Sec. 201 [321].”
3 3 See 21 U.S.C. § 321(s).
4 4 21 U.S.C. § 392(b).
5 5 See, e.g., 21 U.S.C. § 644 (regarding transporting in commerce dead, dying, disabled, or diseased animals).
6 6 See, e.g., 21 U.S.C. § 610(c) (regarding transportation in commerce of without complying with inspection and marking provisions).
7 7 88 Stat. 1660 (1974).
8 8 The Nutrilab court references are to the United States Code (U.S.C.) sections rather than the FDCA sections. Note that this U.S.C. citation was created by dropping the middle digit and putting a 3 in the hundred's digit; thus, 201 becomes 321. Most, but not all, FDCA section are codified into the U.S.C. this way.
9 9 Refer to Section 2.1.1 above for the definition of “drug,” in particular, (g)(1)(C).
10 10 United States v. 250 Jars … Cal's Tupelo Blossum U.S. Fancy Pure Honey, 344 F.2d 288 (6th Cir. 1965).
11 11 Sterling Vinegar and Honey, 338 F.2d 157 (2d Cir. 1964).
12 12 United States v. Hohensee, 243 F.2d 367 (3d. Cir. 1957).
13 13 United States v. 500 Plastic Bottles … Wilfrey's Bio Water (D. Or. 1989).
14 14 United States v. Kollman (DC Or. 1985, 1986).
15 15 United States v. Articles of Drug … Neptone (ND Cal. 1983).
16 16 National Nutritional Foods Ass'n v. Mathews, 57 F.2d 325 (2d Cir. 1977).
17 17 Id.
18 18 United States v. Green Coffee Beans, 188 F.2d 355 (1951).
19 19 United States v. Tomahara Enterprises, Ltd. (DC ND N.Y. 1983).
20 20 United States v. Technical Egg Prods., Inc., 171 F. Supp. 326 (N.D. Ga. 1959).
21 21 See 21 U.S.C. § 321(s).
22 22 See, Natick Paperboard Corp. v. Weinburger, 525 F.2d 1103 (1st Cir. 1975).
3 FOOD LABELING
3.1 INTRODUCTION
Labeling, perhaps surprisingly, has been at the center of many aspects of food regulation. Incorrect labeling consistently ranks as the leading cause of food recalls and import denials. This chapter examines food labeling regulation that is designed to protect the economic expectations of both consumers and the food industry. In Chapter 4, we will cover the regulation of the nutritional content and labeling of food. In Chapter 8, we will cover the regulation of the identification of foods in more depth, including the standards of identity requirements and the requirement for common and usual names.
The food labeling requirements designed to protect economic expectations cover both prohibitive and affirmative regulation. The prohibitive requirements protect against fraud and deception. Prevention of false and misleading statements is at the historical foundation of labeling regulation. On the other hand, the affirmative requirements mandate that food manufacturers provide information on their labels that they otherwise might not include.
The affirmative requirements are intended to provide consumers with information they need to make informed choices about the food. What information has been deemed material to informed choice is a surprisingly small set that has remained relatively stable.
This chapter provides:
1 an overview of the labeling laws,
2 the basic knowledge needed to review a label for compliance with applicable requirements,
3 knowledge of where to look up answers, and
4 identification of reference materials.
3.2 LEGAL AUTHORITIES
FDA’s authority to compel the labeling of food products primarily derives from the Food, Drug, and Cosmetic Act (FD&C Act). Many of the statutory labeling requirements come from section 403 of the FD&C Act, which lists circumstances when a food will be considered “misbranded.” The definition of “misbranded” contains the major misbranding requirements:
1 Mandatory labeling of the name of the food, ingredient statement, net quantity, and the name and address of the manufacturer or distributor.
2 Mandatory standards of identity.
3 Labeling of imitation foods.
4 Nutrition information for special dietary foods.
5 Prohibition of any false or misleading claims.
The Fair Packaging and Labeling Act (FPLA), 15 U.S.C. 1451 et seq., was enacted in 1966 to prevent unfair and deceptive trade practices, and to provide consumers with accurate information regarding the quantity and value of products. The FPLA is administered by the FDA for labels on foods, drugs, and cosmetics, while the Federal Trade Commission (FTC) administers the FPLA for most other consumer commodities.
FDA’s labeling regulations are located in 21 C.F.R. 101 and cover both the requirements of the FD&C Act and the FPLA.
Labeling of meat, poultry, and egg products is regulated under separate laws by the United States Department of Agriculture (USDA). The major principles and many of the specifics are the same in both sets of requirements. This chapter provides an overview of the differences.
3.3 LABELING TERMINOLOGY
* * * * *
Federal Food, Drug, and Cosmetic Act
Chapter II—Definitions
SEC. 201. [321] For the purposes of this Act—
….