• Reducir tamaño letra
  • Volver a tamaño letra normal
  • Aumentar tamaño letra
Departamento de Salud y Servicios Humanos de los EE.UU.

Información normativa

  • Imprimir
  • Compartir
  • Correo electrónico
-
-

Legislación

The Food and Drugs Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. Here are a few of the congressional milestones:

  • The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The FD&C Act completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.
  • The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.
  • The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.


Today, the FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm.

-
-

Este sitio web ha sido traducido del inglés al español y se actualiza con frecuencia. Es posible que algunos enlaces lo redirijan a contenidos disponibles únicamente en inglés o que algunas palabras de la página aparezcan en inglés hasta que el proceso de traducción finalice (por lo general, dentro de las 24 horas). Agradecemos su paciencia y comprensión. En caso de que haya discrepancias con el significado, la versión en inglés es la oficial. Gracias por visitar esp.fda.gov/tabaco.