A ‘black box’
The largely industry-run system for evaluating flavors is “fundamentally problematic because it’s so opaque,” said Erik Olson, the Natural Resources Defense Council’s senior strategic director for health and food. “It’s a black box.”
Yet the system factors into food products found in nearly every consumer’s grocery cart.
In recent years, activist groups and social media campaigns have been demanding that food companies become more accountable to consumers and transparent about what they are adding to their products.
But most Americans know as little about the decidedly low-profile Flavor and Extract Manufacturers Association and its safety assessments as they do about the more than 2,700 flavoring chemicals it has declared safe during the past five decades.
Moreover, public interest groups say the FDA’s recent response to a Freedom of Information Act request suggests that even the government may be blind to the science behind many of those flavors.
Much is at stake: The flavor industry’s system of self-policing helps it avoid government oversight, potentially saving companies significant amounts of time and money. In Europe, by contrast, companies must have their flavors and other ingredients reviewed for safety by an independent agency funded by the European Union.
The flavor industry makes its safety evaluations “behind closed doors” and then asks consumers to trust them, said Caroline Cox, research director for the Center for Environmental Health. “We just have enough experience with all kinds of toxic chemicals to know not to want to trust an evaluation if someone says, ‘Trust us, it’s all OK.’”
“There is some real need for reform here,” Rep. Chellie Pingree, D-Maine, who serves on a subcommittee that oversees the FDA, said in an emailed statement. “We can do better than just letting the flavor industry decide for themselves which chemicals they can put in food without any oversight.”
Industry officials say flavors used in food sold in the United States are safe, pointing out that they pose very little health risk because they are used in such small doses. But identifying health concerns would seem to be difficult with so little scientific information publicly available behind some of the trade group’s safety decisions.
A Center for Public Integrity review of documents provided by the Flavor and Extract Manufacturers Association found that four of the group’s most recent safety assessments depended largely on studies that were not published in scientific literature. Public interest groups say that is problematic because it doesn’t allow the scientific community to vouch for the industry’s safety decisions.
The Center for Public Integrity contacted two dozen flavor companies to discuss their ingredients and the process by which they evaluate their safety. Most of them either declined to comment or ignored interview requests.
Two company officials who responded in writing both stressed that flavor companies are very guarded about discussing such information.
“Given the competitive landscape in our industry, many companies, including ours, regard our flavor formulations as valuable proprietary business information,” Donald Wilkes, president and chief executive officer of California-based Blue Pacific Flavors, emailed in response to questions. “We typically do not share this information unless required to do so for legal reasons.”
Nevertheless, the public should be assured food flavor safety standards are high, said Kevin Renskers, president-elect of the Flavor and Extract Manufacturers Association and vice president for corporate safety and regulatory affairs at Takasago International Corp.
“FEMA operates the premier global program to assure the safety of flavor materials,” he responded in an email.
The companies that make up the flavor industry — including international manufacturers such as Givaudan, Firmenich and Sensient — are not household names. But they make their money by selling flavors to big food companies such as Kellogg, Kraft and Nestlé.
Last year, Switzerland-based Givaudan reported 4.4 billion Swiss francs (roughly $4.8 billion) in sales of flavor ingredients. The company leads the industry with about 25 percent of the global market share in flavors and fragrances.
“The modern processed food industry could not flourish without the flavor industry,” said Kantha Shelke, a food scientist and spokeswoman for the Institute of Food Technologists, a society of food science professionals.
Today, Shelke said, the flavor industry is “big, it’s complicated and it’s sophisticated” — to the point where companies can create a product that tastes like guacamole without even using avocado as an ingredient. The goal, one industry scientist told CBS’ 60 Minutes in 2011, is to develop addictive flavors that consumers “want to go back for again and again.”
Shelke says flavor companies don’t like to discuss their flavor compounds, partly because they are worried about scaring “chemophobic” consumers who might be frightened by long, unfriendly-sounding chemical names.
Consumers’ growing unease with chemicals in food has recently led companies to remove some controversial ingredients from their products. Fast food chain Subway, for example, announced last year that it was removing azodicarbonamide from its bread after a popular food blogger revealed that the chemical, used as a dough conditioner, was also used in making yoga mats.
Within the last month, Subway, Taco Bell and Pizza Hut each announced plans to remove artificial colors and flavorings from their products.
By law, flavor ingredients only have to be listed on food labels as “natural” or “artificial” — and rarely do labels volunteer additional information. Natural flavors are derived from plants and animals, while artificial flavors are synthetic chemicals. Both are produced in labs by scientists.
When it comes to questions about safety, flavor companies typically defer to the Flavor and Extract Manufacturers Association. The group is managed by Verto Solutions — a Washington, D.C., firm that provides scientific consulting, communications and government relations services to the flavor group, as well as other similar trade associations, including the International Association of Color Manufacturers, the International Organization of the Flavor Industry and Pickle Packers International.
While the Flavor and Extract Manufacturers Association reports no lobbying, it understands Congress’ power to regulate the food industry. The group is hosting its second annual congressional “fly-in” event on June 16-17 to “increase its visibility” and meet with representatives “to ensure that they are aware of the U.S. flavor manufacturing industry and its importance to the economy,” according to its website.
‘The highest standards for transparency’
The Flavor and Extract Manufacturers Association’s program for evaluating the safety of flavors has won praise from some corners of government, namely the FDA and the Government Accountability Office.
Its flavor safety program launched in 1960 — two years after Congress passed the first law regulating ingredients added to food.
The law allows food companies to bypass a lengthy government-led safety review if they can establish that their ingredients are “generally recognized as safe,” or GRAS, for their intended use.
In other words, companies using the so-called GRAS process must demonstrate that there is a consensus among scientific experts that their ingredients are safe.
Companies have the option of involving the FDA in the process, but most ingredient manufacturers choose to make safety determinations without government oversight.
In Europe, the industry doesn’t have the option to police itself.
The European Union requires companies to have their new flavors and other additives reviewed by the European Food Safety Authority, an independent agency funded by the European Union.
The Flavor and Extract Manufacturers Association’s member companies — which produce 95 percent of all flavors on the market in the United States — typically forgo FDA review and instead choose to submit their flavors to the trade association for a safety review.
A standing panel of six to eight scientific experts oversees the trade group’s safety program and determines whether ingredients are generally understood to be safe by the scientific community. These experts, who are paid by the trade association, review published and unpublished data before making a conclusion on the safety of an ingredient’s use.
“From Takasago’s perspective, to have GRAS approval by the FEMA Expert Panel provides us with a high level of confidence that our material can be used safely,” said Renskers, the company official and Flavor and Extract Manufacturers Association president-elect.
Industry officials stress that flavor ingredients generally pose very little safety risk because they are used in such small amounts in food. The trade group used this argument to support its conclusion that methyl eugenol is safe, despite studies finding that it causes cancer in animals.
The naturally occurring flavor, which the FDA has approved as a food additive, is used in foods including jellies, baked goods and chewing gum. The Flavor and Extract Manufacturers Association first determined methyl eugenol to be GRAS in 1965, but the group revisited that decision in 2001 after studies by the National Toxicology Program found “clear evidence of carcinogenic activity” of the substance in male and female rats and mice.
But the trade group still concluded that methyl eugenol “does not pose a significant cancer risk” to humans because it is used in food at such low levels.
After the trade group reconfirmed that it was safe, the International Agency for Research on Cancer found that methyl eugenol is “possibly carcinogenic to humans.”
The Flavor and Extract Manufacturers Association notes that many of the flavors it has reviewed over the years have also been evaluated for safety by other scientific bodies, including the European Food Safety Authority.
The Government Accountability Office praised the Flavor and Extract Manufacturers Association’s program in a 2010 report about the FDA’s limited oversight of food additives, specifically highlighting its procedures to prevent conflicts of interest and its practice of voluntarily informing the FDA about each of its safety determinations.
Scientists who serve on the flavor group’s expert panel are forbidden from having financial ties to companies submitting flavors for review. To that end, panelists’ stipends come from the trade association, rather than from companies directly. Panelists also review the safety of ingredients without knowing which company submitted them.
For these reasons and more, the trade group bills its GRAS program as “fully objective” and “not subject to bias.”
The Government Accountability Office report further applauded the Flavor and Extract Manufacturers Association for informing the FDA of flavor names, properties and reasons for the expert panel’s conclusion when notifying the agency of new safety determinations.
But if the FDA has such information, it can’t find it, according to the agency’s response to a recent Freedom of Information Act request.
Last October, the Center for Science in the Public Interest requested “all information that the Flavor and Extract Manufacturers Association (FEMA) has supplied to FDA since 1960 as support for its determinations that flavors it has evaluated are generally recognized as safe, or GRAS.”
The FDA’s May 21 response: “We have searched our files and find no responsive information.”