We all need to eat. We also need to eat foods that are safe. That is one of the main reasons why foods are regulated. Food regulations promote industry best practices, encouraging food companies to put systems in place that will protect consumer health. It also prevents unfair trade, since some unscrupulous manufacturers will try to undercut their competition by putting inferior ingredients in foods. There are several agencies in the US involved in regulating food safety. These include the environmental protection agency (EPA), US Customs, Alcohol and Tobacco Tax and Trade Bureau, the Federal Trade Commission, the United States Department of Agriculture (USDA) and the Federal Drug Administration (FDA). These federal agencies are responsible for regulating foods that are involved in interstate commerce (that means, across state lines). The USDA is in charge of regulating meat, poultry and eggs while the FDA is in charge of all other foods.
The history of the FDA goes back to the late 1800s. In 1883, Dr. Harvey Wiley, Medical Doctor was appointed to the UDSA Bureau of Chemistry. In his early work he demonstrated much passion in regards to the use of certain additives that were being used in foods that he thought was unsafe. To prove this, Harvey set up a “Poison Squad” of 12 men who committed to eat food in his lab that were tainted with these additives in order to determine if they really had a negative effect. The experiment ran for about 5 years with these men eating nothing else that the food in Harvey’s lab while they were constantly tested to determine physiological response. The result of the experiment showed that many of the additives that were being used were unsafe. This information was used as a tool to lobby Congress for changes in food laws.
In the meantime, another man who would have a big influence on US food laws was studying working conditions of immigrants working in Chicago’s meat processing plants. His name was Upton Sinclair. Upton Sinclair wrote about the ill-treatment of these workers, and the deplorable working conditions in his book called “The Jungle”. It painted a horrifying picture of the nasty conditions of the factories. This led to public outcry. Therefore in 1906, President Roosevelt signed into law the Meat Inspection Act and the Pure Food and Drugs Act.
The Pure Food and Drugs Act brought about some well needed changes in the food industry, but by the early 1930s there was a push for improvements in the law. While Congress delayed in bringing about the much needed changes, there was a major disaster. It was the death of 107 people from taking a strep throat drug that was not approved. The company had made changes to their formula without any safety testing of the new product. At that time, there was no requirement for testing before distribution. This tragedy led Congress to pass the Federal Drug and Cosmetics Act which we operate on today. Changes in the regulations included:
- Control of cosmetics and therapeutic devices
- Establishment of pre-market proof of safety of drugs
- Establishment of safe tolerances for unavoidable poisonous substances
- Set of standards for quality, labeling and content of containers
- Authorizing factory inspections
- Additional legal remedies for violations
Structure of the US Government
Every student of law must be aware of the basic structure of the US government. It is by the tool of government that laws and regulations are formed. The US government is made up of three branches:
- Legislative (Congress): for establishing statutory law
- Executive (President): for executing the laws of the land
- Judiciary (Courts): for evaluating the law and establishing the common law
Statutory laws are established by Congress by a process of listening to the will of the people and taking their ideas to the floor of the legislature where they are debated and the best ideas moved forward to the President for signing and passing into law. After the President signs the law, the appropriate federal agencies reviews them and develop regulations to carry out the law. These regulations are written in a journal called the Federal Registry which is opened to the public for reviewing and comments before the laws are finally implemented. The final regulations are written and published in the Code of Federal Regulation (CFR). Regulations pertaining to food and drugs can be found in the 21st title of the CFR (21 CFR). The CFR is structured into 50 subject matter titles. The titles are broken down into, chapters, parts, sections, and paragraphs. For example, 21 CFR 320.11(a) would be read as “title 21 part 320, section 11, paragraph (a).”
The process of establishing food laws is the same as any other law. Watch this video to learn how bills become law.