Source: https://ods.od.nih.gov/About/DSHEA_Wording.aspx
Timestamp: 2019-04-25 02:25:56+00:00

Document:
§1. Short Title; Reference; Table Of Contents.
This Act may be cited as the "Dietary Supplement Health and Education Act of 1994".
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.
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.
Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act.
(3) by adding at the end the following new subparagraph (6) "an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.".
(2) in clause (ii), by striking "does not simulate and".
§4. Safety of Dietary Supplements and Burden of Proof on FDA.
"(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
"(b) APPLICATION. - Subsection (a) shall not apply to or restrict a retailer or wholesaler of dietary supplements in any way whatsoever in the sale of books or other publications as a part of the business of such retailer or wholesaler.
"(c) BURDEN OF PROOF. - In any proceeding brought under subsection (a), the burden of proof shall be on the United States to establish that an article or other such matter is false or misleading.".
§6. Statements of Nutritional Support.
"(C) the statement contains, prominently displayed and in boldface type, the following: "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.".
A statement under this subparagraph may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. If the manufacturer of a dietary supplement proposes to make a statement described in the first sentence of this subparagraph in the labeling of the dietary supplement, the manufacturer shall notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.".
§7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling.
"(II) fails to meet the quality (including tablet or capsule disintegration), purity, or compositional specifications, based on validated assay or other appropriate methods, that the supplement is represented to meet.".
"(iv) the nutrition information shall immediately precede the ingredient information required under subclause (i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.".
"(F) Subclause (i) clause (A) does not apply to a statement in the labeling of a dietary supplement that characterizes the percentage level of a dietary ingredient for which the Secretary has not established a reference daily intake, daily recommended value, or other recommendation for daily consumption.".
"(b) PETITION. - Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action.
"(c) DEFINITION. - For purposes of this section, the term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.".
"(g)(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2).
"(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.".
(a) SECTION 201 - The last sentence of section 201(g)(1) (21 U.S.C. 321(g)(1)) is amended to read as follows: "A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.".
(b) SECTION 301 - Section 301 (21 U.S.C. 331) is amended by adding at the end the following: (u) The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 413.".
(c) SECTION 403 - Section 403 (21 U.S.C. 343), as amended by section 7, is amended by adding after paragraph (s) the following: "A dietary supplement shall not be deemed misbranded solely because its label or labeling contains directions or conditions of use or warnings.".
§11. Withdrawal of the Regulations and Notice.
The advance notice of proposed rulemaking concerning dietary supplements published in the Federal Register of June 18, 1993 (58 FR 33690-33700) is null and void and of no force or effect insofar as it applies to dietary supplements. The Secretary of Health and Human Services shall publish a notice in the Federal Register to revoke the item declared to be null and void and of no force or effect under subsection (a).
§12. Commission on Dietary Supplement Labels.
(a) ESTABLISHMENT. - There shall be established as an independent agency within the executive branch a commission to be known as the Commission on Dietary Supplement Labels (hereafter in this section referred to as the "Commission").
(1) COMPOSITION. - The Commission shall be composed of 7 members who shall be appointed by the President.
(2) EXPERTISE REQUIREMENT. - The members of the Commission shall consist of individuals with expertise and experience in dietary supplements and in the manufacture, regulation, distribution, and use of such supplements. At least three of the members of the Commission shall be qualified by scientific training and experience to evaluate the benefits to health of the use of dietary supplements and one of such three members shall have experience in pharmacognosy, medical botany, traditional herbal medicine, or other related sciences. Members and staff of the Commission shall be without bias on the issue of dietary supplements.
(c) FUNCTIONS OF THE COMMISSION. - The Commission shall conduct a study on, and provide recommendations for, the regulation of label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for the evaluation of such claims. In making such recommendations, the Commission shall evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families.
(1) HEARINGS. - The Commission may hold hearings, sit and act at such times and places, take such testimony, and receive such evidence as the Commission considers advisable to carry out the purposes of this section.
(2) INFORMATION FROM FEDERAL AGENCIES. - The Commission may secure directly from any Federal department or agency such information as the Commission considers necessary to carry out the provisions of this section.
(3) AUTHORIZATION OF APPROPRIATIONS. - There are authorized to be appropriated such sums as may be necessary to carry out this section.
(1) FINAL REPORT REQUIRED. - Not later than 24 months after the date of enactment of this Act, the Commission shall prepare and submit to the President and to the Congress a final report on the study required by this section.
(2) RECOMMENDATIONS. - The report described in paragraph (1) shall contain such recommendations, including recommendations for legislation, as the Commission deems appropriate.
(3) ACTION ON RECOMMENDATIONS. - Within 90 days of the issuance of the report under paragraph (1), the Secretary of Health and Human Services shall publish in the Federal Register a notice of any recommendation of Commission for changes in regulations of the Secretary for the regulation of dietary supplements and shall include in such notice a notice of proposed rulemaking on such changes together with an opportunity to present views on such changes. Such rulemaking shall be completed not later than 2 years after the date of the issuance of such report. If such rulemaking is not completed on or before the expiration of such 2 years, regulations of the Secretary published in 59 FR 395-426 on January 4, 1994, shall not be in effect.
§13. Office of Dietary Supplements.
"(5) coordinate funding relating to dietary supplements for the National Institutes of Health.
"(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.
"(e) AUTHORIZATION OF APPROPRIATIONS. - There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 1994 and such sums as may be necessary for each subsequent fiscal year.".
"(E) The Office of Dietary Supplements.".

References: §4

§6

§7

§11

§12

§13