Month: September 2019

Lead Acetate in Cosmetics

Since 1980 lead acetate has been considered a safe color additive for use in cosmetics for hair coloring. In 2017, a color additive petition requesting repeal of regulation that allows for the use of lead acetate in cosmetics was submitted. After carefully reviewing the submission and other relevant information, FDA concluded that there is no reasonable certainty of no harm from this use of lead acetate. On October 30, 2018, FDA published a final rule banning the use of Lead Acetate in cosmetic products intended for hair coloring. The rule is effective from December 03, 2018 and the industry has 12 months to make the transition and reformulate their products. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements.

Hair dye products containing Lead Acetate are required to bear such a warning statement:

CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.

Manufacturers and labelers of cosmetic products must comply with FDA labeling requirements otherwise their products are considered misbranded and are subject to detention.

Liberty Management Group Ltd. can help companies with labeling compliance. Our label experts check your labels against current labeling regulations and help you avoid detention and import refusals.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 25, 2019

ISO 9001

ISO 9001 is the international standard for a Quality Management System (QMS) laid out by the International Organization for Standardization. The standard is implemented by organizations to demonstrate that their products and services meet regulatory requirements.

An organization may choose to implement 9001 for its entire operations or for a particular operation or department.

ISO 9001 can be implemented in all types of industries, small or large, service or manufacturing industry.  ISO 9001 is process based standard. It does not define quality of products. It helps streamline the processes that must be followed to obtain desired outcome.

Some benefits of becoming ISO 9001 certified are:

  1. Improved quality of products or services
  2. Defined roles, responsibilities and guidelines that are easy to follow for everyone in the organization thus clarity to the employees
  3. Better financial performance
  4. Minimum scope for errors as everything is documented
  5. Constant improvement in processes
  6. Improved credibility of business

Some companies obtain an ISO certification as it improves their chances to bag business opportunities. Others may obtain a certification just to improve their business processes.

Liberty Management Group Ltd can help organizations with ISO 9001 right from documentation to implementation to certificate issuance. A certificate could be from an accredited or a non-accredited certification body depending upon the choice of companies.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: September 11, 2019