MoCRA Compliance

   

Global Regulatory Affairs Consulting Agency, KGMP CORP.

U.S. FDA & MoCRA Compliance for Cosmetic

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

As a leader in cosmetic and personal care consulting, KGMP provides expert guidance to help you navigate market-specific regulations, ensuring your products meet local standards for safe export and distribution. Partner with us to ensure your products are safe, effective, and compliant with both local and global regulations.

 

MoCRA Compliance for Cosmetic: Essential Requirements for U.S. Market

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) enhances federal oversight of cosmetic and personal care products, establishing a uniform national regulatory framework. Understanding the regulatory landscape is crucial for companies in the U.S. cosmetic industry.

It includes two key components: the introduction of basic requirements for the cosmetics industry and the delegation of authority to the U.S. Food and Drug Administration (FDA) to establish Good Manufacturing Practices (GMPs). In addition, the FDA regulates cosmetics under these acts, ensuring compliance with ingredient, labeling, and claim requirements for products on the market or imported into the U.S. States may also enact their own regulations, creating additional compliance obligations.

KGMP provides tailored strategies to meet compliance requirements of U.S. FDA and MoCRA regulations, minimize risks, and avoid penalties. Partnering with us allows you to focus on your core business while we manage the complexities of regulatory compliance.

KGMP U.S. FDA Cosmetic Registration Service 

GAP Analysis	Ingredient & Label Review	Appoint U.S. Agent	Cosmetic Facility Registration	Cosmetic Product Listing

U.S. FDA Cosmetic Registration Process

U.S. FDA Cosmetic Registration is mandatory for manufacturers and processors, who must register their facilities with the FDA and renew their registration every two years. Additionally, cosmetic products must be listed with the FDA. The responsible person must list each marketed cosmetic product, including its ingredients, and provide annual updates.

STEP 1: GAP Analysis

Whether a product is classified as a cosmetic or drug under U.S. law primarily depends on its intended use and ingredients. Companies sometimes violate regulations by marketing cosmetics with drug claims or presenting drugs as cosmetics without meeting the necessary drug requirements. Given the distinct regulations for each category, KGMP's GAP analysis for your entry into the U.S. market, as well as the subsequent registration steps, will vary accordingly.

Q) How is a product defined?

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ㆍ Cosmetic: It is defined as 'articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering appearance,' and as 'preparations of cosmetic ingredients with a set qualitative and quantitative composition for use in a finished product.'

ㆍ Drug: It is defined by its 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 function of the body in humans or animals.'

ㆍ Both a cosmetic and a drug: Some products meet the definitions of both cosmetics and drugs when they have multiple intended uses, for example, antidandruff shampoos, toothpastes that freshen breath and clean teeth, antiperspirant deodorants, and sun-protective moisturizers or makeup.

ㆍ Cosmeceuticals: The FD&C Act does not recognize a category called 'cosmeceuticals.' A product may be classified as a drug, a cosmetic, or a combination of both, but 'cosmeceutical' has no legal meaning.

STEP 2. Ingredient & Label Review

The FD&C Act does not require FDA approval for cosmetics, their ingredients, and labeling. Therefore, the U.S. FDA strictly monitors the market for violations. This is one of the primary reasons cosmetic companies receive warning letters, underscoring the importance of KGMP's services.

Q) What are the requirements that must be met for cosmetic ingredients?

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The FD&C Act does not require FDA approval for cosmetics and their ingredients before marketing, except for color additives used in coal tar hair dyes. However, under specified or conventional use conditions, these products must be safe for consumers. Companies and individuals selling cosmetics are legally responsible for the safety of their products and ingredients. The U.S. FDA emphasizes the safe use of allergens in cosmetics, as well as certain ingredients such as AHA, BHA, DEA, and fragrances.

Q) What are the requirements that must be met for cosmetic labeling?

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Proper labeling is essential for cosmetic marketing, as it must be truthful and not misleading. Some cosmetics may make claims that go beyond what the law permits, potentially leading consumers to mistakenly perceive them as drugs, which could result in administrative actions from the U.S. FDA. The U.S. FDA legally mandates labeling formats and requirements, and although there are no specific legal obligations, cosmetic companies are encouraged to include certain statements due to their responsibility for product safety.

ㆍ Prominence and conspicuousnes

ㆍ Language

ㆍ Format: Principal Display Panel, Placement of Information on Labels, Type size

ㆍ Mandatory requirements: Identity, Net quantity of contents, Ingredients list, Directions, Warning statements, Name and place of business, etc.ㆍ Other statements for product safety responsibilities

STEP 3. Appoint U.S. Agent (Only for foreign facility)

Foreign facilities that manufacture or process cosmetics for import into the United States must designate a U.S. Agent, who can be an individual or a private company residing in the country. The U.S. Agent acts as an intermediary between the U.S. FDA and the foreign facility, receiving direct updates related to registration and approval. Ensure accurate and timely communication with the U.S. FDA through KGMP.

Q) What are the responsibilities and roles of a U.S. Agent?

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ㆍ Communication: Communicate directly with the U.S. FDA on your behalf.

ㆍ Fast response: Provide fast and efficient responses to any inquiries from the U.S. FDA or the foreign facility regarding applications or approvals.

ㆍ Inspection coordination: Organize inspection schedule between the U.S. FDA and the foreign facility.

ㆍ Effective communication: Ensure accurate and timely communication between the U.S. FDA and foreign facility.

Q) What is the difference between a U.S. Agent and a Responsible Person?

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The Responsible Person (RP) means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label. They are primarily responsible for the safety and compliance of the cosmetic products, which includes managing product listings, ensuring compliance with formula and labeling, completing safety substantiation, maintaining an adequate adverse event recording system, and reporting any serious adverse events to the U.S. FDA.

In contrast, the U.S. Agent facilitates communication and assists foreign facility in navigating the regulatory requirements of the U.S. market. It is important to note that the U.S. Agent has no responsibilities regarding compliance with cosmetic safety regulations.

STEP 4. Cosmetic Facility Registration

Cosmetic manufacturers and processors must register their facilities with the U.S. FDA and renew their registration every two years. KGMP provides an alarm service to help manufacturers and processors maintain their registered facilities by ensuring timely renewals and proper facility registration.

Q) Who is responsible for cosmetic facilities registration?

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Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States to register each facility, except in small business.

Q) What information is required for cosmetic facility registration?

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ㆍ Facility informationㆍ FEI number (FDA Establishment Identification Number), which is a unique identifier assigned by the U.S. FDA to identify firms

ㆍ DUNS number, which is used to maintain up-to-date and timely information on more than hundreds of millions global businesses

ㆍ U.S. Agent information (only for foreign facility)

ㆍ All brand names under which cosmetic products are manufactured or processed in the facility

ㆍ The product category or categories and Responsible Person for each cosmetic product, and etc.

STEP 5. Cosmetic Product Listing

A responsible person must list each marketed cosmetic product with the U.S. FDA, including its ingredients, and provide annual updates. KGMP provides an alarm service to help responsible persons maintain their listed cosmetic products by ensuring timely renewals and accurate product listings.

Q) Who is responsible for cosmetic product listing?

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The responsible person must submit a cosmetic product listing, or ensure its submission, within 120 days of marketing the product in interstate commerce.

Q) What information is required for cosmetic product listing?

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ㆍ Facility registration number

ㆍ Responsible Person information and DUNS number

ㆍ Cosmetic product information

ㆍ Ingredients and labeling information

ㆍ Cosmetic product webpage link, and etc.

 

KGMP MoCRA Compliance Service

Adverse event record & Serious adverse event report	Safety substantiation	GMP compliance	1:1 Customized MoCRA compliance consulting

Adverse Event Record Keeping & Serious Adverse Event Reporting

A Responsible Person must record and retain adverse events related to the use of cosmetics in the United States for 6 years. If a serious adverse event occurs, the Responsible Person must report it to the FDA within 15 business days, including a copy of the label on or within the retail packaging of the cosmetic product. This record must also be retained for 6 years.

Q) What is a serious adverse event?

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ㆍ (A) results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or

ㆍ B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

Contact us for adverse event records or serious adverse event reports service

Safety Substantiation

A Responsible Person is required to ensure and maintain records that support adequate safety substantiation for cosmetic products. Since the U.S. FDA does not mandate specific testing to demonstrate the safety of products or ingredients, existing relevant safety data can be utilized to support product safety.

However, it is crucial that all data used for safety substantiation is derived from scientifically robust methods. This information can reference the CPSR (Cosmetic Product Safety Report), which is a legal requirement in the EU.

For more details about KGMP: Cosmetic PIF and CPSR services to make an adequate safety substantiation for cosmetic products ▶ Click here

GMP (Good Manufacturing Practice) Compliance

Good Manufacturing Practice (GMP) requirements apply to facilities that manufacture cosmetic products. Additionally, as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), the FDA has agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance.

For more details about KGMP: GMP & ISO compliance service ▶ Click here

Remember that different regulations apply in each country.

Contact us today to discover how our product registration services can benefit your business.

 

KGMP simplifies compliance with complex cosmetic regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final cosmetics.     

	GAP Analysis		Ingredients and Label		Registration
	U.S. Agent		Facility Inspection		Food Safety
	Batch Master File		GRAS, NDI and Novel Food		Food Contact Substance

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of cosmetic products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our cosmetic regulation compliance services, please contact our expert directly.

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