Is Your Cosmetics Business Exempt from MoCRA? Small Business Rules Explained

Does MoCRA Apply to Your Business?

While the Modernization of Cosmetics Regulation Act (MoCRA) applies to most cosmetics businesses, Congress included specific exemptions for very small businesses to avoid placing disproportionate compliance burdens on artisanal and micro-scale cosmetics producers.

Understanding whether you qualify for an exemption could save significant compliance costs — or get you into serious trouble if you wrongly assume you're exempt.

The Small Business Exemption for Facility Registration

Under MoCRA, a business qualifies for the small business exemption from facility registration and product listing if:

• The business (including all related companies) had average annual gross sales of cosmetics of $1,000,000 or less in the previous 3-year period
• The business does not manufacture or process cosmetic products that regularly come into contact with mucus membrane, are injected, or are intended for internal use
• The business does not manufacture or process cosmetic products intended for use by children under 12

What the Exemption Does NOT Cover

Even if your business qualifies for the small business exemption from facility registration and product listing, you are still required to comply with:

• Adverse event reporting — You must still report serious adverse events to the FDA within 15 business days
• Safety substantiation — Your products must still be safe for their intended use
• Labeling requirements — All FD&C Act and FPLA labeling requirements still apply
• Good Manufacturing Practices (GMP) — MoCRA directs FDA to establish GMP regulations for cosmetics; these will apply to all businesses including small ones once finalized

Products That Are Never Exempt

Regardless of business size or revenue, certain product categories have no exemption from MoCRA registration:

• Products that contact mucus membranes (lip products, eye products, nasal sprays used cosmetically)
• Injected products
• Products intended for use by children 12 and under
• Products intended for internal use

Extended Deadlines for Small Businesses

Businesses that qualify as small businesses (but are not fully exempt due to product type) received an extended compliance deadline:

• Standard businesses: December 29, 2023 registration deadline
• Small businesses: December 29, 2024 extended registration deadline

How to Determine Your Status

1. 1
   Calculate your 3-year average cosmetics sales Include all cosmetics revenue from all related businesses (parent companies, subsidiaries, affiliates) under common ownership or control.
2. 2
   Review your product portfolio Identify any products that contact mucus membranes, are injected, intended for internal use, or for children under 12. These products require registration regardless of revenue.
3. 3
   Assess if exemption applies If revenue is under $1M AND no exempt-excluded products exist, you may be fully exempt from registration/listing but must still comply with safety, labeling, and adverse event reporting.
4. 4
   Monitor your revenue If your cosmetics sales grow beyond $1M, you lose the exemption and must register within one year of exceeding the threshold.

How Regovant Can Help

Regovant can assess your specific situation, determine whether you qualify for the small business exemption, and if registration is required, handle the complete MoCRA registration process on your behalf as your U.S. Agent.