Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act

ICR 201108-0910-012

OMB: 0910-0626

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-08-30
ICR Details
0910-0626 201108-0910-012
Historical Active 200804-0910-008
HHS/FDA
Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection   No
Regular
Approved without change 02/06/2012
Retrieve Notice of Action (NOA) 08/30/2011
  Inventory as of this Action Requested Previously Approved
02/28/2015 36 Months From Approved 02/29/2012
2,001 0 1,334
189,428 0 189,428
0 0 0

Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. Under section 403(r)(6)(A) of the act (21 U.S.C. 343(r)(6)(A)), such a statement is one that claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans, characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or describes general well-being from consumption for a nutrient or dietary ingredient. The guidance document entitled, Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, provides the FDA recommendation to manufacturers about the amount, type, and quality of evidence they should have to substantiate a claim under section 403(r)(6). The guidance does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim. The guidance document is intended to assist manufacturers in their efforts to comply with section 403(r)(6).

US Code: 21 USC 343 Name of Law: FFDCA
  
None

Not associated with rulemaking

  76 FR 32215 06/03/2011
76 FR 51988 08/19/2011
Yes

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,001 1,334 0 0 667 0
Annual Time Burden (Hours) 189,428 189,428 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$18,976
No
No
No
No
No
Uncollected
Denver Presley 3018271462

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
08/30/2011


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