As Reported by the Senate Agriculture 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-METTLER-BENDER-O'BRIEN-HARRIS-ROBERTS-
JERSE-STEVENS-HOOPS-SENATOR MUMPER 11
_________________________________________________________________ 13
A B I L L
To amend section 4759.10 and to enact sections 15
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 16
3715.85, and 3715.86 of the Revised Code 17
regarding the regulation of dietary supplements. 18
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 20
Section 1. That section 4759.10 be amended and sections 22
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 3715.85, and 3715.86 24
of the Revised Code be enacted to read as follows: 25
Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.86 OF 27
THE REVISED CODE, "DIETARY SUPPLEMENT" HAS THE MEANING GIVEN IN 29
THE FEDERAL "FOOD, DRUG, AND COSMETIC ACT," 108 STAT. 4327 31
(1994), 21 U.S.C.A. 321(ff), AS AMENDED. 33
Sec. 3715.81. FOR PURPOSES OF THIS CHAPTER, A DIETARY 35
SUPPLEMENT SHALL BE TREATED AS A FOOD. THE DIRECTOR OF 36
AGRICULTURE SHALL ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 38
3715.86 OF THE REVISED CODE AND ANY RULES ADOPTED UNDER THOSE 40
SECTIONS IN ACCORDANCE WITH CHAPTER 3717. OF THE REVISED CODE.
Sec. 3715.82. THE DIRECTOR OF AGRICULTURE MAY ADOPT RULES, 43
IN ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE, TO 44
ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.86 OF THE REVISED 45
CODE. IF RULES ARE ADOPTED, THE RULES SHALL BE NO MORE 46
RESTRICTIVE THAN THE REGULATIONS PROMULGATED UNDER THE FEDERAL 47
"FOOD, DRUG, AND COSMETIC ACT," 52 STAT. 1040 (1938), 21 U.S.C.A. 49
2
301, ET SEQ., AS AMENDED. 50
Sec. 3715.83. IN ADDITION TO THE CONDITIONS SPECIFIED IN 52
SECTION 3715.59 OF THE REVISED CODE, A DIETARY SUPPLEMENT IS 53
ADULTERATED IF IT PRESENTS A SIGNIFICANT OR UNREASONABLE RISK OF 54
ILLNESS OR INJURY UNDER THE CONDITIONS OF USE RECOMMENDED OR 55
SUGGESTED IN ITS LABELING OR, IF THERE ARE NO RECOMMENDED OR 56
SUGGESTED CONDITIONS OF USE, UNDER THE ORDINARY CONDITIONS OF 57
USE. 58
IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 60
BELIEVE THAT A DIETARY SUPPLEMENT IS ADULTERATED UNDER THIS 61
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 62
CHAPTER APPLICABLE TO ADULTERATED FOOD. IN ANY ACTION TAKEN 63
UNDER THIS SECTION, THE BURDEN OF PROOF SHALL BE ON THE DIRECTOR. 64
Sec. 3715.84. (A) A DIETARY SUPPLEMENT IS NOT MISBRANDED 67
UNDER SECTION 3715.60 OF THE REVISED CODE SOLELY BECAUSE THE 68
LABEL OR LABELING CONTAINS A STATEMENT THAT CHARACTERIZES THE 69
RELATIONSHIP OF A NUTRIENT OR DIETARY INGREDIENT TO A DISEASE OR 70
HEALTH-RELATED CONDITION IF ALL OF THE FOLLOWING CONDITIONS ARE 71
MET:
(1) THE STATEMENT DOES ONE OF THE FOLLOWING: 73
(a) CLAIMS A BENEFIT RELATED TO A CLASSICAL NUTRIENT 76
DEFICIENCY DISEASE AND DISCLOSES THE PREVALENCE OF THE DISEASE IN 77
THE UNITED STATES;
(b) DESCRIBES THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 80
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 81
(c) CHARACTERIZES A DOCUMENTED MECHANISM BY WHICH A 84
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 85
FUNCTION OF THE HUMAN BODY;
(d) DESCRIBES GENERAL WELL-BEING FROM CONSUMPTION OF A 88
NUTRIENT OR DIETARY INGREDIENT.
(2) THE MANUFACTURER OF THE DIETARY SUPPLEMENT HAS 90
SUBSTANTIATION THAT THE STATEMENT IS NOT FALSE OR MISLEADING. 92
(3) THE LABEL CONTAINS, PROMINENTLY DISPLAYED AND IN 94
BOLDFACE TYPE, ONE OF THE FOLLOWING STATEMENTS: 95
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(a) IN THE CASE OF A PRODUCT MANUFACTURED OR SOLD IN OHIO 98
AND IN OTHER STATES, "THIS STATEMENT HAS NOT BEEN EVALUATED BY 99
THE UNITED STATES FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS 101
NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 102
(b) IN THE CASE OF A PRODUCT MANUFACTURED AND SOLD ONLY 104
WITHIN THE STATE OF OHIO, "THIS STATEMENT HAS NOT BEEN EVALUATED 105
BY THE OHIO DEPARTMENT OF AGRICULTURE. THIS PRODUCT IS NOT 106
INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 107
(4) THE MANUFACTURER OF THE DIETARY SUPPLEMENT COMPLIES 109
WITH THE REQUIREMENTS OF THE FEDERAL "FOOD, DRUG, AND COSMETIC 111
ACT," 108 STAT. 4327 (1994), 21 U.S.C.A. 343(r)(6), AS AMENDED. 114
(B) THE STATEMENT DESCRIBED IN DIVISION (A)(1) OF THIS 118
SECTION SHALL NOT CLAIM THAT THE SUPPLEMENT IS TO BE USED TO
DIAGNOSE, MITIGATE, TREAT, CURE, OR PREVENT A SPECIFIC DISEASE OR 120
CLASS OF DISEASES.
(C) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 123
BELIEVE THAT A DIETARY SUPPLEMENT IS MISBRANDED UNDER THIS 124
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 125
CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION TAKEN UNDER 126
THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH MISBRANDING IS ON 127
THE DIRECTOR.
(D) A DIETARY SUPPLEMENT IS NOT A DRUG WITHIN THE MEANING 130
OF SECTION 3715.01 OR 4729.01 OF THE REVISED CODE SOLELY BECAUSE 131
THE LABEL OR LABELING CONTAINS A STATEMENT AUTHORIZED BY THIS 132
SECTION OR BECAUSE A WARNING APPEARS ON THE SUPPLEMENT'S LABEL. 133
Sec. 3715.85. (A) AS USED IN THIS SECTION, "PUBLICATION" 136
INCLUDES A BOOK CHAPTER, ARTICLE, OR OFFICIAL ABSTRACT OF A 137
PEER-REVIEWED SCIENTIFIC ARTICLE PREPARED BY THE ARTICLE'S AUTHOR 138
OR THE EDITORS OF THE PUBLICATION IN WHICH THE ARTICLE IS 139
PUBLISHED.
(B) A PUBLICATION USED IN CONNECTION WITH A SALE TO 142
CONSUMERS OF A DIETARY SUPPLEMENT IS NOT CONSIDERED PART OF THE 143
LABEL OF THE DIETARY SUPPLEMENT IF THE PUBLICATION MEETS ALL OF 144
THE FOLLOWING CRITERIA:
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(1) THE PUBLICATION IS REPRINTED IN ITS ENTIRETY. 146
(2) THE PUBLICATION IS NOT FALSE OR MISLEADING. 148
(3) THE PUBLICATION DOES NOT PROMOTE A PARTICULAR 150
MANUFACTURER OR BRAND OF DIETARY SUPPLEMENT. 151
(4) THE PUBLICATION IS DISPLAYED OR PRESENTED, ALONE OR 153
WITH OTHER PUBLICATIONS ON THE SAME SUBJECT MATTER, SO AS TO 154
PRESENT A BALANCED VIEW OF THE AVAILABLE SCIENTIFIC INFORMATION 155
ON A DIETARY SUPPLEMENT. 156
(5) IF THE PUBLICATION IS DISPLAYED IN A LOCATION WHERE 158
DIETARY SUPPLEMENTS ARE OFFERED FOR SALE, THE PUBLICATION IS 159
PHYSICALLY SEPARATE FROM THE DIETARY SUPPLEMENTS. 160
(6) THE PUBLICATION DOES NOT HAVE ANY OTHER INFORMATION 162
AFFIXED TO IT.
(C) DIVISION (B) OF THIS SECTION DOES NOT APPLY TO OR 166
RESTRICT THE ACTIONS OF A PERSON WHO OFFERS DIETARY SUPPLEMENTS 167
FOR SALE AT RETAIL OR WHOLESALE IN THE SALE OF BOOKS OR 168
PUBLICATIONS AS PART OF THE PERSON'S BUSINESS. 169
(D) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 172
BELIEVE THAT A PUBLICATION UNDER DIVISION (B) OF THIS SECTION IS 173
A LABEL AND THAT LABEL IS FALSE OR MISLEADING UNDER DIVISION (B) 174
OF THIS SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS 175
OF THIS CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION 176
TAKEN UNDER THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH 177
MISBRANDING SHALL BE ON THE DIRECTOR. 178
Sec. 3715.86. A DIETARY SUPPLEMENT IS NOT CONSIDERED A 180
"FOOD ADDITIVE" WITHIN THE MEANING GIVEN IN THE FEDERAL "FOOD, 182
DRUG, AND COSMETIC ACT," 21 U.S.C.A. 321(s), AS AMENDED. 184
Sec. 4759.10. Sections 4759.01 to 4759.09 of the Revised 193
Code do not apply to any of the following: 194
(A) A person licensed under Chapters 4701. to 4755. of the 196
Revised Code who is acting within the scope of his THE PERSON'S 197
profession, provided that he THE PERSON complies with division 198
(B) of section 4759.02 of the Revised Code; 199
(B) A person who is a graduate of an associate degree 201
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program approved by the American dietetic association or the Ohio 202
board of dietetics who is working as a dietetic technician under 203
the supervision of a dietitian licensed under section 4759.06 of 204
the Revised Code or registered by the commission on dietetic 205
registration, except that the person is subject to division (B) 206
of section 4759.02 of the Revised Code if he THE PERSON uses a 207
title other than "dietetic technician"; 208
(C) A person who practices dietetics related to employment 210
in the armed forces, veteran's administration, or the public 211
health service of the United States; 212
(D) Persons employed by a nonprofit agency approved by the 214
board or by a federal, state, municipal or county government, or 215
by any other political subdivision, elementary or secondary 216
school, or an institution of higher education approved by the 217
board or by a regional agency recognized by the council on 218
postsecondary accreditation, who performs only nutritional 219
education activities and such other nutritional activities as the 220
board of dietetics, by rule, permits, provided the person does 221
not violate division (B) of section 4759.02 of the Revised Code; 222
(E) A person who has completed a program meeting the 224
academic standards set by the American dietetic association for 225
dietitians, received a baccalaureate or higher degree from a 226
school, college, or university approved by a regional 227
accreditation agency recognized by the council on postsecondary 228
accreditation, works under the supervision of a licensed 229
dietitian or registered dietitian, and does not violate division 230
(B) of section 4759.02 of the Revised Code; 231
(F) A person when acting, under the direction and 233
supervision of a person licensed under Chapters 4701. to 4755. of 234
the Revised Code, in the execution of a plan of treatment 235
authorized by the licensed person, provided the person complies 236
with division (B) of section 4759.02 of the Revised Code; 237
(G) The free dissemination of literature in the state; 239
(H) Provided that the persons involved in the sale, 241
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promotion, or explanation of the sale of food, food materials, or 242
dietary supplements do not violate division (B) of section 243
4759.02 of the Revised Code, the sale of food, food materials, or 244
dietary supplements and the marketing and distribution of food, 245
food materials, or dietary supplements and the promotion or 246
explanation of the use of food, food materials, or dietary 247
supplements provided that the promotion or explanation does not 248
violate Chapter 1345. of the Revised Code; 249
(I) A PERSON WHO OFFERS DIETARY SUPPLEMENTS FOR SALE AND 252
WHO MAKES THE FOLLOWING STATEMENTS ABOUT THE PRODUCT IF THE 253
STATEMENTS ARE CONSISTENT WITH THE DIETARY SUPPLEMENT'S LABEL OR 254
LABELING:
(1) CLAIM A BENEFIT RELATED TO A CLASSICAL NUTRIENT 256
DEFICIENCY DISEASE AND DISCLOSE THE PREVALENCE OF THE DISEASE IN 257
THE UNITED STATES;
(2) DESCRIBE THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 259
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 261
(3) CHARACTERIZE THE DOCUMENTED MECHANISM BY WHICH A 263
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 264
FUNCTION OF THE HUMAN BODY; 265
(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A 267
NUTRIENT OR DIETARY INGREDIENT. 268
(J) Provided that the persons involved in presenting a 270
general program of instruction for weight control do not violate 271
division (B) of section 4759.02 of the Revised Code, a general 272
program of instruction for weight control approved in writing by 273
a licensed dietitian, a physician licensed under Chapter 4731. of 274
the Revised Code to practice medicine or surgery or osteopathic 275
medicine or surgery, a person licensed in another state that the 276
board considers to have substantially equivalent licensure 277
requirements as this state, or a registered dietitian; 278
(J)(K) The continued practice of dietetics at a hospital 280
by a person employed at that same hospital to practice dietetics 281
for the twenty years immediately prior to July 1, 1987, so long 282
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as the person works under the supervision of a dietitian licensed 283
under section 4759.06 of the Revised Code and does not violate 284
division (B) of section 4759.02 of the Revised Code. This 285
division does not apply to any person who has held a license 286
issued under this chapter to practice dietetics. As used in this 287
division, "hospital" has the same meaning as in section 3727.01 288
of the Revised Code. 289
Section 2. That existing section 4759.10 of the Revised 291
Code is hereby repealed. 292
Section 3. Sections 3715.80 to 3715.86 of the Revised 294
Code, as enacted by this act, are intended to codify in Ohio law 295
portions of the federal "Dietary Supplement Health and Education 296
Act of 1994," 108 Stat. 4325 (1994), 21 U.S.C.A. 301, et seq., as 297
amended. 298