The Food and Drug Administration oversees a broad range of medical and consumer products. In fact, the agency estimates that up to a quarter of all U.S. consumer spending is on FDA-regulated items. The Pew Charitable Trusts understands the tremendous impact these products have on public health. This project complements our work supporting drug safety and effective and efficient regulation of medical devices by focusing attention on over-the-counter drugs and dietary supplements, as well as fields such as regenerative medicine, in order to safeguard consumers and patients.
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Americans routinely reach for over-the-counter (OTC) drugs to treat a wide variety of ailments. And they have a growing number of choices at their local drugstore: The OTC market now includes more than 300,000 products with annual sales of $32 billion. The items are diverse, ranging from antiperspirants and sunscreens to cough and cold medications and pain relievers. Read More
The Pew Charitable Trusts submitted comments this month supporting draft guidance that the Food and Drug Administration issued in August on the new dietary ingredients (NDI) notification process for supplement manufacturers and distributors. NDIs are vitamins, minerals, or herbs that were not on the market before Oct. 15, 1994. Manufacturers are required in most cases to notify FDA before... Read More
Pew submitted comments in December 2016 to the Drug Enforcement Agency in response to its deliberations over whether to classify the dietary supplement kratom as a schedule 1 substance, a drug with no currently accepted medical use and a high potential for abuse. Read More