As Reported by House Commerce and Labor Committee 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
_________________________________________________________________ 11
A B I L L
To amend section 4759.10 and to enact sections 13
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 14
3715.85, and 3715.86 of the Revised Code 15
regarding the regulation of dietary supplements. 16
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 18
Section 1. That section 4759.10 be amended and sections 20
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 3715.85, and 3715.86 22
of the Revised Code be enacted to read as follows: 23
Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.86 OF 25
THE REVISED CODE, "DIETARY SUPPLEMENT" HAS THE MEANING GIVEN IN 27
THE FEDERAL "FOOD, DRUG, AND COSMETIC ACT," 108 STAT. 4327 29
(1994), 21 U.S.C.A. 321(ff), AS AMENDED. 31
Sec. 3715.81. FOR PURPOSES OF THIS CHAPTER, A DIETARY 33
SUPPLEMENT SHALL BE TREATED AS A FOOD. THE DIRECTOR OF 34
AGRICULTURE SHALL ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 36
3715.86 OF THE REVISED CODE AND ANY RULES ADOPTED UNDER THOSE 38
SECTIONS IN ACCORDANCE WITH CHAPTER 3717. OF THE REVISED CODE.
Sec. 3715.82. THE DIRECTOR OF AGRICULTURE MAY ADOPT RULES, 41
IN ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE, TO 42
ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.86 OF THE REVISED 43
CODE. IF RULES ARE ADOPTED, THE RULES SHALL BE NO MORE 44
RESTRICTIVE THAN THE REGULATIONS PROMULGATED UNDER THE FEDERAL 45
"FOOD, DRUG, AND COSMETIC ACT," 52 STAT. 1040 (1938), 21 U.S.C.A. 47
301, ET SEQ., AS AMENDED. 48
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Sec. 3715.83. IN ADDITION TO THE CONDITIONS SPECIFIED IN 50
SECTION 3715.59 OF THE REVISED CODE, A DIETARY SUPPLEMENT IS 51
ADULTERATED IF IT PRESENTS A SIGNIFICANT OR UNREASONABLE RISK OF 52
ILLNESS OR INJURY UNDER THE CONDITIONS OF USE RECOMMENDED OR 53
SUGGESTED IN ITS LABELING OR, IF THERE ARE NO RECOMMENDED OR 54
SUGGESTED CONDITIONS OF USE, UNDER THE ORDINARY CONDITIONS OF 55
USE. 56
IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 58
BELIEVE THAT A DIETARY SUPPLEMENT IS ADULTERATED UNDER THIS 59
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 60
CHAPTER APPLICABLE TO ADULTERATED FOOD. IN ANY ACTION TAKEN 61
UNDER THIS SECTION, THE BURDEN OF PROOF SHALL BE ON THE DIRECTOR. 62
Sec. 3715.84. (A) A DIETARY SUPPLEMENT IS NOT MISBRANDED 65
UNDER SECTION 3715.60 OF THE REVISED CODE SOLELY BECAUSE THE 66
LABEL OR LABELING CONTAINS A STATEMENT THAT CHARACTERIZES THE 67
RELATIONSHIP OF A NUTRIENT OR DIETARY INGREDIENT TO A DISEASE OR 68
HEALTH-RELATED CONDITION IF ALL OF THE FOLLOWING CONDITIONS ARE 69
MET:
(1) THE STATEMENT DOES ONE OF THE FOLLOWING: 71
(a) CLAIMS A BENEFIT RELATED TO A CLASSICAL NUTRIENT 74
DEFICIENCY DISEASE AND DISCLOSES THE PREVALENCE OF THE DISEASE IN 75
THE UNITED STATES;
(b) DESCRIBES THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 78
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 79
(c) CHARACTERIZES A DOCUMENTED MECHANISM BY WHICH A 82
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 83
FUNCTION OF THE HUMAN BODY;
(d) DESCRIBES GENERAL WELL-BEING FROM CONSUMPTION OF A 86
NUTRIENT OR DIETARY INGREDIENT.
(2) THE MANUFACTURER OF THE DIETARY SUPPLEMENT HAS 88
SUBSTANTIATION THAT THE STATEMENT IS NOT FALSE OR MISLEADING. 90
(3) THE LABEL CONTAINS, PROMINENTLY DISPLAYED AND IN 92
BOLDFACE TYPE, ONE OF THE FOLLOWING STATEMENTS: 93
(a) IN THE CASE OF A PRODUCT MANUFACTURED OR SOLD IN OHIO 96
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AND IN OTHER STATES, "THIS STATEMENT HAS NOT BEEN EVALUATED BY 97
THE UNITED STATES FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS 99
NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 100
(b) IN THE CASE OF A PRODUCT MANUFACTURED AND SOLD ONLY 102
WITHIN THE STATE OF OHIO, "THIS STATEMENT HAS NOT BEEN EVALUATED 103
BY THE OHIO DEPARTMENT OF AGRICULTURE. THIS PRODUCT IS NOT 104
INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 105
(4) THE MANUFACTURER OF THE DIETARY SUPPLEMENT COMPLIES 107
WITH THE REQUIREMENTS OF THE FEDERAL "FOOD, DRUG, AND COSMETIC 109
ACT," 108 STAT. 4327 (1994), 21 U.S.C.A. 343(r)(6), AS AMENDED. 112
(B) THE STATEMENT DESCRIBED IN DIVISION (A)(1) OF THIS 116
SECTION SHALL NOT CLAIM THAT THE SUPPLEMENT IS TO BE USED TO
DIAGNOSE, MITIGATE, TREAT, CURE, OR PREVENT A SPECIFIC DISEASE OR 118
CLASS OF DISEASES.
(C) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 121
BELIEVE THAT A DIETARY SUPPLEMENT IS MISBRANDED UNDER THIS 122
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 123
CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION TAKEN UNDER 124
THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH MISBRANDING IS ON 125
THE DIRECTOR.
(D) A DIETARY SUPPLEMENT IS NOT A DRUG WITHIN THE MEANING 128
OF SECTION 3715.01 OR 4729.01 OF THE REVISED CODE SOLELY BECAUSE 129
THE LABEL OR LABELING CONTAINS A STATEMENT AUTHORIZED BY THIS 130
SECTION OR BECAUSE A WARNING APPEARS ON THE SUPPLEMENT'S LABEL. 131
Sec. 3715.85. (A) AS USED IN THIS SECTION, "PUBLICATION" 134
INCLUDES A BOOK CHAPTER, ARTICLE, OR OFFICIAL ABSTRACT OF A 135
PEER-REVIEWED SCIENTIFIC ARTICLE PREPARED BY THE ARTICLE'S AUTHOR 136
OR THE EDITORS OF THE PUBLICATION IN WHICH THE ARTICLE IS 137
PUBLISHED.
(B) A PUBLICATION USED IN CONNECTION WITH A SALE TO 140
CONSUMERS OF A DIETARY SUPPLEMENT IS NOT CONSIDERED PART OF THE 141
LABEL OF THE DIETARY SUPPLEMENT IF THE PUBLICATION MEETS ALL OF 142
THE FOLLOWING CRITERIA:
(1) THE PUBLICATION IS REPRINTED IN ITS ENTIRETY. 144
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(2) THE PUBLICATION IS NOT FALSE OR MISLEADING. 146
(3) THE PUBLICATION DOES NOT PROMOTE A PARTICULAR 148
MANUFACTURER OR BRAND OF DIETARY SUPPLEMENT. 149
(4) THE PUBLICATION IS DISPLAYED OR PRESENTED, ALONE OR 151
WITH OTHER PUBLICATIONS ON THE SAME SUBJECT MATTER, SO AS TO 152
PRESENT A BALANCED VIEW OF THE AVAILABLE SCIENTIFIC INFORMATION 153
ON A DIETARY SUPPLEMENT. 154
(5) IF THE PUBLICATION IS DISPLAYED IN A LOCATION WHERE 156
DIETARY SUPPLEMENTS ARE OFFERED FOR SALE, THE PUBLICATION IS 157
PHYSICALLY SEPARATE FROM THE DIETARY SUPPLEMENTS. 158
(6) THE PUBLICATION DOES NOT HAVE ANY OTHER INFORMATION 160
AFFIXED TO IT.
(C) DIVISION (B) OF THIS SECTION DOES NOT APPLY TO OR 164
RESTRICT THE ACTIONS OF A PERSON WHO OFFERS DIETARY SUPPLEMENTS 165
FOR SALE AT RETAIL OR WHOLESALE IN THE SALE OF BOOKS OR 166
PUBLICATIONS AS PART OF THE PERSON'S BUSINESS. 167
(D) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 170
BELIEVE THAT A PUBLICATION UNDER DIVISION (B) OF THIS SECTION IS 171
A LABEL AND THAT LABEL IS FALSE OR MISLEADING UNDER DIVISION (B) 172
OF THIS SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS 173
OF THIS CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION 174
TAKEN UNDER THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH 175
MISBRANDING SHALL BE ON THE DIRECTOR. 176
Sec. 3715.86. A DIETARY SUPPLEMENT IS NOT CONSIDERED A 178
"FOOD ADDITIVE" WITHIN THE MEANING GIVEN IN THE FEDERAL "FOOD, 180
DRUG, AND COSMETIC ACT," 21 U.S.C.A. 321(s), AS AMENDED. 182
Sec. 4759.10. Sections 4759.01 to 4759.09 of the Revised 191
Code do not apply to any of the following: 192
(A) A person licensed under Chapters 4701. to 4755. of the 194
Revised Code who is acting within the scope of his THE PERSON'S 195
profession, provided that he THE PERSON complies with division 196
(B) of section 4759.02 of the Revised Code; 197
(B) A person who is a graduate of an associate degree 199
program approved by the American dietetic association or the Ohio 200
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board of dietetics who is working as a dietetic technician under 201
the supervision of a dietitian licensed under section 4759.06 of 202
the Revised Code or registered by the commission on dietetic 203
registration, except that the person is subject to division (B) 204
of section 4759.02 of the Revised Code if he THE PERSON uses a 205
title other than "dietetic technician"; 206
(C) A person who practices dietetics related to employment 208
in the armed forces, veteran's administration, or the public 209
health service of the United States; 210
(D) Persons employed by a nonprofit agency approved by the 212
board or by a federal, state, municipal or county government, or 213
by any other political subdivision, elementary or secondary 214
school, or an institution of higher education approved by the 215
board or by a regional agency recognized by the council on 216
postsecondary accreditation, who performs only nutritional 217
education activities and such other nutritional activities as the 218
board of dietetics, by rule, permits, provided the person does 219
not violate division (B) of section 4759.02 of the Revised Code; 220
(E) A person who has completed a program meeting the 222
academic standards set by the American dietetic association for 223
dietitians, received a baccalaureate or higher degree from a 224
school, college, or university approved by a regional 225
accreditation agency recognized by the council on postsecondary 226
accreditation, works under the supervision of a licensed 227
dietitian or registered dietitian, and does not violate division 228
(B) of section 4759.02 of the Revised Code; 229
(F) A person when acting, under the direction and 231
supervision of a person licensed under Chapters 4701. to 4755. of 232
the Revised Code, in the execution of a plan of treatment 233
authorized by the licensed person, provided the person complies 234
with division (B) of section 4759.02 of the Revised Code; 235
(G) The free dissemination of literature in the state; 237
(H) Provided that the persons involved in the sale, 239
promotion, or explanation of the sale of food, food materials, or 240
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dietary supplements do not violate division (B) of section 241
4759.02 of the Revised Code, the sale of food, food materials, or 242
dietary supplements and the marketing and distribution of food, 243
food materials, or dietary supplements and the promotion or 244
explanation of the use of food, food materials, or dietary 245
supplements provided that the promotion or explanation does not 246
violate Chapter 1345. of the Revised Code; 247
(I) A PERSON WHO OFFERS DIETARY SUPPLEMENTS FOR SALE AND 250
WHO MAKES THE FOLLOWING STATEMENTS ABOUT THE PRODUCT IF THE 251
STATEMENTS ARE CONSISTENT WITH THE DIETARY SUPPLEMENT'S LABEL OR 252
LABELING:
(1) CLAIM A BENEFIT RELATED TO A CLASSICAL NUTRIENT 254
DEFICIENCY DISEASE AND DISCLOSE THE PREVALENCE OF THE DISEASE IN 255
THE UNITED STATES;
(2) DESCRIBE THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 257
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 259
(3) CHARACTERIZE THE DOCUMENTED MECHANISM BY WHICH A 261
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 262
FUNCTION OF THE HUMAN BODY; 263
(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A 265
NUTRIENT OR DIETARY INGREDIENT. 266
(J) Provided that the persons involved in presenting a 268
general program of instruction for weight control do not violate 269
division (B) of section 4759.02 of the Revised Code, a general 270
program of instruction for weight control approved in writing by 271
a licensed dietitian, a physician licensed under Chapter 4731. of 272
the Revised Code to practice medicine or surgery or osteopathic 273
medicine or surgery, a person licensed in another state that the 274
board considers to have substantially equivalent licensure 275
requirements as this state, or a registered dietitian; 276
(J)(K) The continued practice of dietetics at a hospital 278
by a person employed at that same hospital to practice dietetics 279
for the twenty years immediately prior to July 1, 1987, so long 280
as the person works under the supervision of a dietitian licensed 281
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under section 4759.06 of the Revised Code and does not violate 282
division (B) of section 4759.02 of the Revised Code. This 283
division does not apply to any person who has held a license 284
issued under this chapter to practice dietetics. As used in this 285
division, "hospital" has the same meaning as in section 3727.01 286
of the Revised Code. 287
Section 2. That existing section 4759.10 of the Revised 289
Code is hereby repealed. 290
Section 3. Sections 3715.80 to 3715.86 of the Revised 292
Code, as enacted by this act, are intended to codify in Ohio law 293
portions of the federal "Dietary Supplement Health and Education 294
Act of 1994," 108 Stat. 4325 (1994), 21 U.S.C.A. 301, et seq., as 295
amended. 296