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fda cosmetic labeling

Does the FDA regulate cosmetic labeling?

Cosmetics are an essential part of many people’s lives. However, with the variety of products available on the market, consumers may struggle to choose suitable and safe products.

As the agency responsible for protecting consumer health, the U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety of cosmetic products. So, does the FDA have regulations on cosmetic labeling? Let’s delve deeper into this topic with GOL in the following article!

Definition of Terminology Related to Cosmetic Labeling

Before delving into FDA cosmetic labeling requirements, let’s clarify the definitions of some legal terms.

What is Cosmetic?

According to the U.S. Food, Drug, and Cosmetic Act (FDA), cosmetics encompass products intended for application to the human body, such as for cleansing, aesthetic enhancement, or alteration of appearance. This includes lotions, creams, deodorants, lipsticks, mascaras, baby care products, and similar items.

Additionally, if a product is intended to prevent and treat diseases alongside enhancing appearance, it is classified as both a cosmetic and a drug. Such products are required to comply with FDA labeling regulations for both cosmetics and drugs.

For example, shampoo is considered a cosmetic. However, an anti-dandruff shampoo is categorized as both a cosmetic and a drug because it can prevent and treat dandruff, which is a form of seborrheic dermatitis (a disease). The same principle applies to fluoride-containing toothpaste, antiperspirant deodorants, and skincare and makeup products that claim to provide sun protection.

Definition of Terminology Related to Cosmetic Labeling

What is cosmetic packaging?

Cosmetic packaging refers to the materials and containers used to package and present cosmetic products, such as skincare items, makeup, hair care products, fragrances, and personal hygiene products. It plays a crucial role in the marketing, protection, and usability of the cosmetic product.

What is a cosmetic label?

A cosmetic label is a piece of packaging material that contains important information about a cosmetic product. It typically consists of a label affixed to the outer packaging or directly onto the product container. 

The Principal Display Panel (PDP)

The Principal Display Panel (PDP) refers to the main area of a product’s packaging where key information, branding elements, and product imagery are prominently displayed to attract consumers’ attention. It is the primary surface of the packaging that is most likely to be seen by consumers when the product is displayed on store shelves or online.

The PDP serves as the focal point for communicating important details about the product, such as its brand name, product name, key features, and any claims or benefits the product offers.

The Information Panel (IP)

The Information Panel (IP) refers to the portion of a product’s packaging where detailed information about the product is provided, typically located on the back or side of the packaging. Unlike the Principal Display Panel (PDP), which focuses on attracting consumer attention with branding and key features, the Information Panel serves to provide more in-depth details about the product’s ingredients, usage instructions, warnings, and regulatory information.

The Information Panel (IP)

>> Read more: Impact of MoCRA on Cosmetic Industry

Guidelines for Cosmetic Labeling Issued by the FDA

In accordance with FDA regulations governing the labeling of skincare products and cosmetics, it is imperative that cosmetic labels adhere to specific guidelines and present essential information in a standardized format. This not only ensures consistency across products but also mitigates the risk of conveying misleading or inaccurate information to consumers.

The following information must appear on the principal display panel:

Statement of identity

Statement of identity is a crucial aspect of cosmetic labeling, encompassing both the product name and its designated category. This declaration not only serves to uniquely identify the cosmetic but also communicates its intended purpose or nature to consumers. The product name should be clear and distinctive, facilitating easy recognition and recall among consumers. Additionally, the identity of the cosmetic provides essential information about its form or function, aiding consumers in understanding its intended use.

For instance, consider the scenario of marketing LuxeGlow Facial Serum. In this case, “LuxeGlow” serves as the distinctive product name, while “Facial Serum” indicates the specific category or nature of the cosmetic. This statement of identity effectively communicates to consumers that LuxeGlow is a body lotion intended for skin care purposes. Furthermore, if the nature of the cosmetic is readily apparent from its name or presentation, such as in the case of LuxeGlow, additional descriptors or illustrative elements may be employed to enhance consumer comprehension and appeal.

Guidelines for Cosmetic Labeling Issued by the FDA

Net quantity of contents declaration

The declaration of net quantity of contents on cosmetic labels is a crucial aspect, representing the total weight or volume of the product. Precision in expressing this information is paramount and must adhere to the standards of the Imperial System of Measurement.

For weight measurements, it is imperative to utilize avoirdupois pounds and ounces. The weight statement should commence with either “net weight” or “net wt.” to accurately convey the product’s weight.

In the case of fluid measurements, adherence to US gallons, pints, and quarts is necessary. While it is not obligatory to prefix terms, adding “net contents” or “net” before the fluid measurements can enhance clarity for consumers.

This meticulous approach ensures that consumers are provided with accurate and standardized information regarding the quantity of the cosmetic product they are purchasing. It fosters transparency and confidence in the product’s specifications, contributing to consumer satisfaction and informed decision-making.

 

Unit Terms Additional Abbreviations
Weight wt.
Ounce oz.
Pound lb.
Fluid fl.
Gallon gal.
Quart qt.
Pint pt.
Weight ounce oz.
Fluid ounce fl. oz.

 

Below are some examples of correct net quantity declarations:

  • Net wt. 3 oz.
  • 3 oz. Net wt.
  • Net 3 qt.
  • 3 fl. oz.
  • Net contents 3 fl. oz.

Declaration of fractions:

You have the option to use common fractions between ½ and 1/32 or switch to decimal fractions with less than two significant numbers. Examples of correct net quantity declarations with fractions include:

  • Net wt. 24 oz. (1 1/2 lb.)
  • 56 fl. oz. (1 qt. 1-1/2 pt.

Supplemental statements:

Supplemental statements can be used to describe the net quantity of the product on any panel except the Principal Display Panel (PDP). However, these statements should not deceive the user or exaggerate the net quantity. Here are some ways to use supplemental statements without risking a misbranded label:

(i) Package size: Representations of size (e.g., economy, large) may be stated only if the product is available in more than one size and there’s a 5% price difference between the two packages.

(ii) Giant pint: Terms like “giant pint” or “full quart” may be used to describe the net quantity of the product, provided the statement isn’t deceptive.

(iii) Number of applications: Numerical declarations of quantity may be supplemented with the number of applications when the product is used according to instructions. An example of a correct supplemental statement would be “Net 10 fl. oz.” and “Ten Applications.”

Note: For product kits containing multiple items, supplemental statements can state the net contents of each item. For instance, if a product kit contains 6 facial serums with 1 fl. oz. of fluid each, the net quantity declaration will be “Net 6 fl. oz.” and “6 Bottles of 1 fl. oz. Each.”

Location:

Net quantity of content declarations must appear within the bottom 30% of the label if the product is displayed in an external container and on the Information Panel (IP) of the inner container.

Note: If the area of the Principal Display Panel (PDP) is less than 5 sq. in, displaying the net quantity content on the inner container is not required.

The following information must appear on an information panel:

The following information must appear on an information panel (IP)

Name and Location of Business

The identification of the manufacturer, packer, or distributor on the cosmetic label must include specific details such as the firm’s name and primary business location.

The address displayed on the cosmetic label should encompass:

  • Street address
  • City and state
  • ZIP code

In cases where the manufacturer’s address is not explicitly provided on the label, it is imperative to include phrases such as “manufactured for…” or “distributed by…” preceding the address.

Cosmetic information panel (IP)

Below is a template outlining the correct declaration format for address information:

Label Information Details
Name and Address on Label May be those of the manufacturer, packer, or distributor.
Name and Address Not of Manufacturer Must be preceded by phrases such as “Manufactured for…”, “Distributed by…”, or other appropriate wording.
Firm Name The corporate name, stating a particular division is optional.
Business Address Must include street address, city, state, ZIP code. Street address may be omitted if listed in a current directory.
Country of Origin Required by the Tariff Act of 1930; must state the English name of the country of origin on the label.

Warning and caution statements

Cosmetic warning labels play a crucial role in ensuring consumer safety by providing essential information about potential health hazards associated with the use of the product. These warnings must be included on cosmetic labels wherever appropriate.

The nature of warning statements varies depending on the type of cosmetic product. Below is a detailed list of different types of warning statements:

Cosmetics with Unsubstantiated Safety:

Before marketing a cosmetic product, every ingredient must undergo thorough safety substantiation. Failure to do so renders the product misbranded unless it includes a specific warning label. The warning label must state:

“Warning: The safety of this product has not been determined.”

However, there are exceptions where displaying a warning label may not be necessary, despite new information casting doubt on the safety of an ingredient. These exceptions include:

  • If the safety of the product was determined before the release of new information.
  • If the new information does not indicate any health hazards in humans.
  • If studies are underway to determine the safety of the product.

By providing clear and comprehensive warning labels, consumers are empowered to make informed decisions about the cosmetics they use, ensuring their well-being and safety.

Warning Labels for Cosmetic Aerosols

Cosmetic aerosols encompass products housed in self-pressurized containers designed for expulsion, such as hair sprays or other hair care products. These products typically pose specific hazards due to their flammability and potential eye irritation. As such, it’s imperative that your label includes the following warning statement:

“Warning: Avoid spraying your eyes. Contents under pressure. Do not puncture or incinerate. Do not store at a temperature above 120°F. Keep out of reach of children.”

Furthermore, if your cosmetic product utilizes a propellant containing hydrocarbon or halocarbon in a self-pressurized container, a second warning must be included:

“Warning: Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.”

Additionally, please note the following considerations:

  • If the product is not a spray, you may exclude the phrase “Avoid spraying in the eyes.”
  • If your product is contained in glass packaging, replace “puncture” with “break.”
  • Include the phrase “except under adult supervision” if the product is intended solely for children.

By incorporating these detailed warning labels, consumers are alerted to the specific hazards associated with cosmetic aerosols, promoting safe and responsible use of the product.

Warning Labels for Cosmetic Aerosols

Warning Labels for Feminine Deodorant Sprays

According to federal regulations, feminine deodorant sprays are defined as “any deodorant spray intended for use in the female genital area or all over the body.”

These deodorant sprays have the potential to cause irritation or itching, necessitating specific warning labels mandated by the FDA. The warning statement must include:

“Caution: For external use only. Spray at least 8 inches from the skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.”

Please note the following considerations:

  • If the deodorant spray does not contain propellants made of hydrocarbon, you may omit the phrase “Spray at least 8 inches from the skin.”
  • Avoid using the words “hygiene” or “hygienic” in the warning, as this may render your product misbranded.

By adhering to these warning label requirements, consumers are informed about the proper usage and potential risks associated with feminine deodorant sprays, promoting safer and more responsible use of the product.

Warning Labels for Tanning Products without Sunscreen

Achieving the perfect tan can be a delightful experience, but tanning products lacking sunscreen can pose risks to your skin due to harmful UV rays from the sun.

To address these potential risks, tanning products must include the following FDA-mandated warning label:

“Warning: This product does not contain sunscreen and does not protect against sunburn. Repeated exposure to unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.”

Please note the following clarification:

  • The term “tanning products” encompasses all topical products, such as gels and creams, that rely on either UV exposure or permitted color additives to tan the skin.

By including this warning label, consumers are made aware of the absence of sun protection in the tanning product, emphasizing the importance of taking appropriate precautions to safeguard their skin from potential harm.

Warning Labels for Tanning Products without Sunscreen

Cosmetic Ingredient Labeling Requirements

The FDA stipulates that ingredients must be disclosed exclusively on the labels of the product containers. This requirement does not extend to products distributed for free at establishments, unless they are also sold at retail stores.

Typically, ingredients are listed on cosmetic labels in descending order of predominance, meaning those with the highest concentration are listed first.

Identifying Ingredients

Maintaining standardized ingredient names is crucial to prevent confusion and misrepresentation. Therefore, it is imperative to express ingredient names using the nomenclature established by the Commissioner, avoiding fanciful names like “Devil Red” for red dye.

How Ingredients Should be Listed on Cosmetic Labels?

If the Commissioner has not established a name for an ingredient, the following compendia should be consulted in the specified order:

  • CTFA’s (Cosmetic, Toiletry and Fragrance Association, Inc.) Ingredient Dictionary
  • United States Pharmacopeia
  • National Formulary
  • Food Chemical Codex
  • USAN and the USP Dictionary of Drug Names

If an ingredient is not listed in any of the above directories, a commonly known name or the technical description of the ingredient should be used on the label.

How Ingredients Should be Listed on Cosmetic Labels

Order of Ingredient Declaration

The order in which ingredients are listed on cosmetic labels is as follows:

  • Cosmetics that are also drugs: Active ingredients must be listed before cosmetic ingredients.
  • Products with insignificant concentration: Ingredients with less than 1% concentration can be listed in any order after those with a concentration greater than 1%, which are listed in descending order of predominance.
  • Color additives: These can be listed in any order after active and cosmetic ingredients. If color additives are used for correction, they must be listed on the label with the phrase “may contain.”
  • Incidental ingredients: These are substances used in preparation, added during manufacturing but removed before packaging, or added for technical effect during manufacturing but have no impact on the finished product due to their low concentration.
  • Trade secrets: Ingredients deemed trade secrets by the FDA are exempt from labeling. The term “and other ingredients” may be used to represent secret ingredients, subject to providing factual and legal justification to the authorities for exemption.

FAQs about Cosmetic Labeling Regulations by the FDA

Are all cosmetics FDA approved?

The FDA does not mandate pre-approval for cosmetic products and their ingredients, with the exception of color additives. However, cosmetics must adhere to strict guidelines to prevent adulteration or misbranding. This entails ensuring that they are safe for consumer use when used as directed on the labeling or in customary application, and that they are accurately labeled.

What do I need to know about using color additives in cosmetics?

Any color additive, excluding those designated for coal-tar hair dyes, requires FDA approval for its intended purpose. These color additives are outlined in regulations referred to as “listing regulations.” Some may only be utilized if they originate from batches certified within FDA laboratories.

Is facility registration or product listing with the FDA necessary for my cosmetic products?

Yes, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) outlines requirements for facility registration and product listing, including exemptions for certain small businesses.

The MoCRa (Model Risk Management Compliance Regulations) rules are a set of guidelines designed to enhance the governance, risk management, and oversight of model risk for financial institutions. These regulations require firms to implement robust processes for the development, implementation, and continuous monitoring of models used in decision-making and risk assessment. The compliance deadline for MoCRa is set for 1st July 2024, by which organizations must fully integrate these practices into their risk management frameworks. This includes ensuring models are accurate, reliable, and appropriately validated to prevent financial losses and maintain regulatory compliance.

MoCRA provides exemptions for certain small businesses from facility registration and product listing obligations. However, exemptions do not apply to manufacturers or facilities handling specific types of cosmetic products, including:

  • Products intended for use in the mucus membrane of the eye under customary conditions.
  • Injectable products.
  • Products intended for internal use.
  • Products intended to alter appearance for over 24 hours without consumer removal as part of customary use.

Additionally, exemptions exist for products and facilities subject to drug and medical device requirements, such as Class I and Class II Device Exemptions.

However, if your products qualify as drugs, or if they are classified as both cosmetics and drugs, they must adhere to drug registration requirements.

We hope that the article has provided you with valuable information regarding FDA regulations on cosmetic labeling. Understanding these regulations plays a crucial role in ensuring your products comply with the law and meet the standards of the US market.

If you have any questions about MoCRA rules and label compliance, please contact GOL. We have a team of experienced experts in this field who are always ready to assist you!

References: 

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Cosmetics Labeling Guide

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