What does NDI mean in UNCLASSIFIED
NDIs are dietary ingredients, including food additives, that have not been marketed in the United States before October 15, 1994. These ingredients must undergo a premarket approval process with the FDA to ensure their safety.
NDI meaning in Unclassified in Miscellaneous
NDI mostly used in an acronym Unclassified in Category Miscellaneous that means New Dietary Ingredients
Shorthand: NDI,
Full Form: New Dietary Ingredients
For more information of "New Dietary Ingredients", see the section below.
- NDI (New Dietary Ingredients) are ingredients that have not been used in food or dietary supplements in the United States before October 15, 1994.
- The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines NDI as any ingredient that:
- Is a dietary ingredient for which there was no approved food additive regulation or an existing dietary ingredient prior to October 15, 1994.
- Is a dietary ingredient that:
- Has a new chemical structure.
- Is produced using a new production process.
- Has a new combination of ingredients.
- Is intended to be used in a manner that is different from its traditional use.
NDI Notification
- Manufacturers of products containing NDIs must submit a New Dietary Ingredient Notification (NDIN) to the Food and Drug Administration (FDA) at least 75 days before marketing the product.
- The NDIN must include:
- The name and chemical structure of the NDI.
- The intended use of the NDI.
- The amount of the NDI to be used in the product.
- The safety data for the NDI.
FDA Review of NDINs
- The FDA reviews NDINs to ensure that the NDI is safe for consumption.
- The FDA may request additional information from the manufacturer if necessary.
- If the FDA determines that the NDI is not safe, it may issue a warning letter or take other enforcement actions.
Essential Questions and Answers on New Dietary Ingredients in "MISCELLANEOUS»UNFILED"
What are New Dietary Ingredients (NDIs)?
Why is there an NDI premarket approval process?
The NDI premarket approval process is designed to protect consumers from potential safety risks associated with new dietary ingredients. The FDA evaluates the safety data submitted by the manufacturer to assess the likelihood of adverse effects before allowing the ingredient to be marketed.
What information is required for NDI premarket approval?
Manufacturers must submit a detailed notification to the FDA that includes information on the NDI's:
- Identity and composition
- Intended use and dosage
- Manufacturing process
- History of use
- Safety data, including animal and human studies
What are the consequences of marketing an NDI without premarket approval?
Marketing an NDI without premarket approval is a violation of the Food, Drug, and Cosmetic Act and can result in:
- Seizures of the product
- Injunctions against the manufacturer
- Criminal charges
Final Words:
- The NDI notification process helps to ensure the safety of new dietary ingredients used in food and dietary supplements.
- Manufacturers must submit a NDIN to the FDA at least 75 days before marketing a product containing a NDI.
- The FDA reviews NDINs to ensure the safety of the NDI.
NDI also stands for: |
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| All stands for NDI |