The Modernization of Cosmetics Regulation Act of 2022 — MoCRA — gave FDA authority over cosmetics that it hadn't held in more than eighty years. For an industry that had operated under the Federal Food, Drug, and Cosmetic Act's relatively light-touch cosmetics provisions since 1938, the change was significant.
Several years into MoCRA's implementation, most beauty brands have adapted their approach to facility registration and ingredient reporting. Fewer have worked through what MoCRA means specifically for how they review, verify, and manage the accuracy of what goes on their labels — a discipline that spans the whole FMCG/CPG category, not just cosmetics.
What MoCRA Changed for Labeling
MoCRA requires cosmetic brands to maintain safety substantiation records for their products, including documentation that supports the safety of ingredients and formulations. This obligation connects directly to labeling: if an ingredient appears on the label, safety documentation for that ingredient must exist. Notably, FDA has not yet issued full guidelines interpreting what "adequate substantiation" requires in practice, more than three years after the requirement took effect — FDA's own guidance confirms that US regulations do not specify any particular testing regimen for cosmetic products or ingredients, leaving brands to meet the standard without a complete rulebook for what satisfies it.
More practically, MoCRA expanded FDA's authority to require mandatory recalls of cosmetics — something FDA could not do under the previous regulatory framework. A cosmetics labeling error that previously might have been addressed through voluntary recall now exists in an environment where FDA can mandate corrective action. The risk calculus has changed.
MoCRA also requires that the Responsible Person — the brand or contract manufacturer whose name appears on the label — register with FDA and report adverse events. The Responsible Person designation on the label is a compliance-relevant data point, not just a commercial one.
Where MoCRA Implementation Actually Stands
Two developments worth tracking as of mid-2026 change the practical picture for labeling teams. FDA's proposed rule on fragrance-allergen labeling disclosure — a US equivalent to the kind of allergen transparency already required in the EU — was anticipated to reach the Notice of Proposed Rulemaking stage around May 2026, with the final rule not expected to be enforced until 2027 or later. Brands with EU operations already managing the expanded EU fragrance-allergen list have a head start on the underlying compliance work, but the specific US labeling requirement remains a proposal, not a current obligation. Separately, MoCRA's mandated cosmetic GMP regulations — meant to establish binding manufacturing standards — have been moved to FDA's long-term rulemaking list, meaning final GMP requirements are not expected in the near term despite the statutory deadline having already passed.
Neither delay reduces what's currently enforceable: facility registration, product listing, safety substantiation, adverse event reporting, and FDA's recall authority are all active requirements today, with biennial facility registration renewals now coming due on a rolling basis tied to each facility's original registration date.
Where Post-MoCRA Labeling Compliance Is Still Falling Short
INCI (International Nomenclature of Cosmetic Ingredients) listing errors remain prevalent — not because brands don't know INCI is required, but because INCI naming conventions are precise and formulation changes don't always trigger a systematic label review. A reformulation that substitutes one emollient for a chemically similar but differently named alternative may not trigger a label review. The new ingredient enters the formulation; the label retains the old INCI name.
Post-Brexit, the Responsible Person requirement for EU and UK markets has also generated labeling errors for brands operating in both markets. A label that correctly identifies the EU Responsible Person may not correctly reflect the UK Responsible Person — a separate legal requirement since 2021. These are separate data fields that must be managed independently, and brands managing both markets from a single label master are vulnerable to updating one without updating the other.
The Label Verification Gap
The broader issue is that cosmetics labeling verification has historically been less rigorous than pharmaceutical labeling verification — partly because the regulatory stakes were lower. MoCRA has changed the stakes. A cosmetics brand operating today faces a regulatory environment where FDA has recall authority, where facility registration is mandatory and subject to recurring renewal, and where the accuracy of Responsible Person information on a label has legal implications.
The verification standard should reflect the new risk level. That means systematic comparison of labels against approved masters, not just visual review. It means version-controlled label management across markets — increasingly relevant as the US fragrance-allergen proposal moves toward the same territory the EU already occupies. And it means treating each label revision — however minor it appears — as a compliance event.
↗ InformaIT's Content Compare supports cosmetics label verification in the post-MoCRA environment — from INCI accuracy to Responsible Person information and multilingual version control. Compare what to look for in a compliance-grade platform, or request a demo.
