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As Passed by the Senate
123rd General Assembly
Regular Session
1999-2000 | Sub. H. B. No. 381 |
REPRESENTATIVES PERZ-GARDNER-FORD-OLMAN-BATEMAN-BRITTON-
CORBIN-FLANNERY-HOLLISTER-OPFER-PADGETT-TAYLOR-WINKLER-
YOUNG-D. MILLER-METTLER-BENDER-O'BRIEN-HARRIS-ROBERTS-
JERSE-STEVENS-HOOPS-
SENATORS MUMPER-WHITE-LATTA-
WATTS-GARDNER-HAGAN
A BILL
To amend section 4759.10 and to enact sections 3715.80, 3715.81,
3715.82, 3715.83, 3715.84, 3715.85, and 3715.86
of the Revised Code regarding the
regulation of dietary supplements.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That section 4759.10 be amended and sections 3715.80,
3715.81, 3715.82, 3715.83, 3715.84, 3715.85, and
3715.86 of the Revised Code be
enacted to read as follows:
Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.86 of the Revised Code,
"DIETARY
SUPPLEMENT" HAS THE MEANING GIVEN IN THE FEDERAL
"FOOD, DRUG, AND COSMETIC ACT," 108
STAT. 4327 (1994), 21
U.S.C.A.
321(ff), AS AMENDED.
Sec. 3715.81. FOR PURPOSES OF THIS CHAPTER, A DIETARY
SUPPLEMENT SHALL BE TREATED AS A FOOD. THE DIRECTOR OF
AGRICULTURE SHALL ADMINISTER AND
ENFORCE SECTIONS 3715.80 TO
3715.86 of the Revised Code AND ANY RULES ADOPTED
UNDER THOSE SECTIONS IN ACCORDANCE WITH CHAPTER 3717. of the Revised Code.
Sec. 3715.82. THE DIRECTOR OF AGRICULTURE MAY ADOPT
RULES, IN ACCORDANCE WITH
CHAPTER 119. of the Revised Code, TO ADMINISTER AND ENFORCE
SECTIONS 3715.80 TO 3715.86 of the Revised Code. IF RULES ARE ADOPTED, THE RULES SHALL
BE NO MORE RESTRICTIVE THAN THE REGULATIONS PROMULGATED UNDER THE FEDERAL
"FOOD, DRUG, AND
COSMETIC ACT," 52 STAT. 1040 (1938), 21
U.S.C.A.
301, ET SEQ., AS AMENDED.
Sec. 3715.83. IN ADDITION TO THE CONDITIONS SPECIFIED IN SECTION 3715.59
of the Revised Code, A DIETARY SUPPLEMENT IS
ADULTERATED IF IT PRESENTS A SIGNIFICANT OR UNREASONABLE RISK OF
ILLNESS OR INJURY UNDER THE CONDITIONS OF USE RECOMMENDED OR
SUGGESTED IN ITS LABELING OR, IF THERE ARE NO RECOMMENDED OR
SUGGESTED CONDITIONS OF USE, UNDER THE ORDINARY CONDITIONS OF
USE.
IF THE DIRECTOR OF AGRICULTURE FINDS OR HAS CAUSE TO BELIEVE THAT A
DIETARY SUPPLEMENT IS ADULTERATED UNDER THIS SECTION, THE
DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS CHAPTER
APPLICABLE TO ADULTERATED FOOD. IN ANY ACTION TAKEN UNDER THIS
SECTION, THE BURDEN OF PROOF SHALL BE ON THE DIRECTOR.
Sec. 3715.84. (A) A
DIETARY SUPPLEMENT IS NOT MISBRANDED UNDER SECTION 3715.60 of the Revised Code SOLELY BECAUSE
THE LABEL OR LABELING CONTAINS
A STATEMENT THAT CHARACTERIZES THE RELATIONSHIP OF A NUTRIENT OR
DIETARY INGREDIENT TO A DISEASE OR HEALTH-RELATED CONDITION IF
ALL OF THE FOLLOWING CONDITIONS ARE MET:
(1) THE STATEMENT DOES ONE OF THE FOLLOWING:
(a) CLAIMS A BENEFIT RELATED TO A
CLASSICAL NUTRIENT DEFICIENCY DISEASE AND DISCLOSES THE
PREVALENCE OF THE DISEASE IN THE UNITED STATES;
(b) DESCRIBES THE ROLE OF A NUTRIENT
OR DIETARY INGREDIENT INTENDED TO AFFECT THE STRUCTURE OR
FUNCTION OF THE HUMAN BODY;
(c) CHARACTERIZES A DOCUMENTED
MECHANISM BY WHICH A NUTRIENT OR DIETARY INGREDIENT ACTS TO
MAINTAIN THE STRUCTURE OR FUNCTION OF THE HUMAN BODY;
(d) DESCRIBES GENERAL WELL-BEING FROM
CONSUMPTION OF A NUTRIENT OR DIETARY INGREDIENT.
(2) THE MANUFACTURER OF THE DIETARY SUPPLEMENT HAS
SUBSTANTIATION THAT THE STATEMENT IS NOT FALSE OR
MISLEADING.
(3) THE LABEL CONTAINS, PROMINENTLY DISPLAYED AND IN
BOLDFACE TYPE, ONE OF THE FOLLOWING STATEMENTS:
(a) IN THE CASE OF A PRODUCT MANUFACTURED OR SOLD IN
OHIO AND IN OTHER STATES, "THIS STATEMENT HAS NOT
BEEN EVALUATED BY THE UNITED
STATES FOOD AND DRUG
ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE,
TREAT, CURE, OR PREVENT ANY DISEASE."
(b) IN THE CASE OF A PRODUCT MANUFACTURED AND SOLD ONLY WITHIN
THE STATE OF OHIO, "THIS STATEMENT HAS NOT BEEN EVALUATED BY THE
OHIO DEPARTMENT OF AGRICULTURE. THIS PRODUCT IS NOT INTENDED TO
DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE."
(4) THE MANUFACTURER OF THE DIETARY SUPPLEMENT COMPLIES
WITH THE REQUIREMENTS OF THE FEDERAL
"FOOD, DRUG, AND COSMETIC ACT," 108
STAT. 4327 (1994), 21
U.S.C.A.
343(r)(6), AS AMENDED.
(B) THE STATEMENT
DESCRIBED IN DIVISION (A)(1) OF
THIS SECTION SHALL NOT CLAIM THAT THE SUPPLEMENT IS TO BE USED TO DIAGNOSE,
MITIGATE, TREAT, CURE,
OR PREVENT A SPECIFIC DISEASE OR CLASS OF DISEASES.
(C) IF THE DIRECTOR OF AGRICULTURE
FINDS OR HAS CAUSE TO BELIEVE THAT A DIETARY SUPPLEMENT IS
MISBRANDED UNDER THIS SECTION, THE DIRECTOR SHALL PROCEED UNDER
THE PROVISIONS OF THIS CHAPTER APPLICABLE TO MISBRANDED
FOOD. IN ANY ACTION TAKEN UNDER THIS SECTION, THE BURDEN OF PROOF TO
ESTABLISH MISBRANDING IS ON THE DIRECTOR.
(D) A DIETARY SUPPLEMENT IS NOT A DRUG
WITHIN THE MEANING OF SECTION 3715.01
OR 4729.01 of the Revised Code SOLELY BECAUSE THE LABEL
OR LABELING CONTAINS A STATEMENT AUTHORIZED BY THIS SECTION OR BECAUSE A
WARNING APPEARS ON THE SUPPLEMENT'S LABEL.
Sec. 3715.85. (A) AS
USED IN THIS SECTION, "PUBLICATION" INCLUDES A BOOK
CHAPTER, ARTICLE, OR OFFICIAL ABSTRACT OF A PEER-REVIEWED SCIENTIFIC
ARTICLE PREPARED BY THE ARTICLE'S AUTHOR OR THE EDITORS OF THE PUBLICATION IN
WHICH THE ARTICLE IS PUBLISHED.
(B) A PUBLICATION USED IN
CONNECTION WITH A SALE TO CONSUMERS OF A DIETARY SUPPLEMENT IS NOT
CONSIDERED PART OF THE LABEL OF THE DIETARY SUPPLEMENT IF THE PUBLICATION
MEETS ALL OF THE FOLLOWING CRITERIA:
(1) THE PUBLICATION IS REPRINTED IN ITS ENTIRETY.
(2) THE PUBLICATION IS NOT FALSE OR MISLEADING.
(3) THE PUBLICATION DOES NOT PROMOTE A PARTICULAR MANUFACTURER OR BRAND
OF DIETARY SUPPLEMENT.
(4) THE PUBLICATION IS DISPLAYED OR PRESENTED, ALONE OR WITH OTHER
PUBLICATIONS ON THE SAME SUBJECT MATTER, SO AS TO PRESENT A
BALANCED VIEW OF THE AVAILABLE SCIENTIFIC INFORMATION ON A
DIETARY SUPPLEMENT.
(5) IF THE PUBLICATION IS DISPLAYED IN A LOCATION WHERE
DIETARY SUPPLEMENTS ARE OFFERED FOR SALE, THE PUBLICATION IS PHYSICALLY
SEPARATE FROM THE DIETARY SUPPLEMENTS.
(6) THE PUBLICATION DOES NOT HAVE ANY OTHER INFORMATION AFFIXED TO IT.
(C) DIVISION
(B) OF THIS SECTION DOES NOT
APPLY TO OR RESTRICT THE ACTIONS OF A PERSON WHO OFFERS
DIETARY SUPPLEMENTS FOR SALE AT RETAIL OR WHOLESALE IN THE SALE
OF BOOKS OR PUBLICATIONS AS PART OF THE PERSON'S
BUSINESS.
(D) IF THE DIRECTOR OF AGRICULTURE
FINDS OR HAS CAUSE TO BELIEVE THAT A PUBLICATION UNDER DIVISION (B)
OF THIS SECTION IS A LABEL AND THAT LABEL IS FALSE OR MISLEADING UNDER
DIVISION (B) OF THIS SECTION, THE
DIRECTOR SHALL PROCEED UNDER THE PROVISIONS OF THIS CHAPTER
APPLICABLE TO MISBRANDED FOOD. IN ANY ACTION TAKEN UNDER THIS
SECTION, THE BURDEN OF PROOF TO ESTABLISH MISBRANDING
SHALL BE ON THE DIRECTOR.
Sec. 3715.86. A DIETARY SUPPLEMENT IS NOT CONSIDERED A "FOOD
ADDITIVE" WITHIN THE MEANING GIVEN IN THE FEDERAL
"FOOD, DRUG, AND COSMETIC ACT," 21
U.S.C.A.
321(s), AS AMENDED.
Sec. 4759.10. Sections 4759.01 to 4759.09 of the Revised
Code do not apply to any of the following:
(A) A person licensed under Chapters 4701. to 4755. of the
Revised Code who is acting within the scope of his THE PERSON'S
profession, provided that he THE PERSON complies with division
(B) of section 4759.02 of the Revised Code;
(B) A person who is a graduate of an associate degree
program approved by the American dietetic association or the Ohio
board of dietetics who is working as a dietetic technician under
the supervision of a dietitian licensed under section 4759.06 of
the Revised Code or registered by the commission on dietetic
registration, except that the person is subject to division (B)
of section 4759.02 of the Revised Code if he THE PERSON uses a
title other than "dietetic technician";
(C) A person who practices dietetics related to employment
in the armed forces, veteran's administration, or the public
health service of the United States;
(D) Persons employed by a nonprofit agency approved by the
board or by a federal, state, municipal or county government, or
by any other political subdivision, elementary or secondary
school, or an institution of higher education approved by the
board or by a regional agency recognized by the council on
postsecondary accreditation, who performs only nutritional
education activities and such other nutritional activities as the
board of dietetics, by rule, permits, provided the person does
not violate division (B) of section 4759.02 of the Revised Code;
(E) A person who has completed a program meeting the
academic standards set by the American dietetic association for
dietitians, received a baccalaureate or higher degree from a
school, college, or university approved by a regional
accreditation agency recognized by the council on postsecondary
accreditation, works under the supervision of a licensed
dietitian or registered dietitian, and does not violate division
(B) of section 4759.02 of the Revised Code;
(F) A person when acting, under the direction and
supervision of a person licensed under Chapters 4701. to 4755. of
the Revised Code, in the execution of a plan of treatment
authorized by the licensed person, provided the person complies
with division (B) of section 4759.02 of the Revised Code;
(G) The free dissemination of literature in the state;
(H) Provided that the persons involved in the sale,
promotion, or explanation of the sale of food, food materials, or
dietary supplements do not violate division (B) of section
4759.02 of the Revised Code, the sale of food, food materials, or
dietary supplements and the marketing and distribution of food,
food materials, or dietary supplements and the promotion or
explanation of the use of food, food materials, or dietary
supplements provided that the promotion or explanation does not
violate Chapter 1345. of the Revised Code;
(I) A PERSON WHO OFFERS DIETARY SUPPLEMENTS FOR SALE
AND WHO MAKES THE FOLLOWING
STATEMENTS ABOUT THE PRODUCT IF THE STATEMENTS ARE CONSISTENT WITH THE DIETARY
SUPPLEMENT'S LABEL OR LABELING:
(1) CLAIM A BENEFIT RELATED TO A CLASSICAL NUTRIENT DEFICIENCY DISEASE AND
DISCLOSE THE PREVALENCE OF THE DISEASE IN THE UNITED STATES;
(2) DESCRIBE THE ROLE OF A NUTRIENT OR DIETARY INGREDIENT
INTENDED TO AFFECT THE STRUCTURE OR FUNCTION OF THE HUMAN
BODY;
(3) CHARACTERIZE THE DOCUMENTED MECHANISM BY WHICH A
NUTRIENT OR DIETARY INGREDIENT ACTS TO MAINTAIN THE STRUCTURE OR
FUNCTION OF THE HUMAN BODY;
(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A
NUTRIENT OR DIETARY INGREDIENT.
(J) Provided that the persons involved in presenting a
general program of instruction for weight control do not violate
division (B) of section 4759.02 of the Revised Code, a general
program of instruction for weight control approved in writing by
a licensed dietitian, a physician licensed under Chapter 4731. of
the Revised Code to practice medicine or surgery or osteopathic
medicine or surgery, a person licensed in another state that the
board considers to have substantially equivalent licensure
requirements as this state, or a registered dietitian;
(J)(K) The continued practice of dietetics at a hospital by a
person employed at that same hospital to practice dietetics for
the twenty years immediately prior to July 1, 1987, so long as
the person works under the supervision of a dietitian licensed
under section 4759.06 of the Revised Code and does not violate
division (B) of section 4759.02 of the Revised Code. This
division does not apply to any person who has held a license
issued under this chapter to practice dietetics. As used in this
division, "hospital" has the same meaning as in section 3727.01
of the Revised Code.
Section 2. That existing section 4759.10 of the Revised Code is hereby
repealed.
Section 3. Sections 3715.80 to 3715.86 of the Revised Code, as
enacted by this act, are intended to codify in Ohio law portions of the
federal "Dietary Supplement Health and Education Act of 1994,"
108 Stat. 4325 (1994), 21 U.S.C.A. 301, et seq., as
amended.
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