Do You Know How To Label Your Product Under New MoCRA Labeling Rules?

MoCRA modified the cosmetic product FDA Labeling Rules in a couple of notable ways:

– Responsible Person: The Responsible Person is the party distributing the cosmetic product, which is generally the Brand. MoCRA requires that the Responsible Party and their contact information be listed on the product label.

– Under MoCRA, the contact information for the Responsible Person may now be electonic including website and e-mail address or physical address and telephone number

– Inclusion of the Responsible Person and their contact information is for consumers to have that information readily available to report an Adverse Event or Serious Adverse Event

– The FDA Labeling Rules on the List Of Ingredients are unchanged. Ingredients must be listed in descending order of inclusion by % weight. The exception being the 1% Rule that allows all ingredients included at 1% or less to be included in any order.

– Listing Fragrance Allergens: In October 2024 FDA will publish a Notice Of Proposed Rulemaking (“NPR”) with its proposed list of Fragrance Allergens that will need to be declard in your List Of Ingredients. The EU list of Fragrance Allergens is comprised of 82 individual compounds, including some essential oils such as Cinnamon, Eucalyptus, Lavender, Lemon Peel, Bergamot and others.

It is likely that FDA will harmonize its proposed list of Fragrance Allergens with the EU Fragrance Allergens list. Companies may be required to list Fragrance Allergens in the 2025/2026 timeframe.

MoCRA is now in full force and effect! Contact Us for a complimentary MoCRA Audit of your company and products!  We provide MoCRA Compliance Services to help protect your Brand Reputation and Revenues!

We can help you with MoCRA compliance including Product Label Reviews, MoCRA Compliance Officer and tailored services including Cosmetic Ingredient Safety Reports, Adverse Event Reporting & FDA Product Registration.

View our slideshow on our MoCRA Compliance Services for Product Labeling: https://www.linkedin.com/posts/mark-broussard-420514289_productlabelingundermocra-activity-7231606622559596544-C6sr?utm_source=share&utm_medium=member_desktop