FDA cosmetic regulations In the U.S., all color additives—including dyes, pigments, or any other substances that add color to a cosmetic product—are subject to regulation by the U.S. FDA. Cosmereg offers assistance helping you to meet the standards and file for cosmetic color additive and color batch certification from the FDA. Our team can prepare reports on the specific requirements, lend guidance on the protocol, and help you file for certification to help the process go more quickly and smoothly.
FDA Cosmetic Regulations 2024: MOCRA
The U.S. FDA regulates all cosmetic products intended for sale and use in the U.S. Additionally, California has specific requirements that exceed federal regulations. Learn about the FDA cosmetic regulations and the new Modernization of Cosmetic Regulation Act (MOCRA) listings below. Discover how these updated guidelines impact your cosmetic products and ensure compliance with both federal and state laws. Stay informed about the latest regulatory changes and requirements to maintain your product's marketability and safety standards.
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MOCRA FDA COSMETIC REGULATIONS SERVICES
Cosmereg provides assistance for both United States-based and non-US-based companies with FDA cosmetic regulations and new MoCRA listing system former VCRP registration who wish to sell cosmetics products in the United States and the state of California.
COSMETIC US AGENT
The FDA’s stance on the US Agent’s precise role under MoCRA remains forthcoming. However, insights from other FDA-regulated industries like food, pharmaceuticals, and medical devices provide valuable guidance. Essentially, the US Agent serves as a legal entity or individual capable of efficiently communicating with the FDA and other stakeholders while dutifully fulfilling the legal obligations of the Responsible Person, executed within the United States.
FDA MoCRA COSMETIC LABELING AND INGREDIENT REQUIREMENTS
FDA cosmetic regulations have strict laws regarding both the ingredients and labeling of cosmetic products. New MoCRA regulation is becoming effective by next year 2024 with new labeling requirements. Some cosmetics are even classified as drugs, making the requirements even stricter and more difficult to comply with. Cosmereg can assist you in FDA cosmetic labeling requirements and ingredient compliance by cross-referencing your labeling against the Code of Federal Regulations, the Federal Register, the former VCRP Cosmetic Ingredient Dictionary, the FDA Labeling Manual, and more.
FDA MoCRA Former VCRP COSMETIC REGISTRATION
Due to current change of Regulations MoCRA (Modernization Cosmetic Regulations Act) the old VCRP system will be replaced to list cosmetic products.
Cosmereg can assist you with all United States FDA cosmetic regulations, providing confirmation to the industry that you’re fulfilling United States FDA registration requirements, including reporting required by the California Safe Cosmetics Program and the United States FDA VCRP (Voluntary Cosmetic Registration Program)
CSCA (CALIFORNIA SAFETY COSMETIC ACT) – CALIFORNIA PROPOSITION 65)
California release its Safe Cosmetic Act and became the first state to pass a legislation around safety and reporting cosmetic ingredients. The program aims to protect consumers and promote the safe manufacture of cosmetic products.
It requires manufacturer, packer or distributor, with at least $1 million annual revenue, to identify any cosmetics products that contains ingredient known to be potentially harmful or harmful to consumers – e.g. ingredients that could cause cancer, birth defects, etc. They also have to report ingredients concentration within the product and continuously update the report in the case of any change.
FDA OTC REGISTRATION
There are some products that meet the legal definitions of both cosmetics and drugs. This may happen when a product has two lawful intended uses. One of the primary cosmetic/drug combinations are products with Anti-Acne, Toothpaste & anti-cavity, Anti-Dandruff, Hair growth / hair loss, Skin bleaching, Hand sanitzer and, Sunscreen protection claims.
Cosmereg can assist you in complying with the FDA’s Cosmetic Drug Establishment Registration, request the labeler code and Drug Listing, no matter the specific category.
FDA DETENTION ASSISTANCE
Cosmetic products are found to be noncompliant with FDA regulations may be detained by FDA Compliance Officers at the U.S. Port of Entry. If you need immediate assistance with FDA detention, we can work with you to solve the problem so the product can move past the Port of Entry and into the intended recipients’ hands.If you need a product added to a Green List or removed from a Red List, we can also help you.
Do you want to know more about MoCRA?
Understanding FDA Cosmetic Regulations: MOCRA. The Modernization of Cosmetics Regulation Act (MoCRA) includes some of the most transformative new cosmetic regulations FDA in recent history. This act has already started and it required to comply with it.
US Agent and Responsbile Person Roles
MoCRA Cosmetic Regulations
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FAQ
Beauty products (cosmetics) do not need to be approved by the FDA before marketing. However, some of their ingredients, such as color additives, may require independent approval. Companies that produce cosmetics are now required by the new MoCRA regulations to register their establishment and list the products in the new FDA system which is replacing the former VCRP.
Sometimes, beauty products that claim to have benefits beyond improving or altering appearance may be classed as drugs. Sunscreen is one example of this. In cases such as this, these products require FDA approval.
The FDA classifies products as cosmetics based on their intended use. The purpose of a product can be evaluated in a number of ways – through the effects described in its marketing, what customers expect from it, and even through certain ingredients. The FDA defines cosmetics 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.” Some examples of products that are defined as cosmetics are:
- Lipsticks, eye shadows, foundations and other make-up products.
- Face and body moisturizers.
- Hair dyes and perming solutions.
- Body scents and perfumes.
- Nail polish, cuticle creams, etc.
Drugs, in comparison, are products that are defined 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.” Sometimes, a product fits the criteria to be classed as both a drug and a cosmetic, based on its intended use and effects.
The FDA recognizes ‘medical devices’ and ‘dietary supplements’ as separate categories in their own right, while other products, such as soaps, are regulated by the Consumer Product Safety Commission.
The FDA encourages both national and international cosmetics companies to register with its Voluntary Cosmetic Registration Program (VCRP). Registration to this program is entirely voluntary and no registration number is required to import cosmetics into the United States. The VCRP will only accept Cosmetic Product Ingredient Statements (CPIS) for products that are already ins distribution in the US.
However, if your products are classified as drugs, or both cosmetics and drugs, they must be approved by the FDA. Similarly, businesses that import ingredients for their cosmetics that can also be classified as food products, must meet the registration requirements of the Bioterrorism Act of 2002.
The FDA does not specify the testing required for each beauty product or ingredient. However, as a manufacturer, it is your responsibility to ensure that your products are safe when used as indicated in the instructions.
Some manufacturers, particularly those who are new to the market, may believe that a product is safe because they have used it themselves without any adverse effects, or because the ingredients are all ‘natural’. This is not correct.
OTC drugs are those that can be sold without a prescription from a medical professional. In these cases, the FDA regulates the formulations and labelling of different classes of drug, rather than the individual products. The FDA develops ‘monographs’ with guidelines for their production, distribution and application. Once the monograph is developed, companies can produce and sell these drugs without FDA pre-approval, as long as they are manufactured according to the guidelines. Monographs are used to establish the safety, effectiveness and required labelling of all OTC products.
A ‘monograph’ is used to define the safe and appropriate manufacture and use of OTC drugs. It covers ingredients, doses, formulation, indications for use and how the product should be labelled. Companies can manufacture and sell these drugs without a specific product license, as long as they conform to what is stipulated in the monograph. Monographs are published in the government’s Code of Federal Regulations(CFR). The function of the FDA is to ensure that the obligations of the Federal Food, Drug and Cosmetic Act are fulfilled.
US agent is responsible of assisting foreign cosmetic manufacturer to register their establishment to the FDA and maintain communication between the manufacturers, distributors and the FDA for products inquiries and facilities inspections.
WE OFFER OTHER SERVICES FOR THE UNITED STATES
ANY FOREIGN COMPANY THAT WISHED TO SELL FOOD OR BEVERAGE PRODUCTS, MEDICAL DEVICES, COSMETICS OR DRUGS IN THE U.S. MUST DO SO VIA AN AUTHORIZED U.S. AGENT.
U.S. FDA REGULATES ALL COSMETIC PRODUCTS THAT ARE INTENDED TO BE SOLD AND USED IN THE US.
IN THE U.S. THE FDA REGULATES ALL FOOD AND BEVERAGE PRODUCTS THAT ARE INTENDED FOR HUMAN OR ANIMAL CONSUMPTION.
ENORMOUS RANGE OF PRODUCTS, FROM PROTECTIVE CLOTHING FOR HEALTHCARE PROFESSIONALS, TO SOFTWARE, TO SURGICAL TOOLS AND MORE.