FDA Regulatory Framework For Cosmetics Gets Major Overhaul – Food and Drugs Law

Enacted on December 29, 2022, as part of the 2023 omnibus bill, the Modernization of
Cosmetics Regulation Act (MoCRA) is a major overhaul of the Food
and Drug Administration’s current regulatory framework for
cosmetics. MoCRA amends Chapter VI of the Federal Food, Drug, and
Cosmetic Act (FDCA) to include new provisions for cosmetic
products. These provisions create significant new authorities for
the FDA and, for the first time since the FDCA was enacted in 1938,
enhance the FDA’s regulatory oversight of cosmetics. While
MoCRA does not include a premarket approval requirement for
cosmetics, it does create new obligations for the cosmetics
industry. Some of the key provisions are outlined below.

Facility registration

Owners and operators of facilities that manufacture or process
cosmetic products must now register with the FDA and renew such
registration biennially. Notably, unlike food and dietary
supplement facility requirements, facilities that only perform
activities related to the labeling, relabeling, packaging,
repackaging, holding and/or distributing of cosmetic products will
not be required to register.

Product listing

“Responsible persons” (i.e., manufacturers, packers or
distributors of a cosmetic product whose name appears on the label,
as set forth under the Fair Packaging and Labeling Act) are
required to list with the FDA each cosmetic product, including its
ingredients and information about where the cosmetic product is
manufactured, and update cosmetic product labels to include contact
information through which the responsible person can receive
adverse event reports.

Mandatory adverse event reporting

Responsible persons are obligated to submit reports of serious
adverse events to the FDA no later than 15 days after receiving the
report and maintain all records related to serious adverse events
for a minimum of six years, similar to adverse event reporting
requirements for dietary supplements and nonprescription drugs.
Unlike the FDA’s other regulated products, for cosmetics, MoCRA
provides specific details on what constitutes a reportable event to
include infections or “significant disfigurement,” such
as “serious and persistent rashes, second- or third- degree
burns, significant hair loss, or persistent or significant
alteration of appearance[], other than as intended, under
conditions of use that are customary or usual.”¹
Currently, the FDA uses MedWatch for voluntary cosmetics adverse
event reporting and presumably will continue to do so for mandatory
serious adverse event reporting.

Safety substantiation

Responsible persons will be required to maintain records
supporting “adequate substantiation” that the cosmetic
product is safe. Cosmetic products that do not have adequate safety
substantiation will be considered adulterated under a newly created
adulteration provision within the FDCA.

Current good manufacturing practice for cosmetics

For the first time, the FDA must issue mandatory current good
manufacturing practice (GMP) regulations for cosmetics that are
consistent with national and international standards. As the
FDA’s current draft guidance for cosmetic GMP leverages
elements from ISO 22716, we anticipate that the FDA’s future
cosmetic GMP regulations will do the same.

Mandatory allergen labeling

MoCRA requires the FDA to determine by regulation fragrance
allergens that must be disclosed on a cosmetic’s label. This
labeling requirement applies regardless of whether a cosmetic
product is subject to drug or device regulations.

Mandatory recall

MoCRA grants the FDA the authority to order a mandatory recall
of a cosmetic product if it determines that the cosmetic product is
likely to cause serious adverse health consequences or
death.²

In addition to the mandatory recall authority, MoCRA creates
attendant adulteration and misbranding provisions to facilitate the
FDA’s enforcement of these new authorities under existing FDCA
prohibited acts.³ For example, products that fail to
comply with the new GMP and safety substantiation regulations will
be deemed adulterated under newly created adulteration provisions
within the FDCA, and if a cosmetic product’s labeling fails to
include the required allergens, a cosmetic product is deemed
misbranded under a newly created misbranding provision within the
FDCA.⁴ The FDA’s enforcement authority under MoCRA
also allows the agency to suspend the registration of a cosmetic
facility if there is a determination that a product manufactured or
processed by the facility has a reasonable probability of causing
serious adverse health consequences or death, and there is a
reasonable belief that other products manufactured by the facility
may be similarly affected.⁵

Overall, these provisions bring cosmetics regulation into
greater alignment with other FDA-regulated products, particularly
those such as dietary supplements and over-the-counter drugs that
do not require premarket approval.

Notably, MoCRA gives certain exemptions to small businesses with
gross sales of less than $1 million. For example, while small
businesses still will be required to maintain records of adverse
events, they only will be required to maintain these records for
three years, rather than six.

MoCRA also preempts any state laws or regulations regarding
registration and product listing, GMP, records, recalls, adverse
event reporting, or safety substantiation for cosmetics that is
different from MoCRA’s requirements. Outside of these areas of
express preemption, however, states are free to implement
additional requirements for cosmetics, such as prohibiting the use
or amount of specific ingredients.

Questions remain

Many of the key provisions, such as facility registration,
product listing, and the new adulteration and misbranding
definitions, take effect a year from the enactment date. With this
deadline looming, many open questions remain. For example, to what
extent will the new registration requirements conform with the
regulations that set forth the current requirements for voluntary
registration and voluntary filing of cosmetic product ingredients
statements, respectively?⁶ (How) will the FDA enforce
the adulteration provisions regarding GMP at the end of this year,
when regulations might remain in the rulemaking process until the
end of 2025? Now that registration is mandatory, when will the FDA
begin routine inspections of cosmetic establishments? Will the FDA
create a new division within its Office of Regulatory Affairs to
conduct these inspections, or will it group the inspections under
the food program? Will cosmetic regulation remain within the Center
for Food Safety and Applied Nutrition? While many questions are
outstanding, what we do know is that this new regulatory framework
is likely to have a significant impact on the cosmetics
industry.

Senior regulatory analyst Kelly Marco and law clerk Madelon Bird also contributed to
this alert.

Footnotes

1. Modernization of Cosmetics Regulation Act of 2022,
House Resolution 2617 – 117th Congress (2021 – 2022):
Consolidated Appropriations Act, 2023, HR2617, 117th Cong.,
§3502 (2022).

2. Unlike recall requirements for food and dietary
supplements, the text of MoCRA does not extend mandatory recalls to
serious adverse events in animals. While the omnibus bill does not
contain express requirements that the FDA ban animal testing for
cosmetic product safety, it contains the sense of the Congress that
animal testing should be phased out with the exception of
appropriate allowances.

3. See 21 USC §331.

4. HR2617 – 117th Congress (2021 – 2022):
Consolidated Appropriations Act, 2023, HR2617, 117th Cong.,
§3503(a) (2022), amending 21 USC §331.

5. Modernization of Cosmetics Regulation Act of 2022,
HR2617 – 117th Congress (2021 – 2022): Consolidated
Appropriations Act, 2023, HR2617, 117th Cong., §3502
(2022).

6. See 21 CFR Parts 710 and 720.

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