The Food And Drug Administration Program And Food Additives

1379 words - 6 pages

The Federal Food, Drug, and Cosmetic Act of 1938 was passed not long after the accidental deaths of 100 people who consumed an untested version of a popular drug. It turned out that an additive in the drug was responsible for the poisoning of the 100 individuals. This new law was developed in the interest of the consumer and focused on ensuring that people knew exactly what was in the products they purchased, and that the ingredients were safe. As the food industry has grown into a multi billion-dollar industry, the task of ensuring all ingredients are safe for consumption has become a bit more complicated. The law has been amended over the years in an attempt to address the thousands of new additives that have been developed. A result of attempting to streamline the process has been that companies are permitted to add certain types of ingredients to foods without premarket approval from the overloaded Food and Drug Administration. To put it simply, there are substances in our food that are completely unknown to the FDA (Nicole, 2013).

In depth regulation of food additives began in 1958 when Congress passed the Food Additives Amendment to the FD&C Act of 1938. This amendment required premarket approval of additives, and established safety standards. The amendment had the FDA rule how safe a product was, without consideration of benefits in order to truly keep the safety of the customer priority (FDA, 2011). The 1958 amendment also included the Delaney Clause, which bans any ingredient that has been shown to cause cancer in animals or humans at any dose. A separate amendment in 1960 required premarket approval for all color additives, synthetic and natural (Wirth, 1984). The FDA regulates colors separately from other additives. Currently, nine synthetic dyes are certified by the FDA: FD&C Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, Yellow 6, Citrus Red 2, and Orange B (which is no longer in use due to safety concerns). The FDA also permits many natural colorings that do not require certification such as carmine, annatto, beta-carotene, and caramel color. In order to create and use new color additives, a company must petition the FDA and provide acute and long-term toxicity studies. From these studies, the FDA develops acceptable daily intake values based on a dose that has no adverse effect in animals, and multiplies the value by a safety factor (Nicole, 2013).

Many potentially dangerous additives tend to fall through the cracks. Although the 1958 amendment created strict standards for additives, it exempted substances that were already approved for use in food and those that are “generally recognized as safe” (GRAS). Substances can actually be considered safe for use in food without review by the FDA, and are not investigated unless data is released to cause the FDA to reconsider its safety. Producers are not required to list a flavoring’s chemical name, or even list all flavors present (Gleason, 2011). The reasoning behind this is...

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