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Best Practices
CPT Labs

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (commonly known by its acronym “MoCRA”) was signed into law on December 29, 2022.  Its intent is to modernize federal regulatory oversight of cosmetic and personal care products and create a comprehensive and uniform national framework for their regulation. Contained within MoCRA are two

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Drug Products Containing Carbomers Manufactured With Benzene

What are Carbomers and why do some contain benzene? Carbomers are a group of polymers that are widely used as inactive ingredients in drug products as fillers, emulsifiers, gelling agents, and binding agents.  Some carbomers are manufactured using benzene as a polymerization solvent, whilst others employ a benzene-free manufacturing process.

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Best Practices
CPT Labs

GAO Assessment of FDA Efforts to Implement MoCRA

The Modernization of Cosmetic Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022 and is the most significant expansion of FDA’s authority to regulate cosmetics since the enactment of the Federal Food, Drug, and Cosmetic Act in 1938.  On the one-year anniversary of the enactment of MoCRA, the

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Preservative Efficacy Testing: USP 51 Versus PCPC

As its name suggests, Preservative Efficacy Testing (PET) is a procedure for determining the effectiveness of a product’s preservative system after controlled quantities of test microorganisms have been introduced.  Antimicrobial Preservative Efficacy testing is essential to cosmetic/personal care and drug manufacturers for identifying optimal preservative combination(s) and concentrations(s) of preservatives

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Woman testing a product for cosmetic claims substantation
Businesses
Craig Weiss

Cosmetic Claims Substantiation

Why Are Cosmetic Claims Substantiation Studies Important? When approaching a claims-support study for any product that produces a cosmetic endpoint, it is important to understand the types of claims available. Puffery, or emotive claims, are meant to grab the emotions of consumers but don’t necessarily say much about product benefits.

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Businesses
CPT Labs

Simple Clinical Trial Statistics Overview

Planning a successful clinical study begins with some central questions:   What question(s) do we want to answer?   What statistical methods will help us answer these questions?   What data do we need to collect?   How will we collect it?   From whom and from how many?  

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Cosmetic Claims Substantiation

Why Are Cosmetic Claims Substantiation Studies Important? When approaching a claims-support study for any product that produces a cosmetic endpoint, it is important to understand

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