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                Information for Industry on Dietary Supplements

Information for Industry on Dietary Supplements Home
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          Information for Industry on Dietary Supplements
          Notifications for Structure/Function and Related Claims in Dietary Supplement LabelingInformation for Industry on Dietary Supplements Notifications for Structure/Function and Related Claims in Dietary Supplement Labeling
  
  	
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    PrintThe Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a person or firm that markets a dietary supplement with certain types of claims in the product labeling to notify FDA about the claim within 30 days after first marketing the dietary supplement with the claim.  The labeling claims covered by the notification requirement are:

structure/function claims (defined as a statement that “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function”);
	general well-being claims (a statement that “describes general well-being from consumption of a nutrient or dietary ingredient”); and
	classical nutrient deficiency disease claims (a statement that “claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States”).These claims are referred to collectively as “403(r)(6) claims” because they are defined in section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) and must comply with the requirements of that provision.  A dietary supplement for which a truthful and non-misleading claim is made in accordance with section 403(r)(6) is not a drug solely because the label or labeling contains the claim.  21 U.S.C. 321(g)(1).

A claim made on the label or in the labeling of a dietary supplement is in accordance with section 403(r)(6) if:

the claim is a structure/function claim, a general well-being claim, or a classical nutrient deficiency disease claim as defined in section 403(r)(6)(A);
	the entity making the claim has substantiation that the statement is truthful and not misleading;
	the statement is accompanied by the following standard disclaimer, prominently displayed and in boldface type:  “This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.”; and
	the statement does not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.In addition, the entity making the claim must submit a notification with the text of the claim and other required information to FDA no later than 30 days after first marketing the dietary supplement with the claim.  21 U.S.C. 343(r)(6); 21 CFR 101.93.

Read more on Structure/Function Label Claims.

Submitting Notifications

Electronic Submissions

FDA provides an ePortal (CFSAN Online Submission Module or COSM) for electronic submissions. You may use the same COSM account for future submissions.

To facilitate FDA review and faster processing of notifications, we encourage submitters to utilize the COSM portal.  This also will allow submitters to receive confirmation of receipt and obtain status updates via email.

Visit CFSAN Online Submission Module (COSM) for instructions and account management information.  Also for your reference is a step-by-step guide for using COSM to file a structure/function or other section 403(r)(6) claim notification.

Launch the Structure/Function Claim Notification ePortal
(via the CFSAN Online Submission Module)

Written Submissions

Although FDA encourages the use of the ePortal for electronic submissions, written submissions are also accepted. Required information for a section 403(r)(6) notification includes:

The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement on its label or in its labeling;
	the text of the statement that is being made;
	the name of the dietary ingredient or supplement that is the subject of the statement;
	the name (including brand name) of the dietary supplement that bears the statement; and
	the signature of a responsible individual or other person who can certify the accuracy of the information in the notification.  The person who signs the notification must certify that the information in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.Completed submissions should be mailed to:

Food and Drug Administration (HFS-810)
Office of Dietary Supplement Programs
5001 Campus Drive
College Park, MD 20740-3835

403(r)(6) Claim Notification FAQs

What types of labeling claims for dietary supplements require a notification to FDA under section 403(r)(6) of the FD&C Act and 21 CFR 101.93(a)?
	A notification under section 403(r)(6) of the FD&C Act and 21 CFR 101.93(a) is required only for dietary supplements making a labeling claim under section 403(r)(6) (i.e., a structure/function claim, a general well-being claim, or a classical nutrient deficiency disease claim).  This type of notification is not required for authorized health claims, qualified health claims, or nutrient content claims; however, these claims have their own requirements, and some require a premarket submission to FDA, such as a petition or notification specific to the type of claim.  For more information about the requirements that apply to these claims, see Label Claims for Conventional Foods and Dietary Supplements. Claims such as “vegan” or “non-GMO” do not require any premarket or postmarket submission to FDA.  Like any other claim in the labeling of a dietary supplement or other food, such claims must be truthful and non-misleading.

When submitting a notification, how do I indicate that the notified claim will be used in the labeling of several products and/or brands?
	The notification must include the name of each dietary supplement (both brand name and product name) on whose label, or in whose labeling, the statement appears. [21 CFR 101.93(a)(2)(iv)] It is not permitted to use a generic phrase such as “for other brands/other products” without listing the name(s) of the product(s). On the COSM ePortal form, all products, including different brands, to which the claim applies should be listed in the “Brand Name, Dietary Supplement Name” field. For example, Brand A Magnesium and Brand B Magnesium may be listed together. You may also list different product forms (capsules, powder, etc.), package sizes, strengths, or flavors together, such as “Brand A Magnesium (250 mg, 500 mg, 600 mg)” and “Brand B Vitamin Gummies (berry, grape).”

How long will it take FDA to review my notification?
	Reviewing a notification for a structure/function claim or other section 403(r)(6) claim generally takes up to 1 month but may take longer in some cases. FDA reviews notifications in the order in which they are received. However, FDA does not reply to all 403(r)(6) claim notifications, as discussed in the response to the next question.

Will I be notified when the review is complete?
	That depends on the outcome of FDA’s review.  FDA typically notifies firms by letter (often referred to as a “courtesy letter”) if it objects to the statements that are the subject of the structure/function claim notification.  For example, FDA may object if the statement suggests that the ingredient and/or product diagnoses, treats, cures, mitigates, or prevents a disease.  FDA also may object for other reasons, such as because the product at issue is not a dietary supplement or because the claim is being made for an ingredient that is not a nutrient or dietary ingredient.  If the Agency does not object to a claim notification, we generally do not send a response or otherwise inform the notifier that our review is complete.

FDA’s response to a structure/function claim notification is not intended to be an all-inclusive statement of issues that may exist in connection with the product that is the subject of the claim.  An FDA response, or lack thereof, to a structure/function claim notification should not be read as a statement about the product’s compliance with other legal requirements.

Am I required to respond to a courtesy letter from FDA?
	No, you are not required to respond to FDA if you receive a “courtesy letter.”  If you choose to respond, your response will be filed in the public docket (FDA-1997-S-0006).  If the Agency continues to object to the claims, we may send an additional courtesy letter, but lack of a response does not necessarily mean that the Agency agrees with your position.

Are notifications for structure/function claims and other 403(r)(6) claims publicly available?
	Yes. FDA posts claim notifications with the related courtesy letter, if any, in open public dockets on www.regulations.gov.  Notifications are posted under different docket numbers depending on when they were submitted and whether FDA responded.  To view claim notifications that resulted in a courtesy letter, type “FDA-1997-S-0006” in the search box on regulations.gov.  To view claim notifications that were submitted to FDA before 2012 and did not receive a response, please visit www.regulations.gov and type “FDA-1997-S-0039” in the search box.  Claim notifications that were submitted to FDA after 2012 and did not receive a response are separated by year.  To view those notifications, please include the 4-digit year in the following search term:  FDA-YEAR-S-0024.  For example, if you are looking for notifications submitted in 2022, you would type “FDA-2022-S-0024” in the search box on www.regulations.gov.  Notifications are generally posted in the docket between 60-90 days after they have been processed and reviewed.

Questions?

If you have additional questions, please contact us at:

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

Contact the Office of Dietary Supplement Programs by email at SFCN@fda.hhs.gov for questions related to structure/function claim notifications and other dietary supplement claim notifications required under section 403(r)(6) of the FD&C Act.

To reach FDA’s Food and Cosmetics Information Center,
call: 1-888-SAFEFOOD (1-888-723-3366).

Guidance for Industry

Small Entity Compliance Guide on Structure/Function Claims
	Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
	Small Entity Compliance Guide on Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary SupplementsResources For You

Label Claims for Conventional Foods and Dietary Supplements
	How to Submit Label Claim Petitions and Notifications
	Authorized Health Claims That Meet the Significant Scientific Agreement Standard
	Nutrient Content Claims
	Qualified Health Claims
	Structure/Function Claims

                                                                                  Content current as of:
      02/09/2023
              
              
Regulated Product(s)
		 Dietary SupplementsInformation for Industry on Dietary Supplements
 
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