Writing assignment two full pages in APA style format answering the questions below.

Food, Drugs, and Cosmetics Safety

1. 44.2 Describe government regulation of drugs, cosmetics, and medicinal devices.

The Food, Drug, and Cosmetic Act (FDCA or FDC Act) 1 is a federal statute that regulates the safety of foods, drugs, cosmetics, and medicinal devices. The specific areas regulated by the FDCA are discussed in the following paragraphs.

The following feature discusses the Federal Food, Drug, and Cosmetic Act.

Landmark Law

Food, Drug, and Cosmetic Act

The Food, Drug, and Cosmetic Act (FDCA or FDC Act) was enacted in 1938. This federal statute, as amended, regulates the testing, manufacture, distribution, and sale of foods, drugs, cosmetics, and medicinal devices in the United States. The Food and Drug Administration (FDA) is the federal administrative agency empowered to enforce the FDCA.

Before certain food additives, drugs, cosmetics, and medicinal devices can be sold to the public, they must receive FDA approval. An applicant must submit to the FDA an application that contains relevant information about the safety and uses of the product. The FDA, after considering the evidence, will either approve or deny the application.

The FDA can seek search warrants and conduct inspections; obtain orders for the seizure, recall, and condemnation of products; seek injunctions; and turn over suspected criminal violations to the U.S. Department of Justice for prosecution.

Regulation of Food

The FDCA prohibits the shipment, distribution, or sale of adulterated food. Food is deemed adulterated if it consists in whole or in part of any “filthy, putrid, or decomposed substance” or if it is otherwise “unfit for food.” Note that food does not have to be entirely pure to be distributed or sold; it only must to be unadulterated.

The FDCA also prohibits false and misleading labeling of food products. In addition, it mandates affirmative disclosure of information on food labels, including the name of the food, the name and place of the manufacturer, a statement of ingredients, and nutrition content. A manufacturer may be held liable for deceptive labeling or packaging.

Critical Legal Thinking

What public purpose does the Food and Drug Administration serve? If it were not for federal food protection laws, do you think that companies would voluntarily implement food safety rules comparable to those of federal laws? Why or why not?

Food Labeling

In 1990, Congress passed a sweeping truth-in-labeling law called the Nutrition Labeling and Education Act (NLEA).2 This act requires food manufacturers and processors to provide nutrition information on many foods and prohibits them from making scientifically unsubstantiated health claims.

The NLEA applies to packaged foods and other foods regulated by the Food and Drug Administration. The law requires food labels to disclose the number of calories derived from fat and the amount of dietary fiber, saturated fat, trans fat, cholesterol, and a variety of other substances contained in the food. The law also requires the disclosure of uniform information about serving sizes and nutrients, and it establishes standard definitions for light (or lite), low fat, fat free, cholesterol free, lean, natural, organic, and other terms routinely bandied about by food processors.

The Department of Agriculture adopted consistent labeling requirements for the meat and poultry products it regulates. Nutrition labeling for raw fruits and vegetables and raw seafood is voluntary. Many sellers of these products provide point-of-purchase nutrition information.

The following ethics feature discusses food labeling at restaurants.

Ethics

Restaurants Required to Disclose Calories of Food Items

Did you know that a Big Mac contains 560 calories, a Domino’s medium pepperoni and sausage pizza 2,080 calories, a brownie sundae from Baskin-Robbins 920 calories, a double chocolate chunk brownie from Starbucks 380 calories, a can of original flavor Pringles 960 calories, and a large-size bucket of buttered popcorn at the movie theater approximately 1,000 calories? Well, you will now.

Section 4205 of the Patient Protection and Affordable Health Care Act of 2010 requires restaurants and retail food establishments with 20 or more locations to disclose calorie counts of their food items and supply information on how many calories a healthy person should eat in a day. The disclosures are required to be made on menus and menu boards, including drive-through menu boards. The law also applies to vending machine operators with 20 or more vending machines. The law is administered by the U.S. Food and Drug Administration, a federal government agency that is empowered to adopt rules and regulations to enforce the law.

Other information, such as total calories from fat, trans fat, saturated fat, cholesterol, sodium, sugars, and protein must be made available in writing upon request.

Ethics Questions Why was this federal law enacted? Do you think that the required disclosures will change consumer habits? Has it changed your eating habits?

egulation of Drugs

The FDCA gives the FDA the authority to regulate the testing, manufacture, distribution, and sale of drugs. The Drug Amendment to the FDCA,3 enacted in 1962, gives the FDA broad powers to license new drugs in the United States. After a new drug application is filed, the FDA holds a hearing and investigates the merits of the application. This process can take many years. The FDA may withdraw approval of any previously licensed drug.

This law requires all users of prescription and nonprescription drugs to receive proper directions for use (including the method and duration of use) and adequate warnings about any related side effects. The manufacture, distribution, or sale of adulterated or misbranded drugs is prohibited.