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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The Pew Charitable Trusts submitted comments this month supporting draft guidance that the Food and Drug Administration issued in August on the new dietary ingredients (NDI) notification process for supplement manufacturers and distributors.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
Every day, Americans use a variety of over-the-counter drugs, from cough and cold medicine to pain relievers and antacids. Although most consumers believe these products are safe, their regulation is antiquated and inefficient, which can put consumers at risk and hinder innovation. Read More