LSHC Horizons Brochure 2024 - Flipbook - Page 100
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
100
U.S. cosmetics industry faces new facility registration and product
listing requirements
The regulatory requirements for cosmetics
are becoming more like drug requirements.
On 29 December 2023, new requirements for
registration of cosmetic product manufacturing
establishments and listing cosmetic products
came into effect. These new requirements
were enacted as part of the Modernization of
Cosmetics Regulation Act (MoCRA), along
with requirements for reporting serious
adverse events, compliance with forthcoming
good manufacturing practice regulations, and
substantiation of cosmetic product safety,
among other requirements. Although the
cosmetic registration and listing requirements
went into effect last December, FDA announced
it would not begin enforcing the requirements
until 1 July 2024, to provide more time for the
U.S. cosmetics industry to submit registration
and listing information.
Under the new requirements, owners and
operators of facilities that engage in the
manufacturing or processing of a cosmetic
product for distribution in the U.S. will be
required to register the facility with FDA. The
registration information includes the brand
names and product categories for cosmetic
products manufactured or processed at the
facility. While FDA previously had a voluntary
cosmetics registration program, FDA has
discontinued the voluntary program and stated
that registration information under the prior
voluntary program will not carry over into the
new system.
Heidi Forster Gertner
Partner
Washington, D.C.
In addition, “responsible persons” – defined
as the manufacturer, packer, or distributor of
a cosmetic product whose name appears in
accordance with certain labeling provisions – will
be required to list their cosmetic products with
FDA. The required listing information includes
the facility where the cosmetic was manufactured
and a list of all ingredients in the cosmetic
product, including fragrances, flavors, and colors,
among other information about the cosmetic.
For cosmetics that are also regulated as overthe-counter (OTC) drugs – and hence are subject
to the registration and listing requirements for
drugs – MoCRA provides an exemption to the
cosmetic registration and listing requirements.
MoCRA also includes an exemption to the
registration and listing requirements for small
businesses, defined as businesses whose average
gross annual sales in the U.S. of cosmetic
products for the previous three-year period is
less than $1,000,000, adjusted for inflation,
and who do not engage in the manufacturing or
processing of certain types of cosmetic products
described in the statute.
To submit facility registration and product
listing information, FDA has established a new
online portal, Cosmetics Direct. Submissions
to Cosmetics Direct use the Structured Product
Labeling standard, similar to submissions of
registration and listing information for drugs.
David Horowitz
Partner
Washington, D.C.
Bert Lao
Counsel
Los Angeles
