FDA Warning Letters to CBD Companies: Unapproved Drug & Misbranding Violations

— Written By Marne Coit and last updated by
en Español / em Português
Español

El inglés es el idioma de control de esta página. En la medida en que haya algún conflicto entre la traducción al inglés y la traducción, el inglés prevalece.

Al hacer clic en el enlace de traducción se activa un servicio de traducción gratuito para convertir la página al español. Al igual que con cualquier traducción por Internet, la conversión no es sensible al contexto y puede que no traduzca el texto en su significado original. NC State Extension no garantiza la exactitud del texto traducido. Por favor, tenga en cuenta que algunas aplicaciones y/o servicios pueden no funcionar como se espera cuando se traducen.


Português

Inglês é o idioma de controle desta página. Na medida que haja algum conflito entre o texto original em Inglês e a tradução, o Inglês prevalece.

Ao clicar no link de tradução, um serviço gratuito de tradução será ativado para converter a página para o Português. Como em qualquer tradução pela internet, a conversão não é sensivel ao contexto e pode não ocorrer a tradução para o significado orginal. O serviço de Extensão da Carolina do Norte (NC State Extension) não garante a exatidão do texto traduzido. Por favor, observe que algumas funções ou serviços podem não funcionar como esperado após a tradução.


English

English is the controlling language of this page. To the extent there is any conflict between the English text and the translation, English controls.

Clicking on the translation link activates a free translation service to convert the page to Spanish. As with any Internet translation, the conversion is not context-sensitive and may not translate the text to its original meaning. NC State Extension does not guarantee the accuracy of the translated text. Please note that some applications and/or services may not function as expected when translated.

Collapse ▲

3/23/2021 – Since the 2018 Farm Bill was signed into law, the Food and Drug Administration (FDA) has said that it has authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to regulate food products and dietary supplements that contain CBD, as well as other products that contain CBD that make health claims. Earlier this week the FDA issued warning letters to two companies that used CBD in a way that was not in compliance with the FD&C Act.

The following is from the FDA’s news release:

“Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.”

Read more on the FDA’s website.