LS&HC Horizons 2023 - Flipbook - Page 69
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | United States
69
FDA’s cosmetics expansion
The Modernization of Cosmetics Regulation
Act of 2022 (MOCRA) reflects the most
significant FDA expansion to regulate
cosmetics since 1938. MOCRA will require
cosmetics to comply with various new
requirements, including: Good Manufacturing
Practice (GMP), safety substantiation, adverse
event reporting, registration and listing with
FDA, mandatory recall authority for FDA,
additional labeling, and various recordkeeping
requirements. MOCRA also requires FDA to
establish through regulations requirements
for GMP, fragrance allergen labeling, and
methods to test for asbestos in talc-containing
cosmetic products. The new legislation also
provides for preemption of certain State
requirements for cosmetics but will generally
not preempt product liability litigation under
State causes of action pertaining to cosmetics
with regard to any standard, rule, requirement,
regulation or adverse event report. However,
the law includes exemptions from GMP and
registration/listing requirements for qualifying
small businesses.
Heidi Gertner
Partner, Washington, D.C.
David Horowitz
Partner, Washington, D.C.
Sally Gu
Senior Associate, Washington, D.C.
It will likely take FDA several years to
implement and enforce the new law, for
several reasons. First, the effective date for
the provisions necessary to enforce the new
requirements is deferred for one year (two
years for certain labeling requirements).
Second, the GMP requirements will likely not
come into effect for several years because they
will require a rulemaking proceeding that will
be technical and complicated by numerous
constraints on the authority granted to FDA.
And third, the legislation does not come with
any additional user fee funding, which will limit
FDA’s ability to develop the regulations and
guidance documents that will be necessary for
implementation. Although MOCRA includes
authorization of appropriations for cosmetic
regulation, MOCRA does not include any
actual appropriations, which FDA will need
to obtain through the annual appropriations
process to expand FDA’s cosmetic program
and fund MOCRA implementation. Obtaining
new funds for FDA regulation in a divided
Congress will not be easy. However, cosmetics
manufacturers should begin preparing now to
comply with requirements that FDA is expected
to begin implementing before the end of
2023, including registration and listing, safety
substantiation, adverse event reporting, and
new labeling requirements.
Read this Engage article
for more insight on FDA’s
cosmetic expansion:
Modernization of
cosmetic regulation will
be phased in over time