(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:

Terms Used In Ohio Code 3715.84

  • agriculture: includes farming; ranching; aquaculture; algaculture meaning the farming of algae; apiculture and related apicultural activities, production of honey, beeswax, honeycomb, and other related products; horticulture; viticulture, winemaking, and related activities; animal husbandry, including, but not limited to, the care and raising of livestock, equine, and fur-bearing animals; poultry husbandry and the production of poultry and poultry products; dairy production; the production of field crops, tobacco, fruits, vegetables, nursery stock, ornamental shrubs, ornamental trees, flowers, sod, or mushrooms; timber; pasturage; any combination of the foregoing; the processing, drying, storage, and marketing of agricultural products when those activities are conducted in conjunction with, but are secondary to, such husbandry or production; and any additions or modifications to the foregoing made by the director of agriculture by rule adopted in accordance with Chapter 119 of the Revised Code. See Ohio Code 1.61
  • Cosmetic: means :

    (a) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance;

    (b) Articles intended for use as a component of any such article, except that "cosmetic" does not include soap. See Ohio Code 3715.01

  • Drug: means :

    (a) Articles recognized in the United States pharmacopoeia and national formulary, or any supplement to them;

    (b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

    (c) Articles, other than food, intended to affect the structure or any function of the body of humans or other animals;

    (d) Articles intended for use as a component of any of the foregoing articles, other than devices or their components, parts, or accessories. See Ohio Code 3715.01

  • Food: means :

    (a) Articles used for food or drink for humans or animals;

    (b) Chewing gum;

    (c) Articles used for components of any such articles. See Ohio Code 3715.01

  • Label: means a display of written, printed, or graphic matter upon the immediate container, exclusive of package liners, of any article. See Ohio Code 3715.01
  • Labeling: means all labels and other written, printed, or graphic matter:

    (a) Upon an article or any of its containers or wrappers;

    (b) Accompanying such article. See Ohio Code 3715.01

  • state: means the state of Ohio. See Ohio Code 1.59
  • United States: includes all the states. See Ohio Code 1.59

(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.

  Previous section
Next section  
 Chapter 3715 Contents