Navigating FDA Compliance Rules for Food Grade Packaging
Food packaging protects edibles from possible tampering and contamination before consumption. It can also give information on nutritional facts and provide a way to label the food for easy identification.
The food packaging industry uses a variety of different materials to package food products. From the cardboard used to make cereal boxes to the hot melt adhesives used to close a seam, there are endless options from which to choose.
With the broad range of packaging materials available on the market, the safety of food packaging has become a concern. Luckily, multiple government programs exist to ensure the materials used to package foods meet acceptable safety standards.
Role of the FDA
The U.S. Food and Drug Administration, or the FDA, is a government agency that protects the public’s health. One of its main tasks is ensuring that the processed foods sold throughout the country are safe, sanitary, and have been properly labeled. It also checks the safety of medical drugs and medical devices before they become available on the market.
The FDA was created in 1906 after the passage of the Pure Food and Drug Act. This act was passed to control the number of adulterated and misbranded foods on the market. It came about as a response to the increasing number of fake and ineffective cures on the market for diseases like diabetes, as well as an increase in unsafe cosmetic products. Today, it is the oldest federal agency in America acting in the consumer’s interests.
The FDA has many departments with roles ranging from regulating tobacco products to vaccines. Food is another department, and the FDA oversees the regulation of food safety and performs risk assessment and management.
One of the most important tasks of the FDA is to prevent the adulteration of food. Any process that lowers the quality of food, such as the addition of extraneous materials or the extraction of essential ingredients, will result in adulterated food.
This is especially important in food packaging as the packaging materials have the potential to contaminate the foods. Once the food has been adulterated, it becomes substandard and is considered unsafe to eat.
Food Packaging Adulteration
Food packaging has the potential to adulterate the food it is in direct contact with. The FDA has regulations to define how and when packaging can adulterate food.
Packaging that makes the food unsafe for consumption is considered unacceptable. For example, packaging that contaminates the food with an unpleasant taste or odor has adulterated the food. Also included are poisonous materials and unsafe color additives in the packaging.
Materials in the packaging that are considered food additives can also adulterate food. This means any substance that can become a component of food will be labeled as a food additive. Although some food additives are safe to eat, additives that do not have premarket clearance by the FDA are considered unsafe to eat.
The FDA has strict regulations on what substances are considered additives. Generally, they are defined as a substance used that is expected to become a component in the food.
Additives can be defined as direct or indirect. Direct additives are substances that are added to the food during the manufacturing process. Indirect additives, on the other hand, are substances that are in contact with the food and can migrate into the food. The most common indirect additives would be the materials present in the food packaging.
Premarket clearance is required by the FDA for substances that are direct additives or indirect additives. This process checks for any limitations on the food types, temperature, and quantities of a specific substance. In addition, it also ensures the substance meets the applicable end-test requirements.
It is the responsibility of companies to determine whether the substance they are using is an additive. If this is the case, the company must also obtain clearance from the FDA before they can market any products containing that substance.
Food Contact Notifications
Another way to determine if an additive has been approved for the market is through the food contact notification or FCN process.
Implemented in 2002, this process was established with the intention of speeding up the petition process. Through the program, food additives can be reviewed for safety and can reach the market sooner than via a petition.
The FCN program works by first accepting submissions from a notifier such as a private company. These submissions are then reviewed by an FDA committee. The committee has 120 days to object to the safety of a substance before the notifier can use the substance. If the FDA does not respond within the 120 day timeline, the company can then market this substance.
Many substances are exempt from FDA premarket approval. This means they do not require a petition or a submission to the FCN program before they can go out into the market.
One exemption is for substances used before 1958. These substances have been approved for public use by the FDA or the USDA prior to 1958. Today, their status in the regulations cannot be revoked by the FDA.
Other exempt substances include basic resin substances, such as catalysts, housewares materials like a kitchen knife used to cut food, and GRAS substances.
GRAS Notification Program
Generally recognized as safe, or GRAS substances, are a range of materials exempt from FDA clearances. A separate program was created to categorize and identify these substances to speed up the notification processes.
The GRAS notification program approves new substances to be labeled as safe. It works by allowing manufacturers to submit a notification to the FDA. Unlike the 120 day deadline under the FCN program, the FDA has no deadline under the GRAS program. Therefore, it may take years before a substance can be deemed ‘generally recognized as safe’.
Substances can also be deemed a GRAS substance through research. This process is called manufactured self-determined GRAS, and it works only if a previously published study has proved the substance is safe. The published study can be from an independent publication or from commissions made by the company. And once the substance has been deemed safe, the company does not require an FDA notification prior to releasing the substance to the market.