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產品是否經過FDA認證?

酮能源系統是膳食補充劑,根據法規,並不適用於美國藥物和食品管理局的審批。

酮能源系統受到《膳食補充劑與教育法》規管,其製造設備已在美國藥物和食品管理局註冊為食物製造商設備,符合「良好生產管理規範」。

 

請參考FDA網頁截取的內容及翻譯,了解更多關於膳食補充劑的安全審批知識:

https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm109760.htm

Who is responsible for the safety of dietary supplements?

誰需要對膳食補充劑的安全性負責?

 

FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.

若一款補充劑還未在市面出售,美國藥物和食品管理局則無權審查其安全性與成效性。

 

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market.

在產品銷售前,膳食補充劑的製造商和分銷商須負責確保產品的安全性。

 

If the dietary supplement contains a NEW ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

若膳食補充劑含有某種新成分,製造商必須在產品出售前通知美國藥物和食品管理局。然而,美國藥物和食品管理局(不認可)會針對產品的安全性而不是其成效性展開審查工作。

 

Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to current Good Manufacturing Practice (cGMP) and labeling regulations.

製造商需製造有質量保證的膳食補充劑,確保產品不含有污染物或雜質,而且,其標籤要符合當前的《藥品生產質量管理規範》 和標籤條例。

 

If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

若與膳食補充劑有關的嚴重事件出現時,製造商須向美國藥物和食品管理局報告不良事件。美國藥物和食品管理局若發現膳食補充劑具有不安全性或產品的聲稱出現錯誤和誤導性時,會將此類膳食補充劑下架。

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