E9-11320. 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 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.