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Approved from NMN to talk about NDI, a new dietary ingredient in the United States

 Last Update: 2022-08-19
 Source: Internet
 Author: User

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Recently, the official website of the .
.
Food and Drug Administration (FDA) published the original notification and FDA confirmation of the new dietary ingredient (NDI) of β-nicotinamide mononucleotide (β-NMN) submitted by Shangke Biopharmaceutical (Shanghai) C.
, Lt.
A letter confirming that its NMN raw materials have successfully passed the NDI approva.
This means that the FDA officially accepts NMN as a new substance and approves that NMN can be used as a dietary supplement ingredient in the United State.

.
.
Food and Drug Administration FDA Biomedical Nicotinamide Nucleotide Dietary Supplements

Screenshot of the confirmation letter from the FDA's official website

On August 12, 2016, the .
.
FDA released a revised draft guidance for industry titled "Dietary Supplements: Notification of New Dietary Ingredient and Related Issue.
" The revised draft guidance, once finalized, will assist industry in evaluating whether to submit a premarket safety notification for NDIs or dietary supplements containing NDIs, as well as preparing such premarket safety notifications (also known as NDI notifications.

At present, many companies may have some questions about ND.
Now, for the questions that everyone is more concerned about, FoodPartner.
com will answer them one by on.

Q1: What is NDI?

NDI is the abbreviation of "New Dietary Ingredient", also known as "New Dietary Ingredient", which refers to dietary ingredients that were not placed on the .
.
market before October 15, 1994 All dietary ingredients liste.
According to the Federal Food, Drug, and Cosmetic Act, dietary ingredients include: vitamins; minerals; herbs or other plants; amino acids; substances that supplement the diet by increasing total dietary intake; concentrates, metabolites, extract or combinatio.

Q2: What is the connection between the NDI notification and the listing of dietary supplements?

The Federal Food, Drug, and Cosmetic Act requires that manufacturers and distributors of dietary supplements that contain NDIs must submit safety information to the FDA at least 75 days before the products enter interstate commerce, known as NDI notifications, submitted by Materials should, as far as possible, allow FDA to conclude that the product is "sufficiently saf.
"

Q3: Who needs to submit an NDI notice?

Manufacturers/distributors intending to sell new dietary ingredients, and manufacturers/distributors of dietary supplements containing new dietary ingredients must submit a premarket notificatio.

Q4: How to judge whether a substance is NDI?

　　The core issue of NDI notification is to judge whether the raw material belongs to ND.
At present, the .
.
government has not released a "list of ingredients that have been used in dietary supplements.
Although similar lists have been issued by industry associations, these lists have not been recognized by the FD.
Manufacturers/distributors of products need to judge by themselves whether the raw materials of the products meet the requirements of NDI filin.
The specific judgment of the enterprise can refer to the NDI decision tre.

　　Q5: What information does the NDI notice need to contain?

　　Pursuant to 21 CFR § 196, the notification must contain the following information:

　　(1) The name and full address of the manufacturer/distributor of the dietary supplement or NDI containing the NDI;

　　(2) The name of the pre-market NDI, including the Latin name of any herb or other plant (including the author);

　　(3) A description of the dietary supplement or dietary supplement containing the NDI, including the level of NDI in the dietary supplement; recommended or suggested conditions of use in the dietary supplement's label, or if not in the dietary supplement's label Recommended or recommended conditions of use, the general conditions of use for dietary supplements;

　　(4) History of use or other evidence of safety that the dietary ingredient can reasonably be expected to be safe when used under the conditions recommended or recommended on the dietary supplement label, including citations to published articles or other evidence that It is the distributor or manufacturer's basis for concluding that a new dietary supplement is saf.
Copies of references should be attached to any published information provided in support of the notificatio.
If any part of the submitted material is in a foreign language, it should be accompanied by an accurate and complete English translation;

　　(5) Signature of the person designated by the manufacturer/distributor of the dietary supplement containing the ND.

　　Q6: Will the NDI notice be made public?

　　FDA will keep confidential for 90 days after receiving the NDI notification materials submitted by the enterpris.
After the 90-day period, the FDA will publish it on the public information platform, except for trade secrets or other confidential informatio.

　　Q7: How can an enterprise check the status of an NDI notification?

　　Companies can find a downloadable spreadsheet on the Submitted New Dietary Ingredient 75-Day Premarket Notifications page that contains a list of publicly displayed New Dietary Ingredient Notifications (NDINs) that FDA has reviewed to dat.
The 75-day premarket notification for a submitted new dietary ingredient can also be queried based on information such as the NDI notification number, NDI name or compan.
However, some of these notices contain copyrighted material that can only be obtained through a Freedom of Information (FOI) request or viewed in person in the Dossier Public Reading Roo.

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