As Introduced 1
123rd General Assembly 4
Regular Session H. B. No. 381 5
1999-2000 6
REPRESENTATIVES PERZ-GARDNER-FORD-OLMAN-BATEMAN-BRITTON- 8
CORBIN-FLANNERY-HOLLISTER-OPFER-PADGETT-TAYLOR-WINKLER 9
_________________________________________________________________ 10
A B I L L
To enact sections 3715.80, 3715.81, 3715.83, 12
3715.84, 3715.86, 3715.87, 3715.88, and 3715.89 13
of the Revised Code regarding the regulation of 14
dietary supplements.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 16
Section 1. That sections 3715.80, 3715.81, 3715.83, 18
3715.84, 3715.86, 3715.87, 3715.88, and 3715.89 of the Revised 19
Code be enacted to read as follows: 20
Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.89 OF 22
THE REVISED CODE, "DIETARY SUPPLEMENT" HAS THE MEANING GIVEN IN 23
THE FEDERAL "FOOD, DRUG, AND COSMETIC ACT," 108 STAT. 4327 25
(1994), 21 U.S.C.A. 321(ff), AS AMENDED. 27
Sec. 3715.81. FOR PURPOSES OF THIS CHAPTER, A DIETARY 29
SUPPLEMENT SHALL BE TREATED AS A FOOD. THE DIRECTOR OF 30
AGRICULTURE SHALL HAVE EXCLUSIVE AUTHORITY TO ADMINISTER AND 31
ENFORCE SECTIONS 3715.80 TO 3715.89 OF THE REVISED CODE AND ANY 33
RULES ADOPTED UNDER THOSE SECTIONS. THE BOARD OF PHARMACY SHALL 34
HAVE NO AUTHORITY TO ADMINISTER OR ENFORCE THE PROVISIONS OF THIS 35
CHAPTER RELATING TO DIETARY SUPPLEMENTS. 36
Sec. 3715.83. THE DIRECTOR OF AGRICULTURE MAY ADOPT RULES, 39
IN ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE, TO 40
ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.89 OF THE REVISED 41
CODE. IF RULES ARE ADOPTED, THE RULES SHALL BE CONSISTENT WITH 42
THE REGULATIONS PROMULGATED UNDER THE FEDERAL "FOOD, DRUG, AND 44
COSMETIC ACT," 52 STAT. 1040 (1938), 21 U.S.C.A. 301, ET SEQ., AS 46
2
AMENDED.
Sec. 3715.84. IN ADDITION TO THE CONDITIONS SPECIFIED IN 48
SECTION 3715.59 OF THE REVISED CODE, A DIETARY SUPPLEMENT IS 49
ADULTERATED IF IT PRESENTS A SIGNIFICANT OR UNREASONABLE RISK OF 50
ILLNESS OR INJURY UNDER THE CONDITIONS OF USE RECOMMENDED OR 51
SUGGESTED IN ITS LABELING OR, IF THERE ARE NO RECOMMENDED OR 52
SUGGESTED CONDITIONS OF USE, UNDER THE ORDINARY CONDITIONS OF 53
USE. 54
IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 56
BELIEVE THAT A DIETARY SUPPLEMENT IS ADULTERATED UNDER THIS 57
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 58
CHAPTER APPLICABLE TO ADULTERATED FOOD. IN ANY ACTION TAKEN 59
UNDER THIS SECTION, THE BURDEN OF PROOF SHALL BE ON THE DIRECTOR. 60
Sec. 3715.86. (A) A DIETARY SUPPLEMENT IS NOT MISBRANDED 63
UNDER SECTION 3715.60 OF THE REVISED CODE SOLELY BECAUSE THE 64
LABEL CONTAINS A STATEMENT THAT CHARACTERIZES THE RELATIONSHIP OF 65
A NUTRIENT OR DIETARY INGREDIENT TO A DISEASE OR HEALTH-RELATED 66
CONDITION IF ALL OF THE FOLLOWING CONDITIONS ARE MET: 67
(1) THE STATEMENT DOES ONE OF THE FOLLOWING: 69
(a) CLAIMS A BENEFIT RELATED TO A CLASSICAL NUTRIENT 72
DEFICIENCY DISEASE AND DISCLOSES THE PREVALENCE OF THE DISEASE IN 73
THE UNITED STATES;
(b) DESCRIBES THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 76
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 77
(c) CHARACTERIZES A DOCUMENTED MECHANISM BY WHICH A 80
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 81
FUNCTION OF THE HUMAN BODY;
(d) DESCRIBES GENERAL WELL-BEING FROM CONSUMPTION OF A 84
NUTRIENT OR DIETARY INGREDIENT.
(2) THE MANUFACTURER OF THE DIETARY SUPPLEMENT HAS 86
SUBSTANTIATION THAT THE STATEMENT IS NOT FALSE OR MISLEADING. 88
(3) THE LABEL CONTAINS, PROMINENTLY DISPLAYED AND IN 90
BOLDFACE TYPE, THE FOLLOWING STATEMENT: "THIS STATEMENT HAS NOT 91
BEEN EVALUATED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION. 94
3
THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT 95
ANY DISEASE."
(4) THE MANUFACTURER OF THE DIETARY SUPPLEMENT COMPLIES 97
WITH THE REQUIREMENTS OF THE FEDERAL "FOOD, DRUG, AND COSMETIC 99
ACT," 108 STAT. 4327 (1994), 21 U.S.C.A. 3343(r)(6), AS AMENDED. 102
(B) THE STATEMENT DESCRIBED IN DIVISION (A)(1) OF THIS 106
SECTION SHALL NOT CLAIM THAT THE SUPPLEMENT IS TO BE USED TO
DIAGNOSE, MITIGATE, TREAT, CURE, OR PREVENT A SPECIFIC DISEASE OR 108
CLASS OF DISEASES.
(C) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 111
BELIEVE THAT A DIETARY SUPPLEMENT IS MISBRANDED UNDER THIS 112
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 113
CHAPTER APPLICABLE TO MISBRANDED FOOD. 114
(D) A DIETARY SUPPLEMENT IS NOT A "DRUG" WITHIN THE 117
MEANING OF SECTION 3715.01 OR 4729.01 OF THE REVISED CODE SOLELY 118
BECAUSE THE LABEL CONTAINS A STATEMENT AUTHORIZED BY THIS SECTION 119
OR BECAUSE A WARNING APPEARS ON THE SUPPLEMENT'S LABEL. 120
Sec. 3715.87. (A) AS USED IN THIS SECTION, "PUBLICATION" 123
INCLUDES A BOOK CHAPTER, ARTICLE, OR OFFICIAL ABSTRACT OF A 124
PEER-REVIEWED SCIENTIFIC ARTICLE PREPARED BY THE ARTICLE'S AUTHOR 125
OR THE EDITORS OF THE PUBLICATION IN WHICH THE ARTICLE IS 126
PUBLISHED.
(B) A PUBLICATION USED IN CONNECTION WITH A SALE TO 129
CONSUMERS OF A DIETARY SUPPLEMENT SHALL NOT BE CONSIDERED PART OF 130
THE LABEL OF THE DIETARY SUPPLEMENT IF THE PUBLICATION MEETS ALL 131
OF THE FOLLOWING CRITERIA:
(1) THE PUBLICATION IS REPRINTED IN ITS ENTIRETY. 133
(2) THE PUBLICATION IS NOT FALSE OR MISLEADING. 135
(3) THE PUBLICATION DOES NOT PROMOTE A PARTICULAR 137
MANUFACTURER OR BRAND OF DIETARY SUPPLEMENT. 138
(4) THE PUBLICATION IS DISPLAYED OR PRESENTED, ALONE OR 140
WITH OTHER PUBLICATIONS ON THE SAME SUBJECT MATTER, SO AS TO 141
PRESENT A BALANCED VIEW OF THE AVAILABLE SCIENTIFIC INFORMATION 142
ON A DIETARY SUPPLEMENT. 143
4
(5) IF THE PUBLICATION IS DISPLAYED IN A LOCATION WHERE 145
DIETARY SUPPLEMENTS ARE OFFERED FOR SALE, THE PUBLICATION IS 146
PHYSICALLY SEPARATE FROM THE DIETARY SUPPLEMENTS. 147
(6) THE PUBLICATION DOES NOT HAVE ANY OTHER INFORMATION 149
AFFIXED TO IT.
(C) DIVISION (B) OF THIS SECTION DOES NOT APPLY TO OR 153
RESTRICT THE ACTIONS OF A PERSON WHO OFFERS DIETARY SUPPLEMENTS 154
FOR SALE AT RETAIL OR WHOLESALE IN THE SALE OF BOOKS OR 155
PUBLICATIONS AS PART OF THE PERSON'S BUSINESS. 156
(D) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 159
BELIEVE THAT A DIETARY SUPPLEMENT LABEL IS FALSE OR MISLEADING 160
UNDER DIVISION (B) OF THIS SECTION, THE DIRECTOR SHALL PROCEED 162
UNDER THE PROVISIONS OF THIS CHAPTER APPLICABLE TO MISBRANDED 163
FOOD. IN ANY ACTION TAKEN UNDER THIS SECTION, THE BURDEN OF 164
PROOF TO ESTABLISH MISBRANDING SHALL BE ON THE DIRECTOR. 165
Sec. 3715.88. A DIETARY SUPPLEMENT IS NOT A "FOOD 167
ADDITIVE" WITHIN THE MEANING GIVEN IN THE FEDERAL "FOOD, DRUG, 169
AND COSMETIC ACT," 21 U.S.C.A. 321(s), AS AMENDED. 171
Sec. 3715.89. (A) A PERSON WHO OFFERS DIETARY SUPPLEMENTS 174
FOR SALE AT RETAIL, WHOLESALE, OR DISTRIBUTION MAY MAKE THE 175
FOLLOWING STATEMENTS IF THE STATEMENTS ARE CONSISTENT WITH THE 176
DIETARY SUPPLEMENT'S LABEL: 177
(1) CLAIM A BENEFIT RELATED TO A CLASSICAL NUTRIENT 179
DEFICIENCY DISEASE AND DISCLOSE THE PREVALENCE OF THE DISEASE IN 180
THE UNITED STATES;
(2) DESCRIBE THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 182
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 184
(3) CHARACTERIZE THE DOCUMENTED MECHANISM BY WHICH A 186
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 187
FUNCTION; 188
(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A 190
NUTRIENT OR DIETARY INGREDIENT. 191
(B) A PERSON WHO MAKES A STATEMENT UNDER DIVISION (A) OF 194
THIS SECTION IS NOT PRACTICING NURSING UNDER CHAPTER 4723. OF THE 196
5
REVISED CODE, MEDICINE AND SURGERY UNDER CHAPTER 4731. OF THE 197
REVISED CODE, OR DIETETICS UNDER CHAPTER 4759. OF THE REVISED 198
CODE.
Section 2. Sections 3715.80 to 3715.88 of the Revised 200
Code, as enacted by this act, are intended to codify in Ohio law 201
portions of the federal "Dietary Supplements and Health Education 202
Act of 1994," 108 Stat. 4325 (1994), 21 U.S.C.A. 301, et seq., as 203
amended. 204