Document ID: FDA-2009-D-0209-0001
Agency: fda
Document Type: Notice
Title: Small Entity Compliance Guide: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis; Availability
Posted Date: 2009-05-15T04:00Z

[Federal Register: May 15, 2009 (Volume 74, Number 93)]
[Notices]               
[Page 22942-22943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my09-83]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0209]

 
Small Entity Compliance Guide: Health Claims; Calcium and 
Osteoporosis, and Calcium, Vitamin D, and Osteoporosis; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Food Labeling: 
Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and 
Osteoporosis--Small Entity Compliance Guide.'' The small entity 
compliance guide (SECG) is being issued for a final rule published in 
the Federal Register of September 29, 2008, as corrected on November 
12, 2008, and it is intended to set forth in plain language the legal 
requirements of the regulation and to help small businesses understand 
the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the SECG to

[[Page 22943]]

http://www.regulations.gov. Submit written requests for single copies 
of the SECG to the Office of Nutrition, Labeling, and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740. Send one self-addressed adhesive label to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Blakeley Denkinger, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 29, 2008 (73 FR 56477), as 
corrected on November 12, 2008 (73 FR 66754), FDA issued a final rule 
amending its labeling regulation authorizing a health claim on the 
relationship between calcium and a reduced risk of osteoporosis (21 CFR 
101.72). The amendments allow for a health claim to be made for calcium 
and vitamin D and osteoporosis, and eliminate several requirements of 
the health claim. This final rule becomes effective January 1, 2010.
    FDA examined the economic implications of the final rule as 
required by the Regulatory Flexibility Act (5. U.S.C. 601-612) and 
determined that the final rule will not have a significant economic 
impact on a substantial number of small entities. In compliance with 
section 212 of the Small Business Regulatory Enforcement Fairness Act 
(Pub. L. 104-121), FDA is making available this SECG stating in plain 
language the legal requirements of the September 29, 2008, final rule, 
as corrected on November 12, 2008, concerning calcium and osteoporosis, 
and calcium, vitamin D, and osteoporosis.
    FDA is issuing this SECG as a level 2 guidance consistent with 
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). The 
SECG represents FDA's current thinking on this topic. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this SECG. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The SECG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: May 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-11320 Filed 5-14-09; 8:45 am]

BILLING CODE 4160-01-S