Aspartame
After reviewing scientific studies, FDA determined in 1981 that aspartame was safe for use in foods. In 1987, the General Accounting Office investigated the process surrounding FDA's approval of aspartame and confirmed the agency had acted properly. However, FDA has continued to review complaints alleging adverse reactions to products containing aspartame. To date, FDA has not determined any consistent pattern of symptoms that can be attributed to the use of aspartame, nor is the agency aware of any recent studies that clearly show safety problems.
Carefully controlled clinical studies show that aspartame is not an allergen. However, certain people with the genetic disease phenylketonuria (PKU), and pregnant women with hyperphenylalanine (high levels of phenylalanine in blood) have a problem with aspartame because they do not effectively metabolize the amino acid phenylalanine, one of aspartame's components. High levels of this amino acid in body fluids can cause brain damage. Therefore, FDA has ruled that all products containing aspartame must include a warning to phenylketonurics that the sweetener contains phenylalanine.
Monosodium glutamate
Monosodium glutamate (MSG) has been used for many years in home and restaurant foods, and in processed foods. People sensitive to MSG may have mild and transitory reactions when they eat foods that contain large amounts of MSG (such as would be found in heavily flavor-enhanced foods). Because MSG is commonly used in Chinese cuisine, these reactions were initially referred to as "Chinese restaurant syndrome."
FDA believes that MSG is a safe food ingredient for the general population. It is regarded by the agency as among food ingredients that are "generally recognized as safe." FDA has studied adverse reaction reports and other data concerning MSG's safety. The agency also has an ongoing contract with the Federation of American Societies for Experimental Biology to re- examine the scientific data on possible adverse reactions to glutamate in general. MSG must be declared on the label of any food to which it is added.
Sulfites
Of all the food additives for which FDA has received adverse reaction reports, the ones that most closely resemble true allergens are sulfur-based preservatives. Sulfites are used primarily as antioxidants to prevent or reduce discoloration of light-colored fruits and vegetables, such as dried apples and potatoes, and to inhibit the growth of microorganisms in fermented foods such as wine.
Though most people don't have a problem with sulfites, they are a hazard of unpredictable severity to people, particularly asthmatics, who are sensitive to these substances. FDA uses the term "allergic-type responses" to describe the range of symptoms suffered by these individuals after eating sulfite-treated foods. Responses range from mild to life-threatening.
FDA's sulfite specialists say scientists, at this time, are not sure how the body reacts to sulfites. To help sulfite-sensitive people avoid problems, FDA requires the presence of sulfites in processed foods to be declared on the label, and prohibits the use of sulfites on fresh produce intended to be sold or served raw to consumers (see "A Fresh Look at Food Preservative" in the October 1993 FDA Consumer).
FD&C Yellow No. 5
Color additives must go through the same safety approval process as food additives. But one color, FD&C Yellow No. 5 (listed as tartrazine on medicine labels), may prompt itching or hives in a small number of people.
Since 1980 (for drugs taken orally) and 1981 (for foods), FDA has required all products containing Yellow No. 5 to list it on the labels so sensitive consumers could avoid it. (As of May 8, 1993, food labels must list all certified colors as part of the requirements of the Nutrition Labeling and Education Act of 1990. See "From Shampoo to Cereal, Seeing to the Safety of Color Additives" in the December 1993 FDA Consumer.)