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Recent in Regulatory (page 31 of 32)

NaTrue Offers Raw Material Certification to Aid Formulators

As of March 2010, raw material suppliers can certify their products under the NaTrue label in the same way as finished product manufacturers.

FDA and SDA Address Triclosan Concern

The FDA updated its Web site on Apr. 8, 2010, with its most recent information on triclosan. According to the FDA, triclosan provides a benefit to a number of personal care products, and it does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan. However, the FDA also did not have evidence that triclosan provided any additional benefit when added to antibacterial soaps and body washes.

FDA Cracks Down on Medicinal Claims Regarding Bee By-products

The US Food and Drug Administration (FDA) cracked down on Wisconsin-based Beehive Botanicals Inc. after the company did not comply with requests to remove and change misbranded and unapproved claims from its Web site and labels.

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.

Colorado Judiciary Votes No to Safe Products Act

On March 1, 2010, Colorado's House Committee on Judiciary voted to indefinitely postpone House Bill 10-1248 (HB 1248), or the Colorado Safe Personal Care Products Act.

EU Regulatory Update: CLP Deadlines and Consequences

The European Union’s adaptation of the Globally Harmonized System (GHS) is Regulation (EC) No. 1272/2008 on the classification, labeling and packaging (CLP) of substances and mixtures, which entered into force on Jan. 20, 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.

Bill Proposes the Colorado Safe Personal Care Products Act

On Feb. 3, 2010, a bill was introduced into the Colorado State Legislature to prohibit the sale of personal care products formulated with chemicals identified as causing cancer or reproductive toxicity.

SCCS Rules on Quaternary Ammonium Compounds

The SCCS has adopted the opinion that alkyl trimethylammonium chloride is safe as a non-preservative when incorporated at the recommended use levels.

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.

EU Regulatory Update: Recast of the Cosmetics Directive Published

Regulation (EC) No 1223/2009 was published on Dec. 22, 2009 with the intent to simplify rules and procedures related to the marketing of cosmetic products, a need resulting from different implementations of the Cosmetics Directive.

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