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 to cosmetic products. A brand could, in theory, sell a product indefinitely without ever studying how it changes over time. So why do so many
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 sold. But that lighter pre-market pathway doesn’t mean lighter responsibility. Under US law, cosmetics simply cannot be “adulterated” or “misbranded,” and companies that manufacture or
For R&D, formulation, and regulatory professionals evaluating their safety testing programs, the shift toward in vitro methods is no longer a trend. It’s the established standard. 1. Regulatory frameworks have already moved in the EU and across the U.S. Animal testing restrictions for cosmetics are not pending legislation. The European
Whether you are testing raw materials, in-process samples, or finished goods, the right compendial method depends on your product type, formulation, and regulatory market. Here’s a working overview. 1. USP <61>: Microbial Enumeration USP <61> is the foundational compendial method for quantitative microbial enumeration, measuring Total Aerobic Microbial Count (TAMC),
Regulatory complexity within the OTC drug, cosmetic, and dietary supplement space is intensifying. Here’s how CPT℠ Labs’ consulting services help manufacturers and brands get ahead of it. 1. FDA compliance remediation that addresses the “root cause”, not just the citation point. When a FDA 483 observation or Warning Letter arrives,
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 claims can quickly turn into a regulatory, legal, and PR nightmare. The challenge is that many brands don’t realize there’s a problem until it’s already
In the OTC drug industry, your product is only as good as the partners who help you make it. The raw material supplier who sources your active pharmaceutical ingredient (API), the contract manufacturer (CMO) who blends and packages your product, and the contract testing lab whose results determine the release
If you’re involved in the manufacture or distribution of over-the-counter (OTC) drug products in the United States, you’re already operating in one of the most scrutinized regulatory environments in the world. Yet many companies, especially smaller brands and private-label manufacturers, treat supply chain quality as an afterthought rather than a
MoCRA in 2026: Where Things Stand and What You Should Have Done Yesterday When the Consolidated Appropriations Act of 2023 was signed into law on December 29, 2022, it ushered in the most significant overhaul of cosmetic regulation in the United States since 1938. The Modernization of Cosmetics Regulation Act
Bringing an Over-the-Counter (OTC) drug to market is a high-stakes endeavor. If you missed our live webinar about Launching an OTC Product the Right Way, here are the three most critical takeaways that every brand owner needs to know and how to avoid the most common pitfalls that delay launches
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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
For R&D, formulation, and regulatory professionals evaluating their safety testing programs, the shift toward in vitro methods is no longer a trend. It’s the established
Whether you are testing raw materials, in-process samples, or finished goods, the right compendial method depends on your product type, formulation, and regulatory market. Here’s
Regulatory complexity within the OTC drug, cosmetic, and dietary supplement space is intensifying. Here’s how CPT℠ Labs’ consulting services help manufacturers and brands get ahead
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
In the OTC drug industry, your product is only as good as the partners who help you make it. The raw material supplier who sources
If you’re involved in the manufacture or distribution of over-the-counter (OTC) drug products in the United States, you’re already operating in one of the most
MoCRA in 2026: Where Things Stand and What You Should Have Done Yesterday When the Consolidated Appropriations Act of 2023 was signed into law on
Bringing an Over-the-Counter (OTC) drug to market is a high-stakes endeavor. If you missed our live webinar about Launching an OTC Product the Right Way,