Re-Evaluating Additives on the GRAS List

Those of us who remember riding bicycles without helmets and standing up in the backseats of our parents’ station wagons know that what we once thought of as safe may have been anything but. Armed with new information, we changed our behaviors. But what about food additives that have been considered safe for decades? Are there substances considered innocuous in the 1950s that should get re-evaluated for safety in light of current toxicology knowledge and modern testing technologies? Are there additives once considered safe that should now be banned? That is the question many people are asking about the emulsifier brominated vegetable oil (BVO).

BVO is a synthetic chemical used as an emulsifier in citrus flavored drinks in the U.S. including Mountain Dew and Gatorade from PepsiCo, Powerade, Fanta Orange and Fresca made by Coca-Cola and Squirt and Sunkist Peach soda from the Dr. Pepper Snapple Group. Derived from corn or soybeans, BVO contains bromide atoms that weigh down the citrus flavor and allow it to mix with the sugar water base of the drink. Without BVO or another emulsifier, the fruit flavor would separate and rise to the top. Approximately 10 percent of drinks sold in the U.S. contain BVO.

The use of BVO as an additive dates to the 1930s. When Congress passed the 1958 Food Additives Amendment to the federal Food, Drug and Cosmetic Act, it was placed on the generally recognized as safe (GRAS) list. There are two ways an ingredient can be included on the GRAS list:

• For substances like BVO, in use prior to 1958, a GRAS determination can indeed be made based on common use in food consumed by a significant number of people over a substantial amount of time
• Newer substances can be judged GRAS based on a “consensus of qualified experts” who have reviewed scientific data and currently available information

Although BVO was among the substances grandfathered onto the GRAS list, in the late 1960s and early 1970s, the Flavor and Extract Manufacturers’ Association (FEMA) expert panel decided to evaluate many of these older additives. At that time, they decided that there was insufficient data to support a GRAS claim. The FDA generally follows their recommendations, and in 1970 they revoked the GRAS status of BVO and requested that FEMA study the compound in mice, rats, dogs, and pigs. After several submissions of safety data, the FDA made an interim ruling, pending more studies, that BVO was safe in fruit-flavored beverages in amounts of up to 15 parts per million. But now, over 35 years later, no further studies on BVO have been conducted, and the interim status remains unchanged.

For many experts, this is simply unacceptable. Michael Jacobson, PhD, co-founder and executive director of the Center for Science in the Public Interest, believes that the FDA takes too lax an attitude toward the dangers potentially posed by additives. “The FDA has not been nearly cautious enough in protecting the public from food additives and GRAS substances that cause, or may cause, health problems at the levels consumed,” states Dr. Jacobson.

But the FDA is confident that they have acted with proper vigilance. When questioned about the necessity of conducting further studies on BVO to remove its interim status—either by declaring it GRAS or banning if from the U.S. food supply as it has been in the European Union and Japan—Patricia El-Hinnawy, FDA press officer, was dismissive. In an email, El-Hinnawy states, “The FDA understands that some consumers may have concerns about brominated vegetable oil (BVO) in food products. Based on its review of the science, the FDA has determined that BVO is safe and presents no health risks at the permitted level of 15 parts per million.”