The Rigorous Road to Food Ingredient Approval
Salt, aspartame, baking soda, natural and artificial food colors, vitamin D and fructose have more in common than you might think. They’re part of a group of food ingredients regulated by the Food and Drug Administration (FDA) that includes food and color additives and GRAS (Generally Recognized as Safe) ingredients, which is comprised of more than 3,000 other ingredients that have been given the green light for manufacturers to use in foods.
A food additive is defined by law as “any substance, the intended use of which results or may be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.” That long-winded definition covers a lot of food territory, but essentially, each FDA-approved ingredient serves one of the following specific functions:
- To improve or maintain safety and freshness (ex. preservatives)
- To improve or maintain nutritional value (ex. fortification and enrichment)
- To improve taste, texture and appearance (ex. spices, natural and artificial flavors, sweeteners, emulsifiers, stabilizers, thickeners)
In the US, the FDA is entrusted with the responsibility of overseeing the safety of food additives. But, it wasn’t always this way. It may seem odd today, but a little over a century ago, no safety standards existed for food or food ingredients at all. Laws were passed early in the 20th century to ensure the safety of meat, poultry and eggs. The current system, which ensures the safety of food additives, was put into place with the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act and the Color Additives Amendment of 1960, placing the burden of proof of an additive’s safety on food manufacturers.
Food additives are now evaluated, tightly regulated and regularly monitored by the FDA. The demanding approval process requires a manufacturer to petition the FDA, providing extensive evidence that the additive for which it is seeking approval is safe for its intended use. FDA’s safety evaluation takes into consideration the intended uses and amounts of the ingredient, how much of the additive a person is likely to consume, the effects of consuming small amounts from several sources over time, and studies looking at any potential effects on health. Once the FDA has reviewed all the information submitted by the manufacturer, if it finds no safety concerns, FDA then establishes any limits on the use of the additive necessary to ensure safety. These limits are intended to be protective even if the additive were consumed by individuals in multiple products daily throughout one’s lifetime, including someone who consumes high amounts of the ingredient.
All new food additives must undergo the FDA-approval process. In addition, a group of about 700 ingredients fall into a category known as GRAS (Generally Recognized As Safe). GRAS ingredients have been determined to be safe by the FDA or USDA, either prior to the 1958 food additives law, after the law was passed and based on their extensive history of safe use in food, or based on published scientific evidence. Salt, sugar, spices, caffeine and monosodium glutamate (MSG) are included in the GRAS category.
While the GRAS review process follows a different path, the demand for proof of safety is no less rigorous than for new food additives. For an ingredient to be considered GRAS, safety information must be widely known and available to the public and there must be a general consensus among qualified experts that establishes the ingredient’s safety. According to Dr. Mitchell Cheeseman, former Acting Director of FDA’s Office of Food Additive Safety, “Both food additive and GRAS classifications emphasize safety for consumers and set a high standard that new ingredients and additives must meet to be used in foods and beverages.” A full listing of GRAS Notifications is available on FDA’s website.
The development process for food and color additives and ingredients typically involves input from highly-qualified outside experts that review the research on the ingredient’s safety. In addition, prior to being permitted for use in food, FDA reviews scientific studies that include long-term studies in rats and mice (it would not be ethical to do safety studies on humans) on the effect of a given ingredient on health conditions such as cancer, heart disease, brain health, reproductive health and more. GRAS ingredients and approved food additives will have strong scientific evidence showing they do not cause adverse health effects.
It can take several years for a manufacturer to gather all of the scientific evidence required by FDA to establish an ingredient’s safety, but the FDA’s watchful eye doesn’t stop there. If new evidence suggests that an ingredient currently being used in foods could harm health, or if consumption levels within the population have changed significantly, FDA has the ability to require manufacturers to provide additional safety data or to restrict the use of the ingredient until more is known and any concern is resolved.
Unless otherwise noted, the general population, including pregnant women and children, can enjoy foods and beverages containing GRAS ingredients and approved food additives and feel confident of their safety.
For more information on food ingredients, view the FDA-IFIC Foundation Food Ingredients & Colors brochure.
Rulis, A and Levitt, J. FDA’S food ingredient approval process: Safety assurance based on scientific assessment. Regulatory Toxicology and Pharmacology. 2009 Feb;53(1):20-31.