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US Food and Drug Administration is consulting the public on the premarket notification for a new dietary ingredient.

This notice solicits comments on the procedure to ensure that manufacturers or distributors are producing a safe dietary supplement that contains new dietary ingredient. This requires distributors and manufacturers to submit the following information in the form of a notification.

  • The name and complete address of the manufacturer or distributor;
  • the name of the new dietary ingredient;
  • a description of the dietary supplement(s) that contain the new dietary ingredient, including the level of the new dietary ingredient in the dietary supplement and the dietary supplement’s conditions of use;
  • the history of use or other evidence of safety establishing that the new dietary ingredient will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of the dietary supplement; and
  • the signature of a responsible person designated by the manufacturer or distributor.

Public comment is open up until January 16, 2018.

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