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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0083]
Agency Information Collection Activities; Proposed Collection; Comment
Request;
Gluten-Free Labeling of Food Products Experimental Study
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity
for public comment on the proposed collection of certain information by the
agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal
agencies are required to publish notice in the Federal Register concerning
each proposed collection of information and to allow 60 days for public
comment in response to the notice. This notice solicits comments on a
voluntary consumer study entitled ``Gluten-Free Labeling of Food Products
Experimental Study.''
Gluten-Free Labeling of Food Products Experimental Study
Under section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(b)(2)), FDA is authorized to conduct research relating
to foods and to conduct educational and public information programs
relating to the safety of the nation's food supply. FDA is planning to
conduct an experimental study about gluten-free labeling of food
products. The Gluten-Free Labeling of Food Products Experimental Study
will collect information from both consumers who have celiac disease or
gluten intolerance and those who do not have either condition. The
purpose of the study is to gauge perceptions of characteristics related
to claims of ``gluten-free'' and allowed variants (e.g., ``free of
gluten,'' ``without gluten,'' ``no gluten''), in addition to other
types of statements (e.g., ``made in a gluten-free facility'' or ``not
made in a facility that processes gluten-containing foods'') on the
food label. The study will also
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assess consumer understanding of ``gluten-free'' claims on foods that
are naturally free of gluten, and gauge consumer reaction to a product
carrying a gluten claim concurrently with a statement about the amount
of gluten the product contains.
The data will be collected over the Internet from samples derived
from two sources: (1) A membership list from a celiac disease special
interest organization and (2) an online consumer panel. Participation
in the study is voluntary.
http://edocket.access.gpo.gov/2009/E9-4766.htm
DATES: Submit written or electronic comments on the collection of
information by May 5, 2009.
ADDRESSES: Submit electronic comments on the collection of information to
<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html
<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log
> &log
=linklog&to=http://www.regulations.gov> http://www.regulations.gov
<http://www.regulations.gov/> . Submit written comments on the collection of
information to the Division of Dockets Management (HFA- 305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
Shelley Case, B. Sc., RD
Case Nutrition Consulting, www.glutenfreediet.ca
Author: Gluten Free Diet: A Comprehensive Resource Guide
Medical Advisory Board: Celiac Disease Foundation, Gluten Intolerance Group,
Canadian Celiac Association
Advisory Board: Living Without Magazine
EMail: [log in to unmask]
Phone: (306) 536-7716 Fax: (306) 751-1000
Visit the Celiac Web Page at Http://www.enabling.org/ia/celiac/index.html
Archives are at: Http://Listserv.icors.org/SCRIPTS/WA-ICORS.EXE?LIST=CELIAC
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