As Passed by the House 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 11
_________________________________________________________________ 12
A B I L L
To amend section 4759.10 and to enact sections 14
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 15
3715.85, and 3715.86 of the Revised Code 16
regarding the regulation of dietary supplements. 17
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO: 19
Section 1. That section 4759.10 be amended and sections 21
3715.80, 3715.81, 3715.82, 3715.83, 3715.84, 3715.85, and 3715.86 23
of the Revised Code be enacted to read as follows: 24
Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.86 OF 26
THE REVISED CODE, "DIETARY SUPPLEMENT" HAS THE MEANING GIVEN IN 28
THE FEDERAL "FOOD, DRUG, AND COSMETIC ACT," 108 STAT. 4327 30
(1994), 21 U.S.C.A. 321(ff), AS AMENDED. 32
Sec. 3715.81. FOR PURPOSES OF THIS CHAPTER, A DIETARY 34
SUPPLEMENT SHALL BE TREATED AS A FOOD. THE DIRECTOR OF 35
AGRICULTURE SHALL ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 37
3715.86 OF THE REVISED CODE AND ANY RULES ADOPTED UNDER THOSE 39
SECTIONS IN ACCORDANCE WITH CHAPTER 3717. OF THE REVISED CODE.
Sec. 3715.82. THE DIRECTOR OF AGRICULTURE MAY ADOPT RULES, 42
IN ACCORDANCE WITH CHAPTER 119. OF THE REVISED CODE, TO 43
ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.86 OF THE REVISED 44
CODE. IF RULES ARE ADOPTED, THE RULES SHALL BE NO MORE 45
RESTRICTIVE THAN THE REGULATIONS PROMULGATED UNDER THE FEDERAL 46
"FOOD, DRUG, AND COSMETIC ACT," 52 STAT. 1040 (1938), 21 U.S.C.A. 48
2
301, ET SEQ., AS AMENDED. 49
Sec. 3715.83. IN ADDITION TO THE CONDITIONS SPECIFIED IN 51
SECTION 3715.59 OF THE REVISED CODE, A DIETARY SUPPLEMENT IS 52
ADULTERATED IF IT PRESENTS A SIGNIFICANT OR UNREASONABLE RISK OF 53
ILLNESS OR INJURY UNDER THE CONDITIONS OF USE RECOMMENDED OR 54
SUGGESTED IN ITS LABELING OR, IF THERE ARE NO RECOMMENDED OR 55
SUGGESTED CONDITIONS OF USE, UNDER THE ORDINARY CONDITIONS OF 56
USE. 57
IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 59
BELIEVE THAT A DIETARY SUPPLEMENT IS ADULTERATED UNDER THIS 60
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 61
CHAPTER APPLICABLE TO ADULTERATED FOOD. IN ANY ACTION TAKEN 62
UNDER THIS SECTION, THE BURDEN OF PROOF SHALL BE ON THE DIRECTOR. 63
Sec. 3715.84. (A) A DIETARY SUPPLEMENT IS NOT MISBRANDED 66
UNDER SECTION 3715.60 OF THE REVISED CODE SOLELY BECAUSE THE 67
LABEL OR LABELING CONTAINS A STATEMENT THAT CHARACTERIZES THE 68
RELATIONSHIP OF A NUTRIENT OR DIETARY INGREDIENT TO A DISEASE OR 69
HEALTH-RELATED CONDITION IF ALL OF THE FOLLOWING CONDITIONS ARE 70
MET:
(1) THE STATEMENT DOES ONE OF THE FOLLOWING: 72
(a) CLAIMS A BENEFIT RELATED TO A CLASSICAL NUTRIENT 75
DEFICIENCY DISEASE AND DISCLOSES THE PREVALENCE OF THE DISEASE IN 76
THE UNITED STATES;
(b) DESCRIBES THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 79
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 80
(c) CHARACTERIZES A DOCUMENTED MECHANISM BY WHICH A 83
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 84
FUNCTION OF THE HUMAN BODY;
(d) DESCRIBES GENERAL WELL-BEING FROM CONSUMPTION OF A 87
NUTRIENT OR DIETARY INGREDIENT.
(2) THE MANUFACTURER OF THE DIETARY SUPPLEMENT HAS 89
SUBSTANTIATION THAT THE STATEMENT IS NOT FALSE OR MISLEADING. 91
(3) THE LABEL CONTAINS, PROMINENTLY DISPLAYED AND IN 93
BOLDFACE TYPE, ONE OF THE FOLLOWING STATEMENTS: 94
3
(a) IN THE CASE OF A PRODUCT MANUFACTURED OR SOLD IN OHIO 97
AND IN OTHER STATES, "THIS STATEMENT HAS NOT BEEN EVALUATED BY 98
THE UNITED STATES FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS 100
NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 101
(b) IN THE CASE OF A PRODUCT MANUFACTURED AND SOLD ONLY 103
WITHIN THE STATE OF OHIO, "THIS STATEMENT HAS NOT BEEN EVALUATED 104
BY THE OHIO DEPARTMENT OF AGRICULTURE. THIS PRODUCT IS NOT 105
INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE." 106
(4) THE MANUFACTURER OF THE DIETARY SUPPLEMENT COMPLIES 108
WITH THE REQUIREMENTS OF THE FEDERAL "FOOD, DRUG, AND COSMETIC 110
ACT," 108 STAT. 4327 (1994), 21 U.S.C.A. 343(r)(6), AS AMENDED. 113
(B) THE STATEMENT DESCRIBED IN DIVISION (A)(1) OF THIS 117
SECTION SHALL NOT CLAIM THAT THE SUPPLEMENT IS TO BE USED TO
DIAGNOSE, MITIGATE, TREAT, CURE, OR PREVENT A SPECIFIC DISEASE OR 119
CLASS OF DISEASES.
(C) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 122
BELIEVE THAT A DIETARY SUPPLEMENT IS MISBRANDED UNDER THIS 123
SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS 124
CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION TAKEN UNDER 125
THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH MISBRANDING IS ON 126
THE DIRECTOR.
(D) A DIETARY SUPPLEMENT IS NOT A DRUG WITHIN THE MEANING 129
OF SECTION 3715.01 OR 4729.01 OF THE REVISED CODE SOLELY BECAUSE 130
THE LABEL OR LABELING CONTAINS A STATEMENT AUTHORIZED BY THIS 131
SECTION OR BECAUSE A WARNING APPEARS ON THE SUPPLEMENT'S LABEL. 132
Sec. 3715.85. (A) AS USED IN THIS SECTION, "PUBLICATION" 135
INCLUDES A BOOK CHAPTER, ARTICLE, OR OFFICIAL ABSTRACT OF A 136
PEER-REVIEWED SCIENTIFIC ARTICLE PREPARED BY THE ARTICLE'S AUTHOR 137
OR THE EDITORS OF THE PUBLICATION IN WHICH THE ARTICLE IS 138
PUBLISHED.
(B) A PUBLICATION USED IN CONNECTION WITH A SALE TO 141
CONSUMERS OF A DIETARY SUPPLEMENT IS NOT CONSIDERED PART OF THE 142
LABEL OF THE DIETARY SUPPLEMENT IF THE PUBLICATION MEETS ALL OF 143
THE FOLLOWING CRITERIA:
4
(1) THE PUBLICATION IS REPRINTED IN ITS ENTIRETY. 145
(2) THE PUBLICATION IS NOT FALSE OR MISLEADING. 147
(3) THE PUBLICATION DOES NOT PROMOTE A PARTICULAR 149
MANUFACTURER OR BRAND OF DIETARY SUPPLEMENT. 150
(4) THE PUBLICATION IS DISPLAYED OR PRESENTED, ALONE OR 152
WITH OTHER PUBLICATIONS ON THE SAME SUBJECT MATTER, SO AS TO 153
PRESENT A BALANCED VIEW OF THE AVAILABLE SCIENTIFIC INFORMATION 154
ON A DIETARY SUPPLEMENT. 155
(5) IF THE PUBLICATION IS DISPLAYED IN A LOCATION WHERE 157
DIETARY SUPPLEMENTS ARE OFFERED FOR SALE, THE PUBLICATION IS 158
PHYSICALLY SEPARATE FROM THE DIETARY SUPPLEMENTS. 159
(6) THE PUBLICATION DOES NOT HAVE ANY OTHER INFORMATION 161
AFFIXED TO IT.
(C) DIVISION (B) OF THIS SECTION DOES NOT APPLY TO OR 165
RESTRICT THE ACTIONS OF A PERSON WHO OFFERS DIETARY SUPPLEMENTS 166
FOR SALE AT RETAIL OR WHOLESALE IN THE SALE OF BOOKS OR 167
PUBLICATIONS AS PART OF THE PERSON'S BUSINESS. 168
(D) IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO 171
BELIEVE THAT A PUBLICATION UNDER DIVISION (B) OF THIS SECTION IS 172
A LABEL AND THAT LABEL IS FALSE OR MISLEADING UNDER DIVISION (B) 173
OF THIS SECTION, THE DIRECTOR SHALL PROCEED UNDER THE PROVISIONS 174
OF THIS CHAPTER APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION 175
TAKEN UNDER THIS SECTION, THE BURDEN OF PROOF TO ESTABLISH 176
MISBRANDING SHALL BE ON THE DIRECTOR. 177
Sec. 3715.86. A DIETARY SUPPLEMENT IS NOT CONSIDERED A 179
"FOOD ADDITIVE" WITHIN THE MEANING GIVEN IN THE FEDERAL "FOOD, 181
DRUG, AND COSMETIC ACT," 21 U.S.C.A. 321(s), AS AMENDED. 183
Sec. 4759.10. Sections 4759.01 to 4759.09 of the Revised 192
Code do not apply to any of the following: 193
(A) A person licensed under Chapters 4701. to 4755. of the 195
Revised Code who is acting within the scope of his THE PERSON'S 196
profession, provided that he THE PERSON complies with division 197
(B) of section 4759.02 of the Revised Code; 198
(B) A person who is a graduate of an associate degree 200
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program approved by the American dietetic association or the Ohio 201
board of dietetics who is working as a dietetic technician under 202
the supervision of a dietitian licensed under section 4759.06 of 203
the Revised Code or registered by the commission on dietetic 204
registration, except that the person is subject to division (B) 205
of section 4759.02 of the Revised Code if he THE PERSON uses a 206
title other than "dietetic technician"; 207
(C) A person who practices dietetics related to employment 209
in the armed forces, veteran's administration, or the public 210
health service of the United States; 211
(D) Persons employed by a nonprofit agency approved by the 213
board or by a federal, state, municipal or county government, or 214
by any other political subdivision, elementary or secondary 215
school, or an institution of higher education approved by the 216
board or by a regional agency recognized by the council on 217
postsecondary accreditation, who performs only nutritional 218
education activities and such other nutritional activities as the 219
board of dietetics, by rule, permits, provided the person does 220
not violate division (B) of section 4759.02 of the Revised Code; 221
(E) A person who has completed a program meeting the 223
academic standards set by the American dietetic association for 224
dietitians, received a baccalaureate or higher degree from a 225
school, college, or university approved by a regional 226
accreditation agency recognized by the council on postsecondary 227
accreditation, works under the supervision of a licensed 228
dietitian or registered dietitian, and does not violate division 229
(B) of section 4759.02 of the Revised Code; 230
(F) A person when acting, under the direction and 232
supervision of a person licensed under Chapters 4701. to 4755. of 233
the Revised Code, in the execution of a plan of treatment 234
authorized by the licensed person, provided the person complies 235
with division (B) of section 4759.02 of the Revised Code; 236
(G) The free dissemination of literature in the state; 238
(H) Provided that the persons involved in the sale, 240
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promotion, or explanation of the sale of food, food materials, or 241
dietary supplements do not violate division (B) of section 242
4759.02 of the Revised Code, the sale of food, food materials, or 243
dietary supplements and the marketing and distribution of food, 244
food materials, or dietary supplements and the promotion or 245
explanation of the use of food, food materials, or dietary 246
supplements provided that the promotion or explanation does not 247
violate Chapter 1345. of the Revised Code; 248
(I) A PERSON WHO OFFERS DIETARY SUPPLEMENTS FOR SALE AND 251
WHO MAKES THE FOLLOWING STATEMENTS ABOUT THE PRODUCT IF THE 252
STATEMENTS ARE CONSISTENT WITH THE DIETARY SUPPLEMENT'S LABEL OR 253
LABELING:
(1) CLAIM A BENEFIT RELATED TO A CLASSICAL NUTRIENT 255
DEFICIENCY DISEASE AND DISCLOSE THE PREVALENCE OF THE DISEASE IN 256
THE UNITED STATES;
(2) DESCRIBE THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT 258
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN BODY; 260
(3) CHARACTERIZE THE DOCUMENTED MECHANISM BY WHICH A 262
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR 263
FUNCTION OF THE HUMAN BODY; 264
(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A 266
NUTRIENT OR DIETARY INGREDIENT. 267
(J) Provided that the persons involved in presenting a 269
general program of instruction for weight control do not violate 270
division (B) of section 4759.02 of the Revised Code, a general 271
program of instruction for weight control approved in writing by 272
a licensed dietitian, a physician licensed under Chapter 4731. of 273
the Revised Code to practice medicine or surgery or osteopathic 274
medicine or surgery, a person licensed in another state that the 275
board considers to have substantially equivalent licensure 276
requirements as this state, or a registered dietitian; 277
(J)(K) The continued practice of dietetics at a hospital 279
by a person employed at that same hospital to practice dietetics 280
for the twenty years immediately prior to July 1, 1987, so long 281
7
as the person works under the supervision of a dietitian licensed 282
under section 4759.06 of the Revised Code and does not violate 283
division (B) of section 4759.02 of the Revised Code. This 284
division does not apply to any person who has held a license 285
issued under this chapter to practice dietetics. As used in this 286
division, "hospital" has the same meaning as in section 3727.01 287
of the Revised Code. 288
Section 2. That existing section 4759.10 of the Revised 290
Code is hereby repealed. 291
Section 3. Sections 3715.80 to 3715.86 of the Revised 293
Code, as enacted by this act, are intended to codify in Ohio law 294
portions of the federal "Dietary Supplement Health and Education 295
Act of 1994," 108 Stat. 4325 (1994), 21 U.S.C.A. 301, et seq., as 296
amended. 297