Spelman College's eSpelman Cosmetic Science Online Certificate

Cosmetic Regulations: What Are They?

Nearly everyone uses cosmetic products in their daily lives. Makeup, moisturizers, colognes, perfumes, hair dyes, nail products, and many others fall under the broad category of cosmetics. If you are interested in becoming a cosmetologist, or you want to start your own business in making and selling cosmetic products to people, you need to have a greater understanding of the types of cosmetic regulations that can impact your work. You may have wondered who regulates the cosmetics space– is it the Federal Drug Administration (FDA) or does another organization handles this task?

What Are Cosmetic Regulations?

Cosmetic regulations are rules and standards that apply to the cosmetic industry. These laws typically apply to the manufacturing and branding of products that are shipped to consumers. These regulations are designed to help promote safety and prevent adverse health effects. They also help inform consumers about product benefits. Two regulations in the United States that govern the cosmetics industry are the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

Who Regulates Cosmetics?

There is no global authority that provides regulations on cosmetics for everyone. Instead, each individual country will have regulations regarding cosmetic products manufactured within their borders. In the United States, the Federal Drug Administration (FDA) regulates cosmetics across the country. In Europe, the European Union (EU) Commission governs finished products and enforces all regulations for member states.

Although the FDA must provide premarket approval for color additives, they do not need to approve cosmetics or ingredients. However, the FDA does enforce action against cosmetics that do not comply with the law. Certain states have regulations that also govern cosmetics, such as California, Washington, and Minnesota. It is important to follow up with your state as they may, in the future, also develop cosmetics regulations.

What Does the FDA Do?

The FDA has the authority to require certain manufacturing standards to be upheld during the making of cosmetics. These standards may involve the ingredients that are in the products and how the cosmetics are labeled. They also provide good manufacturing practices that companies can follow to minimize the risks of producing poor-quality products. The FDA can also report and recall cosmetics that pose health problems.

Labeling and Ingredient Requirements

All cosmetics need to be properly labeled by providing an ingredient list that customers can read before purchasing the product. The product labeling should include the name and address of the manufacturer and applicable warnings as stated in the 21 CFR 740.11, 740.12, and 740.17 federal rules on the information panel of the product and 21 CFR 740.10 cosmetic act warning on the principal display panel. It should also include any other necessary warning to protect the consumer and instructions regarding the safe use of the product.

The FDA has the authority to prohibit a cosmetic product from being introduced or delivered through interstate commerce if it has a misleading or false label. They can also enforce regulations if the cosmetics do not conspicuously state necessary required information, i.e., misleading ingredient labeling that doesn’t reflect the actual contents of a cosmetic product container.

For raw materials and ingredients, the materials need to be handled and stored in a safe manner that prevents contamination, decomposition, or any mix-ups. Containers storing the materials should be kept off the floor, stamped, and tested to ensure there are no microorganisms or other extraneous materials.

In the past, the FDA did not require companies to register their cosmetic formulations with the agency. Companies could voluntarily register their formulations with the FDA's Voluntary Cosmetic Registration program. However, recent legislation has been passed to require the FDA to perform a formal registration of cosmetic manufacturing facilities, ingredients, and products. In addition, if a particular cosmetic is also considered a drug, companies must follow drug registration requirements, while cosmetics with ingredients that are also classified as food must follow the Bioterrorism of 2002 registration requirements.

Good Manufacturing Practices (GMPS)

Good Manufacturing Practices (GMPS) are systems that outline production standards for specific industries. These systems provide assurances that the manufacturing of products is done under standard industry conditions. Cosmetic manufacturers can follow GMP guidelines to minimize health and safety risks as well as avoid misbranding or adulteration of personal care products. In addition to the ingredient and labeling requirements already mentioned above, Good Manufacturing Practices can cover every aspect of manufacturing operations.

Building: They detail the design and construction of the manufacturing and storage building, as well as all the internal construction, materials, fixtures, and systems.
Equipment: Cleaning and sanitizing guidelines for all equipment, utensils, transfer piping, and contact surfaces.
Personnel: Workers supervising, controlling, or handling cosmetics should have the training, education, and appropriate protective clothing to promote personal cleanliness.
Production: Equipment should be clean and only approved materials should be used in the creation of cosmetics. This section also covers proper labeling of batch and filling equipment, ensures materials are weighed and measured, requires samples to be taken before and after processing for testing, and other factors. It also provides guidance involving the examination of any cosmetic products returned for contamination or deterioration.
Laboratory Controls: Samples of water, raw materials, and finished products are tested (and retested) for identity verification, compliance, and for microbial contamination along with other hazardous elements.
Records: Control records for raw materials, packaging, manufacturing batches, finished products, distribution, and other operational processes are maintained.
Complaints: The cosmetic firm should keep and maintain a consumer complaint file to record reported injuries, the medical treatment involved, the product associated with the injury, and other factors. The file should also include the name/location of any government agency, poison control center, or physician group that has received the toxicity data and formula information.

The FDA will also perform evaluations and inspections to determine if the cosmetic manufacturer is using unlisted or uncertified color additives or prohibited ingredients. The above list is not comprehensive, as there may be additional guidelines and added regulations from the FDA. It is always advisable to periodically review the GMP for new regulations that may be introduced.

Reporting Problems

The FDA does not have specific testing requirements or lab requirements for cosmetic samples. The manufacturers have the legal responsibility to use the tests that best fit the product to evaluate its safety. However, the FDA will collect samples for analysis to evaluate the cosmetic products if there have been follow-up complaints or as part of an inspection evaluation of the cosmetic facility. If the cosmetic manufacturer or FDA discovers a safety issue, the FDA will request that the manufacturer performs a product recall.

If the cosmetic product has been misbranded or adulterated, the FDA may take regulatory action that is pursued through the Department of Justice. Using the federal court system, the FDA can have a product removed from the market, perform a seizure to take possession of the product or file restraining orders to stop any further shipments. For foreign cosmetic products, the FDA will work with the U.S. Customs and Border Protection agency to refuse the admission of imported cosmetics into the United States.

Other Rules to Know About Cosmetic Regulation

There has not been a lot of federal oversight of the cosmetic industry. Recently, the Modernization of Cosmetic Regulations Act was signed into law in 2022 to update the antiquated regulations in an attempt to promote more cosmetic safety. This act now requires adverse reporting, company and ingredient registration, public disclosure of salon product ingredients and fragrances, and disclosure of flavor and fragrance ingredients to the FDA. The law also gives the FDA authority to issue product recalls. Other countries, states, and local municipalities have their own rules that cosmetic manufacturers must abide by.

International Regulations

Canada and the EU have stringent regulations for personal care products and cosmetics. For Canada, the Foods and Drugs Act, as well as the Cosmetics Regulation, requires cosmetics manufacturers to provide full ingredient disclosure and notification to Health Canada if they are selling a cosmetic product. The country also has labeling requirements and a cosmetics ingredient hotlist of prohibited chemicals and contaminants.

The EU has the strongest regulations for the cosmetics industry. The EU Regulation (EC) No 1223/2009 bans 1693 chemicals (3-Amino-2,4- dichlorophenol and its salts) from cosmetics and restricts maximum concentrations of 324 chemicals (tranylcypromine and its salts). EU laws also require pre-market safety assessments, mandatory product registration, and other standards.

State and Local Regulations

California, Washington, and Minnesota have enacted regulations that govern cosmetic products. In Minnesota, the chemical formaldehyde is banned from all children's personal care products. Washington has enacted the Children's Safe Product Act to require companies to report any product that has chemicals of high concern to children.

California has the most regulations compared to other states. The Safe Cosmetics Act, Professional Cosmetics Labeling Requirements Act, the CA Toxic-Free Cosmetics Act, and the CA Cosmetic Fragrance and Flavor Ingredients Right to Know Act are designed to ban dangerous chemicals, require ingredients labels, require full disclosure of products containing Proposition 56 chemicals, and require disclosure of secret ingredients for fragrances.

Honest Advertising

Labeling and branding standards are important factors in most regulations introduced by the United States, Canada, EU, and state organizations. While the FDA does not have standards to prevent companies from using terms like "organic" or "natural," it is advisable to refrain from placing such terms in ingredient listings. Otherwise, most honest advertising rules for cosmetics fall under the misleading container presentation, fill, and misbranded sections of the Federal Food, Drug, and Cosmetic Act.

Why Follow Cosmetic Regulations?

Safety

Having regulations designed to keep harmful chemicals out of products reduces false branding and ensures consumers can make the right decisions when selecting personal care products. By having the correct labeling and ingredients listed on products, people who may have minor, moderate, or severe allergies can evaluate the listed ingredients and avoid cosmetics that could cause allergic reactions. In addition, constant retesting of products over a long period can determine if the cosmetics may cause health issues with continued use, or at a specific concentration.

Consequences of Breaking the Rules

Cosmetic firms that break the rules and offer dangerous products to consumers could face federal penalties and fines through the federal judicial system. Also, if they are found guilty of misbranding or adulteration of the products, they could be prohibited from importing, exporting, or shipping their cosmetics to retailers and consumers. Companies will also face negative branding and PR from any court cases, which could lower sales for their other products.

Learn More About Cosmetics with Spelman College

The cosmetics industry has many regulations regarding the manufacturing, formulating, labeling, and packaging of personal care products. Engaging in product safety ensures that people are happy with the cosmetics they obtain and know how to use them properly. If you are interested in making and selling your own beauty products or want to work in a laboratory to formulate and test cosmetics and fragrances, Spelman College offers a cosmetic science certificate through their eSpelman online program. Learn about this exciting career by requesting more information.