U.S. Guide to FDA, FTC, and FPLA Packaging and Labeling Requirements
Packaging and labeling requirements play a crucial role in ensuring regulatory compliance and building consumer trust. As informed and conscientious consumers demand transparency, brands must navigate a complex landscape of federal regulations, including those set by the FDA and FTC, to meet these strict standards.
These regulations are designed to protect consumers by ensuring that they have access to accurate information about the products they buy, from food and drugs to cosmetics and everyday consumer goods.
Failure to comply with packaging and labeling requirements can lead to severe consequences, including costly recalls, legal penalties, and lasting damage to a brand’s reputation. As regulatory bodies continually update their guidelines to address new market trends and emerging technologies, staying compliant can become a daunting task for any business. Incorporating custom product labels into your packaging strategy can help ensure compliance by providing clear and accurate product information while also enhancing consumer trust and brand recognition.
Understanding the core requirements of the FDA, FTC, and relevant laws such as the FPLA can provide a solid foundation for navigating these challenges. From the accurate disclosure of product contents to the need for effective product label printing, every detail matters.
This guide will help you navigate the key regulatory requirements that ensure your packaging and labeling practices meet legal standards and reinforce consumer confidence in your brand.
FDA Packaging and Labeling Requirements
Understanding the Food and Drug Administration’s (FDA) role is essential for any business involved in the packaging and product label printing of food, drugs, cosmetics, and medical devices. Compliance with these FDA packaging and labeling requirements is both a legal necessity and a vital step in ensuring consumer safety and trust. The following guidelines are key to compliant product labeling.

FDA Packaging Formats
The FDA sets guidelines on custom product labels to ensure that they are:
- Readable: Fonts must be legible, and information should be easy to locate on the packaging.
- Properly placed: Key details must be placed where they are easily seen by consumers.
RFID labels can offer an innovative solution to enhance your packaging strategy, particularly for products that require stringent tracking and security measures. These labels use radio-frequency identification to monitor products through the supply chain, which is especially useful for pharmaceuticals and other high-value items.
Whether you’re using paperboard boxes or other packaging types, embedding RFID tags into pressure-sensitive labels can improve the traceability and authenticity of your products while adding a layer of security against tampering. This technology is becoming increasingly important as regulatory demands evolve, making it a valuable consideration for modern packaging.
FDA Prohibited Claims
Avoid misleading or unapproved:
- Health claims: Do not imply that a product can treat, cure, or prevent diseases without FDA approval.
- “FDA-approved” labels: Only use this label if the product has undergone the required FDA review process (typically for drugs, not cosmetics).
FDA Review Process
To label a product as “FDA-approved,” it must undergo a thorough review process, which varies depending on the type of product.
FDA requirements for food products
Food products are subject to rigorous labeling requirements, including the need to provide nutritional information, ingredient lists, and allergen warnings. Product labels must be accurate, not misleading, and must provide clear information on the identity of the food, net quantity, and the label manufacturer’s details. The FDA monitors and enforces compliance with these labeling regulations to ensure consumer safety and informed choices.
Mandatory information for food labels:
The FDA mandates that food product labels must include specific information:
- Product name: Clearly state what the product is.
- Net quantity: Include the amount of the product in the package (weight, volume, or numerical count).
- Manufacturer information: Provide the name and address of the manufacturer, packer, or distributor.
- Ingredients list: Required for food, drugs, and cosmetics, listing ingredients in descending order by weight.
- Nutritional information: Necessary for food products, including serving size, calories, and nutrient content.
- Usage instructions and warnings: Particularly important for drugs and medical devices to ensure safe usage.

Food additives
Before a new food additive can be marketed, it must be proven safe to the FDA through a Food Additive Petition. This process involves providing data on the additive’s chemical composition, intended use, and any possible health risks.
The FDA’s Food Labeling & Nutrition page breaks down more specific requirements and guidelines, as well as the latest updates.
FDA requirements for cosmetics
Most cosmetics do not require FDA approval before they go to market. However, they must be safe for use under labeled or customary conditions. The FDA does monitor cosmetics for compliance with labeling regulations, particularly regarding the use of color additives, which must be FDA-approved for their specific intended uses.
Additionally, cosmetics packaging and labeling must not be misbranded or contaminated, and manufacturers are responsible for ensuring product safety before marketing.

FDA requirements for drugs
Drugs must go through clinical trials to demonstrate its safety and effectiveness. This involves multiple phases of testing, first in a laboratory setting, then on animals, and finally in human trials.
Once these trials are completed, the manufacturer submits a New Drug Application (NDA). The FDA reviews the NDA, which includes all the data from the trials, manufacturing details, and proposed labeling. Only after this rigorous evaluation can a drug be approved for marketing.
The review process ensures that products are safe, effective, and accurately labeled before they reach the market. For more detailed information on the FDA’s review and approval processes, you can visit the FDA’s Drug Approval Process page.

FDA requirements for medical devices
Medical devices are classified into three categories based on their potential risk: Class I (low risk), Class II (moderate risk), and Class III (high risk).
- Class I devices typically do not require premarket approval.
- Class II devices usually require a premarket notification (510(k)) to demonstrate they are substantially equivalent to an existing legally marketed device.
- Class III devices, being the most complex, must go through the rigorous premarket approval (PMA) process, similar to the process for drug approvals.
FTC Labeling Requirements for Consumer Goods
The Federal Trade Commission (FTC) plays a crucial role in ensuring that product labels are truthful and not misleading. This requirement is particularly important for businesses selling consumer goods in the United States, as compliance with these product label printing requirements is key to maintaining consumer trust and avoiding legal consequences.

Truth in Advertising
The FTC’s primary focus is on preventing deceptive advertising practices. Brands must ensure that all claims made on custom product labels are truthful and substantiated. Key areas of concern include:
- Health and safety claims: If you claim that your product offers health benefits or enhances safety, you must have solid scientific evidence to back up these claims. For example, a label stating that a dietary supplement “boosts immune function” must be supported by credible research.
- Environmental claims: Any claims about a product’s environmental benefits (e.g., “eco-friendly” or “biodegradable”) must be clear and substantiated. The FTC’s Green Guides offer specific guidelines on how to make environmental claims without misleading consumers.
- Made in USA claims: If your product is labeled as “Made in the USA,” it must be “all or virtually all” made in the United States. This means that all significant parts, processing, and labor that go into the product must be of U.S. origin.

Specific FTC Packaging and Labeling Requirements
The FTC also sets specific labeling requirements for certain types of products:
- Clothing and textiles: Labels on clothing must include the fiber content, country of origin, and care instructions. These FTC clothing label requirements are designed to help consumers make informed purchasing decisions and care for their garments properly.
- Consumer goods: For products such as electronics or household items, labels must provide clear information about what the product is, its features, and how it should be used. Consumers must have all the necessary information to make informed choices. These FTC labeling requirements for consumer goods help protect consumers from misleading claims and ensure transparency.
Packaging and the FTC
The FTC also recognizes the role of packaging in consumer protection. Pressure-sensitive labels, especially in custom packaging design, must be easy to read and understand, with key information prominently displayed. In recent years, the integration of RFID technology into packaging has also become increasingly relevant.
These custom product labels can enhance transparency and consumer confidence by allowing easy tracking of products from the manufacturer to the point of sale. For example, RFID product labels on high-value items like electronics or luxury goods can provide an additional layer of authenticity verification, helping to prevent fraud and counterfeit products.

Compliance and Best Practices
Staying compliant with packaging and labeling requirements involves more than just following basic rules. It requires a proactive approach to ensure that all claims are truthful, well-substantiated and presented clearly on your pressure-sensitive labels. Here are some best practices to consider:
- Substantiate Claims: Always have reliable evidence to support any claims made on your product labels.
- Stay Updated: Regularly review FTC guidelines and updates to ensure ongoing compliance.
- Utilize RFID Technology: Consider integrating RFID labels into your packaging strategy to improve product tracking and enhance consumer trust.
What is the Fair Packaging and Labeling Act (FPLA)?
The FPLA is a U.S. law enacted to ensure that consumers have accurate information about the products they purchase, promoting fair competition and preventing deceptive practices. Compliance with these FPLA requirements is essential for brands to avoid legal issues and build consumer trust.
FTC primarily enforces FPLA for most consumer goods, while the FDA enforces it for food, drugs, cosmetics, and medical devices.

Purpose of the FPLA
The FPLA requires that all consumer commodities be labeled to disclose the following:
- Product identity: Clearly state what the product is. Identification must be displayed prominently on the principal display panel and should be easily understood by consumers.
- Net quantity of contents: Accurately describe the amount of product in the package, which can be in terms of weight, volume, or numerical count. This information must be in both metric and U.S. customary units.
- Manufacturer information: Include the name and address of the manufacturer, packer, or distributor to ensure accountability and allow consumers to contact the company if necessary.
These packaging and labeling requirements apply to a wide range of consumer goods, making compliance with the law necessary for any brand involved in the production or distribution of these products.
FPLA Impact on Packaging
The FPLA also influences packaging design and presentation, ensuring that labels are not misleading and that consumers have the information they need to make informed decisions. Here are some specific impacts:
- Clarity and accuracy: Labels must be clear and not deceptive. For example, a product that appears to be larger due to oversized packaging must still accurately represent the quantity of its contents.
- Placement of information: All required information must be placed on the principal display panel or other appropriate locations where it is easily visible to consumers.
Custom-printed folding cartons for retail are commonly used packaging types impacted by the FPLA. For instance, food products, personal care items, and household goods often come in folding cartons that must comply with FPLA regulations. Eco-friendly folding cartons with custom design can also be affected, especially in industries where sustainability and transparency are key concerns.
The design of these cartons must allow for the clear display of required information without misleading the consumer about the product’s size or quantity.

FPLA Challenges and Common Issues
Compliance with the FPLA can present several challenges for businesses, including:
- Ensuring accuracy: Maintaining accuracy in labeling is critical, particularly when dealing with complex product lines or multiple packaging formats.
- Adapting to changes: Regulations and consumer expectations can change over time, requiring businesses to stay updated and adjust their labeling practices accordingly.
To avoid these challenges, brands should regularly review their packaging and labeling strategies to ensure they meet all FPLA labeling requirements and remain compliant.

Best Practices for FPLA Compliance
Here are some best practices to help ensure your packaging complies with the FPLA:
- Regular audits: Conduct regular audits of your product labels to ensure they meet all FPLA requirements.
- Clear design: Work with packaging designers to ensure that all mandatory information is clearly visible and not obscured by packaging design elements.
- Stay informed: Keep up with any changes in FPLA regulations to ensure ongoing compliance.
Challenges to FDA, FTC, and FPLA Compliance (+ 5 Packaging and Labeling Solutions)
Navigating the complex landscape of U.S. packaging and labeling regulations can present numerous challenges for manufacturers. Understanding these challenges and implementing effective solutions is key to ensuring compliance, avoiding costly mistakes, and maintaining consumer trust.
1. Keeping up with regulatory changes
Regulatory bodies like the FDA, FTC, and FPLA regularly update their guidelines to adapt to new industry practices, consumer demands, and safety concerns. Staying informed about these changes can be overwhelming, especially when operating in different regions and managing multiple product lines.
Solution: Implement a proactive strategy to stay updated on regulatory changes. Subscribe to updates from the FDA and FTC, participate in industry forums, and consider appointing a compliance officer or team dedicated to monitoring regulatory developments. Regularly review and update your product labels to reflect the latest guidelines, ensuring ongoing compliance.
For instance, a brand sourcing from wholesale recyclable folding cartons suppliers must monitor both sustainability trends and legal obligations. This approach ensures that every aspect of the packaging process supports the brand’s commitment to eco-friendly practices while remaining fully compliant with relevant laws.

2. Ensuring label accuracy
Inaccurate labeling, whether in terms of product identity, ingredient lists, or net quantity, can lead to legal repercussions, product recalls, and damaged consumer trust. Ensuring accuracy is particularly challenging when dealing with complex products or when regulations vary between product categories.
Solution: Establish a rigorous quality control process that includes multiple checks before finalizing your custom product labels. Utilize digital tools and software that specialize in label management to automate accuracy checks and reduce human error. Regularly audit your labeling process to ensure that all information is up-to-date and compliant with FDA packaging and labeling requirements, manufacturer labeling requirements, and other applicable regulations.
3. Managing multi-language and regional labeling
For products sold in multiple regions, especially internationally, labels should meet local regulations and language requirements. This step adds complexity to the labeling process and increases the risk of non-compliance.
Solution: Develop a standardized template for product label printing that can be easily adapted for different regions. Use professional translation services to ensure accuracy in multi-language labeling. Additionally, stay informed about regional labeling requirements and adjust your labels accordingly to comply with local laws.

4. Addressing misleading packaging and labeling
Packaging that creates a false impression about the product’s size, quantity, or benefits can lead to consumer complaints and legal action under FTC and FPLA regulations. This issue often arises when packaging is designed to be visually appealing but inadvertently misleads consumers.
Solution: Work closely with your packaging design team and a trusted label suppliers to ensure that the packaging accurately reflects the product’s contents. Conduct consumer testing to identify any potential misunderstandings before the product hits the market. Regularly review packaging and labeling to ensure they comply with FTC and FPLA labeling requirements and do not mislead consumers.
5. Integrating technology in labeling and packaging
As technology evolves, there is increasing pressure to integrate advanced features like RFID labels into packaging to enhance product tracking, security, and consumer interaction. However, this integration can be complex and costly.
Solution: Start by assessing the specific needs of your product and supply chain to determine whether RFID or other advanced technologies are beneficial. Collaborate with an experienced RFID label manufacturer to implement these features efficiently. Use RFID in pressure-sensitive labels strategically, such as for high-value products or those requiring enhanced tracking, to justify the investment and improve overall supply chain management.

Bringing It All Together: Your Path to Packaging Success
With consumer expectations higher than ever, the ability to navigate the complexities of U.S. packaging and labeling regulations is a significant competitive advantage. The requirements set by the FDA, FTC, and FPLA allow you to foster trust and transparency with your customers. Every label, carton, and claim must reflect your commitment to both quality and honesty.
Staying ahead of regulatory changes requires ongoing attention to detail and a willingness to adapt. As you refine your packaging strategy, consider how each element—from design to labeling—contributes to your brand’s overall story.
Whether you’re exploring custom folding cartons or integrating RFID printing into your products, the right partner can make all the difference in maintaining compliance and elevating your brand.
Meyers is a leading product packaging manufacturer that can provide you with packaging solutions that meet industry standards while resonating with customers. Talk to our experts and discover how we can support your journey to creating compliant, innovative, and impactful packaging today!
Meyers creates folding carton packaging and labels that help shape a better future for people, products, and the planet. Trusted by leading brands like Hormel, Ulta Beauty, and Microsoft, Meyers combines innovation with a commitment to sustainability. Contact us today to learn more.