Dietary Supplement Health & Education Act (DSHEA)
DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994. The law provides FDA with appropriate regulatory authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable, high quality, safe and beneficial dietary supplement products. CRN supports strong enforcement of DSHEA and continues to urge for full enactment of the law.
- DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements.
- DSHEA made it clear that ingredients of dietary supplements could not be regulated as food additives. Instead, the legislation created two categories of dietary supplement ingredients—“old” or “grandfathered” ingredients and “new dietary ingredients.” DSHEA grandfathered all dietary supplement ingredients marketed in the United States before October 15, 1994. These are considered safe for continued consumer use. Before marketing a “new dietary ingredient” manufacturers must submit a New Dietary Ingredient Notification to FDA to providing their basis for judging that the ingredient “is reasonably expected to be safe.” This information must be provided at least 75 days before marketing a new ingredient.
- DSHEA confirmed that dietary supplements must comply with current Good Manufacturing Practices (cGMPs) and also authorized FDA to establish separate GMPs for dietary supplements. The supplement-specific GMP rules were released in June 2007 with a three-year “phase in” compliance period. By June 2010, all manufacturers were expected to fully comply with the new rules. Responsible companies in the industry have fully supported the need for dietary supplements GMPs in order to create a level playing field for companies across the board and help increase consumer confidence in the quality and safety of these products.
- DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an “imminent hazard” clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a “significant or unreasonable risk” clause that allows removal of a product considered to pose an unacceptable risk of illness or injury.
Historical Background: What Findings Did Congress Emphasize in Passing DSHEA by Unanimous Consent?
In passing this landmark legislation, Congress set forth a number of "findings" which emphasize the importance of communicating the positive benefits of supplements to the American public. Congress found that:
- The importance of nutrition and the benefits of dietary supplements in health promotion and disease prevention have been documented increasingly in scientific studies;
- There is a link between ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;
- Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases and reduce long-term health care expenditures;
- Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
- There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;
- National surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals or herbs as a means of improving their nutrition;
- Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness;
- Dietary supplements are safe within a broad range of intake, and safety problems with supplements are relatively rare;
- Although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
- A rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.