For the full text go to

Whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act.

(c) Table of Contents.

The table of contents of this Act is as follows:

Sec. 1. Short title; reference; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
Sec. 4. Safety of dietary supplements and burden of proof on FDA.
Sec. 5. Dietary supplement claims.
Sec. 6. Statements of nutritional support.
Sec. 7. Dietary supplement ingredient labeling and nutrition information labeling.
Sec. 8. New dietary ingredients.
Sec. 9. Good manufacturing practices.
Sec. 10. Conforming amendments.
Sec. 11. Withdrawal of the regulations and notice.
Sec. 12. Commission on dietary supplement labels.
Sec. 13. Office of dietary supplements.

§2. Findings.

Congress finds that -

(1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;
(2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
(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; and
(B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;
(4) healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;
(5) 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;
(6)(A) promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and
(B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country;
(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;
(9) 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;
(10) studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs;
(11) the United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase;
(12)(A) the nutritional supplement industry is an integral part of the economy of the United States;
(B) the industry consistently projects a positive trade balance; and
(C) the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;
(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;
(14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and
(15)(A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and
(B) a rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.

§3. Definitions.

(a) Definition of Certain Foods as Dietary Supplements. Section 201 (21 U.S.C. 321) is amended by adding at the end the following:
"(ff) The term "dietary supplement" -
- "(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
  - "(A) a vitamin;
  - "(B) a mineral;
  - "(C) an herb or other botanical;
  - "(D) an amino acid;
  - "(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
  - "(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
- "(2) means a product that -
  - "(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or
  - "(ii) complies with section 411(c)(1)(B)(ii);
  - "(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
  - "(C) is labeled as a dietary supplement; and
- "(3) does -
  - "(A) include an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and
  - "(B) not include -
    - "(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
    - "(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act.

For the full text click the link http://www.fda.gov/opacom/laws/dshea.html

Last updated: 07/28/2010 10:02 -0400 (c) Dr. Andre Alexander Kulisz

7116 S. Mingo Rd., Suite 101, Tulsa, OK 74133

Office: +1-918-398-0252

Hit Counter