§4.3 Enactment of the Dietary Supplement and Health Education Act of 1994 (DSHEA)

• Jurisdiction: United States
• Publication year: 2022

§4.3 Enactment of the Dietary Supplement and Health Education Act of 1994 (DSHEA)

House bill 1709 (H.R. 1709), entitled "To amend the Federal Food, Drug, and Cosmetic Act to establish provisions regarding the composition and labeling of dietary supplements," was introduced on April 7, 1993.²⁵ H.R. 1709 contained provisions addressing, among other issues, a definition for "dietary supplements,"²⁶ a definition for "dietary ingredient,"²⁷ when a dietary supplement shall be adulterated,²⁸ when a dietary supplement shall be misbranded,²⁹ allowing truthful and non-misleading claims,³⁰ allowing appeals to the Secretary,³¹ and allowing de novo judicial review.³² A provision to establish the Office of Dietary Supplements was also in the bill.³³

On April 7,1993, Senator Hatch introduced Senate bill 784 (S. 784), entitled "To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes."³⁴ S. 784 addressed, among other issues, the power that consumers should have to be able to make choices about particular dietary supplements,³⁵ that dietary supplements are safe within a broad range of intake and safety problems are rare,³⁶ that the purpose of the amendment was to clarify that dietary supplements are not drugs or food additives,³⁷ define "dietary supplement,"³⁸ establish states of adulteration for dietary supplements,³⁹ allow truthful and non-misleading information in the label and labeling of dietary supplements,⁴⁰ allow administrative review by the Secretary,⁴¹ and allow de novo judicial review by district court.⁴² S. 784 also established the Office of Dietary Supplements within the National Institute of Health.⁴³

Following amendments to the bills,⁴⁴ statements, and debates by the Senate⁴⁵ and the House,⁴⁶ and a report to accompany S. 784,⁴⁷ public law 103-417 was signed by the President on October 24, 1994, and enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA) on October 25, 1994.⁴⁸

Importantly, in the Congressional Record detailing the debates on DSHEA, regarding the Statement of Agreement between the House and Senate, it was stated ". . . [we] have agreed that the only legislative history for this legislation will be a statement of agreement . . . ."⁴⁹

Throughout the history of U.S. food and drug law, the courts have turned to the legislative history in determining the intent of the Congress. Whether the statement above removes from the judiciary the right to...