Drink Ingredient Gets a Look
James Edward Bates for The New York Times
By STEPHANIE STROM
Published: December 12, 2012
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.
James Edward Bates for The New York Times
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,” Ms.
Kavanagh 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 Web site, that has almost 200,000 signatures. Ms. Kavanagh, 15, hopes her campaign will persuadePepsiCo, 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 e-mail.
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.
Use of the substance in the United States has been debated for more than
three decades, so Ms. Kavanagh’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.
“B.V.O. is banned other places in the world, so these companies already
have a replacement for it,” Ms. Kavanagh said. “I don’t see why they
don’t just make the switch.” To that, companies say the switch would be
too costly.
The renewed debate, which has brought attention to the arcane world of
additive regulation, comes as consumers show increasing interest in food
ingredients and have new tools to learn about them. Walmart’s app, for
instance, allows access to lists of ingredients in foods in its stores.
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 F.D.A.
or the Department of Agriculture, 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 Web site and pay a law firm or consulting firm to
vet it to establish it as “generally recognized as safe” — without ever
notifying the F.D.A., Mr. 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 F.D.A., according to
Pew’s research. Of those, about 1,000 never come before the F.D.A.
unless someone has a problem with them; they are declared safe by a
company and its handpicked advisers.
“I worked on the industrial and consumer products side of things in the
past, and if you take a new chemical and put it into, say, a tennis
racket, you have to notify the E.P.A. before you put it in,” Mr. Neltner
said, referring to the Environmental Protection Agency. “But if you put
it into food and can document it as recognized as safe by someone
expert, you don’t have to tell the F.D.A.”
Michael R. Taylor, deputy commissioner for food and veterinary medicine
at the agency, said: “From our standpoint, we do need to look at whether
this regime established by Congress almost 60 years ago gives us the
information we need. It would be desirable for F.D.A. to have more
information on products being added to food.”
The F.D.A. 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
F.D.A. 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 B.V.O. 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 F.D.A, wrote in
an e-mail, 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 F.D.A.
while those studies were going on, roughly from 1971 to 1974.
“F.D.A. determined that the totality of evidence supported the safe use
of B.V.O. in fruit-flavored beverages up to 15 parts per million,” Ms.
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 B.V.O.
would require an expenditure of F.D.A.’s limited resources, which is
not a public health protection priority for the agency at this time,”
Ms. El-Hinnawy wrote.
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 F. Jacobson, co-founder and executive director of the Center for
Science in the Public Interest, said some studies show that B.V.O.
collects in fatty tissues, raising questions about what its effect might
be during weight loss. Dr. Jacobson, who looked into the research on
brominated vegetable oil after being asked about it by The New York
Times, concluded, “The testing of B.V.O. 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.
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