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This Act is based on Congressional findings that:
1. Over 158,000,000 Americans regularly consume dietary supplements to maintain and improve their health.
2. Consumer expenditures on dietary supplements reached a reported $17,100,000,000 in 2000, double the amount spent in 1994.
3. According to a recent report issued by the Food and Drug Administration (in this Act referred to as the `FDA') the use of dietary supplements is likely to grow due to factors such as the aging of the baby boom generation, increased interest in self-sufficiency, and advances in science that are uncovering new relationships between diet and disease.
4. In 1994, the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417) (in this Act referred to as `DSHEA') was enacted. This Act balanced continued consumer access to vitamins, minerals, and other dietary supplements, increased scientific research on the benefits and risks of dietary supplements, public education on dietary supplements, and needed consumer protections.
5. DSHEA requires that claims made on dietary supplement labels, packaging, and accompanying material be truthful, non-misleading, and substantiated. Manufacturers are prohibited from making claims that products are intended to diagnose, treat, mitigate, cure, or prevent a disease.
6. DSHEA provides for good manufacturing practice standards setting requirements for potency, purity, sanitary conditions, and recordkeeping for dietary supplements.
7. DSHEA requires that manufacturers submit adequate information as to the safety of any new ingredients contained in dietary supplements before those products can be sold.
8. The FDA has updated and expanded its system for the reporting, collection, and analysis of dietary supplement adverse events reports.
9. DSHEA provides the FDA with a number of authorities to remove unsafe dietary supplements from the marketplace.
10. DSHEA created the Office of Dietary Supplements within the National Institutes of Health to expand research and consumer information about the health effects of dietary supplements.
11. The FDA has not adequately used its authority to enforce DSHEA.
12. The FDA needs adequate resources to appropriately implement and enforce DSHEA. Congress has appropriated additional funds over the last several years beyond those requested in the President's budget to implement and enforce DSHEA, reaching $9,700,000 in fiscal year 2003.
13. However, according to the FDA, full implementation of DSHEA would require substantial additional resources. The FDA asserts that between $24,000,000 and $65,000,000 per year will be needed to fully implement DSHEA.
Thus, it authorizes an appropriation for 5 years escalating upwards from $20MM in 2004, to $65MM in 2008 to provide FDA with the resources it requires to fully implement all the provisions of the Dietary Supplement Health and Education Act of 1994. As a requirement of this funding, FDA would be required to report annually to Congress on its progress, including reporting of the number of personnel devoted to an adverse event reporting system, labeling, Good manufacturing practice enforcement, review of new dietary ingredient applications. It would be required to explain enforcement actions and provide claims information. Monies are also targeted to activities of the Office of Dietary Supplements for research and educational activities. FDA would also be requested to make recommendations to Congress on additional legislative actions it believes would improve implementation of DSHEA.
This bill focuses on stimulants and would prohibit any stimulants, except caffeine, to be sold as dietary supplements without pre approval by FDA.
It would prohibit the sale of steroids as performance enhancing/muscle building dietary supplements and classifies them as controlled substances, unless approved as drugs or marketed under an over the counter drug monograph.
The bill also would provide FDA with the ability to remove a product from the market based on only one adverse event report and require the manufacturer to prove the product is safe before continued marketing would be approved. It also requires a manufacturer to do post market surveillance for products that pose a significant risk to consumers.
Problem 1: FDA would have unprecedented discretion over the standards for clinical evaluation of the safety of all products, even those that have been used safely for centuries.
Problem 2: One adverse event report for products that have been safely used for years could limit access and choice to any dietary supplement, effectively removing the product and entire classes of products from the market. Adverse event is defined as one associated with use, WITHOUT REGARD TO WHETHER THE EVENT IS KNOWN TO BE CAUSALLY RELATED TO dietary supplement use. No proof of causation is required, merely an association.
FACT: There is no adverse event reporting system for the vast majority of over the counter drugs. It is only required for those OTC products marketed under a new drug application, or those prescription drugs switched to OTC.
Problem 3: dietary supplements are safer than most foods, prescription and over the counter drugs, but the safety rules in this bill unfairly subject dietary supplements to unwarranted scrutiny.
FACT: Food borne illness kills 5,000 Americans each year. 5,000 deaths annually due to aspirin. 30,000 deaths annually due to over the counter drugs. Prescription drugs kill over 100,000 Americans every year. In a 9 year period, the number of deaths from dietary supplements was 36. (There is no agreement as to the number of deaths associated with the use of Ephedra containing supplements)
FACT: Dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress gave FDA the authority to develop and implement these standards as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA). But, FDA did not develop mandatory standards until 2003, nine years after it was given the authority. Now FDA claims that its proposed standards will assure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to accurately reflect the active ingredients and other ingredients in the product.
FACT: this bill would raise the cost of manufacturing dietary supplements and increase the cost to consumers