The classification of products is very important in navigating the regulatory landscape. Cosmetic products are often borderline with other classifications of products on the market. Furthermore, cosmetics are not an exclusive class of products – meaning they can be both cosmetics and another type of product. In this article we will go into the varying product types which border cosmetics and discuss their classification.
Classification of Cosmetic Products Series
To learn more about the differences in classification across regional regulations, explore our classification of cosmetic products series:
Classification of Cosmetic Products
Regulation
All cosmetic products are regulated under the Federal Food, Drug, and Cosmetic Act, which has been amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter G – Cosmetics
Definition
The definition of a cosmetic product is outlined in the FD&C Act:
“articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance”
The definition of a cosmetic has been amended by MoCRA:
“a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.”
Examples of cosmetic product classification
Moisturisers
Moisturisers are classified as cosmetic products because they are rubbed onto the skin for the purpose of beautifying. The function of ‘moisturising’ itself is not specified in the definition, but moisturisers do make the skin look and feel healthy (with the potential addition of skincare benefits).
Cleansers (Non-Soap)
Cleansing products such as body washes, face washes, hand wash and cleansing shampoos are all applied to the human body for the purpose of cleansing. It is important to note that the classification of traditional soaps is different to cosmetics – they have their own separate classification. Anti-dandruff shampoos are also not classified as cosmetics due to the mechanism of action which is designed to treat dandruff.
Makeup Products
Mascaras, foundations, lipsticks and eyeliners are all classified as cosmetic products as they are placed in contact with the human body and are designed to beautify, promoting attractiveness and altering the appearance. There are additional requirements for products containing colourants. Products must conform to restrictions set out by Title 21 of the Code of Federal Regulations Parts 73, 74, 81 and 82.
Part | Sections | Titles |
73.1-73-3128 | Listing of Color Additives Exempt from Certification | |
74.101-74.3710 | Listing of Color Additives Subject to Certification | |
81.1-81.32 | General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics | |
82.3-82.2707a | Listing of Certified Provisionally Listed Colors and Specifications |
Classification of General Products
Regulation
All general products are regulated under the Consumer Product Safety Act.
Title 16 – Commercial Practices
Chapter II – Consumer Product Safety Commission
Subchapter B – Consumer Product Safety Act Regulations
Part 1200 – Definition of Children’s Product under the Consumer Product Safety Act
Definition
General use product:
“a consumer product that is not designed or intended primarily for use by children 12 years old or younger. General use products are those consumer products designed or intended primarily for consumers older than age 12. Some products may be designed or intended for use by consumers of all ages, including children 12 years old or younger, but are intended mainly for consumers older than 12 years of age.”
Other products (not intended for children):
“specifically not intended for children 12 years of age or younger.
Examples of general product classification
Christmas Advent Calendar (with Cosmetics)
The cosmetic component is regulated by the Food Drug & Cosmetic Act and the Consumer Product Safety Act regulates the product as a whole.
Each cosmetic must comply with the rules and regulations laid down by the Food and Drug Administration, but the product as a whole is regulated by the Consumer Product Safety Commission.
Classification of Non-prescription/prescription drugs
Regulation
All non-prescription/prescription drugs are regulated under the Federal Food, Drug and Cosmetic Act. They are known as over the counter (OTC) products).
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Definition
The term drug is defined by the FD&C Act:
“(A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.”
Examples of Non-Prescription/Prescription Drug classification
Antipersiprant
Antiperspirants are not considered cosmetics in the USA, however, deodorants are. Antiperspirants are designed to block sweat glands and therefore reduce sweating, whereas deodorants mask unpleasant smells.
Because of the pore blocking function of antiperspirants, they are considered over the counter drugs and regulated as drugs for human use. There is a specific OTC monograph specific to antiperspirants which lays down the obligations for making antiperspirants available on the US market.
Definition of an antiperspirant:
“A drug product applied topically that reduces the production of perspiration (sweat) at that site.”
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Part 350 – Antiperspirant Drug Products for Over-The-Counter Human Use
Sunscreen
Sunscreens are not considered cosmetics because of their therapeutic benefits of protecting the skin against harmful UV radiation. They are regulated as over the counter drugs and have two monographs, the original publication and an amendment.
Sunscreen products are those which contain sunscreen active ingredients. Sunscreen active ingredients are defined by in part 352.3 of the FD&C Act:
“An active ingredient listed in § 352.10 that absorbs, reflects, or scatters radiation in the UV range at wavelengths from 290 to 400 nanometers.”
A sunscreen product is any product which claims to contain SPF (sun protection factor), this includes lip balms with SPF, foundation with SPF and sun lotion.
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Part 352 – Sunscreen Drug Products for Over-The-Counter Human Use
OTC M020 – Sunscreen Drug Products for OTC Human Use
OTC Amending M020 – Sunscreen Drug Products for OTC Human Use
Anticaries Toothpaste
Cavities- their prevention, management and treatment are all considered drug functions, not cosmetic functions, therefore, they are regulated as over the counter drugs in the USA. The OTC monograph states the following methods are considered to be anticaries mechanism of actions: abrasives, fluoride, treatment rinses.
Anticaries products include toothpastes, mouthwashes and any other oral care products which claim to prevent or treat caries.
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Part 355 – Anticaries Drug Products for Over-The-Counter Human Use
OTC M021 – Anticaries Drug Products for Over-The-Counter Human Use
Anti-dandruff Shampoo
In some regions, dandruff is considered a cosmetic concern, therefore, anti-dandruff products are regulated as cosmetics, however, they are considered drugs for human use in the USA.
Dandruff is defined in the OTC monograph M032 as:
“A condition involving an increased rate of shedding of dead epidermal cells of the scalp.”
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Part 358 – Miscellaneous External Drug Products for Over-The-Counter Human Use
Subpart H – Drug Products for the Control of Dandruff, Seborrheic Dermatitis and Psoriasis
OTC M032 – Drug Products for Dandruff Seborrheic Dermatitis Psoriasis
Lip/Skin Protectant Drug Product
Protection is frequently considered a cosmetic function in many regions across the world, it is synonymous with the term ‘prevention’. In the USA, protection is considered a drug function, so we see the rise of lip and skin protectant drugs.
The OTC monograph M016 defines lip protectant drug products as:
“drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called lip balm.”
And skin protectant drug products are defined as:
“A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.”
This category includes products such as lip balms, sudocrem-like products (designed for rashes or broken skin), and skin patches for broken skin.
Title 21- Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Part 347 – Skin Protectant Drug Products for Over-The-Counter Human Use
Antiseptic Products
Antiseptic products are designed to kill microorganisms (bacteria, viruses, fungi), which could be potentially harmful to human health. As these products kill (or make microorganisms harmless through chemical or physical action), they fall outside the scope of a cosmetic as defined by the FD&C Act.
Antiseptic rubs are defined as:
“products that are intended to be used when soap and water are not available and are left on and not rinsed off with water.”
This means that hand sanitisers are regulated under the Food and Drug Administration as an OTC product.
Title 21 – Food and Drugs
Chapter I – Food and Drug Administration, Department of Health and Human Services
Subchapter D – Drugs for Human Use
Part 310 – New Drugs
310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
Anti-Acne Products
Acne is a skin condition, therefore its treatment is considered a drug function. There is a specific acne drug monograph which outlines the actives considered to treat acne and obligations for brands placing these products on the US market.
The OTC monograph M006 defines acne as:
“A disease involving the oil glands and hair follicles of the skin which is manifested by blackheads, whiteheads, acne pimples, and acne blemishes.”
An acne drug product is defined as:
“A drug product used to reduce the number of acne blemishes, acne
pimples, blackheads, and whiteheads.”
OTC M006 – Topical Acne drug products for OTC Human Use
Classification of Soap
Regulation
All traditional soaps are regulated under the Consumer Product Safety Act, not the Federal Food, Drug, and Cosmetic Act, as traditional soaps do not fall under the classification of a cosmetic product.
Definition
The definition of a soap is not strictly defined, however, the The Food and Drug Administration interprets the term “soap” to apply only to articles that meet the following conditions:
“A product which:
(1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and
(2) The product is labeled, sold, and represented only as soap.”
Examples of Soap Classification
Traditional Soap
Traditional soaps are made through the process of saponification which meets the definition of the FDA. It is however important that there are no added cleansing substances such as chemical cleansing agents (e.g. surfactants) and the product does not make any cosmetic claims (e.g. nourishing, moisturising) or any drug claims (e.g. protecting, antiseptic/biocidal). More information on soaps can be found here.
Classification of Children’s Products
Regulation
All children’s products are regulated under the Consumer Product Safety Act and the Consumer Product Safety Improvement Act.
Title 16 – Commercial Practices
Chapter II – – Consumer Product Safety Commission
Subchapter B – Consumer Product Safety Act Regulations
- Part 1107 – Testing and Labelling Pertaining to Product Certification
- Part 1200 – Definition of Children’s Product under the Consumer Product Safety Act
Definition
The definition of a children’s product is outlined in the the Consumer Product Safety Act:
“a consumer product designed or intended primarily for children 12 years of age or younger.”
The term “designed or intended primarily” applies to those consumer products mainly for children 12 years old or younger. Whether a product is primarily intended for children 12 years of age or younger is determined by considering the four specified statutory factors. These factors are:
(i) A statement by a manufacturer about the intended use of such product, including a label on such product if such statement is reasonable.
(ii) Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger.
(iii) Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.
(iv) The Age Determination Guidelines issued by the Commission staff in September 2002 and any successor to such guidelines.
Examples of Children’s Products Classification
Bubble Bath Wand
Cosmetics intended for children are classified as both cosmetic products and products intended for children, which makes them fall under both the FD&C Act and the CPS Act. Bubble bath wands have an element of play, and therefore are also considered chemical toys.
There are additional federal and state regulations which set out specific chemical limits for children’s products:
Title 16 – Commercial Practices
Chapter III
Subchapter B
Part 1303 – Ban Of Lead-Containing Paint And Certain Consumer Products Bearing Lead-Containing Paint
Maine Revised Statutes
Toxic Chemicals in Children’s Products
Title 38 – Water and Navigation
Chapter 16-D – Toxic Chemicals in Children;s Products
Consolidated Laws of New York
Chapter 43-B – Environmental Conservation
Article 37 – Substances Hazardous or Acutely Hazardous to Public Health, Safety or the Environment
Title 9 – Toxic Chemicals in Children’s Products
Section 37-0905 – Chemicals of Concern and High-Priority Chemicals
Vermont Statutes
Title 18: Health
Chapter 38A: Chemicals of High Concern to Children
Section § 1773 – Chemicals of High Concern to Children
Revised Code of Washington
Title 70A
Chapter 70A.430
Section 70A.430.060 – Notice that a children’s product or a consumer product contains a high priority chemical.
