New Label Requirements
MoCRA: This information is applicable to: All Cosmetic Manufacturers
Under the new MoCRA requirements, there are several new requirements for information that must go on a cosmetic product label.1
Contact Information for Adverse Event Reporting
As of December 29, 2023, you have to put enough information on the label so a person can contact you if they have an adverse event to report.2
The business name and address are already required on the label. If you don’t include the full US street address then you must include a phone number, website, or email address that a person could use to send an adverse event report to you.
See Adverse Event Reporting for more information.
At some point in the future, you will need to include any fragrance allergens the ingredient declaration for your cosmetic products.3
The list or fragrance allergens that have to be disclosed hasn’t been created or published. The FDA has until June 29, 2024 to create a proposed list and another six months (or so) to issue the final list. After that there will some time allowed to get your labels updated before the regulation takes effect (usually a year).
See Fragrance Allergens for more information and a discussion on what you can do now to prepare.
Products for Professional Use
As of December 29, 2023, the label of any product you make that is intended to be used by licensed professionals has new label requirements.
First, the label must clearly state that only professionals shall use the product.
Second, all the regularly required cosmetic label content must be on the label of professional products, including the product identity (what it is), net contents, ingredient declaration, business name and address, and any information needed for safe use.4
For more information see Products for Professional Use.
1 21 USC 364e
2 21 USC 364e(a)
3 21 USC 364e(b)
4 21 USC 364d(c)(2)(b)