Life Science Packaging and Regulatory Compliance

May 19,2023 Category: Regulatory Compliance
Pharmaceutical, medical device and cell/gene therapy manufacturers are among the most strictly regulated businesses around the world. As the first point of interaction between the product and the consumer, packaging plays a significant role in regulatory compliance. Regulations for packaging are issued by various government agencies and cover product safety, labeling and marketing claims. 

Proper packaging ensures that the product is protected from contamination, deterioration and damage during shipping and storage. It also ensures that the product's label accurately reflects its contents and meets requirements such as the FDA's labeling regulations for food and pharmaceutical products. Additionally, packaging design can impact marketing claims, such as eco-friendliness or recyclability, which must be supported by evidence and comply with regulations such as the Federal Trade Commission's guidelines for environmental marketing claims. Companies must be mindful of these packaging regulations to ensure they are not violating any laws and putting their customers at risk.

There are several regulations that govern packaging across the world, including:
  • The Federal Food, Drug, and Cosmetic Act (FFDCA) in the United States, which regulates the labeling and safety of food, drug and cosmetic products
  • The Fair Packaging and Labeling Act (FPLA) in the United States, which requires that packaging and labeling provide accurate and informative information to consumers
  • The European Packaging and Packaging Waste Directive, which sets the framework for waste management and reduction, along with the reuse and recycling of packaging in the European Union
  • The Canadian Consumer Packaging and Labelling Act, which regulates the labeling and advertising of consumer packaged goods in Canada
  • The Japan Packaging Law, which requires that packaging be safe and properly labeled and mandates that packaging waste be reduced and recycled
  • The Australian Packaging Covenant, which aims to reduce the environmental impact of packaging through the responsible design, use and disposal of packaging
These regulations vary by jurisdiction and the type of product being packaged, but all aim to protect consumers and the environment through the proper use of packaging. Companies must comply with the relevant regulations to ensure that their packaging meets legal requirements, and their products are safe and accurately labeled.

Packaging regulations are complex and cover a variety of packaging elements,  and there are several common ways brands can find themselves in violation, including:
  • Misleading labeling and advertising: This includes false or misleading information on the packaging, such as incorrect ingredient lists or exaggerated health claims
  • Non-compliant packaging materials: Because packaging materials must be safe and not pose a threat to consumers, brands must be careful not to include components made from toxic or allergenic materials
  • Inaccurate product weight and volume: Packaging must accurately reflect the amount of product contained within, such as the weight or volume of a food or cosmetic items
  • Lack of child-resistant packaging: Some products, such as medications or household cleaners, must be packaged in child-resistant containers to prevent accidental ingestion or exposure
  • Improper disposal of packaging waste: Packaging must be disposed of properly, and companies must comply with local regulations for recycling and waste management
  • Non-compliance with recycling and sustainability regulations: Packaging must meet sustainability standards and regulations for the reduction, reuse, and recycling of waste, such as the European Packaging and Packaging Waste Directive
These violations can result in fines, legal action and damage to a brand’s reputation. Companies must be diligent in ensuring that their packaging complies with relevant regulations to avoid these violations and protect their customers, the environment and their brand reputation.

In recent years, some of the largest fines for packaging violations have been substantial. One notable example is the Johnson & Johnson (J&J) settlement in 2013, where the company agreed to pay $25 million to settle charges that it misled consumers through its packaging and labeling practices. The settlement came after the Federal Trade Commission (FTC) accused J&J of deceptively marketing its products, such as Rolaids and Mylanta, as “natural” or “safe” when they contained synthetic and potentially harmful ingredients.
This case demonstrates the significant financial and legal consequences that can result from packaging violations and highlights the importance of companies complying with packaging regulations to ensure their products are accurately labeled and marketed.

Another sometimes overlooked area is packaging waste regulations. As more and more regions implement regulations that mandate sustainability practices, meeting sustainability standards and regulations for packaging waste reduction, reuse and recycling requires a multi-faceted approach that involves:
  • Design for recyclability: Packaging should be designed to be recyclable and use materials that can be easily processed by recycling facilities
  • Use of recycled materials: Packaging should be made from recycled materials where possible, and companies should work to increase the use of recycled materials in their packaging
  • Reduction of waste: It is important to design packaging to minimize waste and only use the necessary amount of materials
  • Proper labeling: Labels should provide clear information on how to recycle the packaging
  • Collection and recycling systems: Companies should participate in and support the development of effective collection and recycling systems for their packaging waste
  • Monitoring and reporting: It is best practice to monitor compliance with sustainability standards and regulations and regularly report on progress towards reducing environmental impact
By implementing these measures, companies can meet the requirements of regulations such as the European Packaging and Packaging Waste Directive and help to reduce the environmental impact of packaging.

The regulations that cover packaging can vary from region to region and from one type of product to another. These regulations for sustainability, labeling and other categories are evolving rapidly, making it challenging for brands to stay abreast of the pertinent requirements that cover their products. Guidance from a packaging professional with regulatory experience can help brands stay on track and avoid costly – and potentially dangerous – mistakes and fines.

If you need help reviewing your packaging and labeling to ensure compliance or developing new packaging that complies with regulations that cover your products, get in touch. Adept Group has experts with experience in heavily regulated industries and knowledge of best practices for remaining in compliance.