OTC DRUGS

How “Intended Use” Affects Your Product’s Regulation

It is the “intended use,” as established through product labeling, that can cause the FDA to consider a product to be a drug. The FDA notes that a product can meet the definitions of both cosmetics and drugs, by having two intended uses (such as a shampoo that is also intended to treat dandruff, or toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims). Such products must comply with the requirements for both cosmetics and drugs.

Regulation of OTC Drugs

Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain — but not all — over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either:

• Be the subject of an approved New Drug Application (NDA), or
• Comply with the appropriate monograph, or rule, for an OTC drug

OTC Monographs

The OTC monographs represent regulatory standards for the marketing of non-prescription drug products not covered by new drug applications. These standards provide the marketing conditions for some OTC drug products including the active ingredients, labeling, and other general requirements.

If there is an FDA OTC monograph on a given drug category, then the monograph will establish conditions under which the OTC product in that category is generally recognized as safe and effective and not misbranded. Accordingly, the monograph will specify what statement of identity, indications, warnings, and directions are necessary. A drug claim outside a monograph is problematic. Put another way, if you have a product that would fall within a particular drug category by virtue of the claim it makes, then your product must comply with the monograph. For some monographs, your product must have at least one of the ingredients in the monograph, and for others, your product must have all of the ingredients.

If you have a product that does not fall within a given drug category in the OTC monographs because of its claim, then the list of OTC active ingredients may nonetheless provide references to regulation that prohibit certain kinds of statements regarding the ingredient. For example, no claim can be made for chamomile as a digestive aid product. The relevant regulations do not give permission for any particular claims to be made regarding an ingredient; they only prohibit particular claims.

If an ingredient is listed in 21 CFR 310.545 (Drug Products Containing Certain Active Ingredients Offered Over-The-Counter (OTC) For Certain Uses), the regulation provides (depending on under which subsection the ingredient is listed), that either:

(a) A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses;

(b) Any OTC drug product that is labeled, represented, or promoted for the uses specified and containing any active ingredient(s) as specified in paragraph (a) of this section is regarded as a new drug within the meaning of section 210(p) of the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the Act;

(c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for the OTC uses and containing any active ingredient(s) as specified in paragraph (a) of this section is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter; or

(d) Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(37) of this section.

Legal Counsel for OTC Drugs

Our Food and Drug lawyers understand the regulatory distinctions between dietary supplements, homeopathic products, medical foods, prescription drugs, and over-the-counter drugs, and the way that product positioning and marketing can affect regulatory classification by the FTC.

Let our legal team guide you through the complex laws and regulations that can affect the way you bring your OTC drug to market.

Helpful Links

Court upholds right to investigational new drugs

FDA steps up enforcement actions against dietary supplement manufacturers

Legal Advice For New Dietary Supplement, Nutritional Product or Cosmetic