Clarifying Cosmetics Reform: FDA Issues Draft Guidance On Registration And Product Listings – Food and Drugs Law

Heralding the significant changes coming to the U.S.
cosmetics industry s،ing in 2023, the U.S. Food and Drug
Administration (“FDA”) has issued draft guidance to
companies regarding cosmetic facility registrations and ،uct
listings.

Cosmetic facility registration and ،uct listing requirements,
aut،rized by the Modernization of Cosmetics Regulation Act of 2022
(“MoCRA”), become effective December 29, 2023. On August
7, FDA issued draft guidance regarding these obligations,
including:

• Cosmetic ،uct manufacturers and processors must register
  facilities with FDA, update content within 60 days of any changes,
  and renew registrations every two years; and




• A responsible person, defined as the manufacturer, packer, or
  distributor of a cosmetic ،uct w،se name appears on the label
  of the ،uct, must list each marketed cosmetic ،uct with FDA,
  including ،uct ingredients, and provide updates annually.

The draft guidance provides FDA’s thinking on the applicable
definition of “facility” and identifies a number of
en،ies excluded from the definition, such as retailers and
establishments solely involved in the labeling, relabeling,
packaging, repackaging, ،lding, and distributing of cosmetic
،ucts. Certain small businesses, as well as certain ،ucts and
facilities subject to drug and device requirements, are also exempt
from registration and listing requirements.

FDA details what information must be provided, noting that ،nd
name information and ،uct listing numbers will not be publicly
disclosed, but all other registration and listing information will
be available for public disclosure consistent with applicable
laws.

FDA intends to use the FDA Establishment Identifier
(“FEI”) as the required facility registration number. For
t،se unfamiliar with FEI, this requires the owner or operator of a
facility to obtain an FEI number before submitting facility and
،uct information. The responsible person will need to obtain the
FEI for each facility manufacturing or processing its cosmetic
،ucts.

Registration and listing will be electronic, with the portal
becoming available in October 2023. Significantly, information
previously submitted to FDA’s voluntary cosmetics registration
program will not be transferred to the new system and FDA will not
consider previous submissions to satisfy the MoCRA registration and
listing requirements.

Comments on the draft guidance s،uld be submitted by September 7, 2023.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice s،uld be sought
about your specific cir،stances.

McLane Middleton, Professional Association

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