U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
January 2000

Dietary Supplement Strategy

(Ten Year Plan)

Letter from the Director

Dear Colleague, FDA's Food Community:

This document sets forth the Center for Food Safety and Applied Nutrition's (CFSAN's) overall dietary supplement strategy. In January, 1999, CFSAN issued its 1999 workplan. In that workplan, the Center announced that in calendar year 1999, it would "in conjunction with other involved Agency units, and providing an opportunity for stakeholder input, develop an overall strategy for achieving effective regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994." I am pleased to report that this document sets forth that strategy. There are five points I would like to highlight:

1. FDA held public meetings on June 8, 1999 in Washington, D.C. (East Coast) and on July 20, 1999, in Oakland, California (West Coast) to solicit comments on the development of its overall dietary supplement strategy. In addition, throughout the 1999 calendar year, FDA held several other public meetings on other dietary supplement issues that are part of this strategy (e.g., structure/function claims and current good manufacturing practices). All of these public meetings built upon themes that emerged from a broader stakeholder meeting sponsored by CFSAN in June, 1998.
   
   
2. Shortly after the June 8, 1999, public meeting, FDA developed five internal dietary supplement strategy teams to consider the ongoing stakeholder input, and to discuss the dietary supplement activities. The team members were drawn from several Agency units. The teams were organized as follows: Safety, Labeling, Boundaries, Enforcement, and Research. Except for the addition of a section on Outreach, and the broadening of the Research category to Science Base, these categories formed the organizational structure of this strategy.
   
   
3. This strategy is built on the "twin pillars" of law and science. Therefore, the strategy establishes a clear program goal to accomplish, by the year 2010, having a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.
   
   
4. As with other new legislative mandates, there needs to be a long-term implementation process to accomplish all of the dietary supplement activities the Agency and/or its stakeholders identified. Therefore, the Agency developed a strategy that sets forth a ten-year implementation plan. This strategy can be accelerated or decelerated, depending on resource availability and safety concerns. FDA will continue to seek additional resources for initiatives identified in this plan through the established budget process. The items in this strategy are not listed in priority order. Instead, FDA will develop, on an annual basis, specific items that are to be accomplished that year within the level of available resources.
   
   
5. FDA recognizes that the success of this strategy will not only depend on adequate funding levels, but also on FDA's new and continued partnerships with other governmental agencies, academia, health professionals, industry, and consumers. FDA will continue its outreach to stakeholders to enhance two-way dialogue, establish stronger working relationships, leverage resources, and communicate dietary supplement information.

I am pleased that I had the opportunity to personally chair the June 8 and July 20 public meetings. If you had the opportunity to attend either meeting, I'm sure that you'll agree that one theme prevails, and that is we all want to do what's best for the American consumer. I truly believe that this strategy reflects that goal. With the consumer's interest at the forefront, I look forward to working with you during its implementation.

Outline

Ten Year Plan

PROGRAM GOAL.  By the year 2010, have a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.

1. SAFETY

   1. Adverse Event Reporting.

      1. Systems Enhancement. Improve adverse event report monitoring system capability by enhancing the data systems and integrating them into the Agency-wide adverse event report monitoring system program.

      2. Timely Release of Reports. Eliminate freedom of information act backlog and make reports available promptly to manufacturers on an ongoing basis.

      3. Clinical Evaluation and Follow-Up. Institute an efficient system for the monitoring, clinical evaluation, and timely regulatory follow-up of significant adverse event reports.

      4. Outreach. Educate consumers and health care professionals on how to use the adverse event reporting system.

   2. Good Manufacturing Practices. Publish regulations on good manufacturing practices. Once the regulations are issued, establish an outreach program to small business manufacturers and an ongoing inspection program.

   3. Health Hazard Evaluations. Enhance mechanisms for evaluating health hazards of dietary supplement ingredients and contaminants.

   4. Dietary Supplement Safety Database. Explore development of a database to help anticipate health hazards.

   5. New Dietary Ingredients.

      1. Notifications. Continue to review premarket (75-day) notifications for new dietary ingredients within the statutory timeframe.

      2. Guidance. Develop guidance for safety substantiation for premarket (75-day) notifications for new dietary ingredients.

      3. Database. Incorporate the premarket (75-day) notifications in the comprehensive database created for claims notifications (see strategy item in II. C.).

   6. Voluntary Submissions. Explore mechanisms for encouraging voluntary submissions of confidential premarket safety data to FDA (e.g., similar to procedural mechanisms for food additive master files).
   7. Internet Surveillance. Implement an Internet surveillance program to monitor whether products are marketed for safe uses.

2. LABELING

   1. Pearson v. Shalala. Implement court decision as outlined in December 1, 1999, strategy notice.

   2. Health Claim Petitions. Meet statutory obligations by responding to health claim petitions within statutory timeframes.

   3. Database. Complete and activate database for 30-day label claim notifications and courtesy letters.

   4. Substantiation. Identify criteria for substantiation of structure/function and related claims and identify conditions for sharing substantiation documents.

   5. Authoritative Statements. Publish final rule on the applicability to dietary supplements of the FDA Modernization Act provisions on nutrient content/health claim notifications based on authoritative statements.

   6. Consumer and Marketplace Labeling Surveys. Perform surveys and track data of consumer purchases and marketing trends to support sound labeling policies.

   7. Publications. Resolve issues on use of third-party publications.

   8. Small Business Exemption. Resolve small business exemption issues for dietary ingredient claims.

3. BOUNDARIES

   1. Structure/Function Claims.

      1. Final Rule. Publish a final rule on structure/function claims.

      2. Small Business Regulatory Enforcement and Flexibility Act (SBREFA) Guidance. Following publication of final rule, issue SBREFA guidance.

      3. Claims Review. Review 30-day postmarket notifications for supplement claims.

   2. Dietary Supplement vs. Drug.

      1. Definitions. Clarify the boundaries between dietary supplements and drugs by defining key terms and phrases (e.g., "dietary substance" and "intended to supplement the diet").

      2. Claims. Clarify when a disease-related statement is an appropriate health claim for a dietary supplement, and when a disease claim is necessarily a drug claim.

   3. Dietary Supplement vs. Conventional Food.

      1. Definitions. Clarify boundaries between dietary supplements and foods by defining key terms and phrases (e.g., "intended for ingestion" and "represented for use as a conventional food") and clarifying the forms of dietary supplements.

      2. Stakeholder Discussions. Coordinate and review stakeholder discussions addressing structure/function claims issues on conventional foods that may impact dietary supplement boundary issues (e.g., nutritive value).

   4. Botanicals. Develop a regulatory framework for botanicals used in traditional/alternative medicine (including how they relate to over-the-counter drugs).

   5. Dietary Supplement Exclusions. Clarify statutory provisions that exclude selling a product as a dietary supplement if the substance was first approved as a new drug under a New Drug Application or studied as an Investigational New Drug.

   6. Dual Status. Clarify the regulation of dual status products (i.e., one substance intended for use as a supplement and a drug).

   7. Combination Products. Clarify regulation of combination products (i.e., a supplement and a drug combined in a single dose, unit, or package).

   8. Dietary Supplement vs. Cosmetic. Develop criteria for defining boundaries between products intended for cosmetic effect from dietary supplements.

4. ENFORCEMENT ACTIVITIES

   In cooperation with the Office of Regulatory Affairs, and assisted, where appropriate, by other agency components:

   1. Enforcement Strategy.

      1. Safety Issues. Identify the highest priority safety issues and take appropriate action against unsafe products.

      2. Boundary Issues. Take appropriate action on products excluded from being marketed as dietary supplements.

      3. Labeling and Consumer Fraud. Take appropriate action on inaccurate and misleading labeling and consumer fraud, including trade complaints.

      4. Routine Compliance. Maintain routine compliance activities, incorporating enforcement of final rules.

      5. Surveillance and Monitoring. Conduct marketplace surveillance and monitoring activities.

      6. Partnerships. Establish partnerships with federal, state and local agencies to enhance enforcement efforts by sharing data, heightening communication, and utilizing resources.

   2. Capacity Building. Make necessary internal enhancements to effectively fulfill enforcement obligations.

      1. Agency's Compliance Procedures. Develop standard operating procedures for improving the compliance review process.

      2. Case Tracking System. Contract for and activate computerized dietary supplement case tracking system.

      3. Training. Provide in-house training to field and headquarters staff to ensure consistency with current FDA regulatory procedures and practices.

      4. CFSAN/CDER Coordination. Evaluate, and streamline, to the extent possible, current mechanisms for resolution of cross-center compliance issues.

      5. Laboratory Capacity. Enhance analytical lab support for regulatory decisions.

   3. Federal Trade Commission (FTC) Coordination. Enhance coordination with FTC on enforcement cases.

5. SCIENCE-BASE

   In collaboration with stakeholders (e.g., academia, health professionals, other organizations, and industry), enhance research/science capabilities, including:

   1. Strengthen Science-Base. Ensure a sound science-based program for all dietary supplement review and develop a core of well-trained, multidisciplinary scientists in support of supplement review and research.

   2. Strengthen Research Efforts.

      1. Research Agenda. With the assistance of a nationally recognized organization, develop a broad research agenda and needs assessment framework to implement priority-based research for dietary supplement issues.

      2. Research Capabilities.

         1. Inventory and Peer-Review Process. Identify the Agency's scientific research capabilities relative to dietary supplements, and develop a mechanism for ensuring dietary supplement research is mission-relevant, of high scientific quality, and consistent with regulatory priorities.

         2. Intramural/Extramural Research. Determine what research can or should be done by FDA (in-house) and what research should be done by extramural sources.

         3. Laboratory Based Research.  Conduct priority- based methods development and safety research for dietary supplement ingredients and contaminants.

      3. Dietary Supplement Ingredient Reviews. Identify mechanisms for obtaining state-of-the-art science reviews on dietary ingredients in the marketplace, giving highest priority to those with potential health risks.

      4. Leveraging. Identify leveraging opportunities with universities, JIFSAN, and other government agencies.

      5. Consumer Research. Conduct research on consumer understanding of label information, and compare consumer understanding of labeling of conventional foods and dietary supplements for support of regulatory decisions.

      6. Marketplace Research.

         1. Economics and Marketplace Research. Perform necessary economics and marketplace research for support of regulatory decisions.

         2. Market Analysis. Explore innovative mechanisms to determine the nature and scope of the dietary supplement market.

   3. Regulatory Oversight of Human Studies.

      1. Oversight Mechanism. Clarify when an Investigational New Drug filing is necessary for a substance marketed as a dietary supplement and determine whether a separate mechanism needs to be developed for clinical studies on supplements.

      2. Science-Based Standards. Develop science-based standards for conducting human studies of dietary supplements using human subjects.

   4. Adverse Event Report Monitoring System. Conduct research to support enhancing and improving the quality and reporting rate of the adverse event report monitoring system and consider how the adverse event report monitoring system can be used for trend identification of adverse events.

   5. Claims. Evaluate systems used in other organizations (e.g., health care reimbursement) to distinguish "valid substantiation" for claims (structure/function) from "invalid substantiation" for such claims.

   6. Inter-agency Clearinghouse. Explore the establishment of an inter-agency dietary supplement research clearinghouse and develop an integrated list of information to be included.

6. OUTREACH

   Enhance outreach efforts to stakeholders to assure effective communication, including:

   1. Advisory Committee. Establish a standing group to provide a routine public forum to obtain and integrate stakeholder input related to various dietary supplement issues. The group will be comprised of members having expertise relevant to the review of dietary supplement issues (e.g., subcommittee of the Food Advisory Committee).

   2. Additional Stakeholder Outreach.

      1. Public Forums. Sponsor and participate in public forums for enhancing dialogue with stakeholders.

      2. Partnerships. Establish a stronger working relationship with organizations interested in promoting two-way communication and cooperation.

   3. Communication.

      1. Mechanisms. Develop mechanisms to communicate dietary supplement information to the general public, FDA field offices, health care professionals, and industry, including:

         1. Website. Expand use of FDA website to communicate dietary supplement information to the general public and health care professionals, and guidance to the industry.

         2. Information Kits. Develop information kits for FDA field staff.

      2. Information Dissemination. Communicate dietary supplement information to the general public, FDA field offices, health care professionals, and industry, including:

         1. Safety Data.

         2. Enforcement Policies and Procedures.