New Dietary Ingredients in Dietary Supplements - Background for Industry

The Federal Food, Drug, and Cosmetic Act (the 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 413b of the act (21 U.S.C. 350b).) Generally, the notification must include information that is the basis on which manufacturers/distributors have 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:

• What is a new dietary ingredient?
• When you must notify us about a new dietary ingredient?
• What information the notification must contain?
• Where to send your premarket notification and who to contact at FDA, if you have questions?
• What happens after you submit a premarket notification for a new dietary ingredient to us?
• What new dietary ingredient notifications FDA has received and the status of each?

On July 5, 2011, FDA published a draft guidance that addresses these and other topics in more detail.

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(c) of the Federal Food, Drug, and Cosmetic Act (the act), 21 U.S.C. 350b(c)). 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 that a dietary supplement that contained the dietary ingredient was marketed before October 15, 1994.

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 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 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, and liquid 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, dietary supplements do not include products that are approved drugs, certified antibiotics, or licensed biologics. Dietary supplements also do not include products that are authorized for investigation as a new drug, antibiotic, 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 product was marketed as a dietary supplement or as a food before it was approved as a drug, antibiotic, or biologic, or, in the case of investigational products, before the public disclosure of such investigations.

You can find the statutory language of section 201(ff) of the 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 act provides that a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the 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 act (21 U.S.C. 350b) and section 402(f) of the 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, you must show why you consider that the consumption of a new dietary ingredient is reasonably 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 act you may still submit a notification to us. Importantly, if a product containing a new dietary ingredient is marketed without the required notification, unless exempt, the product may be adulterated as a matter of law. Regardless of whether you are required to submit a premarket notification, it is your responsibility to ensure that a dietary ingredient used in a dietary supplement is safe.

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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, unless exempt, 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.

FDA 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 stated in the labeling or if no conditions of use are stated, 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 be reasonably be expected to be safe.
    • Any reference to published materials must be accompanied by reprints or photostatic copies.
    • Any material in a foreign language must be accompanied by a translation.
• A signature by a person designated by you who can be contacted if we have questions.

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. The regulations are codified at 21 CFR §190.6. 

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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 act (21 U.S.C. 350b(a)(2)). You must provide 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. To date, we have not published guidance defining the specific information that the submission must contain. Thus, you are responsible for determining what information provides the basis for your conclusion. Nonetheless, we expect that -- in making a determination that a new dietary ingredient is reasonably expected to be safe, -- you will consider the evidence of safety found in the scientific literature, including an examination of adverse effects associated with the use of the substance.

Where do I send my premarket notification and who can I contact at FDA, if I have questions?

Division of Dietary Supplement Programs
Office of Nutrition, Labeling, and Dietary Supplements (HFS-810)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD, 20740-3835
Telephone Number: (240) 402-2375

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What happens after I submit a premarket notification for a new dietary ingredient to FDA?

Once you submit a premarket notification for a new dietary ingredient, we will acknowledge its receipt in writing within 75 days. We will also notify you of the date it is received, which is the filing date for the premarket notification. For 75 days after the filing date, you cannot market (that is, introduce or deliver for introduction into interstate commerce) the dietary supplement that contains the new dietary ingredient.

We may contact you again if:

• you did not provide all of the information required in the regulations (see 21 CFR §190.6),
• we have questions about the information contained in the notification.

FAILURE OF THE AGENCY TO RESPOND TO A NOTIFICATION DOES NOT CONSTITUTE A FINDING BY FDA THAT THE NEW DIETARY INGREDIENT OR THE DIETARY SUPPLEMENT THAT CONTAINS THE NEW DIETARY INGREDIENT IS SAFE OR IS NOT ADULTERATED UNDER SECTION 402 OF THE ACT.

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 90^th day, all the information in your notification will be placed on public display in docket number 95S-0316 at FDA’s Dockets Management Branch. However, any information that is trade secret or otherwise confidential commercial information will not be disclosed to the public.

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

9/10/01 UPDATE to FDA's Table of New Dietary Ingredient Notifications (Docket #95S-0316)

The table below contains notification we received through March 2001. Other notification responses may be found on our Dockets Management Web site. More recent notifications are filed at http://www.regulations.gov in docket 95S-0316.

The following table contains information on new dietary ingredient notifications we have received, including:

• an identifying code number for the notification;
• the name of the new dietary ingredient;
• the name of the manufacturer or distributor;
• the date the notification was received or "filed" by FDA; and
• the status of the notification.

The information for each new dietary ingredient notification that is available using this Web site is the same information that is available at Dockets Management Web site and Dockets Management Branch (Dockets) under Docket number 95S-0316.  However, some of these notifications contain copyrighted material that can only be obtained through a Freedom of Information (FOI) request or viewed at Dockets. You may view the New Dietary Ingredient notifications inclusive of copyrighted material at:  Dockets Management Branch, Food & Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.  If you would like a hard copy or a copy on CD-ROM of a New Dietary Ingredient notification with the copyrighted material, you may submit an FOI request to: Freedom of Information Staff, Food & Drug Administration, 5600 Fishers Lane, HFI-35, Rockville, MD 20857. For information on how to submit an FOI request, you may wish to refer to "A Handbook for Requesting Information and Records from FDA". There is a cost for duplicating this material under the Freedom of Information Act.

THE FACT THAT A NEW DIETARY INGREDIENT IS LISTED IN THIS TABLE DOES NOT CONSTITUTE A FINDING BY FDA THAT A NEW DIETARY INGREDIENT OR A DIETARY SUPPLEMENT THAT CONTAINS A NEW DIETARY INGREDIENT IS SAFE OR IS NOT ADULTERATED UNDER SECTION 21 U.S.C. 342.  IN ADDITION, THE LISTING OF A NEW DIETARY INGREDIENT IN THIS TABLE DOES NOT MEAN THAT ANOTHER MANUFACTURER CAN LAWFULLY MARKET THE DIETARY INGREDIENT IN A DIETARY SUPPLEMENT.  EACH MANUFACTURER IS RESPONSIBLE FOR ENSURING COMPLIANCE WITH THE ACT.

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TABLE NOTES: The names of the new dietary ingredients are stated as reported to FDA in the notifications. The table states the names of the manufacturers or distributors of the new dietary ingredients that may be different from the submitters of the notifications. The filing date represents the date a notification was received by the FDA.

Key:

& = and; and = indicates two separate companies; c/o = care of; FDA = Food and Drug Administration; Let = letter; M = memorandum; N/A = not applicable; Rpt = report; Rpts = reports; Sup = supplement; Sups = supplements
 

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