FDA Provides Congress Cost Estimate for DSHEA Implementation

WASHINGTON--The Deputy Commissioner of the Food and Drug Administration (FDA), Lester M. Crawford, Ph.D., submitted a report to Congress estimating the costs to implement the Dietary Supplement Health and Education Act (DSHEA). Congress asked for the estimate when it passed the fiscal 2001 appropriations bill in October 2000. In the bill, Congress asked FDA to provide within six months of enactment of the bill an estimate of the cost to implement FDA's Dietary Strategy 10-Year Plan. FDA unveiled the plan in January 2000, six years after the passage of DSHEA.

In FDA's executive summary of the cost breakdown, it noted repeatedly the agency's role in protecting the consumer and ensuring product safety in its post-marketing position. "FDA takes seriously the new and expanded responsibilities that the Congress has entrusted to it through DSHEA," the summary read. "The agency believes that through full implementation of its strategic plan, an opportunity exists to make a meaningful difference in the effort to ensure the safety of one of the world's fastest growing industries. FDA is proud to be in the forefront to lead this effort."

FDA broke its strategic plan into three task sections--safety/regulatory, field and science--each of which has figure for funding through year five of implementation. FDA estimated needing an operating base of between $40 million and $65 million per year and an increase in full-time employees from 133 to 244. During years one and two, the agency expects to use the majority of funds to develop a framework for regulating dietary supplements. This includes the adverse event report monitoring system, drafting new regulations (including final GMP regulations) and overseeing product labeling.

The executive summary of the report was just posted on the Web site for FDA's Center for Food Safety and Applied Nutrition (CFSAN) at www.cfsan.fda.gov/~dms/ds-stra2.html.