June 30, 2010
Ms. Anne Hadley
Dear Ms. Hadley:
Thank you for contacting me to express your support for continued over-the-counter access to dietary supplements. I recognize that millions of people now take natural health supplements to remain healthy and to treat common ailments.
The use of dietary supplements is often promoted as a solution to a number of nutrition problems, including general dietary patterns and nutrient intakes, malnutrition in the elderly, the nutritional needs in pregnant women, poor nutrient intakes in low-income children, the iron needs of infants after six months, and the prevention of disease. In some situations, the use of vitamin and mineral supplements can help maintain and improve the health of certain individuals. The promise of dietary supplements and the potential that they can provide for part of our health care needs was considered among many other issues when Congress enacted the Dietary Supplement Health and Education Act (DSHEA) of 1994 (P.L. 103-417).
Prior to passage of P.L. 103-417, dietary supplements were regulated under the general food provisions of the Federal Food, Drug, and Cosmetic Act (FDCA). DSHEA set out a separate regulatory framework for supplements for the first time. The U.S. Food and Drug Administration (FDA) promulgated regulations for most provisions of the new statute within several years of enactment, including definitions of supplements, safety, third-party literature, nutritional support statements, ingredient and nutrition labeling, good manufacturing practices, and new dietary ingredients. DSHEA also created an Office of Dietary Supplements (ODS) at the National Institutes of Health. The mission of ODS is strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the
DSHEA established procedures for dietary supplements that differ from those that FDCA requires for prescription drugs. Under FDCA, a drug manufacturer must submit evidence of the safety and effectiveness of a product based on human clinical trials before FDA can approve a drug for sale in the United States. Marketing of a supplement product, however, can begin without evidence of safety or effectiveness being submitted to the agency. Under the provisions of DSHEA, FDA must show that a supplement is unsafe and causes harm before it can be removed from the market. Thus, DSHEA placed the burden of proof on FDA to demonstrate that supplements were unsafe after they were already on the market. This provision is different from the burden of proof placed on manufacturers of all other FDA-regulated products to demonstrate that products are safe before they are placed on the market. Adverse event reporting was not part of the legislative
debate when DSHEA was being considered. There was no requirement in either DSHEA or the implementing regulations for manufacturers to report adverse events to the agency. Under the provisions of DSHEA, FDA must show that a supplement is unsafe and causes harm before it can be removed from the market.
In 1993, FDA expanded its post-marketing surveillance capabilities by establishing a voluntary reporting system called MedWatch. The agency designed the MedWatch program to facilitate its use by health professionals (i.e., physicians, nurses, and pharmacists) and consumers through voluntary reporting of side effects and other health problems that they suspect are related to the use of prescription drugs and medical devices. The system also allows the reporting of adverse effects associated with the use of over-the-counter drugs, dietary supplements, infant formulas, and medical foods. When adverse events are reported to FDA, they are entered into MedWatch's post-marketing surveillance database for further evaluation. The collected data are analyzed to assess whether the relationship between the use of a product and the reported adverse events might be causal. If a relationship is determined to be supported by the evidence in the
database, the information is forwarded to the appropriate officials to decide on further study and whether public notification is needed.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act, which became law (P.L. 109-462) on December 22, 2006, requires reports of serious adverse events to be submitted to FDA by manufacturers of dietary supplements and non-prescription drugs. Lawmakers were told of the limitations of data on adverse events attributed to dietary supplements during hearings Congress held on the dietary supplement ingredient ephedra.
I am aware that the dietary supplement industry and supplement users continue to be concerned about international activities that could have a potential impact on the availability of supplements. As originally proposed, recent FDA reform legislation contained provisions on mutual agreements and global harmonization that would have applied to most products under FDA jurisdiction. However, Congress explicitly exempted supplements from the final provisions of the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), which means that these products are not part of ongoing trade discussions. However, the perception of supplement proponents at that time was that such harmonization efforts would limit access and availability of supplement products and was an indication of their reaction to other international supplement agreements ever since. The European Commission adopted a directive on vitamin and mineral supplements in
2002 that was since declared invalid by the Advocate General. The Codex Alimentarius Commission was created in 1963 by the Food and Agriculture Organization of the United Nations and the World Health Organization to develop food standards, guidelines, and codes of practice to protect the health of consumers and ensure fair trade practices in the food trade. Much of the controversy over the Codex Alimentarius's recommendations on foods, food production, and food safety relates to the way in which it treats vitamin and mineral food supplements and the perception that it is a mandatory standard for food, including vitamin and mineral supplement, safety. Some countries categorize vitamin and mineral supplements as foods. Others, however, categorize them as drugs. Meanwhile, other countries, like Canada, have created separate non-drug categories for these products.
Among the many issues discussed at the 28th Session of the Codex Alimentarius Commission that was held from July 4-9, 2005, were the "Guidelines for Vitamin and Mineral Food Supplements," which were adopted during the meeting as new global safety guidelines. However, this text does not seek to ban supplements. Instead, it subjects them to labeling and packaging requirements; sets criteria for the setting of maximum and minimum dosage levels, and requires that safety and efficacy are considered when determining ingredient sources. According to the United Nations, these guidelines are to "stop consumers overdosing on vitamin and mineral food supplements." These are voluntary reference standards and are not binding on any country, unless the provisions are incorporated into the laws of that country. Otherwise, there is no obligation on countries to adopt these Codex food standards.
Please be assured that I will continue to keep in mind the concerns during any future Senate debate on legislation affecting dietary supplement use and access.
Thank you again for sharing your views and concerns with me. I hope you will continue to visit my website at http://lieberman.senate.gov for updated news about my work on behalf of Connecticut and the nation. Please contact me if you have any additional questions or comments about our work in Congress.
Joseph I. Lieberman
UNITED STATES SENATOR