The purpose and effect of the proposed rule amendment is to update material incorporated by reference. SUBJECT AREA: The subject area to be addressed in this rule is the updated federal statutes and federal rules that ....

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.009Cosmetic Labeling Requirements

PURPOSE AND EFFECT: The purpose and effect of the proposed rule amendment is to update material incorporated by reference.

SUBJECT AREA: The subject area to be addressed in this rule is the updated federal statutes and federal rules that are incorporated by reference.

SUMMARY: Updated material incorporated by reference.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Department’s economic analysis of the potential impact of the proposed rule and its determination that there will be no adverse economic impact or increased regulatory costs that would require legislative ratification.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.05, F.S.

LAW IMPLEMENTED: 499.08, 499.009 Florida Statutes

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Janetta Sampson, Operations and Management Consultant Manager, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.009 Cosmetic Labeling Requirements.

The department adopts and incorporated by reference the labeling requirements for cosmetics as set forth in the federal act at 21 U.S.C. ss. 321, 331, and 361-363 301 et. seq. and in Title 21 Code of Federal Regulations Parts 700-740799 (as of 3/18/2110/1/03).

Rulemaking Authority 499.05 FS.  Law Implemented 499.008 499.08, 499.009 FS.  History-New 1-1-77, Amended 12-12-82, Formerly 10D-45.48, Amended 7-1-96, Formerly10D-45.048, Amended 1-26-99, 4-17-01, 1-1-04, __________, Formerly 64F-12.009.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Walter Copeland, Director, Division of Drugs, Devices, and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047.

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Julie I. Brown, Secretary, Department of Business and Professional Regulation.

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 24, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 11, 2021