The FDA Today, Part 1

Today's FDA is the primary consumer protection agency in the United States. Operating under the authority given it by the government, and guided by laws established throughout the twentieth century, the FDA has established a rigorous drug approval process that verifies the safety, effectiveness, and accuracy of labeling for any drug marketed in the United States. When the FDA approves a drug, it is saying that the drug is safe and effective for public use when used as instructed. But "safe does not mean harmless," stated Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER) in an interview with FDA Consumer magazine. "Every drug comes with risks, and our tolerance for risk is higher for drugs that treat serious and life-threatening illnesses. There is no question that cancer drugs can be highly toxic. But they also save lives." The word safe, when applied to FDA-approved drugs, means only that the drug's effectiveness for its intended use (how well it works on the targeted disease or disorder) outweighs its risks (possible side effects). Generally speaking, if clinical studies show that a drug works and its side effects are tolerable, the drug will most likely be approved. If the drug works but kills or seriously harms the patients taking it, the drug will most likely not be approved. The risk of taking the drug has to be worth the benefit the drug provides. And that's the case for most drugs on the market. Accorrding to the Dietary Supplement Health and Education Ac, a dietary ingredient may include: a vitamin a mineral an herb or other botanical an amino acid a dietary substance for use to supplement the diet by increasing the dietary intake a concentrate, metabolite, constituent, or extract

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