To enact sections 3715.80, 3715.81, 3715.83, 3715.84, 3715.86, 3715.87, 3715.88, and 3715.89 of the Revised Code regarding the regulation of dietary supplements.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

Sec. 3715.80. AS USED IN SECTIONS 3715.80 TO 3715.89 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 HAVE EXCLUSIVE AUTHORITY TO ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.89 of the Revised Code AND ANY RULES ADOPTED UNDER THOSE SECTIONS. THE BOARD OF PHARMACY SHALL HAVE NO AUTHORITY TO ADMINISTER OR ENFORCE THE PROVISIONS OF THIS CHAPTER RELATING TO DIETARY SUPPLEMENTS.

Sec. 3715.83. THE DIRECTOR OF AGRICULTURE MAY ADOPT RULES, IN ACCORDANCE WITH CHAPTER 119. of the Revised Code, TO ADMINISTER AND ENFORCE SECTIONS 3715.80 TO 3715.89 of the Revised Code. IF RULES ARE ADOPTED, THE RULES SHALL BE CONSISTENT WITH 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. 3715.84. 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. 3715.86. (A) A DIETARY SUPPLEMENT IS NOT MISBRANDED UNDER SECTION 3715.60 of the Revised Code SOLELY BECAUSE THE LABEL 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, THE FOLLOWING STATEMENT: "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."

(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. 3343(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.

(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 CONTAINS A STATEMENT AUTHORIZED BY THIS SECTION OR BECAUSE A WARNING APPEARS ON THE SUPPLEMENT'S LABEL.

Sec. 3715.87. (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 SHALL NOT BE 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 DIETARY SUPPLEMENT 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. 3715.88. A DIETARY SUPPLEMENT IS NOT 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. 3715.89. (A) A PERSON WHO OFFERS DIETARY SUPPLEMENTS FOR SALE AT RETAIL, WHOLESALE, OR DISTRIBUTION MAY MAKE THE FOLLOWING STATEMENTS IF THE STATEMENTS ARE CONSISTENT WITH THE DIETARY SUPPLEMENT'S LABEL:

(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;

(4) DESCRIBE GENERAL WELL-BEING FROM THE CONSUMPTION OF A NUTRIENT OR DIETARY INGREDIENT.

(B) A PERSON WHO MAKES A STATEMENT UNDER DIVISION (A) OF THIS SECTION IS NOT PRACTICING NURSING UNDER CHAPTER 4723. of the Revised Code, MEDICINE AND SURGERY UNDER CHAPTER 4731. of the Revised Code, OR DIETETICS UNDER CHAPTER 4759. of the Revised Code.