Establishing the Dividing Line: Is Your Product a Drug?

May 6, 2003 | Contact Author | By: Robert J. Buta, Philip G. Trager and Edward J. Murphy, Consumer Product Testing Co., Inc.
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Keywords: drug | regulation | testing | stability | efficacy | active ingredient

Abstract: To avoid regulatory penalties, a company developing an OTC product must institute properly administered shelf-life testing programs as an integral part of its product development and marketing efforts.

To some, the line dividing non-drug form drug products is vague and seemingly unreadable. Most companies go out of their way not to cross the line, in the hopes of not having to deal with the regulatory issues that come with marketing drug products. Yet, more and more often, as new claims come onto the market, the exact point at which your product becomes a drug and not a cosmetic comes into the picture as a critical consideration in product development and marketing.