FDA regulations change with time and not adhering to them may cause your product to be called misbranded.
That’s why we’ve created a comprehensive guide that’ll help you.
Let’s start with the legal definitions of the terms
Legal Definitions Of Terms
Here are the legal definitions of a few terms used in this guide to avoid confusion
Any product that’s intended to cleanse the body, beautify or modify its appearance is called a cosmetic. Raw materials used to prepare the product are also cosmetics by law.
So, personal care products like shampoos, face wash, tampons, etc. fall under the definition of cosmetics, according to the FDA.
- If the product is primarily composed of salts from fatty acids and is intended to cleanse the body, it’s a soap and not a cosmetic unless the product makes cosmetic claims.
- The FDA determines “Intended Use” from its label or labeling.
Drugs are defined as articles that are used to cure, mitigate, treat or prevent diseases and articles that affect the structure and function of the body.
And a product is both a cosmetic and a drug if it's intended to cleanse the body, promote attractiveness, and treat diseases.
For instance, a face wash is a cosmetic. But a face wash that’s intended to treat skin conditions like acne is both a cosmetic and a drug.
A package is the container (other than the shipping container) in which the commodity is delivered or displayed to retailers.
According to the Fair Packaging & Labeling Act (FP&L), the package is the external container (box or folding carton) of the package.
Note: If the package doesn’t come in a box or carton, then the immediate container holding the product is the package.
Any written printed or graphic material that appears on the product’s container or is attached to the package having the commodity.
Note: Attachments include leaflets, display packs, inserts, risers, or any other promotional material or any other printed or written material distributed with the product.
Principal Display Panel (PDP)
The Principal Display Panel (PDP) is the front panel of the label and the part a consumer is most likely to see first under customary display conditions for retail sale. It must be large enough to accommodate all the required label information.
Note: Although products have labels on their inner and outer containers, they have only one PDP on the outer package.
Information Panel (IP)
The Information Panel (IP) refers to the back and side panels of a label.
We’ll discuss all about labeling requirements like size, type, and the information that must go on a PDP and IP, in the next section.
FDA Labeling Guidelines For Personal Care Products
The product’s outer and inner container should be labeled appropriately to direct consumers towards important information.
1. Information to be Displayed on the Outer Container
The package containing the container that has the actual product is called the outer container. Boxes, wrapping papers, cartons, etc. are examples of an outer container.
(Jump to the “Declaration of Information” section of the page to understand how the information mentioned above must be displayed on the label.)
2. Information to be Displayed on the Inner Container
The inner container holds the actual product and can be bottles, jars, etc.
Note: The inner container is the outer container If your product doesn’t have the latter.
For example, A deodorant bottle acts as the internal and external container as it’s not displayed with the packaging it shipped in.
(Jump to the “Declaration of Information” section of the page to understand how the information mentioned above must be displayed on the label.)
3. Ideal PDP size
4. Displaying Information When The Product Has Multiple PDPs
If your product has multiple PDPs, duplicate all the required information on all the other PDPs.
5. Display Information When The Product Contents Are Less
If your product weighs less than 0.25 oz, use a tear-away tag or affix a tape to the container to act as a PDP.
4 Things that Constitute a Readable Label
Readable labels help you avoid legal discrepancies and reduce chances of misbranding.
They also educate your consumer on what goes in the product to help them purchase the right product for them. So, follow the 4 guidelines below to make your label readable.
1. Panel Display
All required information should go on panels that consumers are most likely to view at the time of purchase.
2. Panel Size
All labels must be large enough to display all the required information prominently.
A. Type Size and Style
The PDP’s area determines the label type and size. The following table lists the area and appropriate type size.
The letter height is the equivalent of the lower case or upper case “O.”
B. Ingredient Declaration
3. Warning Statements
The type size of warning statements mustn’t be less than 1/16”.
You must submit a petition to the Division of Docket Management if your package isn’t large enough to accommodate the warning statement in the given height.
Once the amendment is complete, request the Commissioner for an alternate method to display the warning statement.
4. Background Contrast
The label’s background must provide sufficient contrast and be devoid of graphical designs that obscure the printed information.
All labels must be printed in English unless your products are distributed in a region like Puerto Rico, where English isn’t the predominant language.
If your labels have foreign language representations, all labeling statements must be printed in the same language and again in English and for ease of understanding.
Required Label Statements
Required label statements must appear on all product labels in a standard format to prevent misinformation.
The following sections explain the information you must include on your label and the format you must present it in.
1. Statement of Identity
The product name and its nature constitute the statement of identity. The statement of identity must be parallel to the product base and be sized reasonably.
For example, If your product is GlowDew face wash, GlowDew is your product name, and face wash is the identity of the commodity or the nature of the cosmetic.
2. Name and Place of Business
The name and place of business includes details like the firm name, principal place of business, manufacturer name, packer, or distributor.
The label’s address must contain:
- Street Address
- Name of the city and state
- Zip Code
Here’s the template for correct address declaration is given below:
*The address must be in the format ‘street address, city name, state name, zip code.’
3. Net Quantity of Contents Declaration
The net quantity of contents is the product weight or volume and must be expressed accurately using the Imperial System of Measurement. While weights are expressed in avoirdupois pounds and ounces, fluid measurements are expressed in US gallons, pints, and quarts.
Prefixing terms isn’t compulsory for fluids, but you may add the terms “net contents” or “net” before fluid measures. However you must prefix the weight statement with the terms “net weight” or “net wt.”
The following table shows a list of accepted abbreviations for weight measures:
Abbreviations for Net Quantity of Contents Declaration
You can also include the measurements in the Metric System along with the Imperial System. Here are some examples of correct net quantity declarations:
A. Declaration of Fractions
Use common fractions between ½ and 1/32 or switch to decimal fractions with less than two significant numbers.
Here are some examples of correct net quantity declarations with fractions
B. Supplemental Statements
You may use supplemental statements to describe the net quantity of the product on any other panel except the PDP.
If you choose to use a supplemental statement on your label, you mustn’t use any term qualifying weight, measure, or count which deceives the user and exaggerates the net quantity.
If you choose to use a supplemental statement on your label, effective label management is crucial. You must avoid using any term qualifying weight, measure, or count that deceives the user and exaggerates the net quantity.
The net quantity declarations must appear within the bottom 30% of the label if the product is displayed in an external container and the IP of the inner container.
Note: If the area of the PDP is less than 5 sq.in, you needn’t display the net quantity content on the inner container.
4. Cosmetic Warning Statements
Labels must include warning statements wherever appropriate to inform consumers of potential health hazards arising from the use of the product.
The type of warning statements vary according to the type of products, and we’ve included a list of them below:
A. Cosmetics with Unsubstantiated Safety
Every ingredient in a cosmetic must be substantiated for safety prior to marketing the product. Otherwise, the product will be considered misbranded unless it includes a warning label which states:
B. Cosmetic Aerosols
Cosmetic aerosols refer to products that can be expelled from a self-pressurised container.
Most of them are inflammable and contain components that may cause eye irritation. So, your label must include the following warning statement:
And If your cosmetic product contains a propellant made of hydrocarbon or halocarbon in a self-pressurised container, you must include a second warning as given below:
- If the product isn’t a spray, you may omit “Avoid spraying in the eyes”.
- If your product container is glass, you must replace the word “puncture” with “break”.
- Add the phrase “except under adult supervision” if it’s only intended for kids.
C. Feminine Deodorant Sprays
Federal regulation defines feminine deodorant sprays as “any deodorant spray intended to be used in the female genital area or all over the body.”
Since deodorant sprays may cause irritation or itching, their warning labels must include the following warning statement:
Note: If the deodorant doesn’t contain propellants made of hydrocarbon, you can omit “Spray at least 8 inches from the skin.” Don’t use the words hygiene or hygienic in the warning, as it might render your product misbranded.
D. Tanning Products without Sunscreen
Tanning products without sunscreen must have the following warning label:
Note: The term tanning products refers to all topical products (gels, creams, etc.) that rely either on UV exposure or permitted color additives to tan the skin.
E. Foaming Detergent Bath Products
Any product that’s added to a bath to produce foam containing a surface-active agent serving as a detergent or foaming ingredient is called a bubble-bath product or foaming detergent product.
The caution statement below must appear on all bubble-bath products and isn’t exclusively meant for a product intended for use exclusively by adults.
If the product is exclusively meant for adults, then use the phrase “Keep out of reach of children.” and “For adult use only.”
If the product is meant only for kids, then use the phrase, “Keep out of reach of children except under adult supervision.”
Note: Your label must also have adequate directions for safe use.
5. Labeling Claims
The FDA doesn’t have a list of approved or acceptable claims for cosmetics. However, labeling claims must be truthful and not mislead the consumer about the potency of the cosmetic or drug. Here are some most common labeling claims and their requirements:
Any cosmetic that doesn’t contain ethyl alcohol can make an “alcohol-free” claim, although it might contain other alcohols like cetyl, stearate or lanolin alcohol.
USDA regulates the term “organic”, and it refers to ingredients/produce grown on soil that didn’t contain any prohibited substances three years before harvest.
So, a product that makes an “organic” claim must comply with USDA regulations and FDA labeling requirements.
For more information on the organic claim, please visit USDA’s website on organic labels.
The term “cosmeceutical” refers to products that are both drugs and cosmetics. However, this term isn’t recognised by the law. So, cosmetic product companies can’t make a “cosmeceutical” claim on their product.
Since the law doesn’t regulate the definition of cruelty-free, users are advised to research if the products were tested on animals prior to buying/using them.
Hypoallergenic products are referred to as those that cause less allergies than other products. Since this definition isn’t regulated by the law, you don’t have to submit substantial evidence to the FDA before making this claim on your label.
6. Ingredient Declaration
Typically, product ingredients are declared in descending order of predominance and ingredients with the highest concentration are listed first. If your product is also a drug, then the active ingredients are listed before the cosmetic ingredients.
For more information on declaring ingredients, check out our Cosmetic Labeling Guide.
Labeling Requirements for Tampons & Pads
Tampons and pads must familiarise users with the device features and include guidelines to use the product safely. The label must also include a product description and the materials it contains.
In addition to the information mentioned above, tampons should include the following information to prevent TSS
- How to select tampon size and their absorbency.
- Tampon insertion, removal, and disposal.
- How to wear a tampon and the wear time of a tampon.
You must also include instructions that discourage overnight usage of tampons and encourage users to dispose of them after 8 hours of usage.
If your tampons are scented, include the following warning statement to prevent irritation and allergic reactions in users.
Labeling Requirements For Hand Sanitisers
Here’s a short summary of the labeling requirements for hand sanitisers.
- The PDP and Drug Facts label must comply with FDA guidelines
- The ingredient declaration must comply with the specific USP-NF monograph.
For more information on the labeling requirements, check out the FDA’s temporary policy for hand sanitiser products.
Labeling Requirements for Leaflets
Leaflets or padded sheets are off-package label holders that must be used only when the labeling surface area is insufficient and can’t include product information according to the regulations stated above.
Check out our FDA Cosmetic Labeling Guide for more information on the labeling requirements for leaflets.
Note: Leaflets or padded sheets with the display unit must include the following statement in type size not less than 3/16”
"Federal law requires ingredient lists to be displayed here"
Cosmetic labeling requirements are confusing and staying compliant is tough as FDA requirements are scattered over many resources.
That’s why we’ve created this guide and added a FREE downloadable labeling checklist to help you to keep track of labeling compliance.
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