach. For simplicity in presenting its cost analysis, CFSAN combined the six elements into three: safety/regulatory, field and science, Ford noted.

"Twenty-five percent of funds during the first year will be dedicated to field and 18% to science," with the remainder channeled toward safety/regulatory measures, he asserted.

In the second and third years, fewer resources will be devoted to safety and regulatory matters as FDA hopes "by that time...our [Good Manufacturing Practices for supplements] will have been published as well as our labeling rules," Ford stated.

Field activities will "take a much more prominent position," he noted, accounting for 44% and 48% of the center's supplement budget in the second and third years, respectively.

The funding level dedicated to science will jump to 23% in the second year and 27% by year three, according to CFSAN presentation materials.

CFSAN's allocation of 57% of its resources to safety and regulatory issues in the first year reflects the center's strong focus on the GMP and labeling regs, Ford noted.

Outstanding issues under the "labeling" category in the center's 10-year plan include publishing the final rule on nutrient content/health claims based on authoritative statements for dietary supplements, clarifying the necessary substantiation of structure/function claims, and addressing appropriate claims in third-party publications.

Reiterating the resource challenges facing the agency, Ford noted CFSAN was budgeted $6 mil. for dietary supplement-related activities in FY 2001. "This is a $17.1 bil. industry that we are supposed to regulate," he added.

In comparison, the agency was allotted $28 mil. for food additive premarket review, $198 mil. for new drug premarket review and $217 mil. for the food safety initiative, he pointed out.

In a separate presentation at the FDLI conference, U.S. Pharmacopeia CEO Roger Williams, MD, noted USP's certification program for dietary ingredients is slated to launch in early fall.

The USP program is being developed to address the growing concerns about the identity, purity and labeling accuracy of dietary supplements in the U.S. The draft proposal for the program first was introduced at a USP public meeting in September (³ Also see "USP Quality Demonstration Program "Supplements" Monograph Development" - Pink Sheet, 11 September, 2000.).

Stakeholder and industry advisory group meetings are underway to discuss ways to assure quality of complex botanicals and other dietary ingredients, Williams stated.

In addition, USP is working on what Williams referred to as a "'procedures manual' to define the program that would yield [a] certification mark." USP aims to conduct a pilot test of the program this summer, the exec added.

AOAC International in May announced its plan to launch a sponsorship program for establishing validated analytical methods for supplement materials. The program is expected to complement third-party testing efforts by groups such as USP (⁴ Also see "AOAC Supplement Group IDs 16 Raw Materials For Methods Validation" - Pink Sheet, 16 April, 2001.).

CFSAN 10-Year Supplement Plan Costs Ready To Be Sent To Congress

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