Cosmetics

The United States Congress recently passed the Consolidated Appropriations Act, which includes updates to U.S. cosmetics regulations. Years in the making, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant reform of cosmetics law in recent U.S. history. MoCRA expands the U.S. Food and Drug Administration’s (FDA’s) regulatory authority over the cosmetics industry, enabling the agency to increase requirements for marketing cosmetics in the U.S. Though FDA has yet to establish detailed regulations, cosmetic companies should be aware of the changes included in the bill.    

1. Cosmetic Facility Registration and Renewal  

Mandatory FDA registration for owners and operators of facilities that manufacture or process cosmetic products for U.S. distribution with such registration renewal biennially. Existing facilities will have one year from the date of enactment to register their facility with FDA whereas new facilities that manufacture or process cosmetic products for distribution in the U.S. after the enactment date must register within 60 days of marketing a product or 60 days after the deadline for registration, whichever is later.  

Facilities must notify the FDA of any changes to registration information within 60 days of the change and now renew their FDA registration every other year.  

2. Cosmetic Product Listing  

Companies must submit a mandatory product listing to FDA for each cosmetic product no later than one year after the enactment date. Cosmetic products marketed after the enactment must list the product within 120 days of marketing it. Flexible listings will allow for a single submission for multiple cosmetic products with identical formulations or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.  

Companies must renew a product listing annually with any updates. There will be an abbreviated listing option for products that have not changed since their previous listing.  

3. Cosmetic Good Manufacturing Practices (GMP)  

Facilities will be required to adhere to Good Manufacturing Practices (GMPs) that are consistent with national and international standards. GMP is intended to protect the public health and ensure that cosmetic products are not adulterated. This regulation will allow FDA to inspect facilities and have access to records that it deems necessary to verify compliance with GMP established by the FDA. Currently the FDA has 2 years from the enactment, to publish a Notice of Proposed Rulemaking for the Cosmetic GMP, with the Final Rule not later than 3 years after enactment.  

4. New Cosmetic Labeling Requirements 

Product labels must be updated to include a domestic address, domestic phone number, or electronic contact information where a responsible person can receive adverse event reports.  

Cosmetic products that contain fragrance allergens will need to update their label to list those allergens. The proposed fragrance allergens must be issued within 18 months after the date of the enactment, with the final ruling issued no later than 180 days after the public comment period closes 

For professional cosmetic products, labels must indicate a clear and prominent statement that the product is administered or used only by licensed professionals and is in conformity with the existing cosmetic labeling requirements.  

Looking for a hands-off approach to labeling? Our Regulatory Specialists can review and redesign your cosmetic label for FDA compliance. Get started here.  

5. Adverse Event Report  

In the event of a Serious Adverse Event associated with a cosmetic product, the responsible person must submit a report, accompanied by a copy of the label on or within the retail packaging no later than 15 business days after the report is received.   

If a company receives new and material medical information related to the report within 1 year of the initial report, it must submit the information to FDA within five business days of receiving it.  

6. Cosmetic Safety Substantiation 

Companies must maintain records supporting adequate safety substantiation for their cosmetic products. It specifies that substantiation must be in the form of “tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.”  

7. Cosmetic Records Inspection 

Gives authority to the FDA to access and copy certain records related to a cosmetic product if there’s a reasonable belief that a cosmetic product or ingredient presents a threat of serious adverse health consequences or death to humans upon use.  

8. Cosmetic Mandatory Recall 

The FDA determines there is a reasonable probability that a cosmetic is adulterated or misbranded, and the use or exposure to such cosmetic will cause serious adverse health consequences. The Responsible Person has the opportunity to recall the product, but if refused, FDA, by order, can call for the immediate cease distribution and recall the product.  

9. Cosmetic Adverse Report Record-Keeping  

Records of adverse event reports must be maintained for 6 years, and FDA must be able to access them during inspections. FDA may request a written list of all ingredients in the product’s fragrances or flavors if it believes an ingredient or combination of ingredients has caused serious adverse events. This list must be submitted within 30 days of FDA’s request.  

10. Small Business Exemptions 

Small businesses are exempt from certain regulations. FDA defines small businesses as those with average gross annual sales for the previous three-year period totaling less than $1,000,000. This shall not apply to any responsible person or facility engaged in manufacturing cosmetic products that regularly come into contact with eye, are injected, that are intended for internal use, or that alter the appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer.  

Don’t wait. Educate yourself with MoCRA Now! 

You should become familiar with the requirements that apply to your facility or cosmetic products under the forthcoming regulations. New requirement provisions become effective 1 year after MoCRA’s enactment.  

Because many requirements are new to facilities and cosmetic companies—such as standardized GMPs, facility registration, and Cosmetic Product listing—complying with regulations could be challenging. Registrar Corp offers full-service compliance assistance for cosmetics as well as software solutions specialized to help companies comply with cosmetic regulations.  

Registrar Corp provides several solutions for MoCRA’s new requirements, including serving as a domestic U.S. Agent, assisting with Facility registration and renewal, Cosmetic Product listing and renewal, guidance with FDA requirements, and much more!

On December 23, 2022, the United States Congress passed a bill that grants the U.S. Food and Drug Administration (FDA) regulatory authority over the personal care products industry. The legislation includes significant cosmetics provisions found in the Modernization of Cosmetics Regulation Act. This is the first time Congress has updated legislation to federal law regulating personal care products since 1938. 

Prior to the bill’s passage, the Federal Food, Drug, and Cosmetic (FD&C) Act gave FDA oversight over aspects of the cosmetics industry, but regulatory power was limited. The legislation now allows FDA to regulate cosmetics companies as extensively as it does other industries such as food, drugs, and medical devices.   

Cosmetics provisions included in the bill require companies to prove the safety of their products and grants FDA authority to review related records when a cosmetic product poses a risk to consumer safety. Cosmetics companies will also need to register with FDA to market products in the U.S. and administer good manufacturing practices that adhere to FDA’s safety standards. The bill includes many more provisions that will alter the methods and procedures cosmetics companies implement to manufacture their products.  

This legislation will have a substantial impact on the cosmetics industry. Cosmetics companies should prepare to comply with increased regulations, which will likely require additional resources and staff. As the regulatory landscape shifts for cosmetics, enforcement actions will follow for companies that don’t adapt to FDA’s requirements. 

Updated May 1, 2023

Allergic reactions are a common issue in the U.S., often occurring when someone comes into contact with a substance that their body perceives is harmful.

Whether the person is consuming an allergen through food or drink or contacting the substance with their skin, if the individual’s immune system attempts to fight the substance through releasing antibodies, a reaction is likely to occur. Allergic reactions can range from a mild rash to anaphylaxis, a severe and sometimes fatal reaction.

FDA regulates the declaration of allergens on food and beverage labeling extensively, but the same labeling regulations do not apply to allergens in cosmetics. With the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), FDA now has authority to create and enforce requirements for labeling allergens in cosmetic products.

Upcoming FDA cosmetic labeling requirements means cosmetics companies will need to update their products’ labeling to include declaration of fragrance allergens.

Do you need to list allergens on your cosmetic label? What sort of requirements must you meet in California? Keep reading to learn about current federal FDA and California state requirements.

Current Labeling Requirements for Cosmetic Products

Products that FDA regulates as food must bear a label that includes the common name of any “major food allergen” (as specified in the Food Allergen Labeling and Consumer Protection Act of 2004), either in the ingredients list or with a “contains” statement.

However, until FDA releases and enforces guidelines for labeling cosmetics allergens, this same requirement does not currently extend to cosmetics and personal care products.

FDA has determined the allergens that cause most allergic reactions due to use of a cosmetic product. These allergens are divided into 5 classes:

• Preservatives
• Metals
• Fragrances
• Natural rubber
• Dyes

The Fair Packaging and Labeling Act (FPLA) gives FDA the authority to require an ingredient declaration on retail cosmetic products. However, certain ingredients that commonly contain allergens may be exempt from the declaration of the common name. For example, cosmetic labeling regulations permit the labeling of “fragrance” and “flavor” without specifying the exact ingredient(s).

Although FDA requires an ingredient declaration on cosmetic labels, certain allergy claims are unregulated. For example, federal regulations do not govern or define terms like “fragrance-free” “hypoallergenic”, or “for sensitive skin”.

These are terms that the company manufacturing the product define, as FDA has not established any formal definitions or policies for their use.  While these terms may provide a marketing advantage, FDA has stated that they may have very little meaning. Notwithstanding this, FDA has not imposed any specific restrictions on their inclusion on a label.

California Reporting Requirements

While allergen-related regulations for cosmetics is not found at the federal level, products marketed in California will be subject to additional requirements of which manufacturers and distributors should be aware.

Under the California Safe Cosmetics Act of 2005, California established a list of ingredients suspected to cause cancer or reproductive harm, and mandates that products containing any of these ingredients be reported to the state.

The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) went into effect on January 1, 2022. CFFIRKA designates a subset of ingredients called “fragrance allergens” and specific ingredients that must be reported only if used as a fragrance ingredient (regardless of their function).

They must be reported by the company named on the label when present at a concentration of 0.01% (rinse-off cosmetics) or 0.001% (leave-on cosmetics).

Upcoming Changes in FDA Cosmetic Labeling Requirements

MoCRA requires cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States.  The statement must contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings.

Cosmetic products that contain fragrance allergens will need to update their label to list fragrance allergens. FDA must issue a proposed list of fragrance allergens within 18 months after the date of MoCRA’s enactment, with the final ruling issued no later than 180 days after the public comment period closes