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FDA and CPSC Delineate Responsibilities

March 1, 2005

The U.S. Food and Drug Administration (FDA), which has authority over foods, food additives, drugs, medical devices and cosmetics, and the U.S. Consumer Product Safety Commission (CPSC), which has general authority for product safety, have delineated their respective areas of jurisdiction under a longstanding memorandum of understanding (MOU). Of special interest to packaging manufacturers are the provisions regarding authority over food, food containers, and food-related articles or equipment. This MOU, which became effective on July 26, 1976, establishes two central points of agreement. First, articles having food-contact surfaces, such as food containers, cooking utensils, etc., from which there is migration of a substance from the contact surface to the food or food components, are subject to FDA regulatory authority as a "food." Second, the CPSC has regulatory authority over the same article for hazards unrelated to migration into food. Thus, food packaging or containers that present mechanical or physical risks of injuries not related to food contamination, migration or spoilage, such as sharp edges, flammability, etc., are subject to CPSC's jurisdiction.

The Consumer Products Safety Act (CPSA), 15 U.S.C. § 2051, et seq., which is administered by the CPSC, defines a consumer product as any article, or component thereof, produced or distributed for sale to a consumer for use in or around the home, but does not include "food" as that term is defined under the Federal Food, Drug, and Cosmetic Act (FFDCA). Food is defined under the FFDCA as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article." Thus, if components of a food package migrate to contacted food, it is considered food, and thus is excluded from the definition of a consumer product under the CPSA.

While the jurisdictional divide seems clear—FDA regulates substances properly considered "food," and CPSC regulates all other "consumer products"—an agreement between these federal agencies was needed to clarify situations in which a food package presents a physical hazard to consumers through some means other than migrating to, and becoming a component of, food.

The MOU makes it clear that physical hazards from food containers are regulated by CPSC. 1 The MOU reasons that, because articles with physical hazards (like sharp edges) do not present the hazard by becoming a components of food, the physical hazard aspects of the package can be regulated by the CPSC under the CPSA.

The agreement also indicates that articles used in the preparation or holding of food that have the potential to cause spoilage without migrating or becoming a component of food are also properly regulated by the CPSC. Examples of such articles include home canning equipment that may fail to provide an adquate seal of a canned food, refrigerators or freezers that may fail to perform at proper temperature allowing the food to spoil, and can openers that may cause metal particles from the can (as opposed to particles from the can opener) to be deposited in food. Each of these examples have the potential to render food unfit for consumption through a means that does not involve the articles becoming a component of food. Therefore, the articles are not considered food under the FFDCA, and thus, are not exempt from the definition of "consumer product" under the CPSA.

It is especially important to be aware of the CPSC's special concern regarding products intended for use by children, including packaging products that may present a hazard. Choking hazards in particular are an issue.

For example, in 2003, CCDA Waters LLC recalled bottled water products because the cap could come off, posing a choking hazard to young children. Although there were no injuries, there were 10 consumer complaints. An estimated 3.2 million units were involved.2 There have been several other recalls of both single-use and repeat-use water bottles as a result of concerns about detaching spouts posing a choking hazard to children. 3

Another example is cookware. The CPSC has in some instances recalled cookware items as a result of physical or mechanical hazards. A pizza stone product was recalled because when cleaned in accordance with instructions it apparently caught on fire. 4 Microwavable beverage mugs were also recalled because the product could catch on fire when microwaved, and the shell could split, spilling hot contents onto the consumer. 5 When you consider the literally billions of packages in the marketplace today, the actual instance of CPSC recalls because of packaging hazards are extremely small. Nevertheless, packaging manufacturers should be aware of the need to review the physical safety aspects of the packaging product as part of its overall product and quality assurance program.

FOOTNOTES

1Section 402 of FFDCA states that food is adulterated if "it bears or contains any poisonous our deleterious substances which may render [the food] injurious to health." Unlike physical hazards from packaging that does not become a component of food, hard or sharp foreign objects in food are subject to the adulteration provisions of the FFDCA, because the food "bears or contains" the object. See OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, COMPLIANCE POLICY GUIDES, Section 555.425 ("Foods - Adulteration Involving Hard or Sharp Foreign Objects" (available on the internet at: http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-425.htm).

2See Release #03-185; September 17, 2003 at http://www.cpsc.gov/CPSCPUB/PREREL/prhtml03/03185.html.

3See Release #05-012, October 15, 2004 at http://www.cpsc.gov/CPSCPUB/PREREL/prhtml05/05012.html; Release #04-116, April 6, 2004 at http://www.cpsc.gov/CPSCPUB/PREREL/prhtml04/04116.html; Release #01-103, March 13, 2001 at http://www.cpsc.gov/CPSCPUB/PREREL/prhtml01/01103.html; and Release #90-109, June 18, 1990 at http://www.cpsc.gov/CPSCPUB/PREREL/prhtml90/90109.html .

4See Release #97-157, July 14, 1997 at http://www.cpsc.gov/CPSCPUB/PREREL/PRHTML97/97157.html.

5See Release #97-182, September 3, 1997 at http://www.cpsc.gov/CPSCPUB/PREREL/PRHTML97/97182.html.