The beauty industry is a vibrant, multi-billion dollar sector, yet its products must adhere to stringent government regulations to ensure consumer safety and proper labeling. While many consumers assume pre-market government approval, the regulatory landscape is often more complex, resting largely on manufacturer responsibility. This article explores the key regulatory frameworks, focusing on the recent seismic shifts in the United States and the established system in Canada.
The FDA and the Historic Shift: Understanding MoCRA
For decades, cosmetic regulation in the United States was governed by the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this framework, the FDA‘s authority was limited: cosmetic products and ingredients did not require pre-market approval (with the exception of color additives), and compliance was often voluntary. The primary responsibility for safety and correct labeling fell squarely on the cosmetic companies.
However, the regulatory landscape underwent a dramatic transformation with the enactment of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This legislation marks the most significant expansion of the FDA’s oversight since 1938, introducing mandatory requirements that fundamentally change how companies operate in the U.S. market.
MoCRA’s Mandatory Cornerstones
MoCRA introduced several non-negotiable mandates for companies operating or distributing products in the United States:
- Mandatory Facility Registration and Product Listing: Every person who owns or operates a manufacturing facility must register the facility with the FDA. Furthermore, the “responsible person” (manufacturer, packer, or distributor) must submit a list of each marketed cosmetic product, including a list of all ingredients.
- Safety Substantiation: MoCRA requires the responsible person to ensure and maintain records supporting adequate safety substantiation for their products. This means having credible scientific data to support the product’s safety for its intended use.
- Adverse Event Reporting: Companies must maintain records of and report serious health-related adverse events associated with their products to the FDA.
- Good Manufacturing Practice (GMP): MoCRA grants the FDA the authority to establish formal, mandatory Current Good Manufacturing Practice (CGMP) regulations for cosmetic facilities.
- Expanded FDA Authority: The FDA now possesses new enforcement tools, including the power to mandate a mandatory recall if a product is adulterated or misbranded and poses a serious health risk, and the authority to suspend a facility’s registration.
Canada Cosmetic Regulation: Notification and the Hotlist
In Canada, cosmetics are regulated by Health Canada under the authority of the Food and Drugs Act and the Cosmetic Regulations. Unlike the former voluntary system in the U.S., Canada employs a mandatory notification system that is critical for market entry.
The Cosmetic Notification Form (CNF)
To legally sell a cosmetic in Canada, the manufacturer or importer must file a Cosmetic Notification Form (CNF) with Health Canada. This must be done within 10 days of the product’s first sale in Canada.
The CNF requires detailed information, including:
- The product’s function, form, and intended area of application.
- A complete list of ingredients and their concentrations.
- Contact information for the Responsible Person (an entity based in Canada).
The Cosmetic Ingredient Hotlist
A key component of Canada Cosmetic Regulation is the Cosmetic Ingredient Hotlist. This is an administrative list of substances that are either prohibited from use or restricted to certain concentration limits and/or conditions of use in cosmetic products. Manufacturers must rigorously check their formulations against this list to ensure compliance, as it can differ significantly from lists in other jurisdictions.
Bilingual Labeling Mandate
Canadian regulations also enforce strict labeling requirements, most notably the need for all mandatory information—including the ingredient list, warnings, and directions for safe use—to appear in both English and French.
Global Trade Compliance: The Reality of Cosmetic Export
For brands looking to globalize, adherence to the destination country’s specific rules is paramount. The success of Cosmetic Export hinges on recognizing that the manufacturer’s home country rules do not apply abroad.
When exporting cosmetics to the U.S. or Canada, companies must:
- Establish a Responsible Person: For the U.S. (post-MoCRA) and Canada, the exporter must designate a person or entity responsible for the product’s compliance within that country.
- Ingredient Review: Formulas must be meticulously reviewed against the destination country’s restrictive substance lists (e.g., Canada’s Hotlist). Ingredients that are permissible elsewhere may be banned or restricted in the target market.
- Labeling Localization: Labels must be tailored to meet local language requirements (English/French in Canada, specific allergen labeling under MoCRA in the U.S.) and mandatory placement of compliance information.
Conclusion
The regulation of cosmetics is a dynamic process driven by consumer safety and demand for transparency. With the sweeping changes introduced by MoCRA in the U.S., and the long-standing, rigorous notification requirements in Canada, manufacturers today face a higher and more complex bar for compliance. Understanding and meticulously implementing these rules is the only path for sustained success in these major markets.
