by Marion Nestle

Currently browsing posts about: GRAS

Mar 13 2014

No, the FDA has not approved Sweetmyx: another reason to fix the GRAS regs

Yesterday, Emily Main of Rodale Press sent me this question:

Have you ever heard of this new “sweetness enhancer” that just got approved by the FDA? It’s called Sweetmyx and is made by a company called Senomyx, and is apparently licensed by Pepsi for exclusive use.  All I can really find out about it is that it enhances the sweet flavor of other sugars, so soda companies can use less sugar in their regular products…Do you have any insight about it?

Nope.  Never heard of it..  All I could find out was that Pepsi had an exclusive deal to use it, according to a Bloomberg report.

Sweetmyx, a new ingredient by Senomyx Inc. (SNMX), received approval for foods and beverages, clearing the way for PepsiCo Inc. (PEP) to use it to make lower-sugar beverages taste sweeter.

The Flavor and Extract Manufacturers Association’s expert panel has determined that Sweetmyx is generally recognized as safe as an ingredient, San Diego-based Senomyx said today in a statement. PepsiCo has the exclusive right to use the product, a so-called flavor modifier, in many nonalcoholic drinks under a 2010 agreement.

While I was trying to discover what Sweetmyx is, exactly, this notice came in from the FDA: 

On March 11, 2014, 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 U.S. Food and Drug Administration (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. The company’s statement has been corrected and now notes that a third party organization made the determination.

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.

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

For more information on the GRAS notification process, please see: Generally Recognized as Safe (GRAS).

Recall from one of my previous posts the shocking gap in FDA regulatory authority over GRAS determinations.

  • Manufacturers get to decide whether food additives are safe or not.
  • Manufacturers get to decide whether to bother to tell the FDA the additives are in the food supply, and even if they do.
  • Manufacturers get to decide who sits on the panels that review the evidence for safety.

In the case of Sweetmyx, the company’s consultant says it’s safe so why bother to see if the FDA agrees.

My questions:

  • 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

Hey, I can dream.

Additions, March 14:

A reader reminds me that the Center for Food Safety filed a lawsuit to get the FDA to do a better job on GRAS determinations (more information is here).

Another reader points out that Coca-Cola also was flirting with Senomyx a few years ago but evidently gave up the idea.

And another notes that Senomyx’s financial report makes it clear that the company knows it has regulatory issues: “Senomyx may be asked to complete additional studies to evaluate and/or monitor the safety of new flavor ingredients in order to maintain applicable regulatory approvals and/or obtain regulatory approvals outside of the United States.”

Nov 7 2013

Trans-fat: FDA proposes to eliminate GRAS status

The FDA has just announced a proposal to withdraw GRAS (Generally Recognized As Safe) status for trans-fat.

My first reaction: Isn’t trans-fat already out of the food supply?  Hasn’t this been one of the food industry’s greatest public health achievements?

Once the FDA started to require trans-fat to be listed on food labels, food companies quickly stopped using partially hydrogenated oils (the source of trans-fat) and found healthier substitutes.  That’s why most food labels list zero grams trans-fat.

But the FDA allows food labels to say zero trans-fat if its amount is below 0.5 gram per serving.

Some manufacturers are still using a little.  This new initiative will encourage them to get rid of those last little bits.

Contrary to the New York Times headline, this is not exactly a ban on trans-fat.  If trans-fat is no longer GRAS, manufacturers can still file a food additive petition to continue using partially hydrogenated oils.

The Federal Register notice asks for input for the next 60 days.

I say congratulations to all:

  • To food companies who worked hard to find ways to substitute healthier fats for trans-fats.
  • To the FDA for finally taking care of the trans-fat 0.5-gram loophole.
  • To Center for Science in the Public Interest for bringing health problems with trans-fat to public attention.
  • To all of the researchers who did the science linking trans-fat to higher LDL-cholesterol levels and to heart disease risk.
  • To the New York City health department for banning trans-fats from use in city restaurants.

Americans will be healthier as a result of all of your efforts.

Resources

At the moment, the FDA has not yet posted its Federal Register notice on the GRAS status of trans-fat. When it does, the notice should be available here.

CSPI’s home page on trans fat

The FDA trans-fat home page

FDA consumer materials

FDA guidance for industry

Research