FOOD, DRUGS & BIOTECHNOLOGY
GILHOOLEY, SPRING 2005
I. FOODS: DECEPTIVE LABELING
UNITED STATES v. 95 BARRELS OF APPLE CIDER VINEGAR, p. 51
Labeling requirements of § 403
The company was disciplined for having vinegar made from dried or evaporated apples instead of fresh apples
The FDA found the statements on the label to be “false and misleading” in that “it was an imitation of and offered for sale under the distinctive name of another article, namely apple cider vinegar”
Misbranded
Applies to all articles of food or articles which enter into the composition of food, the package or label of which shall bear any statement regarding such article or the ingredients contained therein which shall be false and misleading
When misbranded
If the food is an imitation of or offered for sale under the distinctive name of another article
If it be labeled or branded so as to deceive or mislead the purchaser
If the package containing it or its label shall bear any statement, design or device regarding the ingredients or the substances contained therein, which statement, design or device shall be false or misleading
The vinegar made was not the same – taking approximately 80% of the liquid from the apples and replacing it with other ingredients made it not an “identical product”
UNITED STATES v. 432 CARTONS . . . CANDY LOLLIPOPS, p. 54
The company sold liquor-flavored lollipops which actually contained no liquor
The statute said that the labeling must be only false or misleading “in any particular,” and there is little flexibility in the standard
The court examined whether because the ingredients listed and the labeling on the outside of the box were not misleading, whether the internal designation would be
Summary judgment, so just issues, no verdict
Ingredient Labeling, p. 74
All of the ingredients in food must be listed, in descending order of predominance
Listing is to be by chemical name, rather than by class or functions
Spices, flavorings and uncertified colorings may be listed generically
Label Warnings, p. 82
The FDA has no specific authority to require warning statements on food labels
The warnings in food have increased, many times voluntarily
Types of warnings
Safe use
Allergic reactions
Inborn errors of metabolism (PKU)
Toxicity
Side effects
Nutrition Labeling, p. 138
Mandatory nutrition labeling
Only where a nutrient (ex. Vitamin C) is added to food, or a claim or information with respect to the nutritional properties of food is made on the labeling or advertising
A manufacturer who does not wish to use nutrition labeling need not add nutrients to his products or refer to their nutritional properties in labeling or advertising
II. FOOD SANITATION
A. Aesthetic Adulteration – Filth
UNITED STATES v. 484 BAGS, MORE OR LESS, p. 233
The FDA was asked to decide whether “molded green coffee” is adulterated within the meaning of § 402(a)(3)
§ 402(a)(3), Supp p. 27
A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid or decomposed substance, or it is otherwise unfit for food
The Secretary is able to adopt administrative working tolerances for violations of which he will prosecute
Tolerance level in the present case was 10% moldy beans
Because the beans had an average mold level of 15.2%, they were in violation
The producers of food have a right to know what the tolerance levels are
B. Unsanitary Conditions
UNITED STATES v. GENERAL FOODS CORP., HO p. 1
§ 402(a)(4), Supp p. 27
A food shall be deemed to be adulterated if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health
TEST for § 402
Whether or not the food in issue was processed under conditions whereby there is a reasonable possibility that filth contamination could have occurred
Finished product contamination need not be shown, as long as there is evidence of it
To refute the allegations of an (a)(4) violation
A defendant may introduce evidence of routine customs, business hab
tions in NOVA SCOTIA required the use of heating and salination procedures to inhibit growth of the spores”
“NOVA SCOTIA did not consider the argument before us today, which is that the statute does not authorize regulation of the levels of bacterial infection in incoming raw materials”
4. Philosophy of Regulation, p. 1041
The FDA Act must be regarded as a constitution. It establishes a set of fundamental objectives – safe, effective, wholesome, and truthfully-labeled products – without attempting to specify every detail of regulation
5. Procedure for Rulemaking – See pp. 1247-1251
III. FOOD SAFETY
A. History
Traditional Authority to regulate foods
§ 402(a)(1): a food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health . . ., Supp p. 27
History
Food and Drugs Act of 1938 replaced the 1906 Act
§ 402 was virtually the same, except the current section also deals with food additives
Three standards applicable to potentially toxic substances in food
Ordinarily injurious standard (constituents not added)
May render injurious (constituents that were neither necessary nor unavoidable)
Tolerances provided for the protection of public health (for added constituents whose use was necessary in the production of a food or whose occurrence was unavoidable by good manufacturing process)
Food and Drugs Act in 1958
Added a factor for constituents of food for “special treatment” (the food additives amendment)
Food and Drugs Act in 1968
Carved out different sections for different additives – essentially the same as the FDA act today
