Section 403 (21 U.S.C. 343) of the
Federal Food, Drug, and Cosmetic Act (the act) establishes
requirements that the label or labeling of a food product must meet
so that it is not misbranded and subject to regulatory action.
Certain of the provisions of section 403 require that food
producers disclose information about themselves or their products
on the labels or labeling of their products. FDA has issued various
regulations in parts 101, 102, 104, and 105 (21 CFR parts 101, 102,
104, and 105) that also require food producers to disclose certain
information on the labels or labeling of their food products.
Related regulations require that food producers retain records
establishing the basis for the information contained in the label
or labeling of their products and provide those records to
regulatory officials. Finally, certain regulations provide for the
submission of food labeling petitions. FDAs food labeling
regulations were issued under the authority of sections 4, 5, and 6
of the Fair Packaging and Labeling Act (the FPLA) (15 U.S.C. 1453,
1454, and 1455) and of sections 201, 301, 402, 403, 409, and 701 of
the act (21 U.S.C. 321, 331, 342, 348, and 371). Most of the
regulations in Parts 101, 102, 104, and 105 derive from the
requirements of section 403 of the act, which provides that a food
product shall be misbranded if, among other things, its label or
labeling fails to bear certain required information concerning the
food product, is false or misleading in any particular, or bears
certain types of unauthorized claims. The disclosure requirements
and other collections of information in the regulations in parts
101,102,104, and 105 are necessary to ensure that food products
produced or sold in the United states are in compliance with
labeling provisions of the act and the FPLA.
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.
Form 3570 Reporting: Small Business Nutrition Labeling Exemption Using Form FDA 3570
SS-0910-0381.doc
Reporting: Small Business Nutrition Labeling Exemption Using Form FDA 3570