Consumer Protection Issues in the Regulation & Sale of Food Products

• Pages: 221-259

221

CHAPTER VIII

CONSUMER PROTECTION ISSUES IN THE

REGULATION & SALE OF FOOD PRODUCTS

This chapter details the regulation of the sale of food products by

federal and state authorities. Although government agencies have broad

authority to regulate misleading or confusing advertising and labeling,

their regulation and enforcement appear to have lagged behind changing

consumer preferences. Consumers have filled these regulatory gaps by

taking enforcement into their own hands, filing a large number of claims

relating to alleged misrepresentation in food advertising and labeling,

often under state consumer protection laws.

This chapter also provides an introduction to the extensive rules

about what must, what may be, and what may not be disclosed on a food

label and the related concept of misbranding, as well as the growing use

of concepts such as “natural,” “organic,” and other health-related claims

affecting consumer expectations that have given rise to much of the

contemporary food-related litigation.

A. General Food Labeling Issues

Division of Responsibility Among Government Agencies

For largely historic reasons, jurisdiction over the appropriate way to

describe and define food products in labeling and advertising is divided

among a number of governmental agencies. Several different sets of

statutes regulate the safety, purity, and labeling of food products at the

federal level. Which statute applies depends on the type of food, and

responsibility for specific food commodities has been assigned to

different agencies with significantly different regulatory responsibilities

and authority. In many instances, the consequences of this system are

famously absurd.1

1. The U.S. Department of Agriculture, for example, oversees production of

hot dogs in pastry dough; the U.S. Food and Drug Admi nistration

regulates hot dogs i n rolls. The Depar tment of Agricultur e regulates corn

222 Agriculture and Food Handbook

Two important concepts run through these regulatory schemes:

adulteration and misbranding. Adulteration generally refers to any food

that bears or contains any poisonous or deleterious substance that may

render it injurious to health. The concept of adulteration therefore sets

the baseline for food purity and safety, broadly defining which food

products are safe t o eat, are pure and meet applicable quality standards.2

Misbranding relates to whether a food’s labeling meets regulatory

requirements. The baseline standard for misbranding is that a product’s

label must not be “false or misleading in any particular.”3

a. Federal Food, Drug, and Cosmetic Act

The Food and Drug Administration (FDA) exercises jurisdiction

over labeling for approximately 80 percent of foods sold in the United

States under the Federal Food, Drug, and Cosmetic Act (FDCA).4 In

addition to traditional food products, dietary supplements are considered

foods and are therefore regulated under the FDCA.5 The same is true of

animal food and feed,6 medical foods,7 and infant formula.8

The FDCA, as amended by the Nutrition Labeling and Education Act

of 1990 (NLEA),9 requires, with limited exceptions, that all regulated

food be labeled with five mandatory elements: (1) the product name; (2)

the net quantity of contents; (3) a nutrition fact panel; (4) an ingredient

dogs; the Food and Drug Ad ministration regulat es bagel dogs. The

Department of Agriculture regulates pepperoni pizza; the Food and Drug

Administration regulates cheese pizza. A sandwich made with bread,

ham, cheese, lettuce, and tomato potentially raises regulatory issues of

great complexity.

2. 21 U.S.C. §§ 453(g), 601(m).

3. 21 U.S.C. § 343(a).

4. Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301-399. “Food”

includes pet food and animal feed. For a discussion of the broad scope of

the Act, see U.S. FOOD & DRUG ADMIN., 2013 ANNUAL REPORT ON FOOD

FACILITIES, FOOD IMPORTS, AND FDA FOREIGN OF FICES (Nov. 2013),

available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/uc m37

6478.htm

5. 21 U.S.C. § 321.

6. 21 U.S.C. §§ 301-99.

7. 21 U.S.C. § 360ee(b)(3); 21 C.F.R. § 101.9(j)(8).

8. 21 U.S.C. §§ 321(z), 350a; 21 C.F.R. §§ 106, 107.

9. Pub. L. No. 101-535, 104 Stat. 2353 (1990).

Consumer Protection Issues 223

list; and (5) the name and place of the manufacturer or distributor. The

NLEA and associated regulations govern the health claims that food

manufacturers can make on products, such as statements regarding how

foods affect the “structure and function” of the human body (e.g.,

“Calcium builds strong bones” or “Helps maintain healthy cholesterol

level”); labeling a food as a “substitute” for another; and content claims,

such as whether foods are “light” and have “fewer calories” or “less fat”

than others.10

Finally, the FDA regulates what manufacturers may put on food

labels through published regulations, guidance documents, and

compliance policy guides. Regulated claims include the use of such

terms as “fresh,” “GMO [Genetically Modified Organism] free,”

“pasteurized,” as well as comparative and structure/function claims.11 In

many cases, these regulations specify minute details of how text may be

placed on a label, including font size/type and placement.12

b. Meat and Poultry Inspection Acts

Meat, poultry, and certain egg products are regulated exclusively by

the U.S. Department of Agriculture’s (USDA’s) Food Safety and

Inspection Service (FSIS) pursuant to the Federal Meat Inspection Act

(FMIA), the Poultry Product Inspection Act (PPIA), and the Egg

Products Inspection Act (EPIA).13

10. A labeling statement that a product is “low sodium” is an example of

nutrient content claim, while a statement that a product “may reduce the

risk of heart disease” is an example of a health claim. See 21 C.F.R.

§§101.61, 101.83.

11. See 21 C.F.R. §§101.95, 101.17, 101.54. An example of a

structure/function claim is “calcium builds strong bones.” Comparative

claims are those that compare the nutrient content of one product to that

of another product or a product category, e.g., “25 percent more fiber than

leading brand.”

12. For example the statement of identity (or name of the food) and the net

quantity statement (or amount of product) is to be placed on the principal

display panel (“PDP”). 21 C.F.R. §§ 101.3(a), 101.105(a).

13. Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601-695; Poultry

Product Inspection Act (PPIA), 21 U.S.C. §§ 451-472; Egg Products

Inspection Act (EPIA), 21 U.S.C. §§ 1031-1056. Whole eggs in shells are

regulated under the F DCA, but plants that process shelled eggs into

liquid, frozen, or dried products are regulated under the EPIA.