In this blog, we are going take you through cosmetic labeling requirements along with helping you understand how are cosmetic regulatory, what these regulations focus on, and how the FDA regulates cosmetics. 

Effective cosmetic labeling is a crucial bridge between manufacturers and consumers, providing valuable information about product composition, proper usage, and potential risks.

The Food Drug Administration’s (FDA) guidelines for cosmetic labeling encompass a range of elements, including ingredient listings, net quantity declarations, warning statements, and business contact details.

Correct labeling in the cosmetics industry is not solely a matter of adhering to legal requirements, but it also stands as a vital element in guaranteeing consumer well-being and enabling them to make knowledgeable choices. Navigating the intricacies of cosmetic labeling can be difficult, and this is precisely where Elexes is poised to provide assistance.

How are Cosmetics Regulated?

FDA approval is not needed to market cosmetics in the U.S., yet they are FDA-regulated. However, the following are the laws and acts that the FDA imposes on cosmetics.

⦿ Federal Food, Drug, and Cosmetic Act (FD&C Act)
⦿ Fair Packaging and Labeling Act (FPLA)
⦿ Modernization of Cosmetics Regulation Act of 2022

What does these regulation focus on?

The FDA’s regulation of cosmetics primarily focuses on ensuring that these products are safe for use and that the cosmetic labeling provides accurate information to consumers.

Who is in charge of product safety and effectiveness?

Manufacturers are responsible for ensuring that their cosmetics are safe and properly labeled before they are marketed. This includes conducting appropriate testing and assessment of the product’s ingredients to determine their safety for consumer use.

How does the FDA regulate Cosmetics?

Although the FDA doesn’t conduct pre-market reviews for cosmetics, it retains the authority to respond to products deemed non-compliant with regulations. The FDA’s course of action may involve issuing warning letters, confiscating items, or potentially initiating legal measures against manufacturers who do not align with cosmetic regulations.

Back in 2015, the FDA issued a warning letter to Color Art, Inc as substantial microbial contamination was detected in their product – DBA Solid Ink.

The FDA urges both consumers and healthcare professionals to utilize its MedWatch program for reporting any adverse reactions or concerns associated with cosmetic products.

Wrestling with the task of classifying your product as either a cosmetic or a drug? Read here or you may email us.

What are the Laws and Acts that the FDA imposes for Cosmetics?

The FDA approval is not needed for the marketing or sales of cosmetic products within the US. However, the following are the laws and acts that the FDA imposes on cosmetics.

⦿ Federal Food, Drug, and Cosmetic Act (FD&C Act)
⦿ Fair Packaging and Labeling Act (FPLA)
⦿ Modernization of Cosmetics Regulation Act of 2022

    Of these, the FD&C Act and the FPLA are two important pieces of legislation in the US that play a significant role in regulating different aspects of consumer products, including cosmetics, drugs, and packaging labeling. Here’s an overview of each.

    Food, Drug, and Cosmetic Act (FD&C Act)

    ⦿ Regulatory framework for ensuring the safety, effectiveness, and labeling of foods, drugs, medical devices, and cosmetics.
    ⦿ Enacted in 1938, grants the FDA the authority to oversee and regulate these products to protect public health.
    ⦿ Under this act, the FDA reviews applications, conducts inspections of manufacturing facilities, sets safety standards, and ensures proper labeling and advertising of products.

      Fair Packaging and Labeling Act (FPLA)

      ⦿ Focuses specifically on product packaging and labeling requirements
      ⦿ Enacted in 1967, aiming to ensure that consumer products are properly labeled with accurate data
      ⦿ Contributes to informed consumer choices and product safety by ensuring that packaging accurately represents the package’s contents.

        Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

        ⦿ Legislative updates aimed at enhancing and updating the cosmetic regulations
        ⦿ Requires compliance with GMP standards for manufacturing
        ⦿ Enforces labeling requirements for fragrance allergens

          What are the Specifics of US Cosmetic Labeling Requirements?

          Labeling cosmetics correctly according to the US FDA involves specific guidelines to ensure product safety and accurate information for consumers.

            Principal Display Panel (PDP)

            PDP is defined as the part of a label that the consumer sees or examines when displayed for retail sale.

            To ensure consistent font size when indicating the net quantity of a product’s contents, the crucial factor is the size of the surface area that displays the PDP, rather than the size of the PDP alone.

            The extent of the PDP area varies according to the packaging type:

            ⦿ For rectangular packages: One complete side of the package
            ⦿ For cylindrical packages: 40% of the product’s height multiplied by its circumference
            ⦿ For containers with any other shape: 40% of the entire surface area of the container, excluding the top, bottom, neck, shoulder, and flanges.

              Outer container must include: 

              It’s important to highlight that the PDP is only present on the label of an exterior container.

              The PDP should contain the following:

              ✓ Product name 
              ✓ Identity
              Cautionary warning
              Declaration of net quantity of contents 

              Inner container must include: 

              ✓ User directions
              Cautions 
              Business name and location
              Declaration of ingredients
              ✓ Any additional information

              If the outer container is eliminated and the product is put up for sale without it, the label on the immediate inner container serves as the label for an exterior container.

              Other panel requirements

              ✓ Panel display: Required details should be presented/displayed under usual purchase conditions.
              ✓ Type, style, and size: Typeface size meets minimum requirements, ensuring easy readability.
              ✓ Panel size: The label should be appropriately sized to ensure a clear presentation of the necessary information.
              ✓ Background contrast: Adequate contrast for clear and noticeable label statements.
              ✓ Avoid concealing designs: Label statements shouldn’t be hidden by designs, vignettes, or additional printed matter.

              Language of Labeling Statement

              Any label or labeling statements mandated must be presented in English. In instances where the cosmetic label incorporates any foreign language elements, those statements must also be included on the label in the foreign language.

              When the cosmetic labeling features foreign language elements, the obligatory statements must be present on the label or other forms of labeling as stipulated, and must be in English.

              Product Identity (Cosmetic Labeling Requirements)

              ⦿  The identity statement should be placed on the PDP
              ⦿  Identity can be a common/usual name, descriptive name, fanciful name, or an illustration
              ⦿  The identity statement should be bold, sized relative to prominent printed content, and aligned parallel to the product’s retail display base

              Business Name and Location

              The cosmetic label is permitted to present the name and business address, be it manufacturer, packer, or distributor. If the name and address don’t belong to the manufacturer, the name should be introduced with phrases like “Manufactured for…”, “Distributed by…”, or similar wording.

              Declaration of Contents Quantity

              ⦿  The product’s net quantity of contents must be clearly stated on the cosmetic label
              ⦿  Measurement units should include both avoirdupois weight (ounces, pounds) and metric measurements (grams, kilograms)
              ⦿  Accuracy is crucial; the declaration should reflect the actual amount of product in the container
              ⦿  Place the declaration on the PDP
              ⦿  The size of the type used for the net quantity declaration should be easily noticeable and legible, based on package size and relative to other label information
              ⦿  Standard abbreviations (e.g., “oz” for ounces, “g” for grams) should be used for measurement units
              ⦿  If a product includes multiple containers sold together, state the total net quantity on the label, along with individual container quantities if desired
              ⦿  For products with both solid and liquid components, specify the net quantity of each phase clearly
              ⦿  The net quantity declaration should not be obstructed or overshadowed by other label elements, designs, or graphics
              ⦿  Non-text representations like symbols or graphics should not replace the required net quantity declaration in text form.

              Here’s an example of how the net quantity of contents declaration might appear.

              Moisturizing Cream

              Net Weight: 1.7 oz (48 g)

              This declaration provides the consumer with both avoirdupois weight (ounces) and metric measure (grams) for the net quantity of the product’s contents. The measurement units are clearly indicated, and the information is presented in a legible size, allowing customers to easily understand the amount of product they are purchasing.

              Ingredient Declaration (Essential Part of Cosmetic Labeling Requirements)

              All cosmetic products must have a list of ingredients on the cosmetic label.

              ⦿  Ingredient Order: The list of ingredients must follow a descending sequence based on their predominance by weight, commencing with the ingredient of the highest concentration. Ingredient names shall be based on the International Nomenclature of Cosmetic Ingredients (INCI) system, using standard names or specific approved alternatives.
              ⦿  Incidental Ingredients: Ingredients that have no effect in the final product from a technical or functional standpoint can be listed as “May Contain” or “+/-” after the main ingredient list.
              ⦿  Fragrance and Flavor: For fragrance and flavor ingredients, “fragrance” or “flavor” can be used on the label without listing individual components, but all other ingredients must be listed.
              ⦿  Trade Secret Ingredients: Trade secret ingredients can be listed using a generic term followed by “and other ingredients.”

              Here are the Refreshing Shampoo ingredients disclosed by the manufacturer.

              ✓  Water (Aqua)
              ✓  Sodium Lauryl Sulfate
              ✓  Cocamidopropyl Betaine
              ✓  Glycerin
              ✓  Fragrance (Parfum)
              ✓  Citric Acid
              ✓  Sodium Chloride
              ✓  Methylchloroisothiazolinone
              ✓  Methylisothiazolinone

              In this example, the ingredients are listed in descending order of predominance by weight. Fragrances are appropriately labeled, and trade secret ingredients are not disclosed due to their proprietary nature.

                Warnings and Precautions

                Certain cosmetics, like those containing specific ingredients or posing potential health risks, might necessitate warning statements on the cosmetic labels.

                Safety Warnings: If a product’s use may cause harm or requires precautions, the label should carry appropriate safety warnings.
                ⦿  If a product contains potential allergens, it may include a statement like “Contains [allergen].”
                ⦿ If the product may cause irritation, it could include a statement like “May cause skin irritation.”
                ⦿ If the product poses risks to the eyes, it might carry a warning like “Avoid contact with eyes.”

                Usage Directions: If a product has directions for safe usage, they should be indicated clearly on the label.

                Below is one good example of instruction of use identified by the manufacturer of Retinol Serum.

                For optimal results, apply during your evening skincare routine. After cleansing your face, follow up with any water-based serums you use, and then apply. It’s recommended to use weekly 2-3 times and then frequency can be increased eventually. The use of sunscreen is highly recommended to ensure your skin’s protection.

                  Format and Placement: Warning statements should be prominently placed on the label, using legible and contrasting text.

                  Warning for Professional Use: If a product is intended solely for professional use, it may bear a warning stating “For Professional Use Only.”

                  For example, consider a cosmetic product contains ingredients that could potentially heighten skin sensitivity to sunlight, such as alpha hydroxy acid (AHA), and below warning statement should be featured on the label:

                  Warning: This product contains alpha hydroxy acid (AHA), which can increase your skin’s sensitivity to sunlight. To minimize risk, use sunscreen and limit sun exposure when using this product and for a week after discontinuing use.”

                    Conclusion

                    In conclusion, navigating the regulatory landscape of cosmetic labeling requirements in the USA demands a meticulous understanding of the cosmetic regulations laid out by the FDA. From ingredient listings and net quantity declarations to warning statements and business information, each facet carries significance in ensuring consumer safety and informed decision-making.

                    By adhering to these requirements, businesses not only uphold their legal obligations but also demonstrate a commitment to transparency and integrity. In a market where consumer trust is paramount, accurate labeling becomes a cornerstone of success. The synergy between regulatory compliance and an elevated consumer experience is evident, as it fosters a culture of safety, accountability, and informed choice.

                      How does Elexes help you meet US Cosmetic Labeling Requirements?

                              Elexes have offered invaluable support to many cosmetic companies in ensuring compliance with US Cosmetic Labeling Requirements.

                              Our expertise encompasses the intricate realm of cosmetics, allowing us to provide tailored solutions that align with the specific demands of cosmetic regulations. By tapping into the profound understanding of FDA guidelines, Elexes helps you navigate the complexities of cosmetic labeling, from ingredient listings to warning statements, while maintaining strict adherence to legal standards.

                              Our insights and industry knowledge empower you to optimize your labeling strategy for maximum impact. In an environment where transparent and accurate labeling is pivotal for consumer trust, our experts provide a competitive edge by ensuring your products stand out amidst the competition.

                              Elevate your cosmetic labeling approach today. Partner with us now to guide you through the intricacies of US Cosmetic Labeling Requirements, allowing you to prioritize consumer safety, enhance your brand reputation, and thrive in the dynamic cosmetic industry.

                              Contact us to take the first step toward designing your cosmetic label.

                              Posted in
                              Cosmetics

                              Elexes Team

                              Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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