are therefore subject to the adulteration provisions of the act.19
2.4.2 Products No Longer Fit for Food
A product that is generally regarded as a food is considered a food under the FD&C Act, even if the product is decomposed or otherwise unfit for consumption. For example, a shipment of incubator reject shell eggs was still “food” although a large percentage of them were inedible.20 The product might not be intended to be eaten, but if there is a danger of the product being diverted to food use, the product is considered a food. Note that the intended use of the product is irrelevant to this determination, which is based on the product being in the form of a food.
2.4.3 Packaging Materials
The definition of “food” is significantly broadened by the inclusion of food additives within the definition of food. Food additives include any substance whose intended use results or may reasonably result in its becoming a component or otherwise affecting the characteristics of any food.21 Thus, the definition of food includes any substances that migrate to the food from the packaging materials or containers.22
DISCUSSION QUESTIONS
1 2.2 Bottled water. Within the meaning of the FD&C Act, could bottled water be characterized as a food, a drug, or both? How? Would your answer change if the product were cherry juice concentrate?
2 2.3 Blackboard chalk. When would blackboard chalk be a drug?
3 2.4 “SkyHigh” brand glue is not only efficacious as glue, but is widely known to induce a high when sniffed. The manufacturer advertises the adhesive properties of the glue heavily in magazines that are popular in the drug culture. Can FDA regulate the glue?
4 2.5 Statutory drafting. Is the definition of “food” good statutory drafting?
5 2.6 Coffee is often consumed for its stimulant effect. Coffee is not con sumed for its nutritional value. If a manufacturer promoted its coffee for the stimulant effect, would it be a drug?
6 2.7 Caffeine is regulated as an over‐the‐counter drug when sold as a stimulant pill. 21 C.F.R. § 340. However, FDA does not regulate caffeine added to foods as a drug—even when the food is promoted as a stimulant. How do you reconcile the agency’s decision? Is this exception within the scope of the structure/function exception for foods within FD&CA § 201(g)(1)(C)?
7 2.8 Putrid and decomposed food that is clearly inedible would not be called “food” in everyday speech. What would be the regulatory consequence if putrid and decomposed food were excluded from the definition of food?
8 2.9 Vitamins and minerals without therapeutic claims have generally been classified as foods. However, in the 1970s, reports of human toxicity emerged from consumption of large doses of the vitamins A and D. These fat‐soluble vitamins create special concern because they can accumulate in the fatty tissue. To deal with this problem, in 1972 and 1973, FDA promulgated regulations classifying certain high dosages of vitamin A and D as drugs and requiring that they be sold by prescription. 37 Fed. Reg. 26618 (Dec 14, 1972) and 38 Fed. Reg. 20723 (Aug 2, 1973). However, in National Nutritional Foods Ass’n v. Mathews, 557 F.2d 325 (2d Cir. 1977), the court questioned FDA’s approach and found FDA’s administrative record incomplete. In particular, the court questioned whether FDA could classify vitamins as drugs when no intended therapeutic use was offered by the vendors, the labeling, or any promotional material. The court upheld the regulations, but FDA nonetheless later rescinded them. 43 Fed. Reg. 10551 (Mar 14, 1978).
Notes
1 1 21 U.S.C. Sec. 321 et seq.
2 2 Statutory citations used in this material generally are to the FD&C Act statutory sections. The citation within the brackets is the U.S.C. number. The United States Code (U.S.C.) is organized into subject matter titles with numbering that is unique from the section numbering in the statutes. For example, section 201 of the Food, Drug, and Cosmetic Act is codified as 21 U.S.C. § 321. Thus, this section is cited as “FD&C Act 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.
