ARE YOU READY?
DISCOVER THE NEW RULES
FOR COSMETICS IN USA
Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022
INTRODUCING MoCRA
Prepare for the upcoming changes mandated by the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA),
as it significantly transforms the regulatory landscape
for cosmetic companies in the United States.
The MoCRA, which comes into full effect in 2023,
represents a substantial expansion of the FDA’s authority
over the cosmetics industry.
DON'T STRESS…
…WE SIMPLIFY
Navigating these new requirements
may seem overwhelming, but we’re here
to make it easy for you.
Our mission is to ensure
you’re fully compliant without the headache.
THESE NEW REQUIREMENTS INCLUDE:
Compulsory FDA Facility Registration
All cosmetic facilities must undergo
mandatory
registration with the FDA.
Compulsory FDA Facility Registration
All cosmetic facilities must undergo
mandatory
registration with the FDA.
Product Listing Obligations
Every cosmetic product marketed in the
USA must
be listed as per regulatory
requirements.
Product Listing Obligations
Every cosmetic product marketed in the
USA must
be listed as per regulatory
requirements.
Adverse Event Reporting
Companies will be obligated to report
adverse events associated with
their products.
Adverse Event Reporting
Companies will be obligated to report
adverse events associated with
their products.
Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good
Manufacturing
Practices is mandated.
Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good
Manufacturing
Practices is mandated.
Comprehensive Record-Keeping
This involves the maintenance of records,
including
adverse events and safety
substantiation records.
Comprehensive
Record-Keeping
This involves the maintenance of records,
including adverse events and safety
substantiation records.
Mandatory Recall Procedures
In the event of safety concerns,
mandatory
recalls may be required
Mandatory Recall Procedures
In the event of safety concerns,
mandatory
recalls may be required
Fragrance Allergen Declaration
Companies may be required to declare
fragrance
allergens in their products.
Fragrance Allergen Declaration
Companies may be required to declare
fragrance
allergens in their products.
WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.
OUR SERVICES
SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are
promptly registered with the FDA,
meeting the mandatory
requirement.
EXPERT US AGENT SERVICES
If you’re a foreign cosmetic company,
we’ll be your go-to US agent, handling
communication and compliance
on your behalf.
PRODUCT LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.
TIMELY UPDATES
As the FDA implements additional
MoCRA guidelines, we will keep you
well-informed about the changes and
requirements affecting your business.
WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?
MoCRA empowers the FDA to establish a wide
range
of regulations that impact every facet of
your cosmetic products, from their creation
to their marketing.
BENEFIT FOR YOU
Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.
We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.