Wednesday, April 2, 2014


Many consumers are lulled into believing that if a food product contains an ingredient that is declared as Generally Recognized As Safe ("GRAS") is really safe to consume. But few realize the real meaning of GRAS and who decides about the GRAS status of a substance. According to recent reports there is a conflict of interest on the part of the manufacturer because such determination about GRAS is made by the manufacturer himself with no independent verification by any statutory authority. Probably the underlying philosophy seems to be that industry will never compromise on the safety of the consumer. Unfortunately this is a travesty of truth and history is replete with instances about many GRAS ingredients causing serious health problems, long term as well as short term.

Those who propound the theory that industry should have such a liberty hide under the provision of safety act that the regulatory authority concerned can always haul the culprits if their claim is found to be untrue. world over regulatory agencies find themselves unable to monitor and implement statutory rules let alone take up responsibility like checking the safety of the so called GRAS substances used by hundreds of manufacturers without safety clearance. Of course there is a provision that if challenged the user industry must provide data to back up their claim to classify the ingredients under GRAS list. Here is the latest instance of the US food industry using a sweetener enhancer, presumably synthetic in nature, under the garb of GRAS and the reaction by experts on this ill defined provision allowing use of ingredients self declared as GRAS 

"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."

Is it not a tragedy that the manufacturer of the above product, scientific community, user industry and the regulatory agencies indulge in an ostrich like policy without bothering to think about the far reaching consequences of using substances with very little understanding of its nature in day to day products. The secretive way in which such things happen with sickening regularity must be frowned upon and there must be international protocols that stipulate the methodology for assessing safety of food ingredients.  

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