Posts by Marc Sanchez
FDA QMSR Is Now in Effect: What Medical Device Companies Should Do Next
If you are a medical device company and you are still preparing for FDA inspections using the old Quality System Inspection Technique guide — stop. That document was officially retired on February 2, 2026, the same day the FDA’s new Quality Management System Regulation took effect. If your inspection readiness plan is built around QSIT,…
Read MoreFlavored E-Cigarette PMTAs in 2026: What FDA’s New Draft Guidance Actually Changes
The FDA’s Center for Tobacco Products issued a new draft guidance on March 9, 2026, that is the most detailed statement yet on how the agency will evaluate premarket applications for flavored e-cigarettes. The guidance formalizes a flavor-specific, evidence-scaled framework — and it shifts FDA’s prior position on device access restrictions in a way that…
Read MoreFDA General Wellness Guidance 2026: What Wearable and Digital Health Companies Can and Can’t Do Now
If you’re building a wearable, wellness app, smart ring, recovery tracker, or connected health platform, FDA just updated the playbook — and the changes matter. On January 6, 2026, FDA issued a revised final guidance replacing its 2019 General Wellness policy. The update doesn’t rewrite the rules, but it meaningfully clarifies what companies using non-invasive…
Read MoreWill the FDA Eliminate Self-Affirmed GRAS? What the Proposed Rule Could Mean
The conversation around self-affirmed GRAS is evolving quickly, with lawmakers and regulators signaling potential changes that could reshape how food ingredients are evaluated and brought to market. While the FDA has not eliminated the pathway, proposed reforms and increased scrutiny suggest that companies relying on this framework should begin preparing now. For businesses, the real…
Read MoreFDA GRAS Reform in 2026: What Food and Ingredient Companies Need to Know
The landscape of food ingredient safety is entering a period of significant transition in 2026. For decades, the “Generally Recognized as Safe” (GRAS) pathway has allowed companies to bring new ingredients to market based on their own scientific determinations of safety. However, as the FDA implements a major restructuring of its Human Foods Program, the…
Read MoreThe FDA’s Quality Management System Regulation (QMSR): What the New Inspection Framework Means for Medical Device Companies
The medical device industry is currently navigating one of its most significant regulatory shifts in decades. For nearly thirty years, the Food and Drug Administration (FDA) relied on the Quality System Regulation (QSR) found in 21 CFR Part 820 to ensure the safety and efficacy of devices. However, the landscape has changed. To foster innovation…
Read MoreThe FDA’s New Approach to “No Artificial Colors” Claims: Compliance Risks and Legal Considerations
The U.S. Food and Drug Administration has announced a new enforcement approach to products labeled “no artificial colors,” signaling heightened scrutiny for food and beverage companies that rely on clean-label marketing. While the phrase may appear straightforward, the regulatory analysis behind it is far more nuanced. As outlined in the FDA’s official press announcement, the…
Read More503A vs 503B Compounding Pharmacies: Compliance Risks That Can Pull Products from the Market
Compounding pharmacies play a critical role in patient care, especially when commercially available drugs cannot meet specific clinical needs. However, the regulatory distinction between traditional compounding and large-scale outsourcing remains one of the most common sources of enforcement exposure in the pharmaceutical space. Misunderstanding where that line is drawn can create compliance risks under 503a…
Read MoreCongress Targets the GRAS Process: Four Bills That Could Fundamentally Change FDA Food Ingredient Oversight
GRAS Loophole For more than two decades, the FDA’s “generally recognized as safe” (GRAS) framework has allowed food ingredients to enter the U.S. market either through FDA notification or through a company’s internal “self-GRAS” determination without notifying the agency. That flexibility is now under renewed scrutiny. Four separate bills introduced in the 118th and 119th…
Read MoreWhat the Shutdown-Ending Bill Means for Hemp, CBD, and Cannabinoid Products
The Hemp Provision in H.R. 5371: What the Shutdown-Ending Bill Means for Hemp, CBD, and Cannabinoid Products Congress quietly enacted one of the most sweeping federal cannabis and hemp restrictions in years—and it arrived tucked inside the same bill that ended the 43-day government shutdown. H.R. 5371, the legislation that restored funding for FDA and…
Read MoreThe Longest Shutdown Ends: What FDA & USDA Restart Now and What’s Been Lost
Reopening the FDA and USDA After 43 days, the longest government shutdown in U.S. history is officially over. On November 12, 2025, the President signed H.R. 5371, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, reopening the federal government and restoring funding across agencies. (Business Insider) The package…
Read MoreFDA & USDA Reopening: What Likely Resumes on Day 0, Day 3, and Day 7 (Assuming CR Passage)
Assuming Congress passes and the President signs the pending continuing resolution Backlog and Recovery Timeline: Even after funding is restored, both FDA and USDA face operational backlogs. Expect a staged recovery—FDA typically clears urgent submissions (recalls, safety-critical reviews) within the first week, while standard user-fee submissions and inspections may take two to four weeks to normalize.…
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