U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
OTC vs. Prescription
Objective Intent

The FDA determines your product's “objective intent” by the:

FDA representative with text bubble: Even representations and claims on a product's or a firm's Web site can and are used by FDA in determining an article's intended use.
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