FDA News

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

When the FDA arrives, it’s a different ballgame than what you learned in compliance courses. Standard training provides the rulebook but overlooks the unwritten elements, including the strategic and psychological aspects that make or break an inspection. Preparing for the FDA doesn’t have to be a frantic scramble. By embracing a culture of readiness, you can face your next inspection with confidence. Here are 7 practical tips that compliance courses often overlook. 1. Tell a

If you're in the medical device space, you've likely heard the buzz: the FDA is officially aligning its Quality Management System Regulation (QMSR) with ISO 13485:2016. This is a big deal — and it’s not just regulatory housekeeping. It’s a strategic shift that will impact how U.S. device manufacturers operate, document, and demonstrate compliance. So, What’s Changing? The FDA’s final rule, issued in February 2024, replaces the long-standing 21 CFR Part 820 framework with a sy

If you’re a food brand selling in California — or anywhere in the U.S., really — it’s time to pay close attention. California is once again leading the charge on food safety and environmental responsibility, and the ripple effects are already being felt nationwide. Red Dye No. 3: The End of an Era Red Dye No. 3 (also known as erythrosine) has been under scrutiny for decades. Linked to cancer in lab animals and behavioral issues in children, it’s already banned in cosmetics. N

If you’re in the dietary supplement industry, you’ve probably noticed the winds shifting — and fast. With Robert F. Kennedy Jr. now serving as Secretary of Health and Human Services, and the Trump administration backing his Make America Healthy Again (MAHA)  agenda, the regulatory landscape is being reshaped in real time. A New Era for Supplements? Kennedy has long criticized what he calls the FDA’s “aggressive suppression” of vitamins, herbal remedies, and other natural prod