Federal Packaging Regulations in the US
Although the United States has no all-encompassing federal legislation regulating the packaging industry, the federal government has asserted its authority to regulate food, drug, and cosmetic packaging to preserve consumer safety and confidence. There have also been a number of regulatory programs introduced by states or local jurisdictions to reduce the use and disposal of certain packaging materials and mandate minimum recycling requirements. Here we summarize some current regulations – issued at both a federal and state-level – that have impacted several sectors of the packaging industry.
Looking for state-specific packaging information? Use these resources:
U.S. Food Packaging Regulations
The U.S. Food and Drug Administration (FDA) regulates the packaging and labeling of food. The intent of these regulations is to enhance the safety of food distributed throughout the United States and keep consumers informed about the food they're consuming. The FDA classifies any packaging that comes into direct contact with food as a "food contact substance." It is the responsibility of The Office of Food Additive Safety and The Center for Food Safety and Applied Nutrition (CFSAN) to ensure the safety of these food contact substances. This means packaging materials like plastics, coatings, papers, food colorants, and adhesives must be regulated and deemed safe for use. The Environmental Protection Agency (EPA) requires that antimicrobial technology be built into plastic and textiles used in food packaging to prevent the growth of bacteria, mold, mildew, fungi, discoloration and odor. The FDA's guidelines also require that package labeling include nutrition guidelines, expiration or "best if used by" dates, handling and preparation instructions, and the packaging company's contact information. Allergen labeling has also been a requirement since 2006. The Food Allergen Labeling and Consumer Act not only requires disclosure if the product contains potential allergens like milk, fish, eggs, shellfish, peanuts, wheat or soybeans, but a notification if the product was made or packaged in a facility using any of the aforementioned allergens.
Environmental Impact of Materials Used in Food Packaging
Under the Federal Food, Drug, and Cosmetic Act, it is the FDA’s responsibility to make certain that no packaging materials contaminate food, and determine if new food-contact materials, or new uses of already-used materials, are safe. While the FDA’s principal concern is the safety of the packaging material’s contact with food, the National Environmental Policy Act (NEPA) has required the agency’s evaluation of the packaging materials environmental impact as well. All food-packaging clearances require an Environmental Assessment (EA), followed by a Finding of No Significant Impact (FONSI) and clearance by the FDA. The FDA mainly reviews the environmental impact stemming from the packaging material’s use and disposal. In particular, they require data on the material’s recycling impact. Companies trying to package materials in new containers must provide rationale as to why widely recycled packaging materials like rigid-single use food containers or PET – the type of plastic used by most soda bottlers – cannot be used.
Use of Recycled Content
The FDA’s “Points to Consider for the Use of Recycled Plastics in Food Packaging: Chemistry Considerations” guidelines state that the use of recycled polymers is permissible if it is of a type previously permitted for food-contact, has been kept free of contaminates during the recycling process, and the recycled material has been tested to establish suitable purity for reuse in food packaging.
Prescription Drug Packaging
The quality of a pharmaceutical product’s packaging plays an integral role in preserving the quality and effectiveness of your medication through its shelf life. Per FDA regulations, pharmaceutical packaging must:
- Provide protection against exposure to light, moisture, oxygen and variations in temperature as each of these can adversely alter the medication’s quality. Containers must be well closed and remain airtight if repeatedly reopened/closed.
- Provide protection against physical damage through handling, shipping, and storage processes.
- Provide protection against biological contamination. The container and its materials cannot have any adverse interaction physically or chemically with the medication or allow for leaks, diffusion, and permeation. Packaging can in no way contribute to the altering of the medication’s properties, function, or effectiveness. This means materials used to package pharmaceutical products must be subject to stringent quality assurance requirements.
- Package labeling must clearly identify the product, patient’s name, the name and address of the dispenser, the prescribing doctor’s information and recommended dosage, the medications’ dosage/strength, quantity, cautionary warnings or storage instructions, and expiration date.
Local and State-Level Regulations on Packaging Disposal and Recycling
Beginning in the 1980s, many states sought to reduce the negative environmental impact associated with the disposal of post-consumer packaging. So they took the initiative to ban certain types of packaging.
Polystyrene Containers
There are one hundred plus local ordinances restricting the use of polystyrene containers and utensils within the boundaries of their jurisdiction:
- Alameda, CA: 1/1/2008
- Albany City: 9/1/2008
- Aliso Viejo, CA: 6/2/2004
- Amherst, MA: Styrofoam Ban Effective Jan 1 2014
- Berkeley, CA: 6/1/1990
- Brookline, MA: Styrofoam Ban Effective 12/1/2013
- Calabasas, CA: 4/1/2008
- Capitola, CA: 6/1/2009
- Carmel, CA: 1/1/1989
- Emeryville, CA: 3/1/2007
- Fairfax, CA: 1/1/1993
- Freeport, ME: 1/1/1990
- Glen Cove, NY: 6/1/1989
- Hecules, CA: 5/1/2008
- Huntington Beach, CA: 4/19/2004 (Partial Ban)
- Laguna Beach, CA: 7/1/2008
- Los Angeles, CA: (Partial Ban)
- Malibu, CA: 7/1/2005
- Milbrae, CA: 1/1/2008
- Monterey, CA: 8/17/2009
- Newport Beach, CA: 6/1/2009
- Oakland, CA: 1/1/2007
- Pacific Grove, CA: 6/1/2008
- Pacifica, CA: 1/1/2010
- Palo Alto, CA: 4/22/2010
- Pittsburg, CA: 1/1/1993 (Partial Ban)
- Portland, OR: 6/12/1990
- Rahway, NJ: 12/1/1996
- Richmond, CA: 7/1/2010
- San Bruno, CA: 4/1/2010
- San Clemente, CA: 3/1/2004 (Partial Ban)
- San Francisco, CA: 6/1/2007
- San Jose, CA: 11/10/2009 (Partial Ban)
- San Juan County, WA: 4/22/2010
- San Mateo County: 4/1/2008
- Santa Cruz, CA: 10/18/2008
- Santa Monica, CA: 2/9/2008
- Scotts Valley, CA: 6/17/2009
- Seattle, WA: /1/2010
- Sonoma, CA: 1/1/1989 (Partial Ban)
- Suffolk County, NY: 1/1/1998
- Ventura County, CA: 10/1/2004 (Partial Ban)
- West Hollywood, CA: 7/1/1990
Other Cities Currently Considering Bans
- New York, NY: Proposed Partial Styrofoam Ban
- Boston, MA: Proposed Ban
- Philadelphia, PA: Proposed Partial Styrofoam Ban
- Somerville, MA: Proposed Partial Styrofoam Ban
- Boston, MA: Proposed Styrofoam Ban>
Rigid Plastic Containers
The state of California’s Rigid Plastic Packaging Container (RPPC) Law was enacted to limit the amount of disposed plastic waste filling California landfills and promote the use of recycled plastic. RPPC’s are defined as containers that entirely consist of plastic with the exception of caps, lids, and labels. The containers must maintain their shape regardless of the product they’re holding, have a minimum capacity of 8 fluid ounces, a maximum capacity of 5 gallons, and be capable of reopening/closing. The company name that appears on the container will be designated by the state as the product manufacturer. Oregon and Wisconsin have also enacted similar rigid plastic laws. The statutes of all three states offer several options to manufacturers – for example, the containers must be recyclable or reusable, or must partially consist of previously recycled materials.
Heavy Metal Restrictions
Nineteen states, including New York and California, have Toxics in Packaging regulations in place. Designed to limit the amount of toxic substances found in packaging, most states modeled these laws after a 1989 legislation written by the Coalition of Northeastern Governors (CONEG) that was subsequently updated in 1998. The laws prohibit the intentional and incidental additional presence of metals such as lead, mercury, cadmium, and the hexavalent chromium commonly found in many dyes, inks, pigments, stabilizers and adhesives typically used in packaging. Manufacturers face fines in the range of $25,000 for each item in violation of respective state laws.
Push for Endocrine Disruptor Ban
Endocrine modulators are chemicals that can impair the endocrine system (hormones) in humans and animals and contribute to the development of cancer, obesity, infertility, or birth defects. In particular, there has been a push as of late for the U.S. government to follow the lead of France and banish the use of Bisphenol A (BPA) from all food packaging. BPA is mostly found in plastic food containers and bottles.
Conclusion
With more cities and individuals responsibly recycling or composting, we no longer necessarily fear exhausting all available landfill capacity like we did two decades ago. However, “going green” as a movement has been mainstreamed, and environmental and public health concerns will continue to necessitate changes to state and federal laws that will undoubtedly impact how manufacturers package their products. manufacturers based in the U.S. must also be cognizant of the much more strict international packaging laws. Manufacturers can either resist many of these regulations or use them as an opportunity to build consumer trust by proactively addressing the environmental and public health concerns of their customers.>