USA Regulatory Services
Cosmetics Regulatory Services in the USA
The United States represents the largest global market for cosmetic products. With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA), navigating FDA requirements has become more critical and stringent than ever before. We provide the expertise you need to ensure flawless compliance and rapid market entry.
Navigating the Modernization of Cosmetics Regulation Act (MoCRA)
Historically, the U.S. cosmetics industry operated with relatively minimal pre-market regulatory oversight. The introduction of MoCRA (Modernization of Cosmetics Regulation Act of 2022) revolutionized this landscape, significantly expanding the FDA's regulatory authority and imposing new mandatory compliance standards for manufacturers and brand owners.
Under the new framework, the FDA possesses the authority to review cosmetic products directly and enforce mandatory recalls for non-compliance. Brands must now establish robust protocols for Post-Marketing Surveillance and rigorous adverse event reporting.
A critical step in U.S. compliance is accurate product classification. The FDA strictly distinguishes between standard cosmetics and products with therapeutic claims. Items such as antiperspirants, anti-dandruff shampoos, acne treatments, and fluoride mouthwashes are legally classified as drugs in the U.S. market. Incorrect classification can lead to immediate regulatory action and border detentions.
NKB Regovanta provides end-to-end regulatory support designed specifically to navigate these complexities. From securing your mandatory FDA Facility Registration and Product Listing to conducting meticulous label and claims reviews, we ensure your products align perfectly with the Federal Food, Drug, and Cosmetic (FD&C) Act and MoCRA guidelines.
Comprehensive FDA Compliance Solutions
We assess which FDA obligations apply to your products and activities, then organise the evidence, registration and ongoing compliance work needed for your US market plan.
FDA Product & Facility Registration
We ensure seamless compliance with mandatory MoCRA requirements by managing both your FDA Cosmetic Product Listing and Cosmetic Facility Registration.
MoCRA Compliance & Strategy
Navigate the updated Modernization of Cosmetics Regulation Act with our experts to ensure strict safety substantiation and regulatory adherence.
Product Classification (Cosmetic vs. Drug)
We help determine the precise regulatory category for your product, ensuring items with therapeutic claims are correctly registered under drug pathways if necessary.
FDA Labeling & Claims Review
Our rigorous review process guarantees that your ingredient nomenclature, mandatory warnings, and marketing claims meet all FDA and FD&C Act standards.
Adverse Event Tracking & Reporting
We provide comprehensive post-marketing surveillance support to track, document, and report adverse events securely in accordance with MoCRA.
Ingredient & Formulation Analysis
Thorough scientific evaluation of your cosmetic formulations to guarantee that all ingredients comply with the latest federal safety guidelines.
Frequently Asked Questions
Is FDA registration now mandatory for cosmetics?
MoCRA requires facility registration and product listing for covered facilities and products, but exemptions apply, including for certain small businesses. Eligibility depends on the business and product category. Check FDA's MoCRA exemptions.
What does MoCRA compliance entail?
MoCRA requires strict adherence to updated FDA regulations, which introduce mandatory product/facility registration, enhanced safety substantiation, proactive post-market adverse event reporting, and grants the FDA legal authority to issue mandatory recalls.
What are the FDA cosmetic labeling requirements?
Labels must clearly display the product identity, net contents, a complete ingredient list using standard nomenclature, the manufacturer or importer's details, appropriate safety warnings, and only truthful, non-therapeutic claims.