MoCRA 是 1938 年《联邦食品、药品和化妆品法》（FFDCA）以来 FDA 化妆品监管权最大一次扩张：新增设施注册、产品列名、安全性论证、严重不良事件报告与强制召回五项核心义务，但仍未建立化妆品上市前审批制度（着色剂除外）。
本文为美国国会研究服务部（Congressional Research Service, CRS）报告 R47826《FDA Regulation of Cosmetics and Personal Care Products Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)》（2023 年 10 月 30 日，作者 Nora Wells, Analyst in Health Policy）的英文全文，逐段照录、未作删减。该报告系统梳理 MoCRA 前后 FDA 对化妆品的监管权限边界，是中国化妆品企业判断美国市场准入路径的基础性文件。绿翊合规同步提供2026 美国化妆品 MoCRA 合规指南，可对照阅读。
1938年
FFDCA 首次授权
2022年
MoCRA 签署
184千家
美国相关企业
5293亿美元
全球年零售额
01
Report Identification
CRS R47826
FDA Regulation of Cosmetics and Personal Care Products Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The Food and Drug Administration (FDA) has the authority to regulate cosmetic products and their ingredients. This authority was granted by the 1938 Federal Food, Drug, and Cosmetic Act
R47826
October 30, 2023
Nora Wells Analyst in Health Policy
For a copy of the full report, please call 7-5700 or visit www.crs.gov.
02
Summary
CRS R47826
(FFDCA), which included provisions regarding the adulteration and misbranding of cosmetics. Cosmetic products are also regulated under the Fair Packaging and Labeling Act (FPLA) and related legislation. Although the Color Additive Amendments Act of 1960 and the Poison Prevention Packaging Act of 1970 amended some of FFDCA’s provisions, cosmetics regulation remained largely unchanged from the original FFDCA until 2022, when the Modernization of Cosmetics Regulation Act (MoCRA) was enacted. Most of MoCRA’s provisions will take effect at the close of 2023.
Prior to the passage of MoCRA, FDA had limited authority regarding cosmetic product registration; testing; premarket notification, clearance, or approval; good manufacturing practices; mandatory risk labeling; adverse event reports; and recalls. FDA could not impose registration requirements on cosmetic manufacturers. Rather, manufacturers could voluntarily comply with FDA registration regulations. Additionally, with the exception of color additives, FDA did not require premarket notification, safety testing, review, or approval of the chemicals used in cosmetic products. Although FDA had released draft good manufacturing practices (GMP) guidelines for cosmetic manufacturers, they were not required to adhere to them, nor were manufacturers required to file ingredient information with, or report adverse reactions to, the agency. Instead, under a voluntary FDA program, cosmetic manufacturers and packagers could choose to report the ingredients used in their product formulations. FDA also did not have the authority to require a manufacturer to recall a cosmetic product from the marketplace, although the agency did issue general regulations on voluntary recalls.
With the passage of MoCRA, FDA’s regulatory authority over cosmetics has been expanded. Under MoCRA, FDA will now require facility registration and listing of cosmetics products with the agency, as well as certain product labeling information. FDA will also promulgate final GMP regulations, require the reporting of serious adverse events, and gain the ability to issue mandatory product recalls. Moreover, manufacturers must substantiate cosmetic product safety and maintain related records. The passage of MoCRA, however, will not require cosmetics to be subject to premarket review.
FDA’s authority over cosmetics, both pre- and post-MoCRA, overlaps in some ways with other FDA-regulated products, such as food, drugs, medical devices, and tobacco. For example, prior to MoCRA, FDA had the authority to take certain enforcement actions—such as seizures, injunctions, and criminal penalties—against adulterated or misbranded cosmetics, as it does with foods, drugs, devices, and tobacco products. In addition, FDA could inspect cosmetic manufacturing facilities, as it may with drug and food companies, and prohibit the importation of cosmetics that violate the FFDCA. Moreover, the agency has issued rules restricting the use of ingredients that it determines are poisonous or deleterious.
Despite these similarities in applicability FDA’s authority over cosmetics in certain respects remains less comprehensive than its authority over other FDA-regulated products.
03
Introduction
CRS R47826
The U.S. cosmetic, beauty supply, and perfume retail industry consists of over 184,000 establishments, with a projected combined annual revenue of about $45.2 billion by the close of 2023.1 Worldwide, the cosmetics and personal care products industry collects more than $529.3 billion in annual retail sales.2 The cosmetic market includes numerous personal care products other than the facial makeup that the term “cosmetics” typically implies.3 Domestic industry sales are concentrated in the following areas (percentage of sales by product category): (1) cosmetics, 37.9%; (2) haircare products, 27.1%; (3) skincare products, 20.9%; and (4) nail products, deodorants, and other products, 14.1%.4
The Food and Drug Administration (FDA) has the authority, generally under the Federal Food, Drug, and Cosmetic Act (FFDCA), to regulate cosmetic products and their ingredients. In this context, the agency’s primary regulatory responsibilities include ensuring that cosmetics are not adulterated or misbranded.5 FDA’s authority over cosmetic products has been greatly expanded via the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
This report (1) describes the definitional differences between cosmetics, drugs, and cosmetic/drug combinations; (2) outlines the statutory provisions and rules under which FDA regulates cosmetics, including those newly introduced under MoCRA; and (3) identifies outstanding considerations about FDA’s authority over cosmetics. The report focuses on FDA regulation of cosmetics under MoCRA; it does not discuss Federal Trade Commission (FTC) regulation of cosmetics advertising or the regulation of potentially dangerous chemicals, pesticides, or other products by other agencies.6
04
History of FDA’s Cosmetics Regulation Authority
CRS R47826
Scope and Definitions: Cosmetics, Drugs, and Cosmetic/Drug Combinations
This section discusses how the FFDCA defines cosmetics and drugs. The distinction between them, which determines how products are classified, is a concern for manufacturers because cosmetics are not subject to the same approval, regulatory, or registration requirements as drugs, unless the cosmetic also meets the definition a drug.7 Having a product classified as cosmetic only—not as a drug or cosmetic/drug combination—saves manufacturers time and expense and enables them to market their products with less regulatory oversight.
Cosmetics
FFDCA defines a “cosmetic” as an article intended to be “applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance.”8 The term covers a broad range of FDA-regulated products that may be used externally and internally.9 Cosmetics include products for the eyes, face, nails, hair, skin, and mouth, such as makeup, nail polish, hair dyes and coloring, suntan preparations, fragrances, oral care, and bath products.10 Although soap was explicitly exempted from the definition of a cosmetic, it may be regulated by the FDA as a cosmetic product in certain instances.11 In addition, coal-tar hair dye was provided a limited exemption from the FFDCA’s adulteration provisions.12 Inks used for tattooing are also classified as cosmetics under the FFDCA.13 Under MoCRA, FFDCA will separately define a “cosmetic product” as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”14
Drugs
The FFDCA defines a “drug” in part as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”; articles “(other than food) intended to affect the structure or any function of the body”; and “articles intended for use as a component” of such drugs.15
Drug manufacturers must comply with Current Good Manufacturing Practices (CGMP) rules for drugs.16 Failure to comply will cause a drug to be considered adulterated.17 Drug manufacturers are required to register their facilities,18 list their drug products with the agency,19 and report adverse events to FDA, among other requirements.20
Unlike cosmetics and their ingredients (with the exception of color additives), drugs are subject to FDA approval before entering interstate commerce. Drugs must either (1) receive the agency’s premarket approval under a new drug application (NDA), or an abbreviated NDA (ANDA),21 in the case of a generic drug, or (2) conform to a set of FDA requirements known as a monograph.22 Monographs govern the manufacture and marketing of most over-the-counter (OTC) drugs and specify the conditions under which OTC drugs in a particular category (such as antidandruff shampoos or antiperspirants) will be considered generally recognized as safe and effective (GRASE).23 Monographs also indicate how OTC drugs must be labeled so they are not deemed misbranded.24
Cosmetics Containing Drug Ingredients
Although the term “cosmeceutical” has been used to refer to combination cosmetic/drug products, such products have no statutory or regulatory definition.25 Historically, FDA has indicated that cosmetic/drug combinations are subject to FDA’s regulations for both cosmetics and drugs.26
Determining whether a cosmetic is also a drug, and therefore subject to the additional statutory requirements that apply to drugs, depends on the distributor’s claims regarding the drug’s intent or intended use.27 A product’s intended use may be established in several ways, such as claims on the label or in advertising or promotional materials, customer perception of the product, and the inclusion of ingredients that cause the product to be considered a drug because of a known therapeutic use.28 For example, if a lipstick (a cosmetic) contains sunscreen (a drug), historically, the mere inclusion of the term “sunscreen” in the product’s labeling required the product to be regulated as a drug as well as a cosmetic.29 The text box below provides examples of other cosmetic/drug combinations and compares cosmetic and drug classifications.30
◈
Comparison of Cosmetic and Drug Product Classifications
A suntan product is a cosmetic, but a sunscreen product is a drug. A deodorant is a cosmetic, but an antiperspirant is a drug. A shampoo is a cosmetic, but an antidandruff shampoo is a drug. A toothpaste is a cosmetic, but an anticaries toothpaste is a drug. A skin exfoliant is a cosmetic, but a skin peel is a drug. A mouthwash is a cosmetic, but an antigingivitis mouthwash is a drug. A hair bulking product is a cosmetic, but a hair growth product is a drug. A skin product to hide acne is a cosmetic, but an antiacne product is a drug. An antibacterial deodorant soap is a cosmetic, but an antibacterial anti-infective soap is a drug. A skin moisturizer is a cosmetic, but a wrinkle remover is a drug. A lip softener is a cosmetic, but a product for chapped lips is a drug.
Source: Peter B. Hutt, “Legal Distinction in the United States between a Cosmetic and a Drug,” in Cosmeceuticals and Active Cosmetics, ed. Raja K. Sivamani et al., 3rd ed. (Boca Raton, FL: Taylor & Francis Group, 2016), p. 432.
History
Prior to the enactment of the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938, cosmetics were not regulated by the federal government.31 Instead, they were regulated under a collection of state laws that had been enacted to regulate food and drugs.32 At that time, multiple “cosmetics and drugs were made from the same natural materials” and often the “laws did not include explicit definitions of the products regulated.”33 Following several incidents in which cosmetics were allegedly the cause of serious health problems, as well as industry concerns about states enacting their own laws, provisions were included in the FFDCA that prohibited the sale of adulterated or misbranded cosmetics in interstate commerce.34 The FFDCA also established uniform regulation of FDA-regulated cosmetic products nationwide.35 However, state laws regarding cosmetics regulation have continued to evolve since FFDCA’s passage, with some states implementing stricter measures than others.36
In addition to their regulation under the FFDCA, cosmetics are regulated under the Fair Packaging and Labeling Act (FPLA) and related regulations.37 The FPLA applies to the packaging and labeling of “consumer commodities,” which include cosmetics “customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care … and which [are] usually consumed or expended in the course of such consumption or use.”38 The FPLA does not apply to “wholesale or retail distributors of consumer commodities, except to the extent that such persons
are engaged in the packaging or labeling of such commodities, or
prescribe or specify … the manner in which such commodities are packaged or labeled.”39
The FFDCA prohibits the adulteration and misbranding of cosmetics in interstate commerce and the introduction, receipt, and delivery of adulterated or misbranded cosmetics into interstate commerce.40 From 1938 until 2022, with the exception of provisions governing color additives, the FFDCA statutory provisions addressing cosmetics remained basically unchanged, though the cosmetic industry has continuously grown over the past 80 years. Consequently, the concerns of consumer and industry groups have often remained similar since the enactment of the FFDCA.
Prior to MoCRA, due to statutory authority limitations, certain FDA cosmetics regulations and procedures relied on voluntary manufacturer compliance, even though similar regulations and procedures were mandatory for other FDA-regulated products (such as drugs). For example, FDA had promulgated regulations for the voluntary registration of establishments that manufactured or packaged cosmetics.41 In contrast, mandatory registration requirements existed for other FDA product-category manufacturers (e.g., drugs, food).42 Moreover, unlike drug manufacturers, cosmetic manufacturers were not required to submit safety data on ingredients or to report cosmetic-related injuries to FDA.43 Instead, under a voluntary FDA program, cosmetic manufacturers and packagers could choose to report the ingredients used in their product formulations.44 Furthermore, consumers, health care professionals, and cosmetic manufacturers could voluntarily report adverse reactions to cosmetics to FDA.45 Finally, FDA did not have mandatory recall authority to require a cosmetic manufacturer to recall a product from the marketplace. However, the agency could request a voluntary recall, and FDA has issued general regulations outlining its expectations for manufacturers during such recalls.46 Although FDA did not have the authority to require compliance with these regulations, it could take action against adulterated or misbranded cosmetics.47
FDA’s authority over cosmetics prior to MoCRA was less comprehensive than its authority over other FDA-regulated products with regard to good manufacturing practices (GMP), premarket clearance or approval, testing, and mandatory risk labeling.48 FDA released GMP guidelines for cosmetic manufacturers49 and stated that “[f]ailure to adhere to GMP may result in an adulterated or misbranded product.”50 FDA did not review or approve ingredients used in cosmetic products other than color additives, although cosmetic manufacturers were responsible for substantiating the safety of their products and ingredients before marketing.51 Drug products, on the other hand, generally are reviewed by FDA prior to marketing to ensure they meet FFDCA requirements for safety and effectiveness.52
After decades of minimal regulatory development for cosmetic products, on December 29, 2022, Congress enacted the Consolidated Appropriations Act, 2023 (CAA, 2023).53 The CAA, 2023, included MoCRA,54 which has established several new FDA authorities and responsibilities related to cosmetics regulation. Although MoCRA addresses many stakeholder concerns, some remain outstanding.
05
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
P.L. 117-328 §3502
Table 1. New FFDCA Sections Added by MoCRA Section 3502Source: P.L. 117-328
New FFDCA Sections Added by MoCRA Section 3502
FFDCA Section
Provision
FFDCA Section 604
Definitions
FFDCA Section 605
Adverse Events
FFDCA Section 606
Good Manufacturing Practice
FFDCA Section 607
Registration and Product Listing
FFDCA Section 608
Safety Substantiation
FFDCA Section 609
Labeling
FFDCA Section 610
Records
FFDCA Section 611
Mandatory Recall Authority
FFDCA Section 612
Small Businesses
FFDCA Section 613
Exemption for Certain Products and Facilities
FFDCA Section 614
Preemption
Source: P.L. 117-328, Division FF, Title III, Subtitle E—Cosmetics, §3502.
According to FDA, MoCRA is “the most significant expansion of the FDA’s authority to regulate cosmetics since the [FFDCA] was passed in 1938.”55 The bulk of amendments made to the FFDCA are outlined in Section 3502 of MoCRA.56 Broadly, MoCRA grants FDA a host of new authorities to protect consumer safety. These authorities include the ability, under some circumstances, for FDA to access specific types of cosmetic product records and issue mandatory cosmetic product recalls.57 In addition, MoCRA establishes new industry requirements, including reporting adverse events to FDA, registering manufacturing and processing facilities with FDA, listing marketed products and their ingredients with FDA, and maintaining records of safety substantiation for cosmetic products.58 Furthermore, MoCRA requires that industry follow forthcoming FDA regulations regarding good manufacturing practices (GMP) for cosmetic manufacturing facilities, fragrance allergen labeling, and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics.59 For some small businesses, certain exemptions to specific requirements introduced under MoCRA may also apply.60 These new requirements for cosmetics pursuant to MoCRA, as well as select enforcement mechanisms related to those requirements, are described below.
Cosmetic Regulatory Controls
06
Premarket Requirements
FFDCA §608
Unlike its authority over drugs and some devices, FDA does not have the authority, either pre- or post-MoCRA, to require premarket approval of cosmetics or their ingredients, except for color additives.61 Prior to MoCRA, it was FDA’s position that manufacturers were responsible for substantiating the safety of their products and ingredients before the products were marketed.62
With the passage of MoCRA, manufacturers are now statutorily required to substantiate the safety of their products. MoCRA also expands upon required recordkeeping by manufacturers, packers, and distributors. A “responsible person”63 for a cosmetic product must ensure that it has been adequately tested to substantiate safety,64 and that records supporting this substantiation are maintained by the same responsible person.65 Certain products and facilities already regulated under Chapter V of FFDCA as a drug or device are exempt from MoCRA’s safety substantiation and recordkeeping requirements.66 However, if such a facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the exemption does not apply to those particular cosmetic products.67
Enforcement
Among various enforcement mechanisms, under MoCRA, FDA may access and copy all records related to a cosmetic product that it reasonably believes is likely adulterated and a serious danger to humans. FDA may access and copy all records necessary to determine whether a cosmetic or related product is adulterated and a serious threat to human health, barring certain cosmetic formula, personnel, research, and financial data records. Accessible records include those related to safety substantiation data for cosmetic products and their ingredients.68
07
Registration and Listing
FFDCA §607
Prior to MoCRA, cosmetic manufacturers were not required to register their establishments or list their products with FDA. Instead, according to FDA regulations, owners or operators of establishments that manufactured or packaged cosmetics were requested to register with FDA.69 Likewise, previous to MoCRA, manufacturers, packers, and distributors of cosmetic products were requested to file a cosmetic product ingredient statement (CPIS) containing certain information on each cosmetic product they marketed.70 Entities could submit registration information and CPISs to FDA’s Voluntary Cosmetic Registration Program (VCRP).71
Under MoCRA, both facility72 registration and product listings are now required.73 Existing and new facilities that manufacture or process cosmetic products for distribution in the United States must be registered with FDA. These registrations must be renewed every two years and updated within 60 days of a content revision.74 Domestic facilities registering with FDA must provide the facility’s name, physical address, email address, and phone number, while foreign facilities must provide contact information for an agent within the United States and, if available, electronic contact information. Additionally, a facility must include its registration number, if one was previously assigned, and all brand names associated with cosmetic products sold that were manufactured or processed at that facility. The product categories and responsible person for each cosmetic product manufactured or processed at the facility must also be provided.75
Each responsible person must also ensure the submission of a cosmetic product listing with FDA that is renewed and updated annually.76 The product listing must contain the manufacturing or processing facility’s registration number, the responsible person’s name and contact number, the name of the cosmetic product as it appears on the label, the categories the cosmetic product falls under, and the product’s listing number. Additionally, the product listing must include a list of the cosmetic product’s ingredients, “including any fragrances, flavors, or colors, with each ingredient identified by name.”77 FDA will assign private product and facility identification numbers upon initial listing submission or registration.78
With the advent of MoCRA, FDA reported the VCRP had been discontinued and was no longer accepting submissions. In a draft guidance released in August 2023, FDA stated it is developing a new electronic submission portal for registration and listing information.79 FDA noted that this new portal is expected to be available by October 2023.80 In the interim, FDA requests that no registration or listing information be sent to the agency, adding that information previously listed in the VCRP will not be transferred.81 In September 2023, FDA released for comment draft versions of the prospective electronic submission portal, Cosmetics Direct, and paper forms.82
MoCRA exempts certain small businesses83 from both facility registration and product listing requirements.84 However, a small business is not exempt from these requirements if it is engaged in the manufacturing or processing of higher-risk cosmetic products that “regularly come into contact with [the] mucus membrane of the eye under conditions of use that are customary or usual,” “[c]osmetic products that are injected” (see the text box below), “intended for internal use,” or that are meant to “alter [one’s] 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.”85
◈
Injected Cosmetics: Tattoo Inks
In 2019, one in three Americans reported having at least one tattoo. The ink used in tattooing, including for both decorative and medical purposes, is classified by FDA as a cosmetic. Consequently, the pigments used in tattoo inks are considered color additives and would typically be subject to premarket review. Traditionally, FDA has chosen not to enforce this authority, citing “competing public health priorities and a previous lack of evidence of safety problems specifically associated with these pigments.” However, over the years, reports of adverse events related to tattooing have prompted increased FDA scrutiny. For example, there have been multiple voluntary recalls of tattoo inks, often due to microbial contamination. In one independent survey of sealed tattoo and permanent makeup inks in the United States cited by FDA, 49% were contaminated with microorganisms, including fungi and pathogenic bacteria. Other pigments that have been identified in tattoo inks are chemically similar or identical to industrial paints and printer inks. MoCRA specifically amends FFDCA by adding Section 612(b)(2), which ensures that injected cosmetics may not be exempted from future GMP and registration and product listing requirements. In June 2023, FDA released a draft guidance for industry entitled “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.”
Sources: Jessica C. Dixon, “The Perils of Body Art: FDA Regulation of Tattoo and Micropigmentation Pigments,” Administrative Law Review, vol. 58, no. 3 (Summer 2006), p. 668; FDA, Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination: Guidance for Industry, FDA-2023-D-1083, June 2023; FDA, “Tattoos & Permanent Makeup: Fact Sheet,” https://www.fda.gov/cosmetics/ cosmetic-products/tattoos-permanent-makeup-fact-sheet; and S.W. Nho et al., “Microbiological Survey of Commercial Tattoo and Permanent Makeup Inks Available in the United States,” Journal of Applied Microbiology, vol. 124, no. 5 (May 2018), p. 1296.
Additionally, certain products and facilities already regulated under Chapter V of FFDCA as a drug or device are exempt from facility registration and product listing requirements.86 However, if such a facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the exemption does not apply.87
Enforcement
Under MoCRA, if FDA determines that a cosmetic product has a reasonable probability of causing serious harm to human health, and if FDA has a reasonable belief that other products manufactured or processed at the same facility may be similarly affected, FDA may suspend the registration of the facility connected with such products.88 If a facility’s registration is suspended, any cosmetic product from that facility is barred from introduction or delivery for introduction into U.S. commerce.89
Before suspending a facility’s registration, the FDA must provide notice to a responsible person for the facility specifying the reason for suspension, as well as an opportunity, within five business days of the notice, to present a plan to correct the issue identified.90 FDA must provide the responsible person with the opportunity for an informal hearing to review actions required for registration reinstatement and why the facility registration should be reinstated.91 If, based upon the evidence presented at this informal hearing, FDA determines there are inadequate grounds to continue the suspension, the facility registration will be restored.92 However, if there is insufficient evidence presented, the suspension may continue, and FDA shall require the responsible person to submit a corrective action plan for review.93
If at any point FDA determines there is inadequate evidence to justify the continued suspension of a facility’s registration, the registration shall be promptly reinstated.94
08
Adulterated and Misbranded Cosmetics
FFDCA §601 / §602
Since its passage in 1938, the FFDCA has prohibited the adulteration and misbranding of cosmetics. It also prohibits the introduction, receipt, and delivery of adulterated or misbranded cosmetics into interstate commerce and may take enforcement actions in such instances.95
A cosmetic is deemed adulterated—and potentially subject to FDA enforcement actions—if it
“bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling … except that this provision shall not apply to coal-tar hair dye”;96
consists of “any filthy, putrid, or decomposed substance”;
was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated” or “rendered injurious to health”;
is in a container composed of “any poisonous or deleterious substance which may render the contents injurious to health”;
contains an unsafe color additive, except for hair dyes;97
“has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of [FFDCA] section 606”; or
“is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for safety, as defined in [FFDCA] section 608(c).’’98
FDA has issued rules restricting the use of certain ingredients in cosmetic products. If FDA determines that a cosmetic’s ingredients are poisonous or deleterious, that cosmetic is considered adulterated.99 One example of an adulterated cosmetic is the use of henna, also known as mehndi, for temporary skin decoration.100 Although the color additive used in henna products is allowed for hair dye, it is not allowed for direct skin contact.101 Therefore, under FDA regulations, the use of henna for skin decoration renders the product “adulterated.”102
Under the FFDCA, a cosmetic is deemed misbranded if
the “labeling is false or misleading in any particular”;
the label lacks required information;103 the required labeling information is not prominently placed and “in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use”;
the “container is so made, formed, or filled as to be misleading”;
the use of a color additive does not conform to packaging and labeling requirements; or
the packaging or labeling violates the regulations issued under the Poison Prevention Packaging Act of 1970.104
Cosmetic products that meet the FPLA’s definition of a “consumer commodity”105 are considered misbranded under the FFDCA if they do not comply with FPLA’s requirements.106 Consumer commodity (retail) cosmetic products subject to the FPLA are required to bear a label that identifies the product and the name and place of business of the manufacturer, packer, or distributor, as well as the net quantity of contents on the principal display panel.107 The net quantity of contents information must be declared in a legible type size that is uniform for packages of about the same size.108 FDA’s ingredient labeling rules, issued under the authority of the FPLA, require ingredients be listed on cosmetic products in descending order of predominance.109
Enforcement
If a cosmetic is deemed adulterated or misbranded, FDA may take enforcement actions.110 FDA may issue import alerts111 and warning letters112 to entities that manufacture or distribute a violative product. Other enforcement actions may include, with assistance from the Department of Justice, seeking an injunction (which could prevent a company from making or distributing the violative product), seizing the violative product, or seeking criminal penalties.113
09
Mandatory Recall
FFDCA §611
Prior to MoCRA, FDA did not have the authority to order mandatory recalls of cosmetic products. The agency could, however, request a company to voluntarily recall cosmetic products of concern.114 Under MoCRA, a responsible person may still have the opportunity to voluntarily recall an adulterated or misbranded cosmetic; however, now FDA also has the authority to issue a mandatory recall.115 A mandatory recall may be initiated “[i]f the Secretary 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,” and the responsible person refuses to comply with a voluntary recall in a timely manner. Upon FDA issuing an order for a mandatory recall, the responsible person must immediately stop distributing the identified product.116
If such an order is issued, the responsible person is entitled to an opportunity for a timely informal hearing to review the adequacy of evidence for the order.117 Depending on the outcome of this review, the order may be vacated, continued until a specified date, or amended to further require the recall of the cosmetic product, along with other measures regarding notifications, timetables, and updates.118 FDA may require the responsible person to issue a notice of recall or ceased distribution to appropriate persons, including manufacturers, distributors, importers, and sellers.119 If a product is recalled, FDA must ensure that a press release announcing the action is published, as well as appropriate alerts and public notices, to provide consumers and retailers with information about the cosmetic product and the circumstances of the recall. If an image of the product is available and appropriate, FDA shall also ensure the publication of that image on its website.120 Certain products and facilities already regulated under Chapter V of FFDCA as a drug or device are exempt from MoCRA’s mandatory recall authority.121 However, if such a facility also manufactures or processes cosmetic products not subject to FFDCA Chapter V, the exemption does not apply to those particular cosmetic products. 122
Enforcement
Again, under MoCRA, FDA may access and copy all records related to a cosmetic product that it reasonably believes is likely adulterated and a serious danger to humans.123
10
Labeling
FFDCA §609
Consumers may seek out particular cosmetics based on their labeling, such as those claiming to be made with organic ingredients or not tested on animals. However, FDA does not define certain terms used by manufacturers, including “organic” and “not tested on animals.”124 Though this specifically has not changed under MoCRA, the new act does introduce certain labeling requirements.125
Under MoCRA, cosmetic product labels must include a domestic address, domestic phone number, or electronic contact information (e.g., a website) through which a responsible person may be contacted regarding adverse events in response to usage of the product.126 Cosmetic product labels must also identify each fragrance allergen contained in the product.127 For cosmetic products intended only for professional use,128 labels must include “a clear and prominent statement that the product shall be administered or used only by licensed professionals,” and meet the labelling requirements of the FFDCA and FPLA Section 4(a).129
Enforcement
What constitutes a fragrance allergen is to be decided by FDA via rulemaking. Pursuant to this rulemaking, FDA is to consider “international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure.”130 A notice of proposed rulemaking must be issued no later than June 29, 2024, with a final rule promulgated no later than 180 days after the close of the proposed rule’s public comment period.131
11
Good Manufacturing Practices
FFDCA §606
Prior to MoCRA, cosmetic product manufacturing was not subject to good manufacturing practices (GMP). Instead, FDA had published a draft guidance in 1997, which was later updated in 2008 and 2013, recommending GMP for cosmetic products.132 FDA had also published a web page containing cosmetic establishment instructions, adapted from its Inspection Operations Manual, meant to “serve as guidelines for effective [establishment] self-inspection.” FDA noted that “[a] good inspection score means that an establishment follows good manufacturing practices.”133
With the passage of MoCRA, FDA has been tasked with establishing GMP via rulemaking.134 Subsequently, FDA announced that it plans to withdraw or revise, then reissue, the 2013 draft guidance.135 Under MoCRA, these GMP should be consistent with, to the degree practicable, national and international standards.136 The intent of the GMP should be to “protect the public health and ensure that cosmetic products are not adulterated.”137 These requirements must also be scalable to the size and scope of the businesses subject to them to ensure that smaller businesses are not exposed to undue hardship.138 In developing these GMP, FDA is to consult with cosmetic manufacturers, including smaller businesses.139
Enforcement
To ensure these GMP are followed, MoCRA allows for the inspection of facility records to demonstrate compliance during a larger facility inspection, an authority that predated MoCRA.140 Regarding a timeline for the implementation of these GMP, MoCRA requires that a notice of proposed rulemaking be published no later than December 29, 2024, and that a final rule published no later than December 29, 2025.141
12
Reporting Adverse Events and Reactions to Cosmetics
FFDCA §605
Prior to MoCRA, FDA did not have the statutory authority to require cosmetic manufacturers to notify the agency of adverse events associated with their products, nor could it require cosmetic companies to report information received from consumers and others regarding adverse events.142 Consequently, before MoCRA was enacted, FDA relied exclusively on voluntary reports of adverse events from cosmetic companies and consumers. The public could report adverse events to FDA via MedWatch, the FDA’s product safety reporting program.143
Under MoCRA, a responsible person for a particular cosmetic product used domestically must report associated serious adverse events144 to FDA.145 It is expected that the responsible person will be informed of such events via the required contact information listed on the product’s label.146 Upon learning of an adverse event, a responsible person must relay this information to FDA, along with a copy of the specific product’s label, within 15 business days.147 For one year following this initial report, the responsible person must update FDA on “any new and material medical information” related to the serious adverse event within 15 business days of receipt.148 In addition to reporting a serious adverse event, the responsible person must also maintain related records for a period of six years.149 However, if a responsible person represents a small business that does not engage in the manufacturing or processing of higher-risk cosmetic products, records need only be maintained for three years.150 Exemptions to the requirements surrounding serious adverse events may be established by regulation if FDA determines they “would have no significant adverse effect on public health.”151
Additionally, if FDA reasonably believes that a fragrance or flavor ingredient contributed to a reported serious adverse event, the agency may request a written list of ingredients or ingredient categories in the fragrance or flavor of concern. A responsible person must convey this information to FDA within 30 days of the request.152
Enforcement
Under MoCRA, records kept regarding adverse events are subject to inspection.153 A responsible person must allow an authorized person154 access to these records during a larger facility inspection.155
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Regulation of Specific Cosmetic Ingredients
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Some ingredients used in cosmetic products have received particular attention due to concerns about their potential health risks. For example, there have been long-standing concerns regarding the use of coal-tar hair dyes as color additives. Concerns have also been raised about a group of synthetic compounds known as per- and polyfluoroalkyl substances (PFAS).156 Both coal-tar hair dyes and PFAS have been the focus of congressional interest. However, these substances are not the only ingredients to have raised concern. FDA has online resources with information regarding other ingredients that consumers have inquired about, including talc, parabens, and phthalates, among others.157
Talc
Talc is a naturally occurring mineral composed of magnesium, silicon, oxygen, and hydrogen.158 It is used in many cosmetics, often to “absorb moisture, … prevent caking, … make facial makeup opaque, … [and] improve the feel of a product.”159 Safety concerns regarding talc have existed for decades, with published literature in the 1960s suggesting a possible connection between talc and ovarian cancer, followed in the 1970s by concerns about asbestos contamination. Asbestos, also a naturally occurring mineral, is a proven carcinogen, and often geologically forms in proximity to talc. Thus, when talc is mined, asbestos may sometimes become inadvertently commingled. FDA conducts ongoing research on the safety of talc, and in 2022, the agency published a report testing selected talc-containing cosmetics for asbestos.160 Of the 50 cosmetic samples tested for the report, none contained asbestos.161
Due to the potential for talc to be contaminated by asbestos, FDA has noted the importance of selecting “talc mining sites carefully and tak[ing] steps to test the ore sufficiently.”162 Consequently, MoCRA directs FDA to, no later than December 29, 2023, “promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.”163 FDA must publish a final regulation within 180 days after the public comment period closes.164
PFAS
PFAS are a group of synthesized chemical compounds used in a range of industrial and consumer products, including cosmetics. Although PFAS are sometimes referred to as “forever chemicals,” their persistence varies—both between longer-chain versus shorter-chain PFAS, and between more fluorinated versus less fluorinated PFAS—thus potential health effects may also vary.165 PFAS ingredients may intentionally be added to certain cosmetics to improve their texture or consistency, condition and smooth skin, or give skin a shiny appearance.166 PFAS are used as ingredients in lotions, cleansers, nail polishes, shaving creams, and some makeup products (e.g., lipstick, eyeliner, eyeshadow, and mascara).167 PFAS may be unintentionally added to cosmetics via raw material impurities or the breakdown of PFAS ingredients that form other types of PFAS.168 Although intentionally added PFAS ingredients are typically declared on a cosmetic product’s label, unintentional PFAS may not be.169
According to FDA, research on the presence of PFAS in cosmetics is limited, and it is unclear whether PFAS in cosmetics are absorbed through the skin at levels harmful to humans. Studies have found varying concentrations of PFAS in cosmetics, ranging “from the parts per billion level to the 100s of parts per million range.”170 FDA has called for more research into PFAS, and some Members of Congress have introduced legislation regarding research needs and the use of these compounds in certain consumer goods.171
MoCRA directly addresses this lack of information. Under Section 3506, FDA is tasked with assessing the use of PFAS “in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use.”172 FDA may consult with the National Center for Toxicological Research during this assessment.173 FDA must publish a report summarizing the assessment on its website no later than December 29, 2025.174
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FDA’s Authority to Regulate Cosmetics in the Future
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Prior to MoCRA, various stakeholders, GAO, and some Members of Congress identified limitations to FDA’s authority to regulate cosmetics, noting that these limitations could expose consumers to unnecessary health risks. Some advocacy groups, for example, cited regulatory schemes adopted by foreign governments for cosmetic products and contended that these schemes allowed those governments a greater degree of control over the manufacturing and selling of cosmetic goods.175 Some of the limitations identified by stakeholders included FDA’s lack of authority to require premarket approval for cosmetic products,176 order mandatory recalls,177 require cosmetics facility registration,178 make risk assessments more robust,179 require mandatory reporting of adverse events related to cosmetics,180 and issue cosmetic GMP regulations.181
The passage of MoCRA may alleviate many stakeholder concerns regarding FDA’s cosmetic regulatory capacity, such as FDA’s authority to issue a mandatory recall, require cosmetics facility registration, require mandatory reporting of adverse events, and issue cosmetic GMP. Furthermore, the safety assessment report required for PFAS may allay some concerns about a lack of risk assessment robusticity.
However, even with the enactment of MoCRA, some previously identified issues remain— primarily the ongoing lack of premarket approval for cosmetics and many other ingredients of concern not selected for risk assessment. Among these unaddressed ingredients are parabens, “a family of related chemicals that are commonly used as preservatives” to prevent the contamination and spoilage of many cosmetic products.182 The most common types of parabens found in cosmetics include methylparaben, propylparaben, butylparaben, and ethylparaben.183 FDA has received many consumer inquiries about the safety of parabens due to public concerns, often raised by advocacy groups, primarily about potential links between the ingredient family and endocrine disruption.184 According to the Centers for Disease Control and Prevention (CDC), “[h]uman health effects from environmental exposure to low levels of parabens are unknown.”185 In turn, FDA states that it does not currently “have information showing that parabens as they are used in cosmetics have an effect on human health.”186 However, FDA notes that it continuously reviews published studies on paraben safety and will alert industry and consumers if a health hazard is determined to exist.187
At present, the implementation of MoCRA introduces some uncertainties, such as certain enforcement timelines and what constitutes sufficient safety substantiation. Regarding timelines, some stakeholders have pointed out that enforcement timelines for certain provisions may differ; for example, adulteration provisions are slated for enforcement by the close of 2023, even though they are predicated in part on the promulgation of GMP, which could remain in the rulemaking process until the close of 2025.188 Others have pointed out that MoCRA does not specifically state what will satisfy the requirement for adequate cosmetic product safety substantiation, and have noted that cosmetics companies may need to look elsewhere for guidance.189 Moreover, in the context of these uncertainties, FDA has indicated that cosmetics regulation may be moved to a new office within FDA, in part to better implement MoCRA.190
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Conclusion, Author Information, Acknowledgments and Disclaimer
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Conclusion
Historically, FDA’s regulatory authority over cosmetics has been more limited and static than its regulatory authority over other FDA-regulated products. However, 84 years after the passage of the FFDCA, the enactment of MoCRA represents a significant expansion of FDA’s cosmetic regulatory authority. MoCRA authorizes for appropriation funds through 2027 to accomplish its goals.191 MoCRA’s full effect will be determined over the course of its future implementation.
Author Information
Nora Wells
Analyst in Health Policy
Acknowledgments
Hassan Z. Sheikh, Analyst in Health Policy, and Agata Bodie, Analyst in Health Policy, authored a prior report (CRS Report R42594, FDA Regulation of Cosmetics and Personal Care Products) that was partially adapted for this report.
For assistance with legal issues on this topic, congressional clients may contact Jennifer Staman, Legislative Attorney.
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress. Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has been provided by CRS to Members of Congress in connection with CRS’s institutional role. CRS Reports, as a work of the United States Government, are not subject to copyright protection in the United States. Any CRS Report may be reproduced and distributed in its entirety without permission from CRS. However, as a CRS Report may include copyrighted images or material from a third party, you may need to obtain the permission of the copyright holder if you wish to copy or otherwise use copyrighted material.
