Get the free New Dietary Ingredient Notification

Notification regarding the new dietary ingredient ANKASCIN 568-R, which is a red yeast fermented product extract derived from Monascus purpureus NTU 568, detailing its safety, usage instructions,

How to fill out new dietary ingredient notification

How to fill out new dietary ingredient notification

1. Identify the new dietary ingredient (NDI) you wish to notify about.
2. Gather all necessary information about the NDI, including its composition, source, and intended use.
3. Ensure that the NDI has been marketed as a dietary ingredient prior to 1994 or meets the criteria for new ingredients.
4. Prepare a Notification Submission that contains a comprehensive description of the NDI and supporting data.
5. Include evidence of safety for the target population, which may involve scientific studies or historical use information.
6. File the notification with the FDA at least 75 days before marketing the product containing the NDI.

Who needs new dietary ingredient notification?

1. Manufacturers of dietary supplements who are introducing new dietary ingredients.
2. Companies wishing to market new dietary products with ingredients not previously sold in the U.S. before 1994.
3. Importers of dietary ingredients wishing to ensure compliance with FDA regulations.

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What is new dietary ingredient notification?

New dietary ingredient notification is a process required by the FDA where manufacturers must inform the agency about any new dietary ingredients that were not marketed in the U.S. before October 15, 1994.

Who is required to file new dietary ingredient notification?

Manufacturers or distributors of dietary supplements who intend to introduce a new dietary ingredient into interstate commerce are required to file the notification.

How to fill out new dietary ingredient notification?

To fill out a new dietary ingredient notification, a manufacturer must provide specific information about the ingredient, including its identity, history of use, and safety information, following the guidelines set by the FDA.

What is the purpose of new dietary ingredient notification?

The purpose of new dietary ingredient notification is to ensure that new dietary ingredients are safe for consumers and do not pose any health risks.

What information must be reported on new dietary ingredient notification?

The information that must be reported includes the name of the ingredient, a detailed description, the intended use, a history of use or evidence of safety, and any other information relevant to the safety of the ingredient.