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,
Hair care claims require clinical backing. Here’s how a well-structured study moves from planning to publishable data. 1. Planning: the decisions made before data collection determine study quality. Clinical study planning is where the most consequential decisions are made, and the most expensive mistakes are either made or avoided. Before
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
Your Questions Answered: What Is HDRS Testing and Why Does It Matter? Hybrid Diffuse Reflectance Spectroscopy (HDRS) is one of the most significant advances in sunscreen testing in decades, and it’s already approved for product labeling in Europe. Here, our team answers the most common questions we hear from formulators,
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
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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
Hair care claims require clinical backing. Here’s how a well-structured study moves from planning to publishable data. 1. Planning: the decisions made before data collection
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
Your Questions Answered: What Is HDRS Testing and Why Does It Matter? Hybrid Diffuse Reflectance Spectroscopy (HDRS) is one of the most significant advances in
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