Cosmetic formula listing under MoCRA: everything you need to know

In December 2022, the U.S. Food and Drug Administration (FDA) implemented the Modernization of Cosmetics Regulation Act (MoCRA), a historic reform updating the regulation of cosmetic products in the United States. Driven by growing consumer demand for transparency and safety, this new law introduces legal obligations for manufacturers and distributors, including the mandatory listing of cosmetic formulas with the FDA.

If you are part of the cosmetics industry, understanding this regulation is essential to operate legally and compliantly. Here’s why it matters, what it involves, and who is required to comply.

Why cosmetic formula listing is required

The primary goal of MoCRA is to protect consumer health through greater oversight and transparency in the cosmetics industry. By listing cosmetic formulas:

• The FDA can quickly identify products that pose health risks, such as contamination, undeclared allergens, or prohibited ingredients.

• It ensures that products on the market meet minimum safety standards.

• Companies strengthen their reputation by demonstrating commitment to quality and regulatory compliance.

In short, this requirement benefits consumers and protects brands by reducing legal and commercial risks.

What does cosmetic formula listing involve?

Listing a cosmetic formula requires submitting detailed information about every product marketed in the United States, including:

• Product name as it appears on the packaging.

• Intended use, i.e., the product’s function (e.g., body cream, shampoo).

• Active and inactive ingredients, including their concentrations.

• Name and address of the manufacturer, distributor, or packager responsible for the product.

This information must be submitted to the FDA within the established deadlines. Additionally, the listing must be updated whenever a formula changes or a new product is introduced to the market.

Who must list their products?

Under MoCRA, all manufacturers, packagers, and distributors of cosmetic products sold in the United States must comply. This includes:

• Domestic and international companies: If you export cosmetics to the U.S., you are subject to this regulation.

• Independent brands and small producers, with certain exceptions.

Who is exempt?

While MoCRA has broad scope, some exemptions apply:

• Businesses producing cosmetics for personal use and not for sale.

• Small producers: Exempt if they sell less than $1,000,000 USD annually (excluding packaging costs) and if their products do not:

• Significantly alter the body’s appearance for more than 24 hours.

• Contact mucous membranes, e.g., lipsticks, eyeliners.

• Cosmetic products with pharmaceutical use, such as some sunscreens, which are regulated under separate guidelines.

Trust the experts for MoCRA compliance

The listing process can be technical and demanding, especially for brands with extensive product portfolios. That’s where we come in: Our team has the experience and knowledge to ensure your brand fully complies with MoCRA efficiently and without complications.

We support you every step of the way, from formula review to FDA registration, ensuring your brand not only meets regulatory requirements but also inspires consumer trust.

Don’t let regulations be an obstacle! Contact us today to ensure your brand is compliant and ready to thrive in the U.S. market.

Ready to take the next step? Write to us and let’s turn regulatory compliance into a competitive advantage for your business.