FACT SHEET l Ohio Department of Agriculture

Governor Ted Strickland

Lieutenant Governor Lee Fisher

Director Robert J. Boggs

Food Safety Division

8995 East Main Street • Reynoldsburg, Ohio 43068

Phone: 614-752-9817 • Fax 614-466-4346

ODA URL: www.ohioagriculture.gov

E-mail: foodsafety@agri.ohio.gov
 

FACT SHEET:  OTC Drugs

December 4, 2001

OVER THE COUNTER DRUGS

1.  What Is A Drug?

2.  What is an Over-the-Counter Drug?

3.  What is a Dietary Supplement?

4.  What is a Cosmetic?

1.  What is a Drug?

The Ohio Food, Drug, Cosmetic and Device Law defines drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease… and articles (other than food) intended to affect the structure or any function of the body of humans or other animals.” 

Prescription drugs are those drugs that may be dispensed only by or on the prescription of a licensed practitioner, such as a physician, dentist, or veterinarian.  They are required to be labeled: “Caution: Federal law prohibits dispensing without a prescription”.  In general, a drug is restricted to the prescription class if it is not safe for use except under professional supervision.

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2.  What is an Over-the-Counter Drug?

Nonprescription drugs are drugs that are generally regarded as safe for the consumer to use by following the required label directions and warnings. These are commonly called “over-the-counter” (OTC) drugs because they may be purchased without a prescription.  There are more than 80 classes of OTC drugs, ranging from acne drug products and fluoride dentifrices to weight control products. 

The OTC drug categories are found in 21 CFR 330.5 and are as follows:

3.  What is a Dietary Supplement?

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994.  The Ohio Food, Drug, Cosmetic and Device Law references this definition.  A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.  The “dietary ingredients” in these products may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA and the Ohio Food, Drug and Cosmetic Law places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

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4.  What is a Cosmetic?

Cosmetics are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  Included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanents, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

A product may qualify as both a cosmetic and as an OTC drug.  Some examples of such combinations are: a shampoo (cosmetic) and antidandruff treatment (drug) as a antidandruff shampoo; toothpaste (cosmetic) and fluoride treatment (drug) as a fluoride toothpaste; deodorant (cosmetic) and antiperspirant (drug) as an antiperspirant deodorant; and makeup (cosmetic) combined with sun-protection (drug).

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