SAN FRANCISCO -- When PepsiCo Inc. announced, just before the Super Bowl, it would stop putting an obscure vegetable oil in its Gatorade, one of the loudest cheers came from a high school student who had made it her mission to get rid of the ingredient.
"I was like, `Whoa,"' said Sarah Kavanagh, a 16-year-old from Hattiesburg, Miss., who wanted to know why an oil that contains a chemical also found in flame retardants was in the sports drink. After she posted a petition on Change.org asking Pepsi to remove it, more than 200,000 people signed.
From oil in Gatorade to the amount of caffeine and other stimulants in energy drinks and the so-called "pink slime" found in beef, previously unnoticed ingredients are coming under scrutiny as health-conscious consumers demand more information about what they eat and drink.
The U.S. Food and Drug Administration reviews and approves most additives to food or drinks before they hit the marketplace. Others may bypass that process if they are deemed "generally recognized as safe" by the government or food companies and the experts they hire.
Developed in 1965 at the University of Florida to help football players remain hydrated in the heat, Gatorade was a hit. By 1969, a private company acquired rights to market the drink and began adding brominated vegetable oil to distribute flavor evenly in a new orange version.
In those days, the oil was included in a list of additives, preservatives and chemicals that the government called generally recognized as safe, or GRAS. The GRAS designation took root more than a half-century ago as a way to help the processed food industry avoid lengthy reviews of ingredients that were considered, by qualified experts, to be safe under conditions of intended use.
The list included ingredients such as vitamin A and citric acid -- about 180 in all.
As food scientists create more new ingredients to add health benefits or help food stay fresh, there are at least 4,650 GRAS ingredients, according to the nonpartisan Pew Charitable Trusts. The bulk of them, at least 3,000, were determined GRAS by food manufacturers or trade associations, and their expert scientists.
No one knows exactly how many GRAS ingredients are in products because manufacturers are not required to notify the FDA before adding them.
Brominated vegetable oil was on the safe list when Stokely-Van Camp Inc. developed orange-flavored Gatorade in 1969. The FDA notes the oil contains far less bromine than flame retardants and is considered safe in limited quantities in fruit-flavored drinks. It is used to emulsify citrus oil in fruit-flavored beverages including Mountain Dew, Fanta and Powerade.
The ingredient, banned as an additive in Japan and the European Union, will remain in orange Gatorade through this spring, said spokeswoman Molly Carter of PepsiCo, which now owns Gatorade.
"While our products are safe, we are making this change because we know that some consumers have a negative perception of BVO in Gatorade," Carter said.
In 1958, Congress amended the Federal Food, Drug and Cosmetic Act to establish the generally recognized as safe exemption. In following years, the FDA added ingredients to its safe list after reviewing the supporting science. That proved a time-consuming process, so in 1997 the FDA changed its procedures to allow food companies voluntarily to notify the agency of ingredients they consider safe by submitting published research and expert opinion. Not all do. Since 1997, the FDA has received 451 such notifications, and the agency disagreed with the science in 17 cases.
Industry associations say the process saves the government money and supports innovation by reducing red tape. Representatives also say manufacturers have every incentive to make their products safe.
Even if the FDA disagrees with the supporting science, current law provides no clear recourse to stop companies from adding these GRAS ingredients.
If the FDA suspects an ingredient deemed safe actually is harmful, the government can take action after a product hits the market, but it does not track how often that has happened. In one case, in 2010, the agency issued warning letters to four makers of popular caffeinated alcoholic drinks, declaring caffeine unsafe in alcoholic beverages. Under threat of product seizure, the companies stopped making the drinks.
Consumers may petition the FDA to take an ingredient off the list, although a report by the Government Accountability Office found requests can take years to review.
Michael Taylor, FDA deputy commissioner for foods, believes the program works well but that it is time to consider updating it to ensure the evidence supporting safe designations reflects the latest science. He added FDA would benefit from having access to scientific evidence companies use to determine that an ingredient is GRAS.
Taylor said during the next year FDA may send new administrative rules detailing how companies should demonstrate ingredient safety, but he noted it would take an act of Congress to force companies to share all their information with FDA.
Carl Keen holds the chair in developmental nutrition at the University of California, Davis -- a position funded by Mars Inc., the candy company. As such, Keen develops ingredients for the company, and his research has found certain nutrients in cocoa powder can lower heart disease risk.
He and other food scientists said the GRAS process is an efficient way to get beneficial new additives to consumers, and companies apply the highest safety standards.
"You'll have the average consumer say industry research taints the system," he said. "But if you ask them should the federal government be vetting research on the health benefits of chocolate and cocoa, they'll probably say no."
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