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FDA Labeling Requirements for Cosmetics

Understanding the Modernization of Cosmetics Regulation Act (MoCRA)

The Modernization of Cosmetics Regulation Act (MoCRA) marks a significant shift. Signed into law in December 2022, it’s a major step forward in ensuring that cosmetic products are safe for consumers. This is the first significant update for cosmetic regulations since the Federal Food, Drug, and Cosmetic Act was established in 1938.

So, what does MoCRA mean for you as a wellness brand professional? The legislation includes new regulations around ingredient safety, labeling requirements, and claims substantiation, which are all aimed at improving transparency and accountability in the cosmetic industry. Simply put, it's about elevating product integrity and consumer trust.

A Closer Look at FDA Labeling Requirements

When it comes to FDA labeling, the focus is on clarity and compliance. The FDA outlines specific requirements for cosmetic labeling, ensuring that consumers have access to vital product information, like ingredients. Let's dive deeper into these requirements and understand how they can impact your brand.

FDA Labeling: The Basics

First things first, FDA labeling mandates that your product labels provide certain fundamental information. This includes the product's identity, the name and place of business of the manufacturer or distributor, and the net quantity of contents. This information must be conspicuous and easily understandable, ensuring that consumers are not misled about what they're purchasing.

The “responsible person,” must list each cosmetic product and its ingredients with the FDA no later than December 29, 2023. After this date, the responsible person has 120 days to submit the product listing and keep it updated annually.

Confused about who might be the “responsible person”? The FDA defines this party as the entity or individual who is accountable for ensuring that the cosmetic product complies with all applicable regulations. It could be the manufacturer, distributor or brand owner, importer, and even the marketer. 

Ingredient Listing: A Key Aspect of FDA Labeling Requirements

One of the cornerstones of FDA labeling is the ingredient list. Under these regulations, you must list all ingredients in your product in descending order of predominance. This not only promotes transparency but also helps consumers make informed choices, especially those with allergies or sensitivities.

Here are some additional insights for listing your ingredients:

The International Nomenclature of Cosmetic Ingredients (INCI) system is often used for naming ingredients. This standardized system helps maintain consistency and clarity in ingredient lists across different products and brands.

For botanicals, the INCI name often includes the plant's Latin name. This provides specificity, especially for consumers who are knowledgeable about different plant-based ingredients.

If your product contains color additives, these must be listed. However, they can be listed at the end of the ingredient list regardless of their concentration.

The term "fragrance" or "flavor" can be used instead of listing each individual component, due to trade secret protections. However, if you're marketing to consumers interested in clean beauty or transparency, consider revealing these components voluntarily.

Some jurisdictions, especially in Europe, require specific listing of known allergens. While not a current FDA requirement, being transparent about allergens can build trust with your customer base.

Warning Statements and Claims

FDA labeling requirements also involve navigating the fine line between cosmetic and drug claims. Your products must not make claims that could classify them as drugs unless they're approved as such. Additionally, if your product requires specific warnings (like sunscreen or hair dye), these must be prominently displayed on the label.

The Details of Font Size, Location, and Language

Getting into the nitty-gritty, the FDA also specifies font size, location, and language for labels. These details matter because they ensure that the information is accessible to all consumers. For instance, the information must be in English, and if another language is used, the information must appear in both languages.

The Principal Display Panel (PDP) is the part of the package most likely to be seen by the consumer at the time of purchase. Key information, like the product name and net quantity of contents, must appear here. Other required information, such as ingredients, the identity of the distributor, and any required warning statements, should be placed on an information panel. This is usually located immediately to the right of the PDP if looking at the product directly.

For small packages where space is limited, the FDA provides allowances. For example, some information can be placed on peel-back labels or tags.

Leveraging FDA Labeling for Marketing

As a wellness brand professional, FDA labeling isn't just about compliance; it's a marketing opportunity. By aligning your brand with these requirements, you demonstrate commitment to transparency and consumer safety. This can be a powerful tool in building consumer trust and differentiating your brand in the crowded wellness market.

Time to Embrace the Change

Understanding and adhering to FDA labeling requirements under MoCRA is crucial. By embracing these regulations, you position your brand as a trustworthy and ethical player in the wellness industry. Remember, consumer trust is your most valuable asset. Find out how you can stay compliant with MoCRA and other FDA regulations with clinical research.


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