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).
This is a new collection. The
new burden hours result from 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)of the
act.
$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto
3018274659
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.
Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act