As Passed by the Senate 1
123rd General Assembly 4
Regular Session Sub. H. B. No. 381 5
1999-2000 6
REPRESENTATIVES PERZ-GARDNER-FORD-OLMAN-BATEMAN-BRITTON- 8
CORBIN-FLANNERY-HOLLISTER-OPFER-PADGETT-TAYLOR-WINKLER- 10
YOUNG-D. MILLER-METTLER-BENDER-O'BRIEN-HARRIS-ROBERTS-
JERSE-STEVENS-HOOPS-SENATORS MUMPER-WHITE-LATTA- 11
WATTS-GARDNER-HAGAN 12
_________________________________________________________________ 14
A B I L L
To amend section 4759.10 and to enact sections 16
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 17
3715.85, and 3715.86 of the Revised Code 18
regarding the regulation of dietary supplements. 19
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 21
Section 1. That section 4759.10 be amended and sections 23
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 3715.85, and 3715.86 25
of the Revised Code be enacted to read as follows: 26
Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.86 OF 28
THE REVISED CODE, "DIETARY SUPPLEMENT" HAS THE MEANING GIVEN IN 30
THE FEDERAL "FOOD, DRUG, AND COSMETIC ACT," 108 STAT. 4327 32
(1994), 21 U.S.C.A. 321(ff), AS AMENDED. 34
Sec. 3715.81. FOR PURPOSES OF THIS CHAPTER, A DIETARY 36
SUPPLEMENT SHALL BE TREATED AS A FOOD. THE DIRECTOR OF 37
AGRICULTURE SHALL ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 39
3715.86 OF THE REVISED CODE AND ANY RULES ADOPTED UNDER THOSE 41
SECTIONS IN ACCORDANCE WITH CHAPTER 3717. OF THE REVISED CODE.
Sec. 3715.82. THE DIRECTOR OF AGRICULTURE MAY ADOPT RULES, 44
IN ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE, TO 45
ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.86 OF THE REVISED 46
CODE. IF RULES ARE ADOPTED, THE RULES SHALL BE NO MORE 47
RESTRICTIVE THAN THE REGULATIONS PROMULGATED UNDER THE FEDERAL 48
2
"FOOD, DRUG, AND COSMETIC ACT," 52 STAT. 1040 (1938), 21 U.S.C.A. 50
301, ET SEQ., AS AMENDED. 51
Sec. 3715.83. IN ADDITION TO THE CONDITIONS SPECIFIED IN 53
SECTION 3715.59 OF THE REVISED CODE, A DIETARY SUPPLEMENT IS 54
ADULTERATED IF IT PRESENTS A SIGNIFICANT OR UNREASONABLE RISK OF 55
ILLNESS OR INJURY UNDER THE CONDITIONS OF USE RECOMMENDED OR 56
SUGGESTED IN ITS LABELING OR, IF THERE ARE NO RECOMMENDED OR 57
SUGGESTED CONDITIONS OF USE, UNDER THE ORDINARY CONDITIONS OF 58
USE. 59
IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 61
BELIEVE THAT A DIETARY SUPPLEMENT IS ADULTERATED UNDER THIS 62
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 63
CHAPTER APPLICABLE TO ADULTERATED FOOD. IN ANY ACTION TAKEN 64
UNDER THIS SECTION, THE BURDEN OF PROOF SHALL BE ON THE DIRECTOR. 65
Sec. 3715.84. (A) A DIETARY SUPPLEMENT IS NOT MISBRANDED 68
UNDER SECTION 3715.60 OF THE REVISED CODE SOLELY BECAUSE THE 69
LABEL OR LABELING CONTAINS A STATEMENT THAT CHARACTERIZES THE 70
RELATIONSHIP OF A NUTRIENT OR DIETARY INGREDIENT TO A DISEASE OR 71
HEALTH-RELATED CONDITION IF ALL OF THE FOLLOWING CONDITIONS ARE 72
MET:
(1) THE STATEMENT DOES ONE OF THE FOLLOWING: 74
(a) CLAIMS A BENEFIT RELATED TO A CLASSICAL NUTRIENT 77
DEFICIENCY DISEASE AND DISCLOSES THE PREVALENCE OF THE DISEASE IN 78
THE UNITED STATES;
(b) DESCRIBES THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 81
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 82
(c) CHARACTERIZES A DOCUMENTED MECHANISM BY WHICH A 85
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 86
FUNCTION OF THE HUMAN BODY;
(d) DESCRIBES GENERAL WELL-BEING FROM CONSUMPTION OF A 89
NUTRIENT OR DIETARY INGREDIENT.
(2) THE MANUFACTURER OF THE DIETARY SUPPLEMENT HAS 91
SUBSTANTIATION THAT THE STATEMENT IS NOT FALSE OR MISLEADING. 93
(3) THE LABEL CONTAINS, PROMINENTLY DISPLAYED AND IN 95
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BOLDFACE TYPE, ONE OF THE FOLLOWING STATEMENTS: 96
(a) IN THE CASE OF A PRODUCT MANUFACTURED OR SOLD IN OHIO 99
AND IN OTHER STATES, "THIS STATEMENT HAS NOT BEEN EVALUATED BY 100
THE UNITED STATES FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS 102
NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 103
(b) IN THE CASE OF A PRODUCT MANUFACTURED AND SOLD ONLY 105
WITHIN THE STATE OF OHIO, "THIS STATEMENT HAS NOT BEEN EVALUATED 106
BY THE OHIO DEPARTMENT OF AGRICULTURE. THIS PRODUCT IS NOT 107
INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 108
(4) THE MANUFACTURER OF THE DIETARY SUPPLEMENT COMPLIES 110
WITH THE REQUIREMENTS OF THE FEDERAL "FOOD, DRUG, AND COSMETIC 112
ACT," 108 STAT. 4327 (1994), 21 U.S.C.A. 343(r)(6), AS AMENDED. 115
(B) THE STATEMENT DESCRIBED IN DIVISION (A)(1) OF THIS 119
SECTION SHALL NOT CLAIM THAT THE SUPPLEMENT IS TO BE USED TO
DIAGNOSE, MITIGATE, TREAT, CURE, OR PREVENT A SPECIFIC DISEASE OR 121
CLASS OF DISEASES.
(C) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 124
BELIEVE THAT A DIETARY SUPPLEMENT IS MISBRANDED UNDER THIS 125
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 126
CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION TAKEN UNDER 127
THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH MISBRANDING IS ON 128
THE DIRECTOR.
(D) A DIETARY SUPPLEMENT IS NOT A DRUG WITHIN THE MEANING 131
OF SECTION 3715.01 OR 4729.01 OF THE REVISED CODE SOLELY BECAUSE 132
THE LABEL OR LABELING CONTAINS A STATEMENT AUTHORIZED BY THIS 133
SECTION OR BECAUSE A WARNING APPEARS ON THE SUPPLEMENT'S LABEL. 134
Sec. 3715.85. (A) AS USED IN THIS SECTION, "PUBLICATION" 137
INCLUDES A BOOK CHAPTER, ARTICLE, OR OFFICIAL ABSTRACT OF A 138
PEER-REVIEWED SCIENTIFIC ARTICLE PREPARED BY THE ARTICLE'S AUTHOR 139
OR THE EDITORS OF THE PUBLICATION IN WHICH THE ARTICLE IS 140
PUBLISHED.
(B) A PUBLICATION USED IN CONNECTION WITH A SALE TO 143
CONSUMERS OF A DIETARY SUPPLEMENT IS NOT CONSIDERED PART OF THE 144
LABEL OF THE DIETARY SUPPLEMENT IF THE PUBLICATION MEETS ALL OF 145
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THE FOLLOWING CRITERIA:
(1) THE PUBLICATION IS REPRINTED IN ITS ENTIRETY. 147
(2) THE PUBLICATION IS NOT FALSE OR MISLEADING. 149
(3) THE PUBLICATION DOES NOT PROMOTE A PARTICULAR 151
MANUFACTURER OR BRAND OF DIETARY SUPPLEMENT. 152
(4) THE PUBLICATION IS DISPLAYED OR PRESENTED, ALONE OR 154
WITH OTHER PUBLICATIONS ON THE SAME SUBJECT MATTER, SO AS TO 155
PRESENT A BALANCED VIEW OF THE AVAILABLE SCIENTIFIC INFORMATION 156
ON A DIETARY SUPPLEMENT. 157
(5) IF THE PUBLICATION IS DISPLAYED IN A LOCATION WHERE 159
DIETARY SUPPLEMENTS ARE OFFERED FOR SALE, THE PUBLICATION IS 160
PHYSICALLY SEPARATE FROM THE DIETARY SUPPLEMENTS. 161
(6) THE PUBLICATION DOES NOT HAVE ANY OTHER INFORMATION 163
AFFIXED TO IT.
(C) DIVISION (B) OF THIS SECTION DOES NOT APPLY TO OR 167
RESTRICT THE ACTIONS OF A PERSON WHO OFFERS DIETARY SUPPLEMENTS 168
FOR SALE AT RETAIL OR WHOLESALE IN THE SALE OF BOOKS OR 169
PUBLICATIONS AS PART OF THE PERSON'S BUSINESS. 170
(D) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 173
BELIEVE THAT A PUBLICATION UNDER DIVISION (B) OF THIS SECTION IS 174
A LABEL AND THAT LABEL IS FALSE OR MISLEADING UNDER DIVISION (B) 175
OF THIS SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS 176
OF THIS CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION 177
TAKEN UNDER THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH 178
MISBRANDING SHALL BE ON THE DIRECTOR. 179
Sec. 3715.86. A DIETARY SUPPLEMENT IS NOT CONSIDERED A 181
"FOOD ADDITIVE" WITHIN THE MEANING GIVEN IN THE FEDERAL "FOOD, 183
DRUG, AND COSMETIC ACT," 21 U.S.C.A. 321(s), AS AMENDED. 185
Sec. 4759.10. Sections 4759.01 to 4759.09 of the Revised 194
Code do not apply to any of the following: 195
(A) A person licensed under Chapters 4701. to 4755. of the 197
Revised Code who is acting within the scope of his THE PERSON'S 198
profession, provided that he THE PERSON complies with division 199
(B) of section 4759.02 of the Revised Code; 200
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(B) A person who is a graduate of an associate degree 202
program approved by the American dietetic association or the Ohio 203
board of dietetics who is working as a dietetic technician under 204
the supervision of a dietitian licensed under section 4759.06 of 205
the Revised Code or registered by the commission on dietetic 206
registration, except that the person is subject to division (B) 207
of section 4759.02 of the Revised Code if he THE PERSON uses a 208
title other than "dietetic technician"; 209
(C) A person who practices dietetics related to employment 211
in the armed forces, veteran's administration, or the public 212
health service of the United States; 213
(D) Persons employed by a nonprofit agency approved by the 215
board or by a federal, state, municipal or county government, or 216
by any other political subdivision, elementary or secondary 217
school, or an institution of higher education approved by the 218
board or by a regional agency recognized by the council on 219
postsecondary accreditation, who performs only nutritional 220
education activities and such other nutritional activities as the 221
board of dietetics, by rule, permits, provided the person does 222
not violate division (B) of section 4759.02 of the Revised Code; 223
(E) A person who has completed a program meeting the 225
academic standards set by the American dietetic association for 226
dietitians, received a baccalaureate or higher degree from a 227
school, college, or university approved by a regional 228
accreditation agency recognized by the council on postsecondary 229
accreditation, works under the supervision of a licensed 230
dietitian or registered dietitian, and does not violate division 231
(B) of section 4759.02 of the Revised Code; 232
(F) A person when acting, under the direction and 234
supervision of a person licensed under Chapters 4701. to 4755. of 235
the Revised Code, in the execution of a plan of treatment 236
authorized by the licensed person, provided the person complies 237
with division (B) of section 4759.02 of the Revised Code; 238
(G) The free dissemination of literature in the state; 240
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(H) Provided that the persons involved in the sale, 242
promotion, or explanation of the sale of food, food materials, or 243
dietary supplements do not violate division (B) of section 244
4759.02 of the Revised Code, the sale of food, food materials, or 245
dietary supplements and the marketing and distribution of food, 246
food materials, or dietary supplements and the promotion or 247
explanation of the use of food, food materials, or dietary 248
supplements provided that the promotion or explanation does not 249
violate Chapter 1345. of the Revised Code; 250
(I) A PERSON WHO OFFERS DIETARY SUPPLEMENTS FOR SALE AND 253
WHO MAKES THE FOLLOWING STATEMENTS ABOUT THE PRODUCT IF THE 254
STATEMENTS ARE CONSISTENT WITH THE DIETARY SUPPLEMENT'S LABEL OR 255
LABELING:
(1) CLAIM A BENEFIT RELATED TO A CLASSICAL NUTRIENT 257
DEFICIENCY DISEASE AND DISCLOSE THE PREVALENCE OF THE DISEASE IN 258
THE UNITED STATES;
(2) DESCRIBE THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 260
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 262
(3) CHARACTERIZE THE DOCUMENTED MECHANISM BY WHICH A 264
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 265
FUNCTION OF THE HUMAN BODY; 266
(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A 268
NUTRIENT OR DIETARY INGREDIENT. 269
(J) Provided that the persons involved in presenting a 271
general program of instruction for weight control do not violate 272
division (B) of section 4759.02 of the Revised Code, a general 273
program of instruction for weight control approved in writing by 274
a licensed dietitian, a physician licensed under Chapter 4731. of 275
the Revised Code to practice medicine or surgery or osteopathic 276
medicine or surgery, a person licensed in another state that the 277
board considers to have substantially equivalent licensure 278
requirements as this state, or a registered dietitian; 279
(J)(K) The continued practice of dietetics at a hospital 281
by a person employed at that same hospital to practice dietetics 282
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for the twenty years immediately prior to July 1, 1987, so long 283
as the person works under the supervision of a dietitian licensed 284
under section 4759.06 of the Revised Code and does not violate 285
division (B) of section 4759.02 of the Revised Code. This 286
division does not apply to any person who has held a license 287
issued under this chapter to practice dietetics. As used in this 288
division, "hospital" has the same meaning as in section 3727.01 289
of the Revised Code. 290
Section 2. That existing section 4759.10 of the Revised 292
Code is hereby repealed. 293
Section 3. Sections 3715.80 to 3715.86 of the Revised 295
Code, as enacted by this act, are intended to codify in Ohio law 296
portions of the federal "Dietary Supplement Health and Education 297
Act of 1994," 108 Stat. 4325 (1994), 21 U.S.C.A. 301, et seq., as 298
amended. 299