MoCRA Deadline Calculator

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022 as part of the Consolidated Appropriations Act, represents the most significant update to US cosmetic regulation since the Federal Food, Drug, and Cosmetic Act of 1938. For the first time, cosmetic companies selling in the United States face mandatory registration, product listing, safety substantiation, adverse event reporting, and Good Manufacturing Practice (GMP) requirements. Understanding which requirements apply to your business -- and when they take effect -- is critical to avoiding enforcement actions, import holds, and market disruption.

The MoCRA Small Business Exemption

MoCRA provides a targeted exemption for small businesses, but it is narrower than many brands assume. To qualify, a company must have average annual gross sales of cosmetic products in the United States of less than $1,000,000 over the preceding three-year period. This figure is calculated on gross sales, not net revenue, and includes all cosmetic products sold under the company's ownership or control. If a parent company or affiliate exceeds the threshold in aggregate, the exemption does not apply to any entity within that group.

Even for businesses that meet the revenue threshold, the exemption does not cover products that contact the eye area (such as eyeliners, mascaras, and eye creams), products that are injected, or products intended for internal use. These categories are considered higher-risk and must comply with all MoCRA requirements regardless of the manufacturer's revenue. This means a small brand selling a single mascara alongside 50 lip glosses would need to register its facility and list the mascara, even if the lip glosses are exempt.

Importantly, the exemption only relieves businesses from facility registration, product listing, GMP requirements, and records access obligations. It does not exempt any business from safety substantiation, adverse event reporting, or labeling requirements. Every cosmetic company, regardless of size, must be able to demonstrate that its products are safe and must report serious adverse events to the FDA.

What "Adequate Safety Substantiation" Means

Under MoCRA, every cosmetic product must have adequate substantiation of safety. The FDA has not issued a single prescriptive standard for what constitutes adequate substantiation, but the agency has signaled that it expects companies to rely on a combination of published scientific literature, toxicological assessments, clinical testing data, and historical use data to support the safety of each ingredient and the finished product as a whole.

In practice, this means brands should maintain a safety dossier for each product that includes an ingredient-by-ingredient safety review, an assessment of the finished formulation (including potential interactions between ingredients), exposure calculations based on intended use, and any available clinical or consumer testing data. The Cosmetic Ingredient Review (CIR) panel's published assessments are widely accepted as authoritative sources for ingredient safety, and brands should reference these wherever available. For novel ingredients or concentrations that exceed CIR recommendations, additional testing or expert toxicological review may be necessary.

The key risk for brands is that the FDA can now request access to safety substantiation records and can take enforcement action if a product lacks adequate support. This is a significant shift from the pre-MoCRA environment where the burden of proving a product was unsafe rested almost entirely on the FDA. Brands that have historically relied on supplier certificates of analysis alone should consider building more comprehensive safety files. For guidance on building a complete safety dossier, see our Complete Guide to MoCRA Compliance in 2026.

The 15-Business-Day Adverse Event Reporting Rule

One of MoCRA's most operationally demanding requirements is the mandatory reporting of serious adverse events. A "serious adverse event" is defined as any health-related event associated with the use of a cosmetic product that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance).

When a responsible person (the manufacturer, packer, or distributor whose name appears on the product label) receives a report of a serious adverse event, they must submit a report to the FDA within 15 business days. This is not 15 calendar days -- weekends and federal holidays do not count, giving companies roughly three calendar weeks in most cases. However, the clock starts from the date the responsible person first becomes aware of the event, which includes reports received through customer service channels, social media, retail partners, or any other source.

Companies must also submit any new medical information related to the adverse event within one year of the initial report. This follow-up requirement means that brands need an ongoing monitoring process, not just a one-time report. Maintaining accurate contact information on product labels is essential, as the FDA considers the responsible person to be the entity named on the label. For a deeper dive into all MoCRA requirements, visit our MoCRA compliance overview.

Key Deadlines at a Glance

The FDA set July 1, 2024 as the initial deadline for facility registration and product listing. Companies that have not yet completed these filings are already past due and should take action immediately to minimize regulatory risk. GMP requirements are expected to be formalized in 2026, with the FDA working on guidance documents that will define specific manufacturing standards for cosmetics. Safety substantiation and adverse event reporting requirements are already in effect and have no grace period -- they apply to all cosmetic products currently on the market.

For brands that are unsure where they stand, this calculator provides a starting point. But MoCRA compliance is not a one-time checklist -- it requires ongoing monitoring, documentation updates, and proactive engagement with evolving FDA guidance. Cosmetica automates the most time-consuming aspects of compliance, from facility registration and product listing to safety documentation and deadline tracking, so your team can focus on formulation, marketing, and growth.