The beauty industry represents a dynamic, multi-billion-dollar global market. Despite its commercial scale and innovation-driven nature, cosmetic products remain subject to strict government regulations designed to protect consumer health and ensure accurate product labeling. While many consumers assume that authorities approve cosmetics before they reach the market, regulatory responsibility in most jurisdictions rests primarily with manufacturers and distributors.
This article outlines the core cosmetic regulatory frameworks in the United States and Canada, with particular focus on the major regulatory shift introduced by the Modernization of Cosmetics Regulation Act (MoCRA) in the U.S. and Canada’s established notification-based compliance system.
U.S. Cosmetic Regulation and the Impact of MoCRA
For many decades, the Federal Food, Drug, and Cosmetic (FD&C) Act governed cosmetic regulation in the United States. Under this framework, the Food and Drug Administration (FDA) exercised limited oversight. Cosmetic products and ingredients did not require pre-market approval, except for color additives, and many compliance activities remained voluntary. Cosmetic companies carried the primary responsibility for product safety and labeling accuracy.
This long-standing regulatory approach changed significantly with the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA represents the most substantial expansion of FDA authority over cosmetics since 1938 and introduces binding obligations that reshape how cosmetic companies operate in the U.S. market.
Core Mandatory Requirements Under MoCRA
MoCRA established several compulsory compliance pillars for companies manufacturing or distributing cosmetic products in the United States.
Facility registration and product listing now apply to all owners and operators of cosmetic manufacturing facilities. Facilities must register with the FDA, and the responsible person must submit a product listing for each cosmetic placed on the market, including a full ingredient list.
MoCRA also introduced mandatory safety substantiation requirements. Responsible persons must maintain scientific evidence demonstrating that each cosmetic product is safe for its intended use under normal or reasonably foreseeable conditions.
Adverse event reporting obligations now require companies to document and report serious health-related adverse events associated with cosmetic products. These records must remain accessible for FDA inspection.
The legislation authorizes the FDA to establish mandatory Current Good Manufacturing Practice (CGMP) regulations for cosmetic facilities, strengthening oversight of production conditions and quality systems.
MoCRA further expands FDA enforcement authority. The agency may now mandate product recalls when cosmetics present serious health risks and suspend facility registrations in cases of significant non-compliance.
Cosmetic Regulation in Canada: Notification and Ingredient Control
Health Canada regulates cosmetic products under the Food and Drugs Act and the Cosmetic Regulations. Unlike the historical U.S. framework, Canada applies a mandatory notification system that companies must follow to legally place cosmetics on the market.
The Cosmetic Notification Form (CNF)
Manufacturers and importers must submit a Cosmetic Notification Form (CNF) to Health Canada within ten days of the first sale of a cosmetic product in Canada. This notification requirement applies to all cosmetic products, regardless of origin.
The CNF includes detailed information such as the product’s function, physical form, and intended area of application. Companies must also provide a complete ingredient list with concentration ranges and identify a Responsible Person established in Canada.
The Cosmetic Ingredient Hotlist
A critical component of Canadian cosmetic compliance is the Cosmetic Ingredient Hotlist. This administrative list identifies substances that Health Canada prohibits or restricts in cosmetic products, often with specific concentration limits or conditions of use.
Manufacturers must carefully review product formulations against the Hotlist before market entry. Ingredients permitted in other jurisdictions may face restrictions or outright bans in Canada, making formulation review essential for compliance.
Bilingual Labeling Requirements in Canada
Canadian cosmetic regulations impose strict labeling standards. All mandatory label information, including ingredient lists, warnings, and directions for safe use, must appear in both English and French. Failure to meet bilingual labeling requirements can result in enforcement actions or market removal.
Cosmetic Export Compliance for the U.S. and Canada
Companies engaged in cosmetic export must recognize that domestic regulatory compliance does not automatically translate to acceptance in foreign markets. Each destination country applies its own legal requirements, and exporters must adapt accordingly.
When exporting cosmetics to the United States or Canada, companies must designate a Responsible Person within the destination country to manage regulatory obligations. Formulations require careful review against local ingredient restriction lists, such as Canada’s Hotlist or MoCRA-related safety expectations in the U.S.
Labeling also requires localization to reflect language requirements, allergen disclosures, and mandatory regulatory statements. Companies must align packaging and documentation with country-specific standards before market entry.
Conclusion: Navigating Evolving Cosmetic Regulations
Cosmetic regulation continues to evolve in response to consumer safety expectations and regulatory modernization efforts. The implementation of MoCRA has significantly increased compliance obligations in the United States, while Canada maintains a long-standing, notification-driven system supported by strict ingredient and labeling controls.
For manufacturers and exporters, long-term success in these markets depends on proactive regulatory planning, detailed formulation review, and accurate documentation. Companies that understand and implement these requirements effectively position themselves for sustainable growth in highly regulated cosmetic markets.
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