Hello and welcome to the U.S. Food and Drug Administration stakeholder webinar to provide
an overview of the Modernization of Cosmetics Regulation Act of 2022. My name is Linda Katz,
and I am the director of the office of cosmetics and colors at FDA.
Following this introduction, you will hear from our chief scientist,
Namandjé Bumpus, who will provide brief opening remarks, after which,
I will go over the requirements mandated by the act, also known as MoCRA, and the current
steps FDA is taking to implement the requirements. Finally, Dr. Bumpus and I will answer frequently
asked questions about MoCRA, then close out the program. I will now turn it over to Dr. Bumpus.
Thank you Dr. Katz. Most Americans use cosmetic products every day. These products include makeup,
face and body cleanser, shaving cream, deodorant, perfume and a number of other products. In
December 2022, Congress passed the Modernization of Cosmetics Regulation Act or MoCRA. It is the
most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug,
and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic
products Americans use daily. In a moment you will hear about the various provisions of MoCRA,
like the mandatory reporting of serious adverse events and mandatory facility
registration and cosmetic product listing. As part of FDA’s mission, the agency is
responsible for protecting the public health by helping to ensure the safety of cosmetics. We
look forward to implementing this new statutory authority to help keep Americans’ cosmetics safe.
Thank you Dr Bumpus for this energizing remarks. As Dr. Bumpus mentioned, MoCRA provides FDA with
new authorities and establishes new requirements for cosmetics companies.
What I'd like to do now are to go through some of the definitions relevant to the
provisions of MoCRA and I'll start with cosmetic products. A cosmetic product is defined in MoCRA
as a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition
for use in a finished product. Facility... any establishment (including an establishment of an
importer) that manufactures or processes cosmetic products distributed in the United States.
There are carve outs for certain beauty shops and salons, hospitals, public health agencies, trade
shows, certain research and testing facilities, and establishments that solely perform one or
more of the following with respect to cosmetic products: labeling, relabeling, packaging,
repackaging, holding, and distributing. A responsible person is defined as the manufacturer,
packer, or distributor of a cosmetic product whose name appears on the label of the cosmetic product.
An adverse event is described and defined as any
health related event associated with the use of cosmetic product that is adverse.
A serious adverse event is an event tthat (A) results in death; a life-threatening experience;
inpatient hospitalization; a persistent or significant disability or incapacity;
a congenital anomaly or birth defect; an infection; or significant disfigurement
(including 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; orequires, based on reasonable medical judgment,
a medical or surgical intervention to prevent an outcome described in the preceding paragraph.
I'd like to address certain provisions in MoCRA
starting with records inspection. o MoCRA amends the FD&C Act to provide that FDA inspections of
facilities that manufacture or process cosmetics shall extend to certain records and information,
such as adverse event report information, when the applicable standard for records
inspection applies. Records Access- If FDA has a reasonable belief that a cosmetic product,
including an ingredient in such product, is likely to be adulterated such that the use or exposure to
the product presents a threat of serious adverse health consequences or death to humans, the FDA
can access and copy certain records related to the cosmetic product, including safety records.
Safety Substantiation-A responsible person is required to ensure and maintain records
supporting adequate substantiation of safety for their products. The next item is mandatory serious
adverse event reporting. Here a rresponsible person is required to report serious adverse
events associated with the use of cosmetic products in the United States to the FDA
within 15 business days after receiving a report of such event. The responsible person must also
provide certain additional information, such as new medical information, received within one year
of the initial report. FDA will also have access to adverse event reports during an inspection.
It also further provides for registration and product listing. Cosmetics manufacturers and
processors must register their facilities with FDA and renew their registration every two years.
FDA has the authority to suspend a facility’s registration if the agency determines that a
cosmetic product manufactured or processed by the registered facility and distributed in the U.S.
has a reasonable probability of causing serious adverse health consequences or death to humans,
and the agency has a reasonable belief that other products manufactured or processed by the facility
may be similarly affected because of a failure that cannot be isolated to a product or products,
or is sufficiently pervasive to raise concerns about other products manufactured in the facility.
Further it is a prohibited act to distribute or sell (or otherwise introduce or deliver
into commerce) in the U.S. cosmetic products from a facility with a suspended registration.
In addition, a responsible person must list each marketed cosmetic product with the FDA,
including product ingredients, and provide any updates annually.
It provides FDA with mandatory recall authority if FDA determines that there is a reasonable
probability that a cosmetic is adulterated or misbranded and use of, or exposure to,
the cosmetic will cause serious adverse health consequences or death, FDA has
the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.
In addition for labeling provisions there is a
professional use labeling provision that requires certain labeling for
cosmetic products that are intended to be used only by licensed professionals.
The following provision is enforceable under MoCRA beginning December 29, 2024:
and this provides for contact information for the labeling and it requires a cosmetic
product labels to include certain contact information through which the responsible
person can receive adverse event reports. Contact information must include = domestic address,
phone number, or electronic contact information which may include a website.
The following requirements will apply following FDA rulemaking: Labeling of Fragrance Allergens
Rule and FDA is to develop regulations to identify fragrance allergens they must also
be disclosed on cosmetics labels, international, state, and local allergen disclosure requirements.
Good manufacturing practice or GMP Rule-the FDA is to establish GMPs consistent,
to the extent practicable and appropriate,
with national and international standards and intended to ensure that cosmetic products are
not adulterated. to This may include records inspections to evaluate compliance with GMPs.
Testing Methods for Detecting Asbestos in Talc-containing Cosmetics Rule - the
FDA is to develop regulations to establish and require standardized testing methods
for detecting and identifying asbestos in talc-containing cosmetic products.
In addition, FDA will be issuing a report on PFAS in cosmetics by December 29,
2025. o This report will summarize an assessment of the safety of the use of
per- and polyfluoroalkyl substances (“PFAS”) in cosmetic products.
Finally the MoCRA statutory dates are listed in the slide.
the key professions are on the left and the order in which they occur in MoCRA
and on the right you can see the line for when those statutory dates occur. The lighter blue
lines indicate places where FDA is required to do a proposed Rule and a final rule. In addition,
FDA is working to implement all of these new requirements with respect to registration and
listing. FDA is creating a new system to handle these submissions. As of March 27,
2023, we have stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP).
Because MoCRA requires certain companies to register their facilities and list their products
with FDA, FDA is creating a new system to handle the large number of submissions that will result.
FDA therefore will no longer use the voluntary registration system
and is no longer accepting and processing submissions to the VCRP. Information in
the VCRP will not be transferred to the program being developed for facility registrations and
product listings mandated by MoCRA. FDA will announce the availability of the new system.
iIn addition, the FDA will host a listening session on good manufacturing practices,
or GMPs, on June 1, 2023. The purpose of the listening session is to hear from cosmetics
manufacturers, including smaller businesses, consumer organizations, and other experts,
so that they can help inform Agency efforts as we develop regulations to establish GMPs for
facilities that manufacture, or process cosmetic products distributed in the United States.
For more information on the registration and listing system, and the GMP listening session,
please visit our website shown here.
Dr. Bumpus, I will now turn it over to you for us to go through some of the frequently
asked questions. Thank you Dr. Katz. We will now answer some frequently asked questions that we
have received so far about MoCRA. To kick us off, we have the following question: many manufacturers
are wondering about the new process for facility registration, product listing, and adverse event
reporting. “When will guidance to comply with the new requirements be made available to industry?”
That’s a great question and one we know many manufacturers are concerned about.
The new law requires certain cosmetics facilities to comply with various new requirements including
mandatory facility registration and product listing by December 29, 2023.
In addition, it establishes mandatory reporting of serious adverse events.
To report a serious adverse event, please submit a MedWatch Online Reporting Form.
FDA is working to address the new provisions in MoCRA and will share new information when
available. We recommend following our social media, @FDACosmetics and @DrBumpusFDA on Twitter,
subscribing to email updates, and checking our Cosmetics News and Events Web page
to stay up to date as we continue to make announcements on FDA’s efforts.
We also encourage you to attend our GMP listening session on June 1, 2023, to share
input as we develop the GMPs mandated by MoCRA. Thanks Dr Katz. Our next question is, where can
we find the forms and online registration needed to be compliant by the December 2023 deadline?
To reiterate, we are creating a new system
to receive the mandatory registration and listing submissions. FDA will therefore no longer be
using the vcrp or voluntary registration program forms. We request that cosmetics
companies wait to register with FDA until we announce the availability of the new system.
Again, we encourage you to follow our social media, @FDACosmetics and @DrBumpusFDA on Twitter,
and check our Cosmetic News and Events Web page so that you can be informed of when we make new
announcements and announcements related to this topic. tThank you. We have time for one
final question: “Will you be introducing new cosmetics requirements in addition to MoCRA?”
FDA enforces laws enacted by Congress and issues regulations as authorized by Congress.
MoCRA is the most recent law enacted to strengthen our regulation of cosmetics.
To implement this new authority, we will be conducting rulemaking and issuing guidance
documents. We will inform the cosmetics industry and other stakeholders throughout this process.
Thank you Dr. Katz. This wraps up today’s webinar.
If you have any questions about MoCRA, please visit our website
or email QuestionsAboutMoCRA@fda.hhs.gov and thank you for joining us and be well.
Thank you.