FWD 2 HerbalEgram

HerbalEGram: Volume 6, Number 5, May 2009

ODS Updating its Strategic Plan
The Office of Dietary Supplements (ODS) is currently developing a new strategic plan for the years 2010–2014.1 As part of the National Institutes of Health (NIH), ODS has a mission to strengthen knowledge and understanding of dietary supplements by supporting, evaluating, and distributing scientific information and research, and by educating the public.

“[The strategic plan] is meant to be a roadmap that highlights our major goals,” said Anne Thurn, director of the ODS evidence-based review program (oral communication, April 10, 2009). Past strategic plans have guided several activities of ODS, including among others: funding for research, studies on dietary supplement impact, training of junior scientists, and public surveys.1

In developing the new strategic plan, ODS is considering the 2004–2009 plan’s goals and activities, as well as comments from several governmental and non-governmental groups. As a result of a smaller proposed Fiscal Year (FY) 2009 budget of $26.6 million, $1 million less than 2008 because of the smaller NIH budget, ODS has said it is important to have a critical evaluation of all programs and their results. Also, the plan must remain based on the congressional mandates set forth by the Dietary Supplement Health and Education Act of 1994 (DSHEA), the DSHEA definition of a dietary supplement, and the ODS mission statement.

ODS has developed the following potential new actions to be considered for the 2010-2014 Strategic Plan:

  • Research Support (73% of ODS FY 2008 Budget): Promote studies on dietary supplement safety and biomarkers; support broader dissemination of information on research gaps; encourage academicians to take ODS assignments.
  • Research Tools (24% of FY 2008 Budget): Accelerate analytical development and validation; develop programs that allow laboratories to demonstrate ingredient analytical proficiency; develop new methodologies for collecting information on dietary supplement use.
  • Communication (Less than 2% of FY 2008 Budget): Redesign Web site home page and navigation and search functions; develop new fact sheets and a glossary of terms for consumers and translate into Spanish; launch Clinical IBIDS (International Bibliographic Information on Dietary Supplements), a different version of the IBIDS database that provides information on publications containing clinical studies of dietary supplements.
  • Science-Policy Interactions (About 1% of FY 2008 Budget): Discuss evidence-based review issues; explore development of tools for improving evidence-based reviews.

ODS collected additional suggestions for the plan through 4 webinars in January and February 2009, as well as a public comment period, which ended March 31, 2009. ODS received few comments from these outlets, Thurn said, estimating a total of about 25 sets of comments with most coming from NIH and other federal agencies, and a few from individuals, professional associations, and industry organizations.

The Council for Responsible Nutrition (CRN) participated by submitting feedback on past ODS performance and activities, and by providing suggestions for the future.2

CRN applauded ODS for its support of dietary supplement research and discussion and also commended the idea for 2 dietary supplement databases. CRN suggested that these be accessible to the US Food and Drug Administration (FDA) to avoid additional databases, as suggested by the recent Government Accountability Office (GAO) report on dietary supplements.3

Though CRN recognized ODS’ progress and achievements, it also criticized several of the office’s recent actions, such as the 2006 NIH State-of-the-Science Conference on Multivitamins.2 CRN said this was poorly-timed and wrongly focused on multivitamins as disease preventatives. The council also disagreed with the budget percentage that ODS dedicates to outreach (less than 2% of ODS FY 2008 Budget), and said the office’s outreach approaches include many unnecessarily negative and unrepresentative staff comments and presentations.

In its suggestions for the 2010-2014 Strategic Plan, CRN recommended that ODS’ communications be more accurate and balanced, dietary supplement fact sheets be redesigned with CRN assistance, and that the annual series Bibliography of Significant Advances in Dietary Supplement Research be used to its full potential. CRN recommended that future ODS research be more holistic and that ODS conduct studies of dietary supplements’ effect on healthcare costs. The council also suggested that ODS emphasize its public education and advisory roles and called for the office to collaborate more with CRN and other industry associations.

The Natural Products Association (NPA) is also planning to submit comments to ODS, though the feedback is not yet finalized, said Daniel Fabricant, PhD, the association’s vice-president of scientific and regulatory affairs (oral communication April 30, 2009). NPA plans to focus on stressing the importance of completing the online dietary supplement label database, which documents dietary supplement label and ingredient ingestion information.1

This tool’s predecessor, a database developed and launched by ODS and the National Center for Health Statistics in 2003, generated complaints of incompleteness and difficulty of use. Currently, ODS is working with several partners, including NPA, to create the Internet-based database, which is in its pilot phase of production.

“We really want to see that project through to the end and have it capture the entire universe of dietary supplements that are out there,” Fabricant said, citing such reasons as the database’s potential to meet regulatory needs as suggested in the GAO report.

ODS staff will review all comments with a federal steering committee made up of staff from NIH, FDA, Centers for Disease Control and Prevention (CDC), the National Institute of Standards and Technology (NIST), and the United States Department of Agriculture (USDA), said Thurn. This team will also develop the finalized 2010–2014 strategic plan, which is expected to be released to the public in late 2009.

—Lindsay Stafford

References

1. A report to the public. Office of Dietary Supplements. Fall 2008. Available at: http://ods.od.nih.gov/pubs/strategicplan/AReportToThePublic.pdf. Accessed April 3, 2009.

2. CRN comments on the ODS strategic plan. Council for Responsible Nutrition; Washington, D.C.: March 31, 2009. Available at: http://www.crnusa.org/pdfs/CRNcomments_ODS%20StratPlan2009033109.pdf. Accessed April 3, 2009.

3. United States Government Accountability Office. Dietary Supplements: FDA should take further actions to improve oversight and consumer understanding. GAO-09-250; January 2009. Available at: http://www.gao.gov/new.items/d09250.pdf. Accessed March 26, 2009.



 


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