Safety - DSHEA amends the adulteration provisions of the Federal Food, Drug and Cosmetic Act. It is a manufacturer's responsibility to ensure that its products are safe and properly labeled prior to marketing. Under DSHEA, a dietary supplement may be adulterated for a number of different reasons. For example, a supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use (if there are no directions). FDA's Adverse Event Report Monitoring System for dietary supplements provides an essential tool for identifying potential safety problems that may be associated with the use of a particular product or type of product already in the marketplace that need to be investigated and critically evaluated. In addition, DSHEA grants FDA the authority to establish GMP regulations governing the preparation, packing, and holding of dietary supplements under conditions that help ensure their safety. Proposed rules for GMP regulation have been drafted and are pending review by the new Administration. For FY 2001, a high priority for the Agency is to publish the dietary supplement GMP proposed rule and conduct outreach. Labeling - DSHEA provides for the use of certain claims in dietary supplement labeling, including claims to affect the structure or function of the body (often called "structure/function" claims), claims of general well-being from consumption of a dietary ingredient, and claims of benefits related to classical nutrient deficiency diseases. Manufacturers must have substantiation that the statements are truthful and not misleading, and the product label must bear the statement--"This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." These claims also require notification to FDA within 30 days of marketing. FDA reviews proposed health claims for dietary supplements under the provisions of the Nutrition Labeling and Education Act of 1990 (NLEA), implementing regulations and relevant case law. Claims that a dietary supplement treats or mitigates a disease subject the supplement to regulation as a drug under the Federal Food, Drug and Cosmetic Act. Boundaries - FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. Through DSHEA, Congress expanded the meaning of the term "dietary supplements" beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, and enzymes. As noted above, DSHEA allows manufacturers to describe the supplement's effects on "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient. However, DSHEA leaves open, for FDA to define further, the precise boundaries between dietary supplements and drugs, between dietary supplements and conventional foods, and even between dietary supplements and cosmetics. As an effort to better define the drug/supplement boundary issues, in January 2000 FDA published the Structure/Function Final Rule (65 FR 9999, January 6, 2000). Enforcement - Under DSHEA, FDA will take appropriate action with respect to unsafe products, inaccurate and misleading labeling, consumer fraud, and trade complaints. FDA will also conduct marketplace surveillance and monitoring activities. Many organizations in the industry have called for stronger FDA enforcement to create a "level playing field" and to ensure that all companies adhere to the same rules. FDA will establish partnerships with federal, state, and local agencies to enhance enforcement efforts by sharing data, heightening communication, and utilizing resources. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.