Consumer scrutiny turns to substance used for decades

Stephanie Strom / New York Times News Service /

Published Jan 3, 2013 at 04:00AM

Sarah Kavanagh and her little brother were looking forward to the bottles of Gatorade they had put in the refrigerator after playing outdoors one hot, humid afternoon last month in Hattiesburg, Miss.

But before she took a sip, Sarah, a dedicated vegetarian, did what she often does and checked the label to make sure no animal products were in the drink. One ingredient, brominated vegetable oil, caught her eye.

“I knew it probably wasn’t from an animal because it had vegetable in the name, but I still wanted to know what it was, so I Googled it,” Sarah said. “A page popped up with a long list of possible side effects, including neurological disorders and altered thyroid hormones. I didn’t expect that.”

She threw the product away and started a petition on Change.org, a nonprofit website, that has almost 200,000 signatures. Sarah, 15, hopes her campaign will persuade PepsiCo, Gatorade’s maker, to consider changing the drink’s formulation.

Jeff Dahncke, a spokesman for PepsiCo, noted that brominated vegetable oil had been deemed safe for consumption by federal regulators. “As standard practice, we constantly evaluate our formulas and ingredients to ensure they comply with federal regulations and meet the high quality standards our consumers and athletes expect — from functionality to great taste,” he said in an email.

In fact, about 10 percent of drinks sold in the United States contain brominated vegetable oil, including Mountain Dew, also made by PepsiCo; Powerade, Fanta Orange and Fresca from Coca-Cola; and Squirt and Sunkist Peach Soda, made by the Dr Pepper Snapple Group. The ingredient is added often to citrus drinks to help keep the fruit flavoring evenly distributed; without it, the flavoring would separate.

Controversial for decades

Use of the substance in the United States has been debated for more than three decades, so Sarah’s campaign most likely is quixotic. But the European Union has long banned the substance from foods, requiring use of other ingredients. Japan recently moved to do the same.

Brominated vegetable oil contains bromine, the element found in brominated flame retardants, used in things like upholstered furniture and children’s products. Research has found brominate flame retardants building up in the body and breast milk, and animal and some human studies have linked them to neurological impairment, reduced fertility, changes in thyroid hormones and puberty at an earlier age.

Limited studies of the effects of brominated vegetable oil in animals and in humans found buildups of bromine in fatty tissues. Rats that ingested large quantities of the substance in their diets developed heart lesions.

Its use in foods dates to the 1930s, well before Congress amended the Food, Drug and Cosmetic Act to add regulation of new food additives to the responsibilities of the Food and Drug Administration. But Congress exempted two groups of additives, those already sanctioned by the FDA or the Agriculture Department, or those experts deemed “generally recognized as safe.”

The second exemption created what Tom Neltner, director of the Pew Charitable Trusts’ food additives project, a three-year investigation into how food additives are regulated, calls “the loophole that swallowed the law.” A company can create a new additive, publish safety data about it on its website and pay a law firm or consulting firm to vet it to establish it as “generally recognized as safe” — without ever notifying the FDA, Neltner said.

About 10,000 chemicals are allowed to be added to foods, about 3,000 of which have never been reviewed for safety by the FDA, according to Pew’s research. Of those, about 1,000 never even hit the FDA’s radar screen unless someone has a problem with them; they are declared safe by a company and its handpicked advisers.

The FDA is aware of the controversy surrounding brominated vegetable oil. It took the ingredient off its list of substances “generally recognized as safe” in 1970, after the Flavor and Extract Manufacturers Association revoked its approval of it. The group’s expert panel is the primary body for evaluating the safety of flavoring substances added to food; if it rules something is “generally recognized as safe,” the FDA goes along.

John Halligan, senior adviser and general counsel to the organization, said that during the late 1960s and early 1970s, the expert panel was reviewing many older additives that had been grandfathered into “generally recognized as safe” status when the federal law was changed.

“They came to BVO and there had been some new studies done which weren’t definitive,” he said. “The panel looked at data and said it doesn’t look like we have an adequate database here to conclude this substance is generally recognized as safe, so they revoked its status.”

Subsequently, Patricia El-Hinnawy, a spokeswoman for the FDA, wrote in an email, the agency asked the association to do studies on brominated vegetable oil in mice, rats, dogs and pigs. She said that the organization made “several submissions of safety data” to the FDA while those studies were going on, roughly from 1971 to 1974.

“FDA determined that the totality of evidence supported the safe use of BVO in fruit-flavored beverages up to 15 parts per million,” El-Hinnawy wrote.

That ruling, made in 1977, was supposed to be interim, pending more studies, but 35 years later it is unchanged. “Any change in the interim status of BVO would require an expenditure of FDA’s limited resources, which is not a public health protection priority for the agency at this time,” El-Hinnawy wrote.

‘Abysmal’ testing

Meanwhile, no further testing has been done. While most people have limited exposure to brominated vegetable oil, an extensive article about it by Environmental Health News that ran in Scientific American last year found that video gamers and others who binge on sodas and other drinks containing the ingredient experience skin lesions, nerve disorders and memory loss.

Michael Jacobson, co-founder and executive director of the Center for Science in the Public Interest, said some studies show that BVO collects in fatty tissues, raising questions about what its effect might be during weight loss. Jacobson, who looked into the research on brominated vegetable oil after being asked about it by The New York Times, concluded, “The testing of BVO is abysmal.”

He said the longest studies of the ingredient he could find covered only four months, while most food additives are usually tested for two years, making it impossible to establish a safe level of consumption.