Food Additives and GRAS (Generally Recognised as Safe): what does that really mean?

Food and drug laws have existed at least since The Code of Hammurabi, dating back to around 1755 BCE. 

However, the real breakthrough in food and drug law came with the publication The Jungle by Upton Sinclar in 1906, where he exposed abuses in the Chicago meat-packing industry.^[2]

Upton Sinclar worked undercover in the meat-packing industry for seven weeks, gathering information. In his novel he described the dangerous, unsanitary practices of slaughterhouses and meat packers.

This publication convinced Congress to pass the Pure Food and Drug Act (also known as the “Act” or “Statute”) and the Meat Inspection Act, both signed into law in 1906 by President Theodore Roosevelt. 

These acts defined food and were primarily focused on adulteration, misrepresentation or sale of otherwise unfit products. Before this Act, there was nothing that could be done to the food that was illegal, because there were no food safety laws. 

For example, we can find cases such as brick dust sold as cinnamon and tinted corn syrup marketed as honey. In the 1850s, food and milk tainted with formaldehyde caused deaths of 8000 American infants a year. This is known as a Swill milk scandal.^[3]

Formaldehyde was used to cover swill milk, which was the tainted result of miasmic dairy cows being fed leftover mash from Manhattan and Brooklyn whiskey distilleries.^[3]

The act laid the foundation for the first consumer protection agency in the United States, the Food and Drug Administration, established in 1927.

The laws were periodically updated, but another big change happened in 1938, due to a tragedy called “Elixir of Sulfanilamide”. 

The Elixir Sulfanilamide disaster of 1937 was one of the most consequential mass poisonings of the 20th century.^[4]

Sulfanilamide is an antibacterial drug, which was being used safely for treatment of streptococcal infections. However, liquid form was required. A new formula with raspberry flavour was prepared with 70 % diethylene glycol. 

Its usage can be fatal and since the company did not carry out any toxical studies, soon after its appearance on the market resulted in the death of 105 patients. From that incident, pre-marketing approval of efficacy and safety of drugs was highly demanded. 

In 1954, and again in 1958, incidents involving the safety of food forced Congress to act. Chairman James J. Delaney examined 840 food additives and only 420 were considered safe. 

The Congress responded with the concept of GRAS. Concept was written into the 1958 Amendment to the Federal Food Drug and Cosmetic Act. They set up new definitions and standards for food additives, created an entirely new class of substances and established a process of approving new substances used for food. 

In the 1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply. 

In the 1960s and 1970s the medical device industry grew extensively. In 1977 Bioresearch Monitoring Programme was introduced. This programme focused on preclinical studies on animals and clinical investigations. 

In 1962, drug safety was improved. For the first time, drug manufacturers were required to prove effectiveness of their products before marketing them. 

In 1990, the Congress passed the Nutrition Labeling and Education Act, which completely reformulated the way food product labels convey basic nutritional information. During the past decade, several laws were passed that focus on clarifying the nutritional and safety information on food labels, including the listing of trans fats and allergens. 

The agency has also launched initiatives to increase public awareness of the adverse effects of tobacco products.