The key ingredients present in most cosmetics include water, emulsifiers, preservatives, thickeners, moisturisers, colours and fragrances. Ingredients can be naturally occurring or artificial, but any potential impact on our health depends mainly on the chemical compounds they are made of.
What defines cosmetic material?
What is a cosmetic? A “cosmetic” is any substance used to clean, improve or change the complexion, skin, hair, nails or teeth. Cosmetics include beauty preparations (make-up, perfume, skin cream, nail polish) and grooming aids (soap, shampoo, shaving cream, deodorant). Some products that seem to be cosmetics may be classified differently and managed by different programs at Health Canada:
Products that claim to have a therapeutic effect (e.g. to prevent or treat disease), or that contain certain active ingredients not allowed in cosmetics are considered to be, for example, topical antibiotic creams. Products containing natural active ingredients that claim to have a therapeutic effect (for example, a topical herbal remedy to speed scar healing) are considered, Items that are intended to be eaten and do not have a therapeutic effect or claim are, such as chewing gum. Insect repellent lotions and sprays are, Products that provide a therapeutic benefit to animals, like dander-reducing creams, are,
How do you list cosmetic ingredients?
What the Law and Regulations Require: Overview – If a cosmetic product is marketed on a retail basis to consumers—such as in stores, online, or “person to person”-the ingredients must be listed by their common or usual names, generally in descending order of predominance.
- FDA requires this information under the Fair Packaging and Labeling Act (FPLA).
- To learn all the requirements, including sources for ingredient names, read the regulation at 21 CFR 701.3,
- In general, the ingredients must be listed on an information panel of the cosmetic package, where the consumer can easily find it when making a purchase.
As an alternative, when cosmetics are distributed on a mail-order basis, the package mailed to the consumer may contain readily visible instructions for locating the ingredient declaration, such as in a product catalog (currently interpreted as including a website), or instructions for requesting a copy of the ingredient declaration.
as free samples, for professional use, or for institutional use, such as at schools, hospitals, or the workplace.
What are the pillars of cosmetics?
Those pillar are Cleansing, Moisturizing, Nourishing and Protecting.
Do cosmetics have to list all ingredients?
Warnings and Precautions – FDA cosmetic labeling requirements state that if there is a possibility of a health hazard being associated with the product, there must be a warning statement on a contrasting background with a minimum character height of 1/16″ and in a bold type.
This is to ensure that consumer will likely read it. If scientific experts cannot reasonably conclude from the available data that the product is safe to use, there must be a statement that the safety of the product has not been determined. Some products have specific regulations for warning statements (aerosols, foaming detergent, feminine deodorant) Canadian labeling requirements for cosmetics indicate that if a product can be associated with an avoidable hazard, warnings should state how to use the product and when not to use it to avoid the risk.
This is satisfied through a combination of cautions, instructions and symbols, in English and French. In addition, some products (flammable products, hair dyes, mouthwashes) have a specific regulation for warning statements. Ingredients Declaration The FDA cosmetic labeling requirements state that ingredients declaration is a must when labeling cosmetics.
Ingredients that do not exceed 1% can be listed in any order, as long as they are after the ones that do.For cosmetics that are also a drug, the active drug ingredients must be stated first.Colour additives can be listed in any order after other ingredients.If there are ingredients accepted by the FDA as a trade secret, they can be stated as “other ingredients.”
Cosmetic labeling requirements for the Canadian market also state that cosmetic labels must include an ingredients declaration. They must be listed according to their INCI (International Nomenclature of Cosmetic Ingredients) name. Health Canada has also set out specific requirements for Botanical ingredients.
What must an ingredient list contain?
What are compound ingredients? – Some ingredients used in foods are called ‘compound ingredients’. These are ingredients made by a mixture of other ingredients. For example, chocolate (cocoa, cocoa butter, sugar) or pasta (flour, egg, water). On food labels, the ingredient list must contain all ingredients including those that make up compound ingredients.
For example, chocolate chip ice-cream lists the ingredients that make up ice-cream, but it also contains chocolate, so the ingredients that make up chocolate are listed too (cocoa, cocoa butter, sugar). If an ingredient makes up less than 5% of the food, it does not have to be listed. Likewise, any compound ingredients that make up less than 5% of the product, can just be listed as the compound ingredient rather than all of its own ingredients – for example ‘chocolate’ (rather than cocoa, cocoa butter and sugar) in a chocolate chip ice cream.
This 5% rule does not apply to any additive or allergen, including if they are part of a compound ingredient – these must be listed no matter how small the amount.
What is the FDA definition of cosmetics?
NOTE on antibacterial soaps: For the latest information, see FDA issues final rule on safety and effectiveness of antibacterial soaps, Available in:
Spanish, PDF: 183KB French, PDF: 194KB Simplified Chinese: PDF 251KB Traditional Chinese, PDF: 260KB Korean, PDF: 217KB
Whether a product is a cosmetic or a drug under the law is determined by a product’s intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.
How does the law define a cosmetic? How does the law define a drug? How can a product be both a cosmetic and a drug? What about “cosmeceuticals”? How is a product’s intended use established? How are the laws and regulations different for cosmetics and drugs? How are approval requirements different? What do these terms mean? How are good manufacturing practice requirements different?” How are registration requirements different? How are labeling requirements different?” And what if it’s “soap”? How does FDA define “soap”? If a cleanser does not meet all of these criteria. More resources
How does the law define a cosmetic? The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “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”,
- Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
- How does the law define a drug? The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”,
back to top How can a product be both a cosmetic and a drug? Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair.
- An antidandruff treatment is a drug because its intended use is to treat dandruff.
- Consequently, an antidandruff shampoo is both a cosmetic and a drug.
- Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.
Such products must comply with the requirements for both cosmetics and drugs. What about “cosmeceuticals”? The FD&C Act does not recognize any such category as “cosmeceuticals.” A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law.
Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells. Consumer perception, which may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do. Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.
This principle also holds true for “essential oils.” For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.
- Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it’s a drug.
- Back to top How are the laws and regulations different for cosmetics and drugs? The following information is not a complete treatment of cosmetic or drug laws and regulations.
It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. Questions regarding laws and regulations for drugs should be directed to FDA’s Center for Drug Evaluation and Research (CDER).
How are approval requirements different? Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.
These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation.
- However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA, or comply with the appropriate monograph for an OTC drug.
- A note on the term “new drug”: Despite the word “new,” a “new drug” may have been in use for many years.
If a product is intended for use as a drug, it must comply with the requirements outlined above.) What do these terms mean?
An NDA is the vehicle through which drug sponsors formally propose that FDA approve a pharmaceutical for sale and marketing in the United States. FDA only approves an NDA after determining, for example, that the data is adequate to show the drug’s safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients and for new indications entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system, and their “switch” to OTC status is then approved, also through the NDA system. FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use. Among the many nonprescription drug categories covered by OTC monographs are
acne medications treatments for dandruff, seborrheic dermatitis, and psoriasis sunscreens
You can find information on FDA’s website, under ” Development and Approval Process (Drugs),” especially ” How Drugs Are Developed and Approved,” If you still have questions about NDAs and OTC monographs, or any other aspect of drug regulation, please contact CDER,
- You can contact CDER’s Division of Drug Information, Small Business Assistance at [email protected] or, for general drug-related inquiries, CDER’s Division of Drug Information at [email protected],
- How are good manufacturing practice requirements different? Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic products are neither adulterated nor misbranded.
However, while FDA has provided guidelines for cosmetic GMP (see ” Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist “), no regulations set forth specific GMP requirements for cosmetics. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs,
Failure to follow GMP requirements causes a drug to be adulterated, How are registration requirements different? FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations, As its name indicates, this program is voluntary. The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA.
In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA, See Drug Registration and Listing System (DRLS and eDRLS), How are labeling requirements different? A cosmetic product must be labeled according to cosmetic labeling regulations.
See the Cosmetic Labeling Manual for guidance on cosmetic labeling and links to the regulations related to cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the “Drug Facts” labeling, as described in 21 CFR 201.66 Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling.
For example, the drug ingredients must be listed alphabetically as “Active Ingredients,” followed by cosmetic ingredients, listed in descending order of predominance as “Inactive Ingredients.” back to top And what if it’s “soap”? Soap is a category that needs special explanation.
- That’s because the regulatory definition of “soap” is different from the way in which people commonly use the word.
- Products that meet the definition of “soap” are exempt from the provisions of the FD&C Act because—even though Section 201(i)(1) of the act includes “articles.for cleansing” in the definition of a cosmetic—Section 201(i)(2) excludes soap from the definition of a cosmetic.
How does FDA define “soap”? Not every product marketed as soap meets FDA’s definition of the term. FDA interprets the term “soap” to apply only when
the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap,
Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC. If a cleanser does not meet all of these criteria.
consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also for other cosmetic uses,
it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin. If a product
consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body,
it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and cleansers that are also intended to treat acne. If a product
is intended solely for cleansing the human body, has the characteristics consumers generally associate with soap, and does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic.
What are functional ingredients in cosmetics?
What are Functional Ingredients? – Functional ingredients are the components of a cosmetic product that actually make the product work. This can include detergents, conditioning agents, moisturizers, colorants in make-ups, food products, etc. that can provide benefits to the consumer. In the food industry, a functional ingredient is a bioactive compound that is useful in the manufacture of functional food products. We can obtain these bioactive products from various sources such as primary produce, marine sources, microorganisms, and inorganic raw material.
- Typically, a functional ingredient does not have a strict definition.
- In the food industry, they are the ingredients having the potential to influence health over and above the basic nutritional value.
- Therefore, functional foods are foods that can display health-promoting properties over and above the nutritional value.
Developing foods, beverages, and supplements with functional ingredients is very important. Some examples of functional ingredients in skincare products include preservatives, water, thickeners, pH adjusters, delivery systems, emollients, and surfactants,
What is the most commonly used cosmetic ingredient?
Water – the most common cosmetic ingredient, water is used as the base of many products. It also acts as the main solvent to dissolve other ingredients in the product. Emulsifiers – these are used to stabilize formulas and prevent the ingredients from separating.
What are the three main items for skincare?
3 (or 5) simple steps to beautiful skin – Caring for your skin is as simple as using a cleanser, moisturizer, and sunscreen. Though there are a million products to choose from, keep it simple, and your skin will thank you. If you’d like personalized recommendations for your skincare routine or want to take it up a notch with an antioxidant serum or prescription retinoid, get in touch.