MOCRA | in-cosmetics Connect

Navigating regulatory compliance in beauty brand development

Cherie Buziak, BeautyEdge LLC — Tue, 03 Dec 2024 16:45:40 +0000

In the dynamic world of beauty and cosmetics, the journey from concept to launch goes beyond crafting an innovative product formula or creating a compelling brand identity.

Navigating the complex regulatory landscape is a crucial step that every beauty brand must master. Compliance, product development, and operational excellence are essential for both emerging and established brands aiming for success.

Highlighted in this article are key points noted in a fireside chat between Cherie Buziak from BeautyEdge LLC and Sara Bumby from First Impact New York.

The Importance of Regulation in Product Development

Regulatory compliance isn’t merely a backdrop to product development; it’s the very framework that supports it. While brands often focus on formulation, sensory experiences, claims, and market targeting, regulatory guidelines form the structure that enables these aspects to be implemented legally and ethically.

According to Sara Bumby from First Impact New York City, “Brands can run into serious trouble if they overlook regulatory details, even unintentionally.”

Top Priorities when considering Regulatory Compliance

1. Understanding Mocra Regulations: The Modernization of Cosmetic Regulation Act (Mocra) is pivotal in the U.S. beauty landscape. It governs product safety, reporting, and transparent labeling. Compliance ensures that a product is legally marketable, preventing potential recalls and legal implications.

1. Global Standards and Variations: For brands eyeing international expansion, it’s essential to understand that regulations differ widely. The European Union’s standards, for example, are more stringent than those in the U.S., with specific requirements on ingredients, safety assessments, and labeling. Per Bumby, aligning with these global standards requires a proactive approach to avoid disruptions when entering new markets.

2. Claims Substantiation: Whether a product promises “anti-ageing” benefits or “24-hour hydration,” each claim must be backed by scientific evidence. This is not only a regulatory requirement but also builds consumer trust.

Balancing Creativity and Compliance

Regulation is the key that connects all aspects of work in the beauty industry. It makes sure that the creativity involved in developing products—whether it’s a new formula or an eye-catching marketing claim—follows the rules and can be defended. Failing to comply with these regulations can lead to fines or harm a brand’s reputation, risks that no brand, big or small, can afford to take.

In a rapidly evolving industry where consumer expectations for transparency and efficacy continue to grow, regulatory compliance has become as essential as the products themselves. Brands must not only develop standout products but must do so within a complex matrix of compliance standards. Ensuring these standards are met requires expertise, foresight, and dedication.

Establishing Accountability and Accurate Claims in Beauty Marketing

In an era where transparency is not just valued but demanded, consumers expect truth in advertising and integrity in claims. When brands approach First Impact, one of Sara’s first priorities is an exhaustive review of their copy, website, and any existing brand book. This foundational step ensures that all language aligns with regulatory standards, facilitating seamless communication for PR teams, marketing agencies, and influencers.

The Responsibility of Compliance Across Platforms

A critical aspect is that brands are fully accountable for all claims made, whether through their packaging, digital platforms, or spokespersons. “Brands need to realize that they are responsible for what their influencers say in the market,” Bumby stressed. This level of responsibility extends beyond a brand’s internal team to third parties, which makes setting up clear, substantiated claims from the beginning paramount.

Brands must also be aware that today’s retail landscape, split between brick-and-mortar and e-commerce, operates on an equal playing field regarding compliance.

This uniformity underscores that regulations apply universally, regardless of where a product is sold or how it is marketed.

Clarifying Responsibility Between Brands and Manufacturers

One point that often confuses new beauty entrepreneurs is the extent of responsibility when working with contract or private label manufacturers. While manufacturers can provide data on active ingredients, they are not liable for the claims brands make based on that data. At the end of the day, it’s your responsibility as the brand to ensure stability testing, efficacy testing, and that all claims have the necessary supporting documentation.

For example, while a manufacturer might provide data showing that a formulation contains vitamin E and highlight its benefits, this alone is insufficient to make broad claims against that one ingredient. Brands must invest in testing the final formulation to substantiate claims accurately. This includes conducting consumer science tests or, when applicable, clinical studies, using tools and methodologies to validate claims rigorously.

Types of Claims and Documentation

Consumer Science Testing: This involves trials conducted with real users under controlled conditions to gather feedback and demonstrate how the product performs. These tests are crucial because they show results based on the final product, not just its individual components.

Clinical Studies: Using specialized equipment and scientific measurements, clinical studies provide quantitative data on a product’s performance. These studies can support claims like “reduces the appearance of fine lines by x% in two weeks,” provided they are backed by reliable results from an independent testing facility.

Building a Foundation of Trust

For new brands, navigating these regulatory demands can seem daunting. However, it is this diligence that lays the groundwork for credibility and trust in an increasingly skeptical market. Developing a brand that is both innovative and compliant requires commitment from day one.

By integrating regulatory expertise into their development process, brands can confidently launch products that meet not only creative aspirations but the rigorous standards of today’s regulatory environment.

For beauty brands looking to succeed in today’s market, regulatory compliance is non-negotiable. As Sara Bumby and Cherie Buziak discussed, understanding and adhering to these guidelines from the outset not only protects the brand legally but also builds trust with consumers. Brands must take responsibility for their claims, ensure they have proper documentation, and work closely with their contract manufacturers to substantiate product
efficacy.

This transparency and attention to regulation will set a brand apart in the
competitive beauty industry.

Sara Bumby President, Co-Founder at First Impact New York are dedicated to providing a wide range of services for the beauty industry, production management, product development, custom formulas, consulting, focus groups and much more.

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MoCRA updates: US FDA unveils the draft guidance for cosmetic facility registration and product listing

Jarius Ji, Cosmetic Regulatory Analyst, ChemLinked, REACH24H Consulting Group — Mon, 18 Sep 2023 11:26:58 +0000

On August 7, 2023, the U.S. Food and Drug Administration released a draft guidance on cosmetic facility registration and product listing (draft guidance), which explained in detail the two mandatory obligations for enterprises from the Modernization of Cosmetics Regulation Act of 2022 (MoCRA): facility registration and product listing. The consultation period for this draft will run until September 7, 2023.

Facility registration: All entities engaged in the manufacture or processing of cosmetic products for the U.S. market—regardless of their geographical location—must register their facilities with the FDA. Facilities in operation when MOCRA was enacted must complete registration with the FDA by December 29, 2023. New facilities must be registered within 60 days after they begin manufacturing or processing cosmetics, or within 60 days after December 29, 2023, whichever is later.

Product listing: Responsible person for cosmetics intended for sale in the U.S., namely, manufacturer, packer and distributor of a cosmetic product whose name appears on the label, must list each marketed cosmetic product, including product ingredients, with the FDA. Existing cosmetic products, which were already on the market prior to the enactment of MoCRA, must be listed with the FDA no later than December 29, 2023. For new products introduced to the market after MoCRA’s enactment, the listing with the FDA should be done within 120 days from the date of their initial marketing.

Key Updates

This draft guidance refines the statutory requirement for cosmetic facility registration and product listing. It clarifies the definitions of key terms such as “contract manufacturer”, “responsible person”, “facility”, “DUNS number”, etc., and offers comprehensive guidance on the entities responsible for submitting applications for registration and listing, the necessary dossiers, submission methods, submission deadlines, and exemptions from registration and listing requirements, etc.

For a comprehensive understanding of the procedures for facility registration and product listing, please refer to the following two articles:

Moreover, the draft guidance introduces additional details, including the rollout schedule for a new electronic portal for enterprises to submit registration and listing, as well as the adoption of the FDA Establishment Identifier (FEI) as the facility registration number.

New Electronic Submission Portal

FDA has announced its plan to launch a new electronic submission portal in October 2023. This portal will serve as the designated platform for submitting facility registration and product listing information. Businesses are strongly encouraged to utilize electronic submissions as it enhances the efficiency and timeliness of data submission. As an alternative, the paper form is also being developed.

In line with this, the FDA is inviting industry players to partake in user acceptance testing pilot program to evaluate the future new electronic submission portal. This initiative, accepting up to nine participants, aims to gather valuable feedback from them for portal improvement. Interested stakeholders can apply electronically via eRLC.testing@fda.hhs.gov.

Adoption of FDA Establishment Identifier (FEI)

FDA will employ the FDA Establishment Identifier (FEI) as the required facility registration number. Prior to initiating the facility registration process, facility owners or operators are required to obtain an FEI number.

Notably, responsible persons are obligated to obtain relevant FEI numbers for each manufacturing or processing facility associated with their cosmetic products, as the facility registration number is a prerequisite for product listing submission. Small businesses exempt from registration can utilize their facility name/address in lieu of the facility registration number for product listing.

ChemLinked Suggestions

Considering the imminent launch of the new submission portal in October 2023, it’s urgent to act. To ensure a seamless transition into the new regulatory landscape, ChemLinked recommends stakeholders take the following proactive measures:

Organize and sort out existing cosmetic products. This should encompass comprehensive details such as product names, labels, and ingredient information. This groundwork will significantly accelerate the registration process once the submission system is accessible.
Initiate FEI Number Application: For enterprises yet to acquire an FEI Number, it’s recommended to initiate the application promptly. This critical step is essential for a smooth engagement with the impending product listing submission.

Further Reading

ChemLinked Cosmetic Portal (cosmetic.chemlinked.com) is a media platform operated by REACH24H Consulting Group. Our focus is on providing comprehensive one-stop-market access information services and solutions to members of the cosmetics industry, including domestic and foreign manufacturers, trade logistics, raw material companies, as well as government departments, industry associations, and research institutions.

We offer a wide range of global cosmetic market entry services, including Global News Alerts, Cosmetics Product Registration and Notification, New Cosmetic Ingredient (NCI) Registration/Notification, Regulatory Consultation, Customized Training, Market Research, and Branding Strategy. Please contact us to discuss how we can help you by cosmetic@chemlinked.com

Author

Winnie Xu

ChemLinked Regulatory Analyst, REACH24H Consulting Group

Winnie Xu is an experienced cosmetic regulatory analyst in the ChemLinked team tasked with tracking, analyzing and interpreting the latest regulatory and market changes in China, Japan, and the rest of the Asia Pacific area. She has published a number of news and articles on cosmetic regulatory compliance and involved in various industry conferences.

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Demystifying the US MoCRA regulation: Key provisions and latest updates

Jarius Ji, Cosmetic Regulatory Analyst, ChemLinked, REACH24H Consulting Group — Fri, 18 Aug 2023 10:53:52 +0000

On December 29, 2022, US President Joe Biden signed the Consolidated Appropriations Act, 2023 into law, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

This new cosmetic legislation establishes a federal standard for cosmetic business registration, product listing, recordkeeping, adverse event reporting, safety substantiation, GMP, recalls, and more.

For years, the US Food and Drug Administration (FDA) had relatively loose regulations on cosmetics. Cosmetics business registration and product listing are voluntary rather than mandatory. FDA can issue a warning letter to cosmetic products or companies involved in violations and deny the entry of such products at ports. Still, FDA has no right to order a mandatory recall of unqualified cosmetics.

Focusing on product safety, MoCRA sets out a number of key provisions and new requirements to amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) and increase FDA’s oversight over cosmetics and ingredients thereof. It marks the first significant reform to the US cosmetics regulation since the enactment of the FD&C Act in 1938.

Key Provisions of MoCRA

Some of the key points of MoCRA are summarized below:

1.Mandatory Facility Registration and Product Listing

MoCRA stipulates that one year after MoCRA is formally promulgated, “responsible persons” (i.e., manufacturers, packers, and distributors of a cosmetic product whose name appears on the product label) will be subject to mandatory facility registration and product listing requirements.

Specifically, all existing US domestic and foreign facilities that manufacture or process cosmetic products for sale in the United States must register with FDA within one year after MoCRA’s enactment. All facility registrations must be renewed every two years. Notably, facilities engaged solely in the labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products are not required to register.

Regarding listing, responsible persons shall list each cosmetic product with FDA, including its ingredients and where the cosmetic product is manufactured. The product listings shall be updated annually. It is worth noting that a single listing submission may include multiple cosmetic products with identical formulations or formulations that differ only in colors, fragrances, flavors, or quantity of contents.

2. Cosmetic Safety Substantiation

MoCRA requires responsible persons to ensure and maintain records supporting “adequate substantiation” that shows that a cosmetic product is safe, and establishes a safety standard that products must meet to be marketed in the US. Cosmetic products without adequate safety substantiation will be considered adulterated.

3.Updated Cosmetic Labeling Requirements

MoCRA updates the labeling requirements for cosmetics, including:

The requirement to include contact information through which the responsible person can receive adverse event reports on cosmetic product labels, which will be effective two years after the date of enactment of MoCRA;
The requirement to include a notice that only licensed professionals may use the product on the labels of cosmetics products for professional use, which will be effective one year after the date of enactment of MoCRA;
The requirement for disclosure of fragrance allergens on product labels. The disclosed information shall be consistent with FDA’s new regulations.

4.Mandatory Adverse Event Reporting

MoCRA requires that responsible persons submit reports of serious adverse events to FDA no later than 15 days after learning the issue, and maintain all records related to health-related adverse events associated with the use of its product for six years. Exceptionally, small businesses need only maintain such records for three years.

Besides, MoCRA expands the definition of “serious adverse event” to include infections 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.”

5.FDA’s Increased Oversight

In addition to the above new requirements for cosmetic manufacturers, packers, and distributors, MoCRA greatly expands FDA’s rulemaking and enforcement authority over cosmetics. It mandates FDA to issue good manufacturing practices (GMPs) regulations and develop regulations that establish and require standardized testing methods for asbestos in cosmetics. It also grants FDA’s mandatory recall authority for a cosmetic product and expands FDA’s access to certain records.

Latest Updates

The implementation and enforcement of MoCRA’s detailed legislation may take years for the FDA, as it will need to develop necessary regulations. Over the next 2-3 years, the FDA will dedicate efforts towards developing necessary implementing regulations, including mandatory GMP regulations for cosmetic manufacturers.

Recently, FDA held a virtual public listening session on good manufacturing practices, seeking input and expertise from stakeholders to inform the development of GMP regulations for the cosmetics industry. The regulations will be formulated with reference to suggestions and opinions put forward by enterprises at the listening session.

Representatives from various organizations and businesses presented public comments, sharing perspectives and suggestions on GMP for cosmetic products. Key themes and concerns emerged, highlighting the importance of addressing safety, quality, and consistency in GMPs regulations to protect consumers and support industry growth.

Safety and Quality Assurance: Many speakers emphasized the necessity for robust GMPs to ensure the safety and quality of cosmetic products. They called for comprehensive guidelines encompassing manufacturing processes, ingredient safety, labeling requirements, and product testing;
Compliance and Enforcement: Effective compliance mechanisms and enforcement actions were highlighted as crucial for ensuring adherence to GMPs. Suggestions included regular inspections, mandatory reporting of adverse events, and appropriate penalties for non-compliance;
Small Business Considerations: Representatives from small cosmetics businesses emphasized the need for adaptable and feasible GMP guidelines tailored to smaller enterprises. They stressed the significance of providing sufficient support, resources, and education to facilitate compliance without burdening small businesses excessively;
Ingredient Transparency: Speakers advocated for clearer labeling requirements, including the disclosure of potential allergens, fragrance components, and other potentially harmful substances;
International Harmonization: Participants stressed the importance of aligning GMP regulations with international standards to facilitate global trade and ensure consistency in quality and safety measures.

The listening session fostered an open and inclusive discussion on the development of GMP regulations for the cosmetics industry. It emphasized the significance of ensuring safety, quality, and transparency in cosmetic manufacturing processes while considering the diverse needs of different stakeholders, including small businesses.

The FDA will utilize the insights and recommendations shared during the session to develop GMP regulations that prioritize public health and promote responsible manufacturing practices in the cosmetics industry.

ChemLinked Comments

MoCRA’s passage is set to have a significant and far-reaching impact on the cosmetics industry. For example, it will require US and foreign facilities that manufacture or process cosmetic products for US distribution to register with the FDA. This mandatory registration must be renewed every two years, adding complexity to proceedings. While major manufacturers may not have an issue with this, smaller manufacturers could face challenges.

Previously, the US had different regulations from other countries, with the Voluntary Cosmetic Registration Program (VCRP) in place. However, this non-mandatory registration system for cosmetic products was decommissioned in March. Each product will require separate registration, creating a bigger burden for brands with a wide range of products.

Stakeholders interested in entering the US market should carefully study the regulatory changes and comply with the corresponding deadlines. Facility registration and product listing will take effect one year after MoCRA’s enactment. Adequate preparations in advance can mitigate compliance risks and increase the chances of successful market entry.