by Marion Nestle

Currently browsing posts about: Additives

Jun 6 2017

New attempt to get the FDA to fix its industry-friendly GRAS rules

Several food safety advocacy groups are suing the FDA to take responsibility for ensuring the safety of food additives.

Doesn’t the FDA already do this?  No, it does not.

As the press release puts it [with my emphasis in bold],

Federal law requires FDA to ensure that substances used in food are safe, taking into account consumers’ entire diet and all exposure to the chemical and similar chemicals. But any substance designated as “generally recognized as safe” (GRAS) by FDA or by a food or chemical company can bypass the rigorous pre-market review and approval process applied to food additives. The GRAS exemption was initially created to cover ingredients that are widely known to be safe, such as vegetable oil, but has been applied in recent practice to novel chemicals and is now a loophole that has swallowed the law.

Under pressure from industry, in 1997 and again in 2016, FDA adopted a practice that allows food and chemical manufacturers to decide for themselves, without notice to FDA or the public, that food chemicals are safe—even if the chemicals are new, not widely studied, and not widely accepted as safe .

I commented on the FDA’s 2016 ruling at the time.  Former FDA Commissioner David Kessler referred to this GRAS policy as a “joke,” noting that it allows the industry to decide whether its own products are safe.

I am particularly interested in this suit because I wrote a commentary on an article about conflicts of interest in GRAS determinations in 2013.   As I said about the article’s findings,

At present, manufacturers of all food additives are permitted to decide on their own whether a substance is GRAS for human consumption, unless the additive affects food color. Companies also can choose whether to even notify the agency about a new additive. In practice, many manufacturers do inform the FDA. But…about a thousand additives are believed to be in the food supply without the FDA’s knowledge…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.

Let’s hope the lawsuit gets this situation fixed.

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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.

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Apr 4 2016

The Guardian: my thoughts on food companies’ taking out the negatives

Here’s my piece from The Guardian, April 2, 2016.

No amount of ‘free from’ labelling will make processed food good for you
Campbell’s is phasing BPA out of its cans. That, and GMO-labelling initiatives, are all great, but canned foods still aren’t fresh, local or sustainable

Americans these days don’t want artificial and unsustainably produced ingredients in the food they buy and eat. For the makers of highly processed foods – ultraprocessed in today’s terminology – there isn’t a lot that they can do to make the products appear fresh and natural.

But Campbell’s is certainly trying. A few months after announcing that it will phase out genetically modified organisms (GMOs), the iconic soup company said on Friday that it will remove Bisphenol-A (BPA) from its cans by next year.

BPA, you will recall, is a chemical typically used in polycarbonate plastic containers and in the epoxy linings of food cans. It’s also an endocrine disrupter, which means it can interfere with the work our hormones are doing. Some research finds BPA to have effects on childhood development and reproduction.

Although the FDA doesn’t believe evidence of potential harm is sufficient to ban BPA from the food supply, the agency discourages use of BPA-polycarbonate or epoxy resins in baby bottles, sippy cups or packaging for infant formulas. For the past year or so, other retailers have been working hard to phase out BPA and to reassure customers that their cans and packages are safe.

All of these companies sell highly processed foods in an era when the public is demanding – and voting with their dollars – for fresh, natural, organic, locally grown and sustainably produced ingredients.

They can’t provide those things, but they can tout the bad, or unpopular, things that aren’t part of their product, the “no’s”: no unnatural additives, no artificial colors or flavors, no high fructose corn syrup, no trans fat, no gluten and, yes, no GMOs or BPA.

Let me add something about companies labeling their products GMO-free. In my view, the food biotechnology industry created this market – and greatly promoted the market for organics, which do not allow GMOs – by refusing to label which of its products contain GMOs and getting the FDA to go along with that decision. Whether or not GMOs are harmful, transparency in food marketing is hugely important to increasing segments of the public. People don’t trust the food industry to act in the public interest; transparency increases trust.

Vermont voted last year to mandate GMO labeling in the state – the US Senate rejected a bill in mid-March attempting to undermine it – and food conglomerates such as Campbell’s, General Mills, ConAgra, Kellogg and Mars have committed to labeling their products as containing GMO.

In addition to removing BPA from packaging and GMO from products, at least 11 other companies have announced recently that say they are phasing out as many artificial additives as possible, as quickly as they can.

Taco Bell, for example, will get rid of Yellow Dye #6, high fructose corn syrup, palm oil and artificial preservatives, and replace them with “natural” ingredients. Huge food companies such as Kraft, Nestlé (no relation) and General Mills are heading in the same direction.

All this may well benefit consumers to an extent. It also makes perfect sense from a business perspective: the “no’s” sell. But what everyone needs to remember is that foods labeled “free from” still have calories and may well contain excessive salt and sugars. The healthiest diets contain vegetables and lots of other relatively unprocessed foods. No amount of subtraction from highly processed foods is going to change that.

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Mar 4 2015

Goodbye to artificial colors?

I was invited by CNN to comment on the announcement by Nestlé that it is removing artificial colors from its chocolates.

Here’s what I said:

(CNN) When food giant Nestle USA (to which I am, alas, not related) last month announced plans to remove all artificial flavors and colors from its chocolate candies, it understandably made headlines. According to the company, by the end of 2015, none of a group of 250 chocolate products including Butterfinger and Baby Ruth will contain artificial flavors or colors such as Red #40 or Yellow #5.

With the expectation that these chemicals will also disappear from the company’s other candies, it looks like the end of the use of artificial flavors and colors in anything but the cheapest food products. If that proves to be the case, it will be a welcome shift.

Nestle USA intends to advertise the reformulated products with a “No artificial flavors or colors” claim on package labels. If sales of the “no artificial” candies grow as expected, the company will surely extend the removal to all of its other colored and flavored food products. After all, Nestle’s international parent company — and the company’s competitors — will have to take notice and find ways to remove these chemicals from all their product lines.

Nestle USA has undeniable clout. It accounts for a quarter of the $100 billion in annual revenues of the more than century-old, privately held parent corporation, which itself is the largest food company in the world. This move surely will not only reverberate through the candy industry, but also affect every other major food company.

In substituting natural for artificial flavors and colors, Nestle USA is responding to what its customers are saying. The company’s own research indicates that Americans prefer their beloved candy brands to be free of artificial flavors and colors, while other surveys find majorities of respondents saying that artificial chemical additives negatively influence their buying decisions.

Nestle is also responding to decades of complaints from consumer advocates about the potential health risks of these chemicals, especially the dyes. Studies in experimental animals have linked high doses of food dyes to health problems, among them organ damage, cancer, birth defects, and allergic reactions. In humans, studies link food dyes to hyperactivity and other behavioral problems in young children.

The credibility of these studies and their implications for human health remain hotly debated. In the 1970s, for example, Ben Feingold, a physician in California, suggested that food additives caused children to become hyperactive. Much of the evidence for the “Feingold hypothesis” rested on anecdotal reports by parents, whereas double-blind, controlled clinical trials produced contradictory results.

On the basis of current evidence, some artificial food dyes have been banned, while others remain in use despite suggestions that they too might be harmful. But the makers and users of food dyes argue that the chemicals are safe at current levels of usage. As a result of all this, and in the absence of convincing evidence of their safety, the advocacy group Center for Science in the Public Interest has campaigned since the 1970s to remove food dyes and other chemicals from foods, and has continued to petition the Food and Drug Administration to ban them.

The opposing views complicate the regulatory status of food dyes. But after one clinical trial reported that dyes induce hyperactivity in half the children studied, the British government asked companies to stop using most food colors; the European Union requires a warning notice on many foods made with them.

In the United States, the FDA does not permit artificial food dyes to be used unless the manufacturers can meet safety requirements. But the amounts of these substances in the country’s food supply have greatly increased in recent years — soft drinks, breakfast cereals, frozen desserts and even salad dressings all contain artificial coloring agents. True, the FDA considers a dye to be safe if there is a reasonable certainty that no harm will result from its intended use. But that standard is vague enough to cause concern.

Given the unresolved scientific questions, it is reasonable to ask why artificial colors have to be in foods at all. From the standpoint of manufacturers, such additives are essential for covering up and hiding unattractive colors in processed foods. To the public, red candy seems to taste better than the drab variety. And while natural colors exist, they are less stable or more expensive to produce. But for Nestle to have taken the action that it has, the company must have found substitutes it can live with. And appealing to consumers’ preference for “natural” makes good business sense.

The truth is that whether artificial colors do or do not cause health problems in adults or children, they are there strictly for cosmetic purposes. For that reason alone, getting rid of them is a good idea.

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Feb 19 2015

Nestlé USA says its chocolates won’t have artificial colors or flavors by the end of this year

Nestlé (the giant food company, not me) announces that it is removing all artificial flavors and colors from its chocolate candies this year.

Nestlé USA announced today its commitment to removing artificial flavors and FDA-certified colors, like Red 40 and Yellow 5, from all of its chocolate candy products. By the end of 2015, more than 250 products and 10 brands including NESTLÉ® BUTTERFINGER®, CRUNCH® and BABY RUTH® will be free of artificial flavors and certified colors. Products will begin appearing on store shelves by mid-2015, and will be identified by a “No Artificial Flavors or Colors” claim featured on-pack.

Just to put this in perspective.  According to figures in Advertising Age (June 2014), this company took in revenues exceeding $99 billion in 2013, with a profit of more than $11 billion.  The U.S. accounted for $25 billion of that amount.

If  Nestlé USA does this, the rest of Nestlé is likely to follow.

And “No Artificial Flavors or Colors” ought to encourage other companies to do the same.

Artificial flavors and colors are totally unnecessary in food products.  Think of them as cosmetics.

Whether they do or do not induce behavioral problems in kids—a problem not easily resolved—getting rid of them makes good sense.

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Jul 15 2014

Food packaging materials contain a lot of iffy chemicals

Authors employed by the Food Packaging Forum Foundation, funded by the packaging industry but working “independently of donors’ special interests,” have produced a surprising analysis of chemical in food packaging that comes into contact with food during production, handling or storage.

Why surprising?  Because the results are indeed against donors’ special interests.

Such chemicals, the authors say, can contaminate food through migration from the packaging.  About 6000 such substances exist, some of which are associated with disease.  These are Chemicals of Concern (COCs).

This study identified chemicals used in packaging that are considered to be COCs.  It found 175 such chemicals in use.  Of these, 54 are “candidates for Substances of Very High Concern.”

From a consumer perspective, it is certainly unexpected and undesirable to find COCs [chemicals of concern] being intentionally used in FCMs [food contact materials], and thus it seems appropriate to replace substances case by case with inherently safer alternatives.

This comes from people in the industry.  I hope makers of packing materials—and food safety regulators—pay close attention.

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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).

 

 

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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!

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