FDA and additives

Thousands of substances are used as food additives. Since the passage of the Federal Food, Drug and Cosmetic Act of 1938 – and more specifically, the 1958 Food Additives Amendment and 1960 Color Additives Amendments to this act – the U.S. Food and Drug Administration (FDA) has been responsible for ensuring the human safety of foods and substances added to them.

The FDA must approve any new additive before it is brought to market. Each year, about 100 new food and color additives are submitted for approval, according to the agency. The majority of these substances are indirect additives used as packaging materials.

The FDA also must approve any new use of an additive that was previously approved for another purpose. The FDA maintains a database of more than 3,000 ingredients. Many of these additives are among the most commonly used substances in daily life, including baking soda, salt, sugar, spices and yeast.

The FDA does not approve any additive until it has been demonstrated that the additive is effective and is reliably detectable or measurable in the final product. Most importantly, the FDA must determine that the product is safe for use. Usually, large doses of the substance are used for long periods of time in animal studies before an additive can be declared safe. In some cases, studies of the additive’s effect on humans also may be part of the approval process.

The FDA considers several factors when deciding whether or not an additive is safe. These include the composition and properties of the substance, the amount that is likely to be consumed, the immediate and long-term health effects, and a variety of other safety factors.

The FDA exercises great caution in this process and only approves substances at levels that are much lower than levels expected to potentially have an adverse impact. The FDA regularly permits additives to be used in amounts that are 100 times below the lowest level that has been found to cause harmful effects.

While the FDA cannot absolutely guarantee the safety of any additive, it does not approve any additive until there is reasonable certainty that the product will not cause harm when used as directed. After approval, the FDA determines the foods in which the additive can be used, the maximum amount that can be used and how the additive should be labeled on the package. On products such as additives for meat and poultry, the FDA consults with the U.S. Department of Agriculture (USDA). The FDA continues to monitor these additives over time and adjusts its policies according for any new data that emerges.

In evaluating an additive, the FDA always tries to weigh the potential risks of the additive against the potential benefits. For example, nitrates are a preservative that can be converted to nitrosamines in humans. Nitrosamines have been shown to cause cancer in animals. However, the FDA has approved nitrates because the risk of harm is low and is less significant than the benefit that nitrates provide in helping prevent diseases caused by spoiled food.

The FDA also requires that additives cannot be used to disguise inferior products or to deceive the consumer. Additives also must not destroy nutrients in significant amounts.

Two special categories of additives are exempted from the regulation process. First, prior-sanctioned substances include additives that were determined to be safe prior to the 1958 Food Additives Amendment. Examples include sodium nitrite and potassium nitrite, which are both used to preserve luncheon meats.

The second category of substances excluded from the food additive regulation process are generally recognized as safe (GRAS) substances. The FDA has a list of about 700 items that are generally recognized as safe (GRAS). Items on this list do not require FDA approval because they have already been shown to be safe. Examples include well-established additives such as caffeine, sugar and many spices. This list is reviewed continually and items may be added or removed from the list as evidence warrants.

Foods that are found on the GRAS list cannot be found to be carcinogenic in any test that is performed on animals or human beings. This requirement is part of the Delaney clause of the U.S. Food, Drug, and Cosmetic Act. This requirement is part of the Delaney clause of the U.S. Food, Drug, and Cosmetic Act, which is named after its congressional sponsor (Rep. James Delaney of New York).