The FDA is the federal agency responsible for labeling medications and supplements. However, the approval process is different for prescription and for over-the-counter medications.
The FDA must regulate and approve new prescription drugs before they can be sold to the public. In 2010, the last year for which information is available, the FDA approved 21 new drugs for use by the general public.1 While this number may seem small, the approval process for drugs is extensive.
First, the manufacturer or sponsor follows a series of important steps, through animal studies and clinical trials, to ensure that the medication is safe, does what it claims to do, and will provide a health benefit. Testing is performed first in laboratories and on animals to determine that the drug is safe and would work well in humans. Sometimes, multiple trials are completed to measure the effectiveness of a particular medication. Participants in the studies are often followed over a period of time. For comparison purposes, some are given a placebo, an inactive or "dummy" medication, while others are given the actual drug. The NICHD and other institutes of the NIH help conduct and support the research but are not involved in the approval or labeling process.
The clinical trial phase can take years to complete. However, once research has shown that the drug is safe and useful, the FDA typically reviews and either approves or denies an application for a new drug within 6 months.
View a PDF of the FDA drug approval process. (PDF - 2.79 MB)
Over-the-counter Drugs, Dietary and Herbal Supplements
Over-the-counter drugs and dietary and herbal supplements are not formally approved through the FDA. The active ingredients and labeling of medications and supplements in certain classes (like antacids, for example) are reviewed by the FDA to ensure that acceptable ingredients are used and that they are safe. Drug companies must conform to the requirements in the medication or supplements class, but they do not need formal FDA approval to make and sell over-the-counter medications and supplements.
The label will indicate whether a drug or supplement has been FDA approved. Talk to your health care provider about any medications you are currently taking or are considering taking to ensure that they are safe.
- U.S. Food and Drug Administration. (n.d.). Is it true FDA is approving fewer new drugs lately? Retrieved August 8, 2012, from http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM247465.pdf (PDF - 494 KB) [top]