FDA Will Have Extensive Authority to Regulate Cosmetics
Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance …”
The U.S. Food and Drug Administration (FDA) has always had limited authority to regulate cosmetics. Enforcement has generally been restricted to requiring that certain information appear on labels; requiring warnings and tamper evident packaging for certain products; asking for voluntary facility registration and a voluntary guidance for good manufacturing practices. When FDA enforces it is most often against products labeled as cosmetics that make express or implied claims to affect the structure or function of the body or treat disease, which render such products “unapproved new drugs.”
Legislation has been introduced in Congress for years with the intent to increase FDA’s authority to regulate cosmetics, without gaining much traction. This changed in December 2022 when, as part of the $1.7 Trillion Consolidated Appropriations Act 2023 (H.R. 2617), the “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), was signed into law [www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf pages 1389 – 1402].
MoCRA, which in many ways is modeled on the Dietary Supplement Health and Education Act, includes provisions for serious adverse event reporting and adverse event recordkeeping, mandatory good manufacturing practice requirements, facility registration (for manufacturers and processors), mandatory product listing, safety substantiation, some new labeling, record inspection and FDA mandatory recall authority, among other things.
There are some limited exemptions for “small businesses” defined as “responsible persons” (the entity identified on the product label), and owners and operators of facilities, whose average gross annual sales in the United States of cosmetics for the previous three-year period is less than $1 million adjusted for inflation, and who do not engage in the manufacturing or processing of certain specified types of cosmetics. These exemptions are discussed in Section 612 (below).
Most of the new requirements become effective one year after the bill was signed into law. Many of the requirements will also be subject to notice and comment rulemaking by FDA.
This is a brief overview of the new MoCRA provisions. Each provision must be carefully reviewed and, obviously, much of how the law will ultimately impact industry will depend on FDA’s guidance together with the notice and comment rulemaking that will create the regulations required to bring the law into effect.
A. Section 605 Adverse Events
MoCRA defines “adverse event” and “serious adverse event.” An adverse event is any health-related event associated with the use of a cosmetic that is adverse. A “serious adverse event” includes, ‘‘(i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; (v) a congenital anomaly or birth defect; (vi) an infection; or (vii) 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; or based on reasonable medical judgment, a medical or surgical intervention to prevent what has been defined as a “serious adverse event.”
The “responsible person” must report serious adverse events occurring in the United States to FDA within 15 business days of receiving notice. The report must include the product label. It must be updated by the responsible person with any new and material medical information received within one year of the initial report within 15 days of receipt.
Records of adverse events must be maintained for a period of six years. There is a provision that limits record retention to three years for small business (defined in Section 612 below) that do not engage in certain specified manufacturing or processing. FDA must be permitted access to these records during inspections.
There is an additional provision specific to fragrance and flavor ingredients. If FDA has reasonable grounds to believe that an ingredient or combination of ingredients in a fragrance or flavor has caused or contributed to a serious adverse event, it may request in writing a list of such ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic, from the responsible person. The responsible person shall ensure that the requested information is submitted to FDA within 30 days of such request.
There are some limitations on disclosure of this information under the Freedom of Information Act. Any report may be accompanied by a statement from the responsible person, which shall be a part of any public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event. Finally, submission of a report will not constitute an admission that the product caused or contributed to the adverse event.
B. Section 606 Good Manufacturing Practices (GMP)
FDA will promulgate GMP regulations for facilities that are consistent, “to the extent practicable, and appropriate,” with national and international standards, to avoid the adulteration of cosmetics. The GMP regulations will include “simplified” requirements for smaller businesses, as appropriate, to ensure that such regulations do not impose undue economic hardship for smaller businesses and may include longer compliance times.
Before issuing GMP regulations, FDA is directed to YFTS-JFCY44-SZAF consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts selected by the FDA.
FDA will be permitted to inspect records necessary to demonstrate compliance with GMPs during inspections conducted under section 704 [FDA’s general facility inspection provision].
MoCRA requires FDA to issue proposed GMP regulations within two years and have them finalized within three years of the enactment of the law. This would require proposed regulations by December 2024 and final regulations by December 2025.
C. Section 607 Facility Registration and Cosmetic Product Listing
Entities that manufacture or process cosmetics for distribution in the United States must register each facility by December 2023. Registration will include foreign manufacturing and processing facilities that import products to the United States. Foreign facility registrations will be required to designate U.S. based agents. Facilities that do not manufacture or process, but are limited to labeling, relabeling, packaging, repackaging, holding and distributing are not required to register. “Packaging” and “repackaging” under this exception is limited to labeling and does not include filling a product container with a cosmetic product.
Registrations will be renewed every two years (like food and dietary supplement facility registration).
FDA may suspend a facility registration if it determines that a cosmetic manufactured or processed by a registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans and there is 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.
The law provides a notice and hearing procedure for review of suspensions, as well as a method for companies to submit corrective action plans to have registrations reinstated.
Cosmetic Product Listing
The “responsible person” must submit to FDA a cosmetic product listing for each cosmetic or ensure that such submission is made. Listings will include, among other things, the facility registration number, information on the responsible person, cosmetic category and list of ingredients. There will be flexibility to allow a single listing for products available in multiple fragrances, flavors or quantities.
MoCRA requires a listing procedure to be in place by December 2023 and will require new cosmetics to be listed within 120 days of introduction into interstate commerce. There will also be an abbreviated procedure for annual listing renewals. There is nothing in MoCRA to suggest that product listing information will be generally made available to the public.
D. Section 608 Safety Substantiation
The responsible person for each cosmetic shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic.
MoCRA defines the term “adequate substantiation of safety” as “tests or studies, research, analyses or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”
MoCRA further defines the term “safe” as meaning “that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.” FDA will not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining whether a cosmetic is safe, FDA may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic, including any ingredient thereof.
Obviously, precisely what type and amount of data will be necessary to satisfy this requirement remains, for now, an open question.
E. Section 609 Labeling
Every cosmetic label will be required to include a domestic address, domestic phone number or electronic contact information, which may include a website through which the company can receive adverse event reports. This is in addition to the existing requirement to have address information on the label. This provision becomes effective two years after the passage of MoCRA (December 2024).
FDA will commence notice and comment rulemaking within 18 months (June 2024) of the passage of MoCRA, to identify allergens in fragrance ingredients that will be required to be identified on product labels.
F. Section 610 Access to Records
If FDA has a reasonable belief that a cosmetic, or an ingredient in a cosmetic is likely to be adulterated such that the use or exposure to such product presents a threat of serious adverse health consequences or death to humans, each responsible person and facility shall, at the request of FDA, as part of a facility inspection, permit access to and copy all records relating to such cosmetics that are needed to assist FDA in determining whether the cosmetic is adulterated and presents a threat of serious adverse health consequences or death to humans.
FDA’s access to records will not include recipes or formulas for cosmetics, financial data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this Act), research data (other than safety substantiation data for cosmetic products and their ingredients), or sales data (other than shipment data regarding sales).
G. Section 611 Mandatory Recall Authority
If FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and “the use of or exposure to such cosmetic will cause serious adverse health consequences or death,” the Secretary will provide the responsible person with an opportunity to voluntarily cease distribution and recall such cosmetic. If the responsible person refuses to or does not voluntarily cease distribution and/or recall the cosmetic within the time and manner prescribed by FDA (if so prescribed), FDA may, by order, require such person to immediately cease distribution of such article. The law provides a process for holding an “informal hearing” within 10 days after such order on whether adequate evidence exists to justify the order.
H. Section 612 Small Business
Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1 million, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described below, shall be considered small businesses.
Such small businesses will only be required to maintain reports of adverse events for a period of three years and will be exempt from Section 606 GMP (good manufacturing practice) requirements and Section 607 Facility Registration and Product listing.
If a company manufactures or processes any cosmetic product that falls into any of the below categories, it cannot take advantage of the small business exemption no matter the amount of its annual sales.
“(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
‘‘(2) Cosmetic products that are injected.
‘‘(3) Cosmetic products that are intended for internal use.
‘‘(4) Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
I. Section 613 Exemption for Certain Products and Facilities — Drugs
Products that are both drugs and cosmetics will continue to be regulated by FDA as drugs under the Food and Drug Act, except as to fragrance allergen requirements if applicable.
J. Section 614 Preemption
No State or local government may establish any requirement for cosmetics that is different from or in addition to, or otherwise not identical with, any requirement applicable under MoCRA with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting or safety substantiation.
States will, however, continue to be able to prohibit the use or limit the amount of an ingredient in a cosmetic,, or continue in effect a requirement of any state that is currently in effect.
K. Other Provisions
FDA is required to promulgate proposed regulations within one year to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. The regulations are to be finalized within 180 days after the public comment period closes.
PFAS in Cosmetics
FDA shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products. In conducting such assessment, the Secretary may, as appropriate, consult with the National Center for Toxicological Research. A report summarizing the results of the assessment must be published within three years.
Sense of the Congress on Animal Testing
As stated in MoCRA, “it is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.”
This is a non-binding resolution without legal affect.
MoCRA authorizes $14,200,000 for fiscal year 2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of fiscal years 2025 through 2027, in order to fund the new agency activities required under the Act.
MoCRA provides FDA necessary oversight over cosmetic manufacturers and processors, which most would agree is long overdue. It is interesting that Congress decided to exempt most small manufacturers and processors from registration, listing, and GMP requirements. Certainly, many cosmetic companies have started with people experimenting in their homes and dorm rooms and it is reasonable that Congress would draft a law that allows these innovators to continue to exist.
Also, when Congress passed dietary supplement legislation, the law provided for no specific for promulgating GMP regulations. Perhaps because of the extraordinary amount of time FDA took to complete dietary supplement GMPs, in MoCRA, Congress has set short and specific timelines, but also provided significant funding.
It will be interesting to see if FDA can meet its statutory obligations to have all of the implementing regulations in place within the time limits set by Congress.
This information is not intended as legal advice. Readers should seek specific legal advice before acting with regard to the subjects mentioned herein. NIE
Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.