Packaging labeling is far more than just a legal necessity for brands to comply with. They’re also an important tool for communication, safety, and trust. Consumers rely on labels to make informed shopping decisions. Regardless of your product’s industry, accurate, transparent labeling is essential to avoid legal penalties, ensure consumer safety, and maintain supply chain traceability. Understanding the nuances of label requirements makes all the difference in staying compliant and competitive.
Basic Labeling Requirements for All Industries
Whether your products fit into the food and food service, health and beauty, medical, pharmaceutical, or pet product industry, your folding carton packaging must include universal label elements to remain compliant. These core components create a foundation for all product labels, ensuring clarity, consistency, and adherence to legal standards:
Identity statement
Clearly defines the product’s legal name or common name. If neither of these identifiers is appropriate, a description of the product or its function is allowed. Brand names do not count as an identity statement.
Examples
“Animal crackers” as a legal name, “animal-shaped biscuits” as a common name, and “sweet-baked, animal-shaped snack crackers” as a description.
Net quantity statement
Specifies the weight, volume, or number of units included in the package.
Manufacturer/distributor information
Includes the name, full address, and contact details of the product manufacturer or distributor.
Ingredient list
When applicable, ingredients must be listed in descending order of weight or concentration. Ingredients under 1% can be listed in any order so long as they follow all other ingredients over 1% in descending order.
Warnings/precautions
Highlight potential risks, usage limitations, or allergen information.
Storage and handling
Provide guidance to maintain product integrity.
Country of origin
Some products may be required to disclose where the product originated from, especially if it was imported.
Food Label Requirements
FDA labeling requirements ensure food products provide consumers with vital nutritional information. Shoppers need to know details like ingredients, serving sizes, and calories to make the best choices for their personal needs. Key label elements for food packaging include:
Nutrition label
Conveys serving size, servings per container, and mandatory nutrients. Mandatory nutrients are total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, though other nutrients may be included. Content claims like “low fat” or “sugar-free” displayed on packaging must be supported by corresponding data on the nutrition label.
Ingredient list
All ingredients must be listed in descending order by weight. All potential allergens, such as milk, eggs, or peanuts, must also be noted in plain language on or near this list.
Expiration dates
With the exception of infant formula, expiration dates are not federally required on food items. However, many state governments require this information on food packaging.
Health and Beauty Product Label Requirements
The FDA considers health and beauty products to be any items applied to the human body for cleansing or altering appearances. Brands must provide potential customers with information concerning proper usage and ingredients, allowing them to make educated purchasing decisions. Key label requirements for health and beauty packaging include:
Ingredient list
Ingredients must be listed by predominance in descending order. However, there are some exceptions. Health and beauty products that include an active ingredient, such as a drug, must state this ingredient first. Color additives can be listed in any order following all other ingredients. Ingredients considered trade secrets, when approved by the FDA, are permitted to show as “other ingredients” on packaging.
Material facts
Directions for safe use or necessary warnings to ensure consumer safety. For example, this involves detailing “fragrance allergens” if they are included in a product or ensuring clearly visible and prominently displayed statements regarding “professional use,” meaning the product can only be administered or used by licensed professionals.
Expiration dates
There are no federal requirements directing manufacturers to include expiration dates. However, brands are responsible for keeping products safe. So, many health and beauty products do include an expiration date or a “period after opening” indicator on packaging.
Medical Device Label Requirements
Medical devices are subject to strict FDA labeling requirements. Seeing as these products are used to manage health concerns or conditions, ensuring reasonable assurance through safe and effective labeling is paramount. Key elements of medical device labeling include:
Device identification
The product name, use, and description must be clearly stated on medical devices.
Unique identifiers
Packaging needs to include a unique device identifier (UDI), which is a distinctive code used to recognize and track a specific device. Lot and serial numbers for manufacturers and distributors are also mandatory.
Special designations
Products that have a special status, such as sterility, single-use, or custom-made, must include verbiage that makes these distinctions apparent to consumers.
Safety information
Warnings, contraindications, adverse reactions, and risks must be prominently displayed on packaging. Expiration dates related to approved shelf life must also be included.
Pharmaceutical Label Requirements
Like medical devices, over-the-counter and prescription medications face rigorous labeling standards under the FDA. Regulations are in place to guide safe administration and highlight potential risks. Key pharmaceutical labeling elements include:
Active and inactive ingredients
Active ingredients must be listed first in descending order by weight or concentration. Inactive ingredients follow suit.
Indications for use
Packaging must describe approved uses for the drug while also disclosing contraindications, or conditions and scenarios where the drug should not be used.
Dosage information
Detailed dosing and administration instructions must be easily found and understood.
Special notices
Expiration dates are legally required for all pharmaceuticals to promote safe usage. Storage conditions should also be included to help ensure product efficacy.
Pet Product Label Requirements
Pet owners often consider their animals to be more than just companions; they are valued family members. Consumers look to purchase food, care items, and toys designed to keep their pets safe. Aside from universal components, key labeling elements for pet product packaging include:
Product identification
Beyond name and intended use, pet products must indicate what species of animal the product is for.
Ingredient list
Similar to other products, ingredients must be ordered by weight. Pet products, such as blankets, containing textiles, wool, or fur must follow the FTC’s relevant regulations for these materials.
Feeding instructions
For pet food and treats, detailed instructions should guide owners on serving sizes or other proper uses.