IV. Appendixes

A. ODS Statutory Authority in the Dietary Supplement Health and Education Act (DSHEA) of 1994

  1. (a) ESTABLISHMENT. — The Secretary shall establish an Office of Dietary Supplements within the National Institutes of Health.
  2. (b) PURPOSE. — The purposes of the Office are —
    1. (1) to explore more fully the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care; and
    2. (2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions.
  3. (c) DUTIES. — The Director of the Office of Dietary Supplements shall —
    1. (1) conduct and coordinate scientific research within the National Institutes of Health relating to dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism;
    2. (2) collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign sources or the Office of Alternative Medicine;
    3. (3) serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and provide advice to the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs on issues relating to dietary supplements including —
      1. (A) dietary intake regulations;
      2. (B) the safety of dietary supplements;
      3. (C) claims characterizing the relationship between —
        1. (i) dietary supplements; and
        2. (ii)(I) prevention of disease or other health-related conditions; and
        3. (II) maintenance of health; and
      4. (D) scientific issues arising in connection with the labeling and composition of dietary supplements;
    4. (4) compile a database of scientific research on dietary supplements and individual nutrients; and
    5. (5) coordinate funding relating to dietary supplements for the National Institutes of Health.
  4. (d) DEFINITION. — As used in this section, the term “dietary supplement” has the meaning given the term in section 201(ff) of the Federal Food, Drug, and Cosmetic Act:
    1. (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
      1. (A) a vitamin;
      2. (B) a mineral;
      3. (C) an herb or other botanical;
      4. (D) an amino acid;
      5. (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
      6. (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
    2. (2) means a product that—
      1. (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);
      2. (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
      3. (C) is labeled as a dietary supplement;
    3. (3) does—
      1. (A) include an article that is approved as a new drug under section 505 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
      2. (B) not include—
        1. (i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 5077, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
        2. (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.