FDA Regulation of Pet Food Packaging: Same Rules Apply
If you have ever supplied packaging materials for use in pet food applications, you may have been surprised when your customer asked you for a statement regarding the FDA food-contact status of your product. In fact, due to the way in which FDA regulates food and food additives, packaging materials used in contact with pet food are subject to the same regulatory requirements as human food packaging.
It is well known that the Food and Drug Administration is responsible for ensuring the safety of all human food, as well as the additives used in such food. What you may not know is that FDA has the same responsibility when it comes to the safety of the food we feed to our pets. The authority for FDA's regulation of pet food packaging stems from the way in which terms such as "food" and "food additive" are defined in the Federal Food, Drug, and Cosmetic Act (the Act).
Section 201(s) of the Act defines a "food additive" as any substance the intended use of which results, or is reasonably expected to result, in its becoming a component of food -- unless the substance is generally recognized as safe (GRAS) or is prior-sanctioned (for more information, see Sections D and E of Fathoming Food Packaging Regulation Revisited). Thus, in addition to those substances that are intentionally added to food, the definition of "food additive" also includes those substances that unintentionally become components of food. For example, in the case of food packaging, there is the potential for small levels of substances used in such materials -- like containers, wraps, and bags -- to transfer to food. Those food packaging components that become, or are reasonably expected to become, components of food are food additives.
To further understand how this applies to pet food, it is important to examine the way in which FDA defines the term "food." FDA makes no distinction between food for humans and food for pets (and other animals). More specifically, FDA defines "food" as follows:
- Articles used for food or drink for man or other animals (emphasis added),
- Chewing gum, and
- Articles used for components of any such article.
Because pet food is included in the general definition of food, a "food additive" includes any substance the intended use of which results, or is reasonably expected to result, in its becoming a component of pet food or human food.
Food additives require FDA premarket clearance.1 More specifically, under Section 409 of the Act, a substance that falls within the statutory definition of a food additive must be the subject of an applicable food additive regulation or an effective food-contact notification (FCN). Again, because the laws and regulations make no distinction between human food and pet food, pet food additives are subject to this premarket clearance requirement. FDA regulates food-contact materials2 that are also food additives in 21 C.F.R. Parts 174 through 179, as well as through FCNs, which are listed on FDA's website. Thus, any component of a pet food package that is reasonably expected to become a component of food, and is not GRAS or prior-sanctioned, must be the subject of a regulation in Parts 174 through 179, or an effective FCN, and must be used in compliance with that clearance. Indeed, consistent with this view, FDA explicitly states as follows in its animal food and drug regulations:
Regulations providing for the use of food packaging materials in parts 174 through 179 of this chapter are incorporated in Subchapter E as applicable to packaging materials used for animal feed and pet food.
In addition, materials used to package pet food must be of a suitable purity for the intended use. Although the requirement of suitable purity applies equally to pet food packaging and to human food packaging, the criteria and considerations to apply in evaluating whether a substance is of a suitable purity for use in pet food packaging differ to some extent from those applicable to a suitable purity evaluation for packaging for human food.
1See Section 409(a) of the Act, which states that food-contact substances that are also food additives are considered unsafe unless they are the subject of a food additive regulation or effective FCN.
2A food-contact substance is defined as "a substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food." See Section 409(h)(6) of the Act.