Launching an Over-the-Counter (OTC) drug in the United States is a rigorous process, but it doesn’t always require the years-long, multi-million dollar path of a New Drug Application (NDA). For most OTC products, the pathway to market relies on the OTC Drug Monograph system. But what exactly is it, and
In today’s cosmetic and personal care product market, claims such as “hypoallergenic,” “suitable for sensitive skin,” or “non-irritating” are powerful differentiators. Consumers want products that are gentle, safe, and less likely to cause adverse skin reactions. However, from a regulatory, scientific, and brand credibility perspective, such claims require solid evidence.
Launching a new product is a high-stakes endeavor. You depend on testing data to validate performance, support claims, and satisfy regulators. Yet many companies stumble before they even get to market. Below are three common “testing traps” that can silently undermine your launch readiness and what you should do to
In R&D, formulation, and for compliance teams working in cosmetics, personal care, or topical pharmaceutical products, understanding the differences between photoallergy and phototoxicity is essential to ensure product safety, meet regulatory requirements, and prevent adverse skin reactions. In this blog, we’ll review the relevant regulatory frameworks and discuss how we
Introduction: A New Era in U.S. Cosmetic Regulation The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most sweeping update to U.S. cosmetic legislation in decades. Among its many new requirements are mandates for standardized asbestos testing in talc and fragrance allergen disclosure. These mandates are not optional
When formulating sunscreen products, it’s essential to validate not only UV protection, such as SPF and broad-spectrum claims, but also thermal stability and performance under heat. Dropping Point testing is a crucial analytical method that helps in R&D, formulation, compliance, and regulatory review. What is Dropping Point Testing? Dropping Point
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Skin hydration testing has evolved significantly over the decades, and today’s options range from low-cost probes to advanced imaging technologies. Here’s a look at the
Dry skin, or xerosis, is one of the most common skin care concerns and one of the most misunderstood. Before you can substantiate a hydration
Marketplaces like Amazon, HSN, and QVC give beauty and personal care sellers fast access to millions of shoppers. But they also set their own testing,
Sunscreen brands are under more scrutiny than ever. Between FDA scrutiny, retailer expectations, consumer watchdog testing, class-action lawsuits, and viral social media callouts, inaccurate SPF
Here’s a fact that surprises many people outside the industry: there are currently no specific US requirements for conducting stability testing or assigning expiration dates
Cosmetic and personal care products occupy an unusual regulatory space in the United States. Unlike drugs, they don’t require FDA approval before they can be