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La FDA advierte a las empresas de suplementos dietéticos que venden ilegalmente productos que contienen cloruro de cesio

U.S. Food and Drug Administration (FDA) logo

News provided by

U.S. Food and Drug Administration

Oct 16, 2020, 18:10 ET

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In English

SILVER SPRING, Maryland, 16 de octubre de 2020 /PRNewswire-HISPANIC PR WIRE/ -- La Administración de Alimentos y Medicamentos de los EE.UU. (FDA, por sus siglas en inglés) publicó hoy cinco cartas de advertencia dirigidas a empresas que comercializan suplementos dietéticos que contienen cloruro de cesio (en inglés). En una alerta de salud pública de febrero de 2020 (en inglés), la FDA advirtió a los consumidores y profesionales de la salud que eviten el uso de suplementos dietéticos que contengan sales de cesio, principalmente cloruro de cesio. En julio de 2018 (en inglés), la FDA alertó a los profesionales de atención médica sobre los riesgos de seguridad significativos asociados con el cloruro de cesio en los medicamentos compuestos. En ocasiones, el cloruro de cesio se promueve como un tratamiento alternativo para el cáncer; sin embargo, la FDA no ha aprobado ningún producto que contenga cloruro de cesio para tratar el cáncer o cualquier otra enfermedad.

El cloruro de cesio es un nuevo ingrediente dietético que no ha estado presente previamente en el suministro de alimentos en una forma no alterada químicamente. Por lo tanto, las empresas deben proporcionar cierta información relacionada con la seguridad del ingrediente a la FDA antes de incluirlo en un suplemento dietético. Las empresas que comercializan estos productos no han cumplido con este requisito y, por lo tanto, sus productos no pueden ser comercializados legalmente.

Las cartas de advertencia fueron enviadas a:

  • American Nutriceuticals, LLC
  • Complete H2O Minerals, Inc.
  • Daily Manufacturing, Inc.
  • Elemental Research, Inc. and The Mineral Store, Inc.
  • Essence-of-Life, LLC

"La FDA continuará tomando medidas contra los suplementos dietéticos que contienen cloruro de cesio debido a las importantes preocupaciones de seguridad, incluida la toxicidad cardíaca y muerte potencial, asociadas con este ingrediente", dijo Steven Tave, director de la Oficina de Programas de Suplementos Dietéticos del Centro de Seguridad Alimentaria y Nutrición Aplicada de la FDA. "Nos tomamos muy en serio nuestro papel de proteger al público de los suplementos dietéticos peligrosos".

Si los consumidores creen que un producto puede haber causado una reacción o enfermedad, deben dejar de usar el producto inmediatamente, comunicarse con su proveedor de atención médica y enviar una queja a la FDA mediante MedWatch o el portal de reportes de seguridad.

La FDA ha solicitado respuestas de las empresas dentro de 15 días hábiles indicando cómo corregirán las violaciones. Si no se corrigen las violaciones con prontitud, o no se proporciona el razonamiento y la información de apoyo de por qué los productos no están infringiendo la ley, puede resultar en una acción legal, incluida la confiscación del producto y/o una orden judicial.

La FDA, una agencia que es parte del Departamento de Salud y Servicios Humanos de los Estados Unidos, protege la salud pública al asegurar la seguridad, eficacia y protección de los medicamentos humanos y veterinarios, vacunas y otros productos biológicos para el uso humano, y los dispositivos médicos. La agencia también es responsable de la seguridad del suministro de alimentos, cosméticos, suplementos alimenticios, y de los productos que emiten radiación electrónica, y de regular los productos de tabaco en nuestra nación.

Información para los medios de comunicación: Gloria Sánchez-Contreras, 301-796-7686, [email protected]
Información al consumidor:  888-INFO-FDA
www.FDA.gov/Espanol

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FUENTE U.S. Food and Drug Administration

SOURCE U.S. Food and Drug Administration

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