Recent in Regulatory (page 16 of 40)

PASS Coalition and Congressman Sam Farr Press FDA for UV Filter Approval

The PASS Coalition expresses its gratitude to subcommittee ranking member Sam Farr (D-CA) for pressing the FDA about the approval of pending sunscreen ingredients but notes that some UV filters have been pending with the FDA for over a decade.

Cosmetic Control Unit in Singapore

In 2008, Health Sciences Authority (HSA) established the ASEAN Cosmetic Directive (ACD) for cosmetic products in Singapore. This is enforced as the Heath Products Act, a subsidiary legislation of the HSA’s Health Products Regulation 2007. HSA created the Cosmetic Control Unit of Singapore to regulate cosmetics.

Canadian Regulatory Update

Discussion of regulatory changes, beginning with the most urgent. In addition, highlights comments published by Health Canada, in conjunction with Advertising Standards Canada, on acceptable and unacceptable cosmetic claims.

Certifying Hair Product Claims

Claims for hair products generally are not associated with clear cut outcomes. Therefore, consumers have no standard by which to compare product efficacy. In relation, the North American Hair Research Society (NAHRS) has proposed standards for hair product claims, outlined here, which relate to characteristics including frizz, color fastness and curl retention, among others.

The FDA's 'Wish List': A Unified Agenda

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the publication of a semiannual inventory of the rulemaking under development, and the US Department of Health and Human Services (HHS) publishes this wish list for the FDA. The latest came out on Dec. 7, 2009.

Translating Data into Claims and Interpreting Regulations: Science vs. Marketing

Substantial evidence, which the FDA requires to support claims for drugs, is applicable to personal care, especially considering the pharmaceutical direction products have taken. The present article considers whether the industry is benefiting from marketing without assuming the responsibility for potential effects. In addition, it considers the limitations of in vitro and in vivo test models.

Recent ATPs and the 8th Amendment

Why does the Cosmetic Directive need the 8th Amendment? Some feel it is necessary since the directive has been changed 55 times, including seven amendments and 48 Adaptations to Technical Progress (ATPs). While the industry waits to see what this new amendment will bring, more ATPs have been published, as are described here. Science moves on contrary to political wishes.

Regulatory Review—Titanium Dioxide

This column will discuss titanium dioxide (TiO2). TiO2 is the most frequently used ingredient in cosmetics after water (aqua), fragrance (parfum), methylparaben, propylparaben, glycerin and propylene glycol, according to the U.S. Food and Drug Administration’s (FDA) Voluntary Cosmetic Registration Program.

Regulatory Review—Titanium Dioxide

This column will discuss titanium dioxide (TiO2). TiO2 is the most frequently used ingredient in cosmetics after water (aqua), fragrance (parfum), methylparaben, propylparaben, glycerin and propylene glycol, according to the U.S. Food and Drug Administration’s (FDA) Voluntary Cosmetic Registration Program.

EU Update—Changes with Implementation of 1223/2009

The implementation of Regulation 1223/2009 is of prime importance to the cosmetics industry. Although many requirements remain the same as in the directive, there are changes that will have an impact on companies, with compliance required by July 11, 2013.

Myanmar Cosmetic Regulations

Myanmar is a member state of the ASEAN community and must abide by ASEAN Cosmetic Directive; however, like other member states, it has local regulatory bodies such as the Ministry of Health that supervise goods sold in the country.

US and Canada Regulatory Updates

Several major regulatory changes are coming in cosmetics from Canada, while in the United States, the U.S. Food and Drug Administration (FDA) has been active in sending out warning letters to cosmetic companies making unapproved drug claims. This column provides an overview of them.

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