DSHEA Legal

• DSHEA
• Congress Findings
• Label Exemptions
• FDA Web Site
• FTC Web Site
• FDA Warning Letters

Supplement Education Initiative

The US FDA and FTC have specific and stringent requriements regarding the allowable representations for marketing of supplements marketed under DSHEA of 1994.

The purpose of DSHEA is to improve the health of Americans by assuring availability supplements and credible scientific information enabling supplement use to both improve health, reduce disease and to curb rapid escalation in the national health care crisis.

Congress had one goal ratifying DSHEA, to improve the health of Americans. This goal is clearly stated in Congressional Findings:

• (3)(A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;
• (7) there is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;
• (8) 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;
• (13) although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.

This site delivers accurate and complete information about dietary supplements.

Distribution of scientific information was strongly encouraged by Congress. The purpose of Section 403B of DSHEA is to facilitate public education regarding positive effects of dietary supplements on health.

Congress established a quality standard for health information in DSHEA. Literature designed to educate the public regarding the potential benefits of dietary supplemens are NOT defined as labeling when used in connection with the marketing of dietary supplements, as long as:

• The material is a publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication;
• Is reprinted entirely;
• Isn't false or misleading;
• Doesn't promote a specific product;
• Is presented with other materials on the same subject matter;
• Is displayed separate from supplements in a physical establishment.

In other words, scientifc literature "shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers". It is exempt from FDA and FTC Regulation.

Supplement sellers often overstep FDA reguations making objectionable marketing statements regarding the products they sell. These statments often result in regulatory inforcement from the FDA or FTC. These regulatory actions represent an ongoing challenge to supplement vendor business.

Labeling regulations are violated supplement vendors; and sometimes over-applied by regulatory agencies. All information on this website complies with labeling exemptions criteria explicitly allowed by congress. No material on this website is subject to FDA regulation.