FDA MoCRA Cosmetics Updates: What Beauty Brands Need to Know to Stay Compliant

Jack Li

by Jack Li · Updated Mar. 05, 2024

FDA MoCRA Cosmetics

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marks a pivotal update in the United States’ approach to cosmetics oversight. Enacted on December 21, 2022, MoCRA delivers the most substantial reform to cosmetic regulation since the inception of the Federal Food, Drug, and Cosmetic Act in 1938. This historic measure entrusts the Food and Drug Administration (FDA) with enhanced regulatory frameworks to oversee the cosmetics industry.

FDA MoCRA Cosmetics Updates introduces several new require ments and standards for cosmetic brands, such as mandatory registration and product listing, new labeling and packaging rules, adverse event reporting, specific ingredient regulations, safety and testing protocols, and more. MoCRA also gives the FDA more authority and resources to oversee and enforce the compliance of cosmetic products in the market.

MoCRA significantly impacts cosmetic brands, influencing all their operations, from the conception and production of products, to the strategies employed in marketing and the procedures of product distribution. MoCRA also has implications for international brands that export their products to the U.S. market. The objective of MoCRA is to safeguard the safety and integrity of cosmetic products while also securing the health and rights of consumers. MoCRA also creates a more level playing field for cosmetic brands, as it eliminates the loopholes and inconsistencies that existed in the previous regulatory system.

In this article, we will provide a comprehensive overview of MoCRA and its impact on the cosmetics industry. We will explain the background and rationale of MoCRA, the key requirements and procedures for compliance, the benefits and challenges of MoCRA, and the best practices and resources for cosmetic brands to prepare for MoCRA. We will also share expert opinions and case studies from industry leaders and successful brands that have adapted to MoCRA. By the end of this article, you will have a clear understanding of what MoCRA means for your cosmetic brand and how you can leverage it to grow your business and reputation.

Table of Contents

I. Registration and Renewal of Facility

A. Who Needs to Register

Businesses engaged in manufacturing or processing cosmetic products for export into the United States must register their facilities.

B. Required Information for Registration

  • Contract manufacturers, packers, and distributors that provide services to cosmetic brands
  • Private label manufacturers, packers, and distributors that sell cosmetic products under their own or other brands
  • Online retailers and e-commerce platforms that sell cosmetic products directly to consumers
  • Importers and exporters of cosmetic products to and from the U.S.

The only exceptions to the registration requirement are:

  • Retail establishments that sell cosmetic products only to consumers and do not manufacture, package, or distribute them
  • Facilities that manufacture, package, or distribute cosmetic products only for personal or household use and not for commercial purposes
  • Facilities that manufacture, package, or distribute cosmetic products that are not intended for the U.S. market

C. Methods of Information Submission

Facility information can be submitted in the following ways:

1. Via FDA’s Electronic Submission Portal (ESG) in Structured Product Labeling (SPL) format for electronic submission. SPL is a document markup standard recognized by the FDA for product and facility information exchange.

2. Using the Cosmetics Direct standard electronic format, which aligns with the required paper form data for registration and listing. This ensures comprehensive submissions in-line with FDA requirements and allows access to past submissions for easier updating.
Access submission portals and detailed registration guidelines below:

Alternatively, the FDA accepts paper submissions using Forms FDA 5066 and 5067 for those who prefer or require this method.

D. Timing for Facility Registration

1. Initial Registration: Businesses initiating production or processing of cosmetics to be sold in the U.S. are required to finalize their registration in line with FDA guidelines by no later than July 1, 2024.

2. Registration Updates: Any changes to registration details must be reported to the FDA within a 60-day window from the date of change.

3. Renewal of Registration: Facilities must renew their business registration biennially. For those with no updates to their registration details, the FDA provides a streamlined process for renewal.

II. Listing and Updating of Cosmetic Products

A. Who Needs to Register

Individuals or entities responsible for cosmetic products, referred to as the “Responsible Person,” must list their products using the Facility Registration Number designated for each of their cosmetics offerings. A “Responsible Person” can be a manufacturer, packer, or distributor of a cosmetic product, identifiable by their name on the product’s label.

Based on the information and instructions for cosmetics listing and updating, here’s a revised version of the content provided:

B. Required Information for Submission

1. Facility Registration Number: The identification number for each facility where the cosmetic product is manufactured or processed.

2. Responsible Person Details: Name and contact number of the responsible person, along with the product name as it appears on its label.

3. Cosmetic Category: The specific category or categories under which the cosmetic product falls.

4. Ingredient List: A comprehensive list of all ingredients in the cosmetic product, including fragrances, flavors, or colors. Ingredients must be named according to either Section 701.3 of Title 21, Code of Federal Regulations (or its successor regulations), or by their common or usual names.

5. Product Listing Number: If assigned, include the product listing number previously designated by the Secretary under Section 607. REGISTRATION AND PRODUCT LISTING (d).

Additional Submission Options include specifying if the cosmetic is for professional use, the parent company name (if applicable), business type as indicated on the product label, label image, product webpage link, DUNS number, UNII codes, and any other relevant information concerning the listing.

C. Submission Portal

Submit all required and additional information electronically via the Structured Product Label (SPL) format through the designated submission portal.

D. Field Names and Updates

1. Listing Deadline: All cosmetic products presently available in the U.S. market must be registered by July 1, 2024.

2. Content Updates and Maintenance: The party responsible for the cosmetic product must annually refresh the listing information for all products. This includes providing updates on discontinued products. Please refer to the official document here for more details.

III. Cosmetic Labeling Guidelines

A. Current Labeling Standards

1. Regulatory Compliance: Cosmetic products available in the U.S. market, regardless of being domestically produced or imported, are required to adhere to the regulations set forth by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA), as well as any regulations promulgated under the auspices of these acts.

2. Ingredient Listing: For consumer safety, product labels should enumerate each ingredient, prioritizing them by predominance.

3. Color Additives: Any color additive in the product must receive prior FDA approval.

4. Ingredient Specification: For detailed information on specific ingredient labeling, visit: CFR – Code of Federal Regulations Title 21

B. Upcoming Labeling Requisites

1. Adverse Event Reporting Contacts:By December 29, 2024, labels must display contact details (address and phone number within the U.S., or electronic contact like email) for reporting adverse effects.

2. Fragrance Allergens Disclosure:Labels must explicitly list any fragrance allergens present in the cosmetics, as determined by the responsible entity.

3. Professional Use Products:Cosmetics marked for exclusive professional use must declare on their packaging that they can only be applied or administered by certified professionals. For more information, consult the official document.

IV. Packaging Standards under MoCRA

A. Principal Display Panel

This refers to the section of the label most visible or examined during normal retail presentation. It must be adequately sized to host all compulsory labeling information, ensuring clarity and visibility without undermining the design through overcrowding, overshadowing, or vignetting.

B. Product Identity

The product identity section primarily encompasses:

1. The commonly recognized or general name of the cosmetic product.

2. A precise description or unique name readily understandable by the public, clarifying the cosmetic’s nature when it is apparent.

3. A fitting visual depiction of the cosmetic’s intended application.

C. Manufacturer, Packer, or Distributor Details

Packaged cosmetics’ labels must prominently feature the name and business address of the manufacturer, packer, or distributor to ensure transparency.

D. Net Quantity Declaration

Cosmetic product labels must accurately display the net quantity of the content, articulated in either weight, measure, numerical count, or a mix of these. The net quantity for liquids should be in fluid measurements, while solids, semi-solids, viscous forms, or combinations thereof should be denoted in weight. Liquid volumes may be expressed in U.S. gallons, quarts, pints, or fluid ounces, and weights in pounds or ounces.

For full regulatory details, refer to the Electronic Code of Federal Regulations.

V. Documenting and Communicating Adverse Events

A. Definitions

1. Adverse Event: An adverse event pertains to any health-related incident arising from the utilization of cosmetic products.

2.1. Serious Adverse Events: Serious adverse events include situations that result in:
○ (i) Death;
○ (ii) A life-threatening condition;
○ (iii) Admission to a hospital;
○ (iv) A sustained or considerable disability or incapacity;
○ (v) A congenital anomaly or birth defect;
○ (vi) An infection;
○ (vii) Substantial disfigurement, such as severe and enduring rashes, second or third-degree burns, significant hair loss, or a persistent or considerable change in appearance, divergent from expected outcomes under normal or usual conditions of use; or

2.2 Requires, based on sound medical judgment, a medical or surgical intervention to avert a situation outlined in part 2.1.

B. Responsibilities and Protocols for Cosmetics Responsible Parties

1. Receipt: The designated responsible party is required to receive reports of adverse events via the domestic address, phone number, or email provided on the product label.

2. Reporting: In the event of a serious adverse incident related to cosmetic products, the responsible party must notify the FDA within 15 business days, including a copy of the product label. Additionally, it’s crucial for responsible parties to furnish current medical information within one year of the initial report.

3. Record Maintenance and Inspection: The responsible party is obligated to retain records concerning adverse events for six years (or three years for smaller establishments), with the FDA entitled to review these records during inspections.

4. Ingredient Disclosure: Should the FDA suspect that a specific ingredient or a blend of ingredients in a flavor or fragrance may have triggered a serious adverse event, it can request a detailed list of these ingredients in the cosmetic product. The responsible party is then required to provide this information within 30 days of the request.

VI. Specific Cosmetic Product Regulations

Under the Federal Food, Drug, and Cosmetic Act, it is prohibited to distribute or deliver any cosmetic product across state lines if it is deemed adulterated or mislabeled. The following specifies requirements for certain ingredients in cosmetics:

1. Bithionol in Cosmetics: Due to its potential to cause photosensitivity and cross-sensitivity reactions with certain chemicals (like halogenated salicylanilides and hexachlorophene), bithionol-containing cosmetics are considered adulterated.

2. Mercury Compounds: Cosmetics may contain mercury compounds up to 65 parts per million (0.0065%) only if used around the eye area, where no safer alternatives are available. Mercury use beyond this specific application or above this concentration renders the cosmetic adulterated.

3. Vinyl Chloride in Aerosol Products: Given its documented risks—including acute toxicity and potential carcinogenic effects—any cosmetic aerosol products with vinyl chloride are considered adulterated.

4. Halogenated Salicylanilides: These chemicals, including tribromsalan, dibromsalan, metabromsalan, and tetrachlorosalicylanilide, have been used as antimicrobial agents but are potent sensitizers that can lead to severe skin disorders. Cosmetics with any level of these compounds are deemed adulterated.

5. Zirconium in Aerosol Cosmetics: The use of certain zirconium compounds in aerosol cosmetics has been linked to skin granulomas and toxic effects in organs. Such products are thus considered adulterated.

6. Chloroform Ingredients: Due to carcinogenic risks identified in animal studies, cosmetics that contain chloroform are considered adulterated.

7. Methylene Chloride Use: Cosmetics incorporating methylene chloride pose significant cancer risks to users, rendering such products adulterated.

8. Prohibition of Chlorofluorocarbons (CFCs): The use of CFCs as propellants in cosmetic aerosols is strictly prohibited due to environmental and health concerns.

9. Prohibited Cattle Materials: Use of specific risk materials from cattle in cosmetics is banned, including certain organs and tissues which may pose a risk of contamination except for certain materials like tallow under specific conditions.

10. Sunscreen Ingredients in Cosmetics: When cosmetics containing sunscreen ingredients label these as “sunscreen” or similar, it usually subjects the product to drug regulations. Such terms must be qualified on the label to denote the cosmetic benefit of the sunscreen ingredient to prevent consumer confusion.

For further details, refer to the regulatory text available on ECFR’s Title 21, Part 700, Subpart B.

VII. Color Additives

A. Definitions

Any dye, pigment, or substance created through synthetic processes or crafted artfully, or obtained, separated, or derived from natural sources like plants, animals, minerals, or others—whether directly or after undergoing transformation—possesses the ability to impart color when added to food, drugs, cosmetics, or applied to the human body or any part of it, either on its own or by reacting with another substance.

B. Basic Requirements

Any product that contains color additives (except coal tar hair dyes) must adhere to the following:

1. Approval: The FDA must approve all color additives used in cosmetics.

2. Certification: Besides approval, many color additives must be batch certified by the FDA to be eligible for use in American cosmetics.

3. Specifications and Characteristics Requirements: The Code of Federal Regulations (CFR) prescribes specific attributes and specifications for all color additives that must be met.

4. Usage and Restrictions: Color additives can only be used as specified in the regulations which may also outline other restrictions like the maximum concentration permissible in the finished product.

C. Classification of Color Additives

1. Color additives requiring certification typically bear names consisting of three components: a prefix such as FD&C, D&C, or External D&C, followed by a color descriptor, and concluding with a unique number. Examples include “D&C Black No. 2” and “FD&C Blue No. 1”. List of Certified Color Additives

2. Exempt from Certification: These color additives are mainly derived from mineral, plant, or animal sources. Despite being exempt from batch certification, they are still considered artificial colors. They must comply with the identity, specifications, uses, restrictions, and labeling requirements outlined in the regulations when used in cosmetics or other FDA-regulated products. List of Colors Exempt from Certification

3. Straight Colors: These are color additives as they come, unaltered.

4. Lakes: These color additives are essentially ‘straight colors’ extended, adsorbed, or chemically combined with a substrate. They don’t include any mixtures made by merely mixing processes.

D. Restrictions on Color Additive Usage

1. Eye Safety: Color additives are prohibited from use in the eye area unless explicitly authorized by regulatory guidelines. Specific color additives are permissible in products like mascaras and eyebrow pencils. However, only silver nitrate, limited to a concentration of 4% by weight in a viscous gel form, is sanctioned for dyeing eyebrows or eyelashes and is solely for professional application.

2. Cosmetics for External Application: The term “externally applied cosmetics” excludes products intended for lips or areas covered by mucous membrane. Color additives approved for external cosmetics may not be used in items such as lipsticks unless such usage is distinctly authorized by regulation.

3. Injectables: Any application of color additives through injection, including skin injections for tattoos or permanent makeup, is strictly forbidden unless specifically permitted by listed regulations. Presently, there are no endorsed color additives for injection purposes.

E. Packaging Norms for Solid Color Additives

Solid color additives must be contained in packaging that secures their composition from any alteration.

F. Labeling Standards for Color Additives

1. General Label Requirements: Each color additive must be labeled clearly to guarantee safe utilisation. Excluding those intended for direct human consumption, labels should disclose:

  • The name of the pure color, or each component in the mixture if it constitutes a blend.
  • Restrictions on usage, articulated with statements like “only for food use,” “approved for food, drug, and cosmetic uses,” or “restricted to external drug applications.”
  • When applicable, the exact amount of pure color, expressed as weight per unit volume or as a percentage.
  • An expiry date, if mandated by stability considerations.

2. Special Provisions for Limited Use: For color additives with established usage limits, labels must provide explicit directions that, if followed, prevent the final product from surpassing tolerance thresholds.

3. Particular Limitations:
If additional specific restrictions apply to the color additive, these must be vividly stated on the label. For example, one might see advisories such as “Not for eye area use” or “Avoid use in injectable drugs.”

4. Non-Exempt Items from Certification:
Uncertified color additives must feature the lot number allocated by the Color Certification Branch on their labeling, except when the product is prepared for household uses, contains no more than 15 percent pure color, and is packaged in quantities not exceeding 3 ounces. In such cases, the label may display a manufacturer-provided code, previously communicated to the Food and Drug Administration as representative of the lot number.

For more details, refer directly to the eCFR (Electronic Code of Federal Regulations) website.

VIII. Conclusion

The new FDA cosmetics regulations are a game-changer for the cosmetics industry. They represent a significant improvement in the safety and quality of cosmetics products and the protection of consumers. They also pose new challenges and opportunities for cosmetics brands, manufacturers, and distributors.

As a cosmetics brand, you need to understand and comply with the new FDA cosmetics regulations to avoid legal actions, penalties, and reputation damage. You also need to leverage the new regulations to enhance your product innovation, differentiation, and competitiveness. To achieve these goals, you need a partner like Ausmetics, who can help you navigate the new regulatory landscape and achieve market success.

Ausmetics is a professional cosmetics contract manufacturer with over 20 years of experience in the industry. We offer a full range of services, from product development, formulation, testing, packaging, labeling, to regulatory compliance. We have a team of experts who are well-versed in the new FDA cosmetics regulations and can help you meet the requirements and expectations of the U.S. market. We also use advanced technology and systems to streamline and optimize your compliance process. We are committed to providing you with the best quality, service, and value.

If you are interested in partnering with Ausmetics for your cosmetics compliance and innovation needs, please contact us today. We would love to hear from you and discuss how we can help you achieve your goals.

VIV. Frequently Asked Questions (FAQ)

Q1: Who is required to submit registration and product listings under the regulations?

All entities engaged in manufacturing or processing cosmetics for the U.S. market must register their business. The Modernization of Cosmetics Regulation Act (MoCRA) provides an exemption for small businesses with average annual gross receipts of less than $1 million over three years. However, this exemption does not extend to manufacturers or processors of:

  • Products that are in frequent contact with the eye’s mucous membranes
  • Injectable products
  • Internally administered products
  • Products that alter appearance for more than 24 hours without the need for removal under normal usage

Please note, a single registration suffices for any business manufacturing or processing cosmetics for multiple responsible persons.

Q2: What registrations are necessary for a manufacturer/processor that produces both standard and OTC cosmetics?

Manufacturers and processors that produce both standard (general) cosmetics and over-the-counter (OTC) cosmetics need to complete two distinct registrations: one for the cosmetic facility and one for the pharmaceutical facility.

Q3: Understanding the FDA Facility Identifier (FEI)

The FDA uses the Facility Identifier (FEI) as the mandatory registration number for facilities. To streamline the registration process, it’s necessary for the owner or operator of a business to secure an FEI number before proceeding with the business registration. Check whether your entity already has an FEI number by using the FEI Search Portal. If your company is yet to be assigned an FEI number by the FDA, you should familiarize yourself with the procedure to apply for one.

Q4: Distinguishing Between a Responsible Person and a US Agent

Yes, there are significant differences:

  • Responsible Person: This is the party in charge of placing the product on the market. The responsible person ensures the cosmetic product complies with current regulations and standards, and is responsible for product listing and necessary updates. This role does not require the individual or company to be located in the U.S.
  • US Agent: Specifically required to be located in the United States, a US Agent serves as the contact point for foreign facilities with the FDA, providing essential communication for registration submissions. The US Agent is pivotal in managing adverse event reporting, responding to inquiries, facilitating emergency communications, and more, acting as an essential intermediary between the FDA and the facility around the clock.

All entities engaged in manufacturing or processing cosmetics for the U.S. market must register their business. The Modernization of Cosmetics Regulation Act (MoCRA) provides an exemption for small businesses with average annual gross receipts of less than $1 million over three years. However, this exemption does not extend to manufacturers or processors of:

  • Products that are in frequent contact with the eye’s mucous membranes
  • Injectable products
  • Internally administered products
  • Products that alter appearance for more than 24 hours without the need for removal under normal usage

Please note, a single registration suffices for any business manufacturing or processing cosmetics for multiple responsible persons.

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