Are Your Labels MoCRA Ready?
FDA’s MoCRA regulations have a big impact on labels including adverse event contact and fragrance allergens.
Registrar experts can help you comply with LabelComply and LabelCheck services.
LabelComply: Peace Of Mind Before Going To Market
Our Regulatory Specialists will review your cosmetic label and ingredient list and recommend updates needed to remain FDA compliant. You’ll receive:
Extensive review of FDA’s 10 mandatory requirements
A revised, print-ready graphic design file of your label
80-100 page report with detailed recommendations
Expertise from 13,000+ label reviews
One set of revisions to the updated label within 30 days
1-on-1 consult with your labeling expert
LabelCheck: Verify Labels are FDA Compliant
Our Regulatory Specialists will review your cosmetic label and ingredient list and recommend updates needed to remain FDA compliant. You’ll receive:
Extensive review of FDA’s 10 mandatory requirements
Expertise from 13,000+ label reviews
30-minute consult with your labeling expert
30-40 page report with recommendations
Let’s Have A Conversation About Your Needs.
Frequently Asked Questions
Cosmetic labels must now include:
- A U.S. address
- A U.S. phone number
- Or, an electronic contact information by which a responsible person can receive adverse event reports (could be through a website)
Cosmetic products that contain certain fragrance allergens must list them on the label. FDA will provide a list of the allergens that are subject to this requirement.
If the product is used by professionals, your cosmetic labels must also present a clear, prominent statement that the product is administered or used only by licensed professionals and be in compliance with existing cosmetic labeling requirements.
FDA’s MoCRA defines the “responsible person” (RP) as “the manufacturer, packer, or distributor of a cosmetics product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”
Under MoCRA, the U.S. RP will be responsible for Product Listings, Adverse Event Reporting, Product Labeling requirements, Safety Substantiation, Fragrance Allergen Disclosures, and Recalls.
The RP can be located anywhere in the world and can hire an authorized agent to handle certain requirements under MoCRA; however, a company cannot designate just anyone to act as their RP. Companies outside the United States should consider hiring a qualified authorized agent to help with those responsibilities under MoCRA.
If a cosmetic product is also a drug, it is not subject to MoCRA’s labeling provisions, except regarding fragrance allergen disclosure and professional use labeling.
If a cosmetic product displays a brand name on the front but includes a manufacturer statement and contact information as required, the entity in that statement would be the responsible person for that product. The brand name would not be the “responsible person” as that term is defined in the statute.
FDA requires the following mandatory statements be included on each cosmetic product label:
- Statement of identity
- Net Quantity of contents
- Directions for safe use
- Any necessary or mandatory warning statements
- Ingredients
- Corporate name and address of the manufacturer, packer, or distributor
Yes, all label statements required by law or regulation must be declared in the English language. If the label contains a foreign language, all required statements must appear in that language as well.