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Senomyx rapped over knuckles by FDA over wording of GRAS press release on sweet taste modifier

By Elaine WATSON , 13-Mar-2014

Senomyx rapped over knuckles by FDA over wording of GRAS press release on sweet taste modifier

Flavor expert Senomyx - which is collaborating with PepsiCo over sweet taste modifier Sweetmyx (S617) - has been rapped over the knuckles by the FDA for implying that the agency had approved (ie. sent a letter of ‘no objection’ about) its GRAS determination for the flavor.

In its press release of March 11 - which has since been amended - Senomyx said S617 had been determined safe “under the provisions of the Federal Food, Drug and Cosmetic Act, administered by the FDA”.

While it made it clear to reporters that this was a FEMA GRAS determination (where safety is determined by the Flavor and Extract Manufacturers Association’s expert panel), this was not explicitly stated in the original release, noted the FDA yesterday (March 12) .

Senomyx, Inc. issued a public statement suggesting that its food ingredient Sweetmyx (also known as S617) was generally recognized as safe (GRAS). The statement appeared to suggest that the FDA had made the GRAS determination. In fact, the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient.

“When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients.”

FEMA GRAS is ‘gold standard’ for safety assessments for flavor substances

As firms choosing to go down the self-determined/affirmed GRAS route are not legally required to notify the FDA that they have done so, the FDA has no central record of all GRAS determinations and no means of checking the quality of the evidence supporting them or the credentials of the experts reviewing that evidence, claim some critics of the GRAS process.

However, GRAS determinations made by the FEMA expert panel are all published in the journal Food Technology and available to the FDA, FEMA executive director John Cox told FoodNavigator-USA.

“The FEMA Expert Panel of independent chemists, toxicologists, pharmacologists and other experts has been assessing the safety of flavors for more than 50 years.  It’s the gold standard when it comes to GRAS programs for flavor substances.

“You could convene a separate independent expert panel to determine if a flavor substance is GRAS, but if you’re a flavor manufacturer and you want to bring a new flavor substance to market you’d be foolish to do it any other way than through FEMA.”

FEMA GRAS determinations are all published and publicly available

John Cox: 'FEMA GRAS is the gold standard when it comes to GRAS programs for flavor substances.'

As for transparency, the identity of all FEMA GRAS substances is also available on the FEMA website , he added, while the scientific information serving as the basis for the panel's determinations of GRAS status is provided to FDA for all FEMA GRAS flavor ingredients.  This allows the agency to include the information in its databases and to challenge any GRAS determinations that it wishes.

Meanwhile, descriptions of the scientific information supporting the GRAS status of individual flavor ingredients are published in the journal Food and Chemical Toxicology as ‘FEMA group summaries’ in which information on individual flavoring substances and their structural relatives is reviewed.   

A company can make an independent GRAS determination without notifying the FDA. However, the agency does have a voluntary GRAS notification program whereby a company can inform the FDA of the company’s determination. The FDA maintains an inventory of such GRAS Notices  on its website, allowing the public to confirm whether FDA has filed and responded to a GRAS notice. 

Click HERE to read more about the FEMA GRAS process. 

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