Food Industry to Americans: It's Safe to Eat (or Drink). Trust Us.


What does it mean when a food ingredient is labeled "safe"? The question seems straightforward, but the answer proves to be disorienting. Recently, the biotechnology company Senomyx, Inc. was in the news following confusion over a safety determination for one of its products.

The San Diego-based company develops, manufactures, and sells a variety of flavor ingredients for use in food and drinks. Their latest product – a flavor modifier called Sweetmyx – is a "sweetener enhancer," which allows food and beverage manufacturers to reduce sweetener use while maintaining taste intensity. Under a 2010 agreement, Pepsi holds exclusive rights to use Sweetmyx in non-alcoholic beverages.

On March 11, Senomyx issued a statement announcing, "Sweetmyx flavor ingredient, previously referred to as S617, has been determined to be Generally Recognized As Safe (GRAS) under the provisions of the Federal Food, Drug and Cosmetic Act, administered by the United States Food and Drug Administration (FDA)."

Shortly after the announcement, news outlets reported that Sweetmyx had been determined safe by the FDA. A Reuters headline read, "FDA says Senomyx sweetener enhancer safe" while a subhead by the financial news outlet Barron's declared, "The biotech received a nod from the FDA for the sweetener Sweetmyx." Subsequently, the value of Senomyx stock shares jumped as high as 26 percent on the day before closing up 17 percent.

So what's the problem?

The FDA Does Not Determine "Generally Recognized As Safe" Status

The FDA issued a statement the day after Senomyx's announcement, underlining the fact that the agency had not made the GRAS determination and even going so far as to chide Senomyx. "When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients," the agency said.

Whether or not the wording of Senomyx's announcement was purposefully misleading, the situation did highlight serious confusion over how GRAS determinations are made and what it means for food ingredients to be labeled "safe."

The GRAS Process

For new ingredients (or by legal terms, "substances") to be added to food, companies must comply with the Federal Food, Drug, and Cosmetic Act of 1938. Food Safety News points out that under the law, "Substances are added to food either as food additives or as GRAS. The difference between the two paths is significant: FDA must sign off on food additives, but companies can use GRAS substances without FDA approval. Notably, companies make their own GRAS determinations, which they may or may not voluntarily submit to FDA for review." (Emphasis added)

In other words, industry is allowed to police itself when it comes to the safety of a significant number of ingredients added to the foods and beverages our families eat and drink every day.

In a recent article, Marion Nestle, a nutrition professor at New York University, weighed in on Sweetmyx, the GRAS process, and what she calls a "shocking gap in FDA regulatory authority over GRAS determinations." She asked the involved parties:

  • Pepsi: Don't you want FDA approval before putting this stuff in your drinks?
  • Chemists: What is Sweetmyx, anyway?
  • FDA: Don't you think you ought to take a look at this thing?
  • Congress: How about insisting that the FDA establish a better system for dealing with food additives?

Nestle isn't alone. The Pew Charitable Trusts and the Natural Resources Defense Council (NRDC) have also been vocal in criticizing the process and expressing hope for reform. Additionally, a 2010 U.S. Government Accountability Office (GAO) report called for the FDA to update the GRAS process, citing conflict of interest issues. A 2013 study published by the American Medical Association backed up those concerns, concluding, "Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS."

Robert McQuate, CEO of GRAS Associates, LLC, doesn't see the GRAS process leaving the public overly vulnerable. In February, McQuate told Kelly Damewood of Food Safety News, "If FDA sees that there is an issue that adversely affects public health, even if [the substance] has previously enjoyed GRAS status, FDA does have the authority and capability to make changes." He went on to cite the FDA's proposal to "de-GRAS" partially hydrogenated oils, the primary source of industrially produced trans fatty acids, which can cause heart disease.

True, the FDA proposal to remove Generally Recognized As Safe status from partially hydrogenated oils was a step in the right direction, one that the Center for Effective Government strongly supported. But the fact that it would take the agency a decade to take action suggests serious flaws in the process, leaving Americans at risk from under-scrutinized food additives that may harm their health.

UPDATE: On April 7, the NRDC released a short video outlining the need to reform the GRAS process. Check it out here.

Image by Flickr user donhomer, used under a Creative Commons license

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