by Marion Nestle

Currently browsing posts about: GRAS

Aug 15 2016

The FDA’s unfortunate ruling on GRAS regulations

The FDA has announced its Final Rule on Substances Generally Recognized as Safe (GRAS).

The FDA explains:

Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives…The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.

Uh oh.  “Appropriate qualified experts?”  Like those selected by the companies themselves?  The FDA has failed the public on this one.

Consumers Union (CU) says

FDA missed a major opportunity to clean up the food system… Companies will still be able to introduce novel substances into food in secret, without having to show they are safe.  The agency also failed to fix the rampant conflicts of interest that affect the review process for ingredients. That is unacceptable and deeply disappointing [CU should know.  It filed comments on the FDA’s proposed GRAS rules in 2011].

Senator Ed Markey (Dem-MA) says

FDA’s Final Rule On Food Safety Process Is A Missed Opportunity…The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take home exam that industry doesn’t even have to hand in…I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply [Sen. Markey sent FDA a letter in April asking if the agency needs statutory authority to ensure the safety of GRAS substances and encouraging the FDA to issue guidance on how to prevent conflicts of interest for outside experts evaluating GRAS substances.

The backstory

The FDA’s final GRAS rule is the result of a settlement agreement following a 2014 lawsuit filed by the Center for Food Safety. The basic issue: GRAS substances are not subject to FDA premarket approvals required for food additives.  Manufacturers are allowed to decide for themselves whether their additives are GRAS without informing the FDA. The new rules confirm this self-managed GRAS notification procedure.

I wrote about this issue in an editorial for JAMA Internal Medicine in 2013 when I commented on a study by Tom Neltner and his colleagues on the blatant conflicts of interest in FDA approval of GRAS substances.

Their study examined conflicts of interest among scientific experts serving on panels deciding whether food additives–substances that preserve, flavor, blend, and thicken food—should be deemed generally recognized as safe (GRAS) and exempt from Food and Drug Administration (FDA) premarket approval requirements.  Their findings are alarming. An astonishing 100 percent of the members of 290 expert panels included in their review worked directly or indirectly for the companies that manufactured the additive in question.  Even more alarming, the experts on these panels form a tight professional cadre.  Although 850 people served on the panels, 10 experts served on 27 panels or more, and one of these ten participated in three-quarters of the panels.

My editorial reviewed the lengthy history of FDA’s dithering about the GRAS process.  None of this would matter if all food additives were safe.  But some are not.  I also pointed out:

The problems created by conflicts of interest for the FDA go well beyond those related to food additives and GRAS exemptions.  A recent analysis of requests for waivers by people serving on FDA advisory committees views conflicts of interest as a severe threat to scientific integrity.  As Neltner et al. argue, the lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, particularly the additives that the FDA does not even know about. It also raises questions about conflicts of interest in other regulatory matters.

The FDA’s decision is a loss for public health.

It constitutes yet another reason not to eat products with long lists of additive ingredients.

Addition, August 16

The Environmental Working Group also issued a statement.

EWG is disappointed the FDA has decided to once again ignore its legal obligation to ensure the safety of our nation’s food supply…The so-called “GRAS loophole” – originally intended to only allow known ingredients proven safe to skip regulatory approval – has swallowed the law, permitting novel chemicals to be added to food without government oversight.

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