Landmark Cosmetic Law Adopted That Significantly Changes How Cosmetics Are Regulated By FDA – Product Liability & Safety

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On Friday, December 23, 2022, Congress passed an approximately
$1.7 trillion omnibus spending bill for fiscal year 2023, which was
signed into law by President Biden on December 29, 2022. While the
unusual circumstances surrounding the 4,000+ page bill’s
passage (including the race to beat dual threats of government
shutdown and  an impending winter storm) have
dominated most news stories about the legislation, the bill also
ushers in numerous landmark reforms, including to the federal
regulation of cosmetics. 

In fact, the “Modernization of Cosmetics Regulation Act of
2022 (MOCRA)” (incorporated as Sections 3501-3508 of the
spending bill) marks the first major change to the US Food and Drug
Administration (FDA)’s authority over cosmetics since
1938—when the Federal Food, Drug, and Cosmetic Act (FDCA) was
signed into law. MOCRA’s provisions (detailed below), including
its addition of new Sections 604-614 to subchapter VI of the FDCA,
significantly expand the scope of FDA’s oversight and add
additional compliance requirements for businesses. Stakeholders in
the cosmetics industry should pay close attention to these new
developments and prepare for these changes to take effect starting
in December 2023, one year after MOCRA’s passage. 

New Reporting Requirements for Businesses

Under MOCRA, the cosmetics industry must now report additional
information about a cosmetic product’s manufacturing,
formulation, and use to FDA. Pursuant to these new reporting
requirements, the business deemed to be the “responsible
person” for any given cosmetic product—i.e., “the
manufacturer, packer, or distributor of a cosmetic product whose
name appears on the label”—must:

  • Register each facility that manufactures a cosmetic
    product for US distribution (FDCA Section 607)
    , and renew
    each registration every two years. Businesses have one year to
    register existing facilities, while new facilities must be
    registered either 60 days after they start manufacturing cosmetics
    or 60 days after the existing facility deadline—whichever
    falls later. Notably, MOCRA exempts facilities that merely label,
    package, hold, or distribute cosmetics products, facilities that
    manufacture ingredients but not final products, and facilities used
    solely for product research and evaluation purposes.

  • Submit to FDA annual cosmetic product listings that
    disclose key product information (including ingredients and
    manufacturer information) (FDCA Section 607).
    listing must also include any fragrances, flavors, or colors within
    the product. Businesses must submit product listings for all
    existing products by December 2023, and submit listings for new
    products within 120 days of commencing marketing.

  • Track and report adverse events associated with its
    cosmetic products (FDCA Section 605).
     Similar to
    existing requirements for certain drugs and supplements, businesses
    must now maintain records for any adverse health event for six
    years (shortened to three for small businesses) and report serious
    adverse events to FDA within 15 days of learning about the issue.
    For the year following an initial report of a serious adverse
    event, businesses must also update FDA with any new and material
    information they learn. MOCRA takes an expansive view of
    “serious adverse effect” and covers infections,
    “significant disfigurement” (e.g. serious and/or
    persistent rashes and burns), significant hair loss, and other
    “persistent” or “significant” changes to the
    user’s appearance.

New Product Labeling Requirements for Businesses

With the addition of Section 609 to the FDCA, MOCRA adds three
additional product labeling requirements for responsible entities,
who now must: 

  • Specify a point of contact for consumers (FDCA Section
    To facilitate the adverse event tracking
    and reporting discussed above, businesses must update cosmetic
    product labels within two years to include the contact information
    for consumers to report any adverse events. Businesses may choose
    to list a US address, US phone number, and/or electronic contact
    information or an interactive website as this point of

  • Disclose fragrance allergens (FDCA Section
    . Cosmetic product labels must now identify each
    and every fragrance allergen within the product. As discussed
    further below, FDA is to issue a regulation with a list identifying
    these allergens within 18 months of MOCRA’s passage.

  • Distinguish products intended for professional use
    (FDCA Section 609(c)).
     Now, cosmetic products
    intended for use by licensed professionals (i.e., estheticians,
    cosmetologists, nail and hair salons, etc.) must be clearly labeled
    as such. Product labels for these professional products must also
    include the additional contact information, and fragrance allergen
    information discussed above.

New Substantiation Requirements for Businesses

While the cosmetics industry is already subject to a variety of
consumer protection and false advertising laws that, broadly
speaking, require substantiation for any product labeling or
advertising claim (including, in many cases the implied or explicit
claim that a cosmetic product is safe for use), MOCRA updates the
FDCA to specifically require responsible persons to:

  • Maintain robust safety substantiation evidence (FDCA
    Section 608). 
    Businesses must maintain robust
    records, including tests, analyses, research, and other evidence
    sufficient to demonstrate to a “reasonable certainty”
    that a cosmetic product is safe. 

Forthcoming FDA Rulemaking Imposing Additional New

In addition to the new requirements discussed above, MOCRA also
directs FDA to issue several regulations that will further increase
compliance requirements for the cosmetics industry. Specifically,
FDA must promulgate additional regulations establishing new:

  • Good Manufacturing Practices (GMPs) (FDCA Section
     FDA is required under the new law to issue
    regulations establishing GMP requirements for facilities that
    manufacture cosmetics. The new GMP regulations also may authorize
    FDA to inspect records related to GMPs during inspections. Notably,
    MOCRA requires FDA to “consult” with key stakeholders in
    the cosmetics industry, including manufacturers, as part of the
    rulemaking process—providing businesses an opportunity to
    help shape the, likely significant, GMP rules before FDA’s
    December 2024, deadline to publish a proposed rule (i.e., two years
    from MOCRA’s passage) and the December 2025, deadline to
    issue the final version (i.e., three years from MOCRA’s

  • Requirements related to the fragrance allergen
    disclosure (FDCA Section 609(b)). 
    MOCRA directs FDA
    to issue a regulation that will enable businesses to comply with
    the fragrance allergen labeling requirement discussed above.
    Specifically, by the end of June 2024 (i.e. 18 months from the
    MOCRA’s passage), FDA must issue a proposed rule that includes
    a list of fragrance allergens, and then issue its final regulation
    no later than 180 days after the close of a public comment period.
    Notably, MOCRA specifically directs FDA to consider European Union
    (EU) and other international, state, and local allergen
    requirements in crafting this rule—perhaps providing some
    foreshadowing of FDA’s eventual course in advance of the formal
    rulemaking process.

  • Requirements related to talc-containing cosmetics
    (MOCRA Section 3505).
     By December 2023, FDA must
    issue a proposed rule to establish and require standardized testing
    methods for detecting and identifying asbestos in talc-containing
    cosmetic products, and must finalize the rule 180 days

MOCRA also identifies perfluoroalkyl and polyfluoroalkyl
substances (PFAS) and animal testing as two additional areas of
focus for FDA in the cosmetic arena. But importantly, MOCRA
confirms federal interest in but stops short of directing the
Agency to impose additional regulatory requirements for these

  • PFAS in cosmetics (MOCRA Section 3506). 
    MOCRA requires FDA to publish a report within three years that
    assesses the use of PFAS in cosmetic products and the safety of
    PFAS used in cosmetic products.

  • Animal testing (MOCRA Section 3507). Although
    the new law does not ban the use of animals in testing the safety
    of cosmetic products, it articulates Congress’ view
    discouraging the use of such activities and recommends they be
    phased out.

Newly Expanded FDA Authority

In addition to the increased compliance requirements it imposes
on the cosmetics industry, MOCRA also expands FDA’s oversight
into cosmetic products and provides the Agency with several
powerful new tools for effectuating its new authority.
Specifically, FDA gained the power to: 

  • Issue mandatory recalls (FDCA Section 611).
    FDA may now issue mandatory recalls if it determines that a
    cosmetic is either adulterated under Section 602 or misbranded
    under Section 601 of the FDCA, and that a reasonable probability
    exists that the use and/or exposure to the product will cause
    serious adverse consequences or death.

  • Access records (FDCA Section 610). FDA may now
    access a company’s records related to a cosmetic product if the
    Agency reasonably believes the product and/or its ingredients are
    adulterated such that they present a risk of serious adverse health
    consequences or death. The Agency also may now request a list of
    ingredients in a product’s fragrance or flavor if it believes
    these components contributed to a consumer’s serious adverse
    event, and access records as needed to enforce the GMP rules,
    adverse event reporting rules, and other new business compliance
    requirements detailed above. Notably, this new records access
    authority does not provide limitless discovery—records
    related to formulas/recipes, financial data (including pricing,
    sales, and employees), and research data unrelated to safety
    substantiation remain out of reach.

  • Suspend facilities (FDCA Section 607). Under
    MOCRA’s new updates to the FDCA, FDA can suspend the
    registration of any facility that manufactures cosmetic products if
    the Agency determines that there is a reasonable probability that a
    product manufactured at that facility caused a serious adverse
    effect and that other products manufactured at that site may do the
    same. This suspension carries serious consequences for a business,
    as products from the impacted facility may not be introduced into
    the market until the facility’s registration is

Other Important Provisions

MOCRA also includes a number of other important provisions that
will significantly impact businesses and the way the new provisions
are enforced:

  • Preemption (FDCA Section 614). 
    Importantly, the new law provides for express preemption of any
    state or local laws that are not identical to
    any requirement discussed above regarding registration and product
    listing, GMPs, records, recalls, adverse event reporting, or safety

  • Key exemptions for products regulated as both drugs and
    cosmetics (FDCA Section 613)
    . Specifically, a cosmetic
    product or facility that is subject to FDCA provisions for products
    regulated as drugs is exempt from the new MOCRA requirements
    relating to adverse event reporting, GMPs, facility registration
    and product ingredient listing, safety substantiation, and contact
    information labeling, as well as FDA’s new records access and
    mandatory recall authority. However, these products must still
    comply with the new fragrance allergen and professional use
    labeling requirements discussed above.

  • Flexibility for small businesses (FDCA Sections
    Businesses with average gross annual sales in
    the United States of cosmetic products for the previous 3-year
    period of less than $1,000,000 are considered small businesses and
    are exempt from the GMP regulations to be issued under Section 606
    and the registration and product listing requirements under Section
    607. Elsewhere within the Act, MOCRA also provides for enhanced
    regulatory compliance flexibility for smaller businesses when
    enforcing many of the new requirements.

Key Takeaways

Stakeholders in the cosmetics industry will need to devote
significant resources to ensure compliance with the new requirement
imposed in MOCRA. While many of these requirements will be
particularly impactful for entities who meet the “responsible
person” definition discussed above, the law will, in general,
significantly change the way cosmetics are regulated, and its
impact will be felt by everyone, from cosmetic ingredient suppliers
to retailers. Moving forward, stakeholders should keep a close
watch on FDA’s efforts to establish regulations to enforce
the various provisions of the new law, and also should be sure to
participate in those rulemakings when necessary. 

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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