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A. Regulation of Internet sales of vitamins comes under the jurisdiction of both the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA). These two agencies work together under a long-standing liaison agreement governing the division of responsibilities between the two agencies. As applied to vitamins, the FDA has primary responsibility for claims on product labeling, including packaging and inserts. The FTC has primary responsibility for claims in advertising, including print and broadcast ads. Marketing on the Internet is subject to regulation in the same way as promotional materials (labeling or advertising) in any other media. FDA and FTC are currently engaged in discussions on how to appropriately apply each agency's authority to sale of products such as vitamins on the Internet.
A. Dr. Henney testified before the Committee on Government Reform on March 25, 1999. In her testimony, she told the committee that the Agency shares the goal of making safe dietary supplement products available to consumers who want to make informed personal choices to improve their health. She also mentioned the Agency's commitment to developing, this calendar year, an overall strategy for achieving effective regulation of dietary supplements under DSHEA. She also stated that in so doing, FDA will provide ample opportunity for public input. As part of this ongoing consultation with FDA's stakeholders, the agency held a public meeting on June 8, 1999, in Washington, DC, and will hold a second meeting on July 20, 1999, in Oakland, California, to solicit comments that will assist FDA's Center for Food Safety and Applied Nutrition in the development of that strategy.
A. In its initial efforts to implement the Dietary Supplement Health and Education Act (DSHEA) in 1994, the Agency concentrated on promulgating the many regulations mandated by DSHEA and began a number of other regulatory actions to establish a framework for implementation of the new statute. Since passage of DSHEA, FDA has published 25 Federal Register documents regarding dietary supplements. For more information on the proposed and final regulations that FDA has issued, please visit the CFSAN Website at: www.cfsan.fda.gov. Just as the Agency is committed to implementing DSHEA fully and ensuring consumers have access to dietary supplements, FDA also is committed to quickly removing unsafe products from the market or taking other timely actions to protect consumers. FDA has a number of tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations of the Federal Food, Drug, and Cosmetic Act, as amended by DSHEA. The agency has used a variety of regulatory tools from enforcement actions to rulemaking, when it has found dietary supplements that cause safety concerns (e.g. digitalis-contaminated plantain, Gamma butyrolactone and Gamma hydroxybutyrate). Additionally, the agency has taken action against products marketed as dietary supplements, but which are illegally making claims as to usefulness in the treatment, diagnosis, cure, or prevention of disease (e.g. Pro-Symbio PLUS).
For more information on dietary supplements and a summary of DSHEA, please visit the Center for Food Safety and Applied Nutrition (CFSAN) Website above or contact CFSAN at the following address:
Center for Food Safety and Applied NutritionA. DSHEA grants FDA explicit authority to establish good manufacturing (GMP) regulations for dietary supplements. On February 6, 1997, FDA published in the Federal Register an Advance Notice of Proposed Rulemaking requesting comment on whether FDA should institute rulemaking to develop current GMP regulations for dietary supplements and dietary supplement ingredients. Specifically, FDA asked for comments on the technical and scientific feasibility of the identification of different types of dietary supplement ingredients. In February, 1998, FDA asked its Food Advisory Committee to establish a working group to assist FDA in examining some aspects of GMP's for dietary supplements, including ingredient identify and testing. Therefore, the Agency is evaluating the mechanisms available to help assure the purity and consistency in dietary supplement products that may be appropriate for consideration in any future rulemaking to establish GMP's for dietary supplements. The Agency is committed to accelerating the development and implementation of GMP regulations. FDA recognizes the importance of such regulations as an effective mechanism for consumer protection.
A. DSHEA amended the Federal Food, Drug, and Cosmetic Act to define the term "dietary supplement" and establish a regulatory framework for dietary supplements. In enacting DSHEA, Congress made 15 significant findings that emphasize the importance of diet and nutrition, including dietary supplement use, in promoting health and reducing the risk of disease. FDA acknowledges these findings and recognizes their potential for health care cost savings to the consumer.
A. FDA will continue to use a variety of mechanisms to disseminate safety information regarding dietary supplements to its stakeholders. For example, FDA's Center for Food Safety and Applied Nutrition (CFSAN) has an established Website. In addition, FDA is establishing in the near future a new "Outreach and Information Center." CFSAN, as part of the its FY99 strategic plan, has placed a high priority on developing an overall strategy for the dietary supplement program, including safety issues, and is actively seeking stakeholder input into this process. FDA posts all 75-day notifications for "new" dietary ingredients, including the agency's "objection" letters, in the public docket. In addition, FDA has convened a Working Group under its Food Advisory Committee to develop recommendations on its adverse event monitoring system, including more effective dissemination of information in this database.
With respect to dietary supplements, herbal "drugs," and homeopathic products, FDA provides information to health professionals on emerging safety issues via MedWatch's outreach programs and through publication of research papers in scientific journals. The agency co-sponsors, in collaboration with other federal agencies, scientific conferences on safety issues. FDA also provides timely information to industry trade associations and individual companies on emerging safety concerns (including the sharing of information on analytical methodologies to address these concerns). Finally, when warranted by the available evidence, FDA has required the use of warning statements on product labels, issued public warnings against marketed products, and taken enforcement actions against unsafe products.
A. DSHEA provides for broad access to dietary supplements for consumers and recognizes that there is a need for a rational regulatory framework that provides FDA authority to remove from the market products that pose a "significant or unreasonable risk" to consumers and that are otherwise adulterated, and to require that labeling for dietary supplements be accurate and not misleading. FDA is aware that many Americans place great faith in dietary supplements to help maintain and improve their health, and that documented scientific evidence of the benefits of a number of supplements is increasing. The challenge to FDA is to strike the right balance between preserving consumers access to dietary supplements while at the same time taking other timely actions to protect the public health of consumers and to ensure that labeling information is accurate and not misleading.
A. The integration of federal, state, and local food safety activities is an on-going effort on which the agency has made substantial progress. This concept is an outgrowth from the President's Food Safety Initiative and grew out of discussions at the 1998 Association of Food and Drug Officials (AFDO) conference on the need to better coordinate outbreak investigations and responses. This meeting led to discussions on difficulties caused by a lack of common standards among laboratories, incompatible data systems, ineffective communications, inadequate resources, etc. There was general agreement that the need to coordinate on outbreaks raised many issues of mutual concern. It was recommended that State Public Health and Agriculture Departments be brought together in order to more effectively reduce foodborne illness in the U.S.. At the AFDO conference, the Food and Drug Administration (FDA) made a commitment to facilitate this process.
In September 1998, FDA co-sponsored, in cooperation with USDA and CDC, a "50-state" meeting in Kansas City, Missouri of state food safety officials to discuss the concept of working towards a seamless, integrated food safety system. From that meeting, it was decided to form 6 work groups to work on ideas and recommendations for advancing an integrated system. In December 1998, FDA co-sponsored a follow-up meeting with the United States Department of Agriculture, the Centers for Disease Control, and the Environmental Protection Agency, in Baltimore, Maryland with the work groups and a coordinating committee. The work groups were charged by the coordinating committee to come up with ideas and recommendations on things that could be done to achieve an integrated system. There was agreement that an integrated system should include: federal oversight, a common vision, national uniform standards, uniform inspections and enforcement, uniform laboratory practices, adequate training, and enhanced communications. In March 1999, the coordinating committee met in St. Louis, Missouri to review the reports of the Work Groups and consider next steps for this project.
FDA has met with industry and consumer groups to discuss the integration project and a public workshop was held at the AFDO Annual Conference on June 5 in San Antonio, Texas. Presentations at the workshop included an update on work group activities as well as perspectives from industry and consumer groups.
In August 1998, the President's Council on Food Safety was formed to ensure a seamless, coordinated federal food safety system. One charge to the Council is to develop a comprehensive food safety strategic plan. In June 1999, the Council's Strategic Planning Task Force will initiate the public process for shaping a strategic plan for food safety, which will be submitted, to the President, in mid-2000. The Task Force work groups will include representatives from federal and state organizations. The strategic planning process will provide opportunities for non-federal partners including industry and consumers to participate in the development of long-term objectives for the future food safety system. The first public meeting will be held on July 15 in Washington, DC.
A. FDA has little or no information that would support actions to raise public awareness of possible health risks associated with the use of fragranced products. Current regulations do require that products that contain added fragrance ingredients must be labeled in the product ingredient statement as containing "fragrance." FDA is aware of concern about this issue and encourages continued participation by its stakeholders in gathering data to address the possible health risks associated with the use of fragranced products. FDA is committed to fostering such participation by its continued sponsorship of stakeholder outreach initiatives, e.g. public meetings. These public forums not only provide interested persons with an opportunity to comment on the potential health risks associated with fragranced products, but also help identify possible solutions to address these risks.