Center for Research on Ingredient Safety

In prior posts, we’ve covered vital U.S. Food and Drug Administration (FDA) safety topics, including Generally Recognized as Safe (GRAS) ingredients and Current Good Manufacturing Practice regulations (CGMP). In this series, we take a look at the Food Additives Amendment of 1958.

What are food additives?

Direct food additives are ingredients that manufacturers and home cooks alike add to foods to help foods achieve their key characteristics. A direct food additive can be a flavor, color, preservative, or more (1).
 
Indirect food additives make their way into foods via packaging, storage, and handling. An indirect food additive can be a pesticide residue, plastic packaging ingredient, or more (1,2,3,4,5).
 
Since additives are part of our food system and to ensure food safety, the FDA put in place legislation that requires manufacturers to get approval for any food additive they plan to incorporate into a product before making it available to the public (1).

For example, if a food company created a new, artificial food coloring they’d like to sell to bakers or include in a new frosting, the company would need to work with the FDA to ensure safety before the food coloring could go on the market.
 

What do food additives do?

The FDA explains that food additives achieve one or more of three goals:

• Maintain or improve food safety and freshness: These ingredients can include preservatives, antioxidants, packaging, and more.
• Improve or maintain nutritional value: These ingredients can include vitamins, minerals, and more that help to fortify foods to improve their nutrition.
• Improve taste, texture, and appearance: These ingredients can include spices, flavors, food dyes, sweeteners, thickeners, anti-caking agents, leavening agents, and more.

Are all food additives regulated before going on the market for sale?

As we’ve covered in a prior post, Generally Recognized as Safe (GRAS) ingredients are not subject to pre-market approval before being added to foods. GRAS ingredients typically include familiar ingredients we’ve safely used for many years, such as spices, sugars, and more.
 
Other ingredients that were determined to be safe before the Food Additives Amendment of 1958 are allowed, such as nitrates (1,2). 
 

How does the regulation work?

When a manufacturer wants to put a new additive on the market, they first need to petition the FDA. An FDA petition must provide evidence proving it’s safe for use/consumption by the community.
 
The FDA then evaluates the ingredients and considers many safety factors. If approved, the FDA establishes a safe use dose with a significant safety margin to ensure the ingredient doesn’t harm people (1).
 
The Current Good Manufacturing Processes (CGMP) regulations ensure manufacturers only use the smallest amount needed to achieve the desired outcome (1). This helps eliminate unnecessary exposure to any ingredient.
 

What happens if an additive is no longer safe?

Scientists are continually learning more and developing new technologies and criteria to evaluate ingredient safety. As we know more, we may discover an additive can cause harm.
 
If regulators think an additive may cause harm, the FDA may conduct a study to see if it’s harmful. If it’s obvious an ingredient is causing adverse health effects, the FDA can prohibit manufacturers from using the dangerous additive in our products (1,2). 
 

Is the FDA the only agency that regulates additives?

No, the FDA works with the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA).

Each agency has its own specialization. For example, the USDA helps regulate additives found in meats while the EPA helps regulate the pesticide additives that can be found in drinking water.
 
Together these agencies help ensure our food and beverages remain safe.
 

The good news.

Before 1958, there were no food additive regulations meaning manufacturers could add many different and potentially harmful ingredients to our food system. The Food Additives Amendment helped make our food system much safer.
 
While science has improved dramatically since 1958, researchers continue to push forward to ensure food safety, and regulators continue to develop and refine legislation to help meet modern scientific discoveries