Currently browsing posts about: Additives

Aug 7 2013

You think the FDA gets to approve all food additives as safe? Not a chance.

I was invited to write the editorial to accompany a study published today in JAMA Internal Medicine looking at the highly conflicted process used to decide whether food additives are Generally Recognized as Safe (GRAS).

Here’s the study.

Here’s my editorial.

I know this sounds completely crazy, but here’s what the study found:

  • 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 if they do volunteer to inform the FDA (and many do),

  • Manufacturers get to decide who sits on the panels that review the evidence for safety.

In reading the study, it seemed to me that:

  • As long as not too many people roll over dead after eating foods with new additives, nobody will ever have a clue whether the additive is safe.
  • The regulatory gap has spawned an entire enterprise of GRAS consultants and GRAS consulting firms who are in the business—presumably lucrative—of providing the scientific documentation the FDA needs to determine additive safety.

Some of the consultants need to do a better job.  The FDA raises enough questions that about 15% (my estimate) of the requests would be denied.

The good news: If the FDA sees the safety documentation, it does its job.

But what happens to the rejected additives?  Or the ones that don’t get voluntarily sent to FDA?

Nobody really knows (think: caffeine in alcohol drinks–the FDA had no idea).

We need a better food safety system in this country and conflicts of interests in GRAS additive approvals are a good place to start.

Here’s what USA Today has to say about this (I’m quoted).

 

 

Mar 31 2011

What’s up with food dyes and hyperactivity?

 I’ve been waiting to see what the FDA panel did before commenting on this week’s hearings on food dyes and hyperactivity in young children. 

According to reports from CNN and from the New York Times, the panel decided—to do nothing. 

Research, says the FDA panel, is insufficient to conclude that food dyes cause hyperactivity.  Despite much concern about this issue in Great Britain, the FDA will not put a warning label on foods that contain the dyes. 

This is déjà vu all over again.  When I first became interested in nutrition in the mid-1970s, food dyes were a big issue.   

Hyperactivity in kids was a new thing.  Ben Feingold, a physician in California, said that a diet devoid of food colors would help calm kids down. 

The Feingold Association still encourages that diet.

But scientfic tests of the Feingold hypothesis produced mixed effects.  In 1980, Science magazine published two reports of such tests. 

The first”by James M. Swanson and Marcel Kinsbourne (Science 1980;207:1485-87) gave pills containing a mix of food additives to 40 children, 20 diagnosed as hyperactive and 20 not.  The children diagnosed with hyperactivity reacted to the food additive challenge but the other children did not.

This study, however, was criticized for using pills, mixing additives, and evaluating the kids’ behavior by methods that were controversial.

A second study (Weiss, et al. Science 1980;207:1487-89) made a valiant effort to correct for those problems.  It created two drinks that looked and tasted the same, one with a blend of seven food colors and one without.    The study was carefully designed to be triple-blind.  The drinks were formulated to look the same and neither the kids, parents, or observers knew what the kids were drinking.  The drinks were tested at different times on 22 kids.

The result?  Twenty of the 22 kids showed no reaction to the dyes.  One showed occasional reactions. 

But one child reacted to the dyes every time.

The interpretation?  A small percentage of kids may react to food dyes.

That was pretty much the end of that except for petitions by Center for Science in the Public Interest to get rid of food dyes.

There things rested until 2007 when a study in England revived the issue.

Food dyes have only one purpose: to sell junk foods.  Candy, Cheetos, and sodas that are brightly colored are perceived as tasting better than the grey alternatives.  The food industry needs food dyes badly.

But nobody else does.  Parents of hyperactive kids can easily do their own experiment and see if removing food colors helps calm their kids down. 

Food dyes have no health benefits that I can think of.  Kids don’t need to be eating those foods anyway.  Kids will not be harmed by avoiding food dyes.

It would be nice to have more conclusive research.  In the meantime, read food labels!

Sep 11 2008

Mars UK commits to reformulation

The Brits are much more worried about artificial colors and flavors than we seem to be, these days as a result of the Southampton study, which linked such additives to cognitive and behavioral deficits in children eating a lot of candy.  Mars has now made a commitment to eventually get rid of artificial colors in its candy bars.  Will they do the same thing here?  If so, what will we do without blue M&M’s?

Apr 11 2008

UK’s Food Agency takes on color additives

Remember the Southampton study of food colors and hyperactivity that I commented on some months ago? On the basis of that study, the British Food Standards Agency is asking food companies to voluntarily get rid of color additives in food products aimed at young children. Since those products are junk foods anyway, and everyone – especially anti-additive advocacy groups - wishes kids would eat less of them, the study gives the agency some ammunition. The point of color additives, after all, is to make junk foods look like they taste good. Kids don’t need junk foods or color additives, but I wish I felt more confident about the science.

Mar 12 2008

What’s the story on MSG?

Last week, Allison wrote: “I recently read the NYTimes article about MSG [monosodium glutamate] and although you were quoted, I’d love to hear more of your thoughts.”

This is a tough one. My files on MSG go back to 1971 when the FDA said this flavor enhancer, the sodium salt of an amino acid that forms part of virtually all proteins, was safe for everyone “except for those who are individually sensitive to the substance.” By these, it meant people who reacted to foods containing MSG with headaches, tingling, flushing or other such neurological symptoms. Because Chinese food contained a lot of MSG, the symptoms came to be known as “Chinese Restaurant Syndrome.” In the late 1970s, scientists weighed in with reports of placebo-controlled trials that showed no reaction to MSG except for the first half hour after eating it. By 1980, scientists concluded that MSG only caused problems for a small percentage of individuals who had a genetic susceptibility. Placebo-controlled trials continue to find no difference in symptoms when people consume MSG or a placebo. That is why I told the reporter that there was no clinical evidence for problems and why “I thought the issue was settled though I know a lot of people will never believe that.” I wish what I had said next had been included because I went on to explain that such studies cannot account for the very real experience of people who experience symptoms, such as those whose letters appear in today’s Times.

How to make sense of this? MSG susceptibility falls into the category of many other food sensitivities and allergies, most of which are exceedingly difficult to diagnose. The science of food sensitivities, like much of nutrition science, is difficult to do, especially when serious symptoms are relatively rare in the population (it is too expensive to do studies on a large enough sample of individuals to get meaningful results).

If you are one of those people who experiences symptoms from MSG, there is only one thing to do: avoid it. And that brings us to the need to have more informative food labels. One again, we are in the realm of food politics.

Sep 7 2007

Food Additives and Hyperactivity–Again!

I thought we were done with food additives as a cause of hyperactivity in kids years ago, but here it comes again. A new and well controlled study in The Lancet, funded by the British Food Standards Agency (which presumably has no axe to grind), reports higher average levels of hyperactivity in young children drinking a mix of sodium benzoate (a preservative) and food colors. For why these results surprise me, take a look at the Wikipedia entry for the Feingold Diet, the additive-free diet developed decades ago to prevent hyperactivity in kids. The first Wikipedia paragraph says it all:

“The Feingold diet is a food elimination program developed by Ben F. Feingold, MD to treat hyperactivity. It eliminates a number of artificial colors and artificial flavors, aspartame, three petroleum-based preservatives, and (at least initially) certain salicylates. There has been much debate about the efficacy of this program. Some mainstream medical practitioners deny that it is of any value, while other medical practitioners, as well as many people living with ADHD and parents of children with ADHD, claim that it is effective in the management of ADHD as well as a number of other behavioral, physical and neurological conditions. The debate has continued for more than 30 years, involving not only consumers and physicians, but scientists, politicians, and the pharmaceutical and food industries.”

After this excellent beginning, the article gets so muddled that the editors warn: “The neutrality of this article is disputed.” Indeed. Until now, my reading of the science was that the more carefully the studies were done, the less benefit they showed. Even the best studies showed wide individual differences–most kids were unaffected by removing additives but a small percentage seemed to get better. This made the studies especially subject to biased interpretation.

This new study seems well done but again shows large individual differences, so expect the debates to continue. In the meantime, it’s good to remember that color additives go into processed foods to cover up flaws and make them look attractive. Kids don’t need to be eating highly processed foods. The study is another good reason to feed kids plenty of fruits, vegetables, and other minimally processed foods.

Here’s what today’s New York Times has to say about the study.