FDA News

Here’s a scenario we see all too often. You’ve spent months, maybe years, perfecting your cosmetic product. You’ve registered your facility under MoCRA . Your labels list every ingredient in descending order of predominance. Your formulations use only approved color additives. You’ve done everything the FDA requires.  Then a customer files a lawsuit claiming your face cream caused a rash. Your legal bills hit $15,000 before you even get to court. Amazon suspends your seller

Selling cosmetics online is easier than ever. You can launch a Shopify store, partner with Amazon, work with influencers, and reach customers worldwide, all without a physical storefront. But here's what most digital-first beauty brands don't realize: the FDA and FTC don't care that you're "just" an online business.  The same regulations apply to you, and in some cases, e-commerce creates additional  compliance risks. Skip even one of these requirements, and you could face wa

You've perfected your formula, designed stunning packaging, and you're ready to launch your cosmetic brand. But before you start selling, there's a legal minefield to navigate. Skip even one of these steps, and you could face costly recalls, regulatory action, or lawsuits that sink your business. The cosmetic industry is more regulated than most entrepreneurs realize, especially after the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) dramatically expanded FDA auth

You’ve spent months perfecting your formula. You’ve sourced the best ingredients. You’ve registered your facility under MoCRA . Your ingredient list is flawless, every component listed in descending order of predominance, using proper INCI names. Then the FDA sends a warning letter . Or worse, your products get seized at the border. Or Amazon suspends your seller account. The reason? Your label is missing required contact information. Or your net weight isn’t bolded. Or your

The FDA's enforcement landscape for cosmetics is rapidly evolving as MoCRA implementation matures and new regulatory priorities emerge. Based on current enforcement patterns and regulatory developments, here are the key trends cosmetics companies should prepare for in 2026. 1. Aggressive MoCRA Compliance Enforcement What's Coming:  The FDA's grace period for MoCRA compliance is ending. Expect systematic enforcement actions against unregistered facilities and unlisted products

The FDA regulates cosmetics to ensure consumer safety. Manufacturers, importers, or sellers in the US must comply. Here's an overview, with condensed points and brief explanations where key concepts need clarification. What Counts as a Cosmetic? The FDA defines cosmetics as products for cleansing, beautifying, enhancing attractiveness, or altering appearance. Examples include: Makeup (e.g., lipstick, foundation, mascara) and skincare (e.g., moisturizers, cleansers, serums) Ha

The FDA's approach to cosmetic registration has undergone a fundamental transformation. The Voluntary Cosmetic Registration Program (VCRP), which operated for decades as an optional reporting system, was discontinued in March 2023. It has been replaced by mandatory facility registration and product listing requirements under the Modernization of Cosmetics Regulation Act (MoCRA). The End of VCRP: What Changed The FDA stopped accepting VCRP submissions on March 27, 2023, as par

The FDA's approach to cosmetic ingredient safety has fundamentally shifted. What once operated on voluntary compliance and industry self-regulation now involves active enforcement, mandatory reporting, and comprehensive oversight. For cosmetics companies, understanding these new priorities isn't optional, it's essential for avoiding enforcement action. MoCRA's Enforcement Revolution The Modernization of Cosmetics Regulation Act (MoCRA) transformed how the FDA regulates cosmet

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Cosmetics are one of the least regulated product categories by the FDA, but that does not mean you can skip on compliance. There are...

Businesses looking to export food, dietary supplements, or cosmetics manufactured in the US may be required to present an export...