Food

New Dietary Ingredients in Dietary Supplements - Background for Industry

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" notify the Food and Drug Administration about these ingredients. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).) Generally, the notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.

If you are a manufacturer or distributor, these pages provide a general overview of the following:

In August 2016, FDA published a new version of a draft guidance that addresses these and other topics in more detail. See How to Submit Notifications for a New Dietary Ingredient for more information.


When to Notify FDA and What is a New Dietary Ingredient

What is a "new dietary ingredient?" 

The term "new dietary ingredient" means a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994. (See section 413(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 350b(d)). There is no authoritative list of dietary ingredients that were marketed in dietary supplements before October 15, 1994. Therefore, manufacturers and distributors (you) are responsible for determining if an ingredient is a "new dietary ingredient" and, if not, for documenting either that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994, or that the dietary ingredient was marketed for use in dietary supplements before that date.

If you want to market a "new dietary ingredient" in a dietary supplement, you must be sure that the substance is considered to be a "dietary ingredient." (See section 201(ff)(1) of the FD&C Act (21 U.S.C 321(ff)(1)). A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

In addition, the product containing the dietary ingredient must be a dietary supplement. (See section 201(ff) of the FD&C Act (21 U.S.C. 321 (ff)). The term "dietary supplement" means a product (other than tobacco) intended to supplement the diet that contains one or more dietary ingredients. A dietary supplement is limited to products that are intended for ingestion in tablet, capsule, powder, softgel, gelcap, liquid, or other form, that are not represented as conventional food or as the sole item of a meal or of the diet, and that are labeled as dietary supplements. Additionally, a product that contains an article that is an approved new drug or licensed biologic cannot be a dietary supplement unless the article was marketed as a dietary supplement or as a food before its approval as a new drug or licensing as a biologic. Dietary supplements also may not include articles that are authorized for investigation as a new drug or biologic (and for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public), unless the article was marketed as a dietary supplement or as a food before it was authorized for investigation.

You can find the statutory language of section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)) by going to the Federal Food, Drug, and Cosmetic Act.

When must I notify FDA about a new dietary ingredient?

The FD&C Act provides that a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the FD&C Act (21 U.S.C. 342(f)) unless it meets one of two requirements:

  1. The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
  2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

(See Section 413 of the FD&C Act (21 U.S.C. 350b) and section 402(f) of the FD&C Act (21 U.S.C. 342(f)).

In other words, if the dietary ingredient has not been present in the food supply as an article used for food in the same chemical form that you plan to use in your dietary supplement, you must show why you consider that the new dietary ingredient will reasonably be expected to be safe under the conditions recommended or suggested in the labeling.

If you are unsure whether a dietary ingredient is a "new dietary ingredient" under the FD&C Act you may still submit a notification to us. Importantly, if a notification is required for a product containing a new dietary ingredient and the product is marketed without the required notification, the product is adulterated as a matter of law. Regardless of whether you are required to submit a premarket notification, you are responsible for evaluating the safety of dietary ingredients you use, and you must ensure that dietary supplements you sell or distribute are not adulterated.

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Information About Submitting Notifications for New Dietary Ingredients (Who, What, Where, How)

Who needs to submit a notification?

You must submit a premarket notification if you are a:

  • manufacturer who intends to market a new dietary ingredient;

  • manufacturer who intends to market a dietary supplement that contains a new dietary ingredient;

  • distributor who intends to market a new dietary ingredient; or

  • distributor who intends to market a dietary supplement that contains a new dietary ingredient.

What information must the notification contain? 

If you plan to market a dietary supplement that contains a new dietary ingredient and the new dietary ingredient has not been present in the food supply as an article used for food in a form in which the food has not been chemically altered,  you must submit to FDA, at least 75 days before the dietary ingredient is introduced or delivered for introduction into interstate commerce, information that is the basis on which you have concluded that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

On September 23, 1997, we published in the Federal Register a final rule that established regulations that you must follow when you make a premarket notification for a new dietary ingredient. The regulations are codified at 21 CFR 190.6. These regulations require that you submit an original and two (2) copies of the notification and all of its attachments. You must also provide in the notification:

  • Your name and complete address.
  • The name of the new dietary ingredient. If the new dietary ingredient is an herb or other botanical, you must include the Latin binomial name (including the author).
  • A description of the dietary supplement or dietary supplements that contain the new dietary ingredient, including the:
    • level of the new dietary ingredient in the product;
    • conditions of use of the product recommended or suggested in the labeling or if no conditions of use are recommended or suggested, the ordinary conditions of use; and
    • history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe.
      • Any reference to published materials must be accompanied by reprints or photocopies.
      • Any material in a foreign language must be accompanied by a translation.
  • The signature of a person you designate who is responsible for the content of the notification and can be contacted if we have questions.

 
See How to Submit Notifications for a New Dietary Ingredient for more information.

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What type of information do I need to submit to provide a basis to conclude that the new dietary ingredient is reasonably expected to be safe?

You are not limited in what evidence you may rely on in determining whether the use of a new dietary ingredient will reasonably be expected to be safe. (See section 413(a)(2) of the FD&C Act (21 U.S.C. 350b(a)(2)). A dietary supplement containing a new dietary ingredient is adulterated unless there is a history of use or other evidence of safety establishing that the new dietary ingredient, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. You are responsible for determining what information provides the basis for your conclusion. At a minimum, we recommend  that  you conduct a thorough search of the scientific literature and consider the evidence of safety found there, including an examination of adverse effects associated with the use of the ingredient. FDA is developing guidance with detailed recommendations on this topic and published a draft guidance for comment in 2011. 

Where do you send your premarket notification and who do you contact at FDA, if you have questions?

Office of Dietary Supplement Programs (HFS-810)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD, 20740-3835
Telephone Number: (240) 402-2375 or by email at ODSP@fda.hhs.gov

What happens after you submit a premarket notification for a new dietary ingredient to us?

We will not disclose the existence of, or the information contained in, your new dietary ingredient notification for 90 days after the filing date. After the 90th day, the information in your notification will be available through FDA’s Division of Dockets Management (Dockets) and at http://www.regulations.gov, except for any information that is trade secret or confidential commercial information.

What new dietary ingredient notifications FDA has received and what is the status of each?

The information for each NDIN that is available using this website is the same information that is available through FDA’s Division of Dockets Management (Dockets) and at http://www.regulations.gov. However, some of these notifications contain copyrighted material that can only be obtained through a Freedom of Information (FOI) request or viewed in person at the Dockets Public Reading Room. Please see FDA’s FOI website for more information on how to view materials in person or to submit a FOI request.
For your convenience, a spreadsheet for download containing a list of publicly displayed New Dietary Ingredient Notifications (NDINs) that we have reviewed to date is available at Submitted 75-Day Premarket Notifications for New Dietary Ingredients

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Page Last Updated: 08/14/2018
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