Currently browsing posts about: Additives

I first read about this in a daily newsletter I subscribe to, Bakery and Snacks:   The Doritos effect: How tartrazine turns tissues temporarily transparent. When a study draws parallels with H.G. Wells’ The Invisible Man, you know it’s bound to be captivating. Could this scientific leap bring us closer to achieving a real-life version of Harry Potter’s invisibility cloak?… Read more

An ingredient in Doritos — tartrazine or Yellow 5 — is helping scientists see through the skin of mice. While they can’t see through human skin (it’s thicker and less permeable), this could be helpful in the future for early skin cancer detection. Imagine if it could replace a mammogram? On the other hand, Doritos food coloring is a chemical that the scientists said might not be totally harmless. (And to think so many people are eating it?) Read the Popular Science article about it. It’s fantastic.

Popular Science: The dye in Doritos can make mice transparent.  ‘It’s not magic, but it’s still very powerful.’

Because of a counterintuitive fundamental physics principle [selective absorption and scattering of light], Tartrazine, also known as Yellow 5, can temporarily turn biological tissue transparent to the naked eye, as described in a study published September 5 in the journal Science. 

The Science study: Achieving optical transparency in live animals with absorbing molecules.  Science.  Vol 385, Issue 6713.  DOI: 10.1126/science.adm6869

We next sought to demonstrate the ability of absorbing molecules to achieve tissue transparency in the mouse abdomen. Specifically, when a tartrazine solution was topically applied to the abdominal skin of a live mouse under anesthesia and gently massaged on the skin (Fig. 1, G and H), the abdominal skin not only darkened in color but also became more transparent in the red window (fig. S8). This transparency effect can be readily visualized with the naked eye and does not require any specialized imaging equipment…The transparent abdomen allowed us to directly observe internal organs, including the liver, small intestine, cecum, and bladder (Fig. 1, I and J). Moreover, we could also discern their movements, such as peristalsis, as well as motions synchronized with the heartbeat and breathing (Movies 1 and 2). The achieved abdominal transparency can be reversed by rinsing and massaging the skin with water (fig. S8).

Tartrazine is FD&C  Yellow #5

Tartrazine is a synthetic food colorant classified as an azo dye. It is lemon yellow in color and water soluble. Tartrazine is approved for use as a food colorant in the EU, USA, Canada, and other parts of the world for use in food, cosmetics, and medications. Its use in foods includes dairy products, beverages, desserts, confectionary, spices, dressings, jellies and sauces…It is one of the most commonly used and best known food additives…Of the synthetic food dyes, tartrazine has been implicated most often as a cause of adverse reactions.

Here’s what CSPI says about it.

Yellow 5 can be found in many foods, including beverages, gelatin desserts, candy, and baked goods. It’s the second-most widely used coloring and sometimes causes allergy-like hypersensitivity reactions, primarily in aspirin-sensitive persons, and triggers hyperactivity in some children. It may be contaminated with such cancer-causing substances as benzidine and 4-aminobiphenyl (or chemicals that the body converts to those substances).

CSPI has filed a petition to

Ban the Use of Yellow 5 and Other Food Dyes, in the Interim to Require a Warning on Foods Containing These Dyes, to Correct the Information the Food and Drug Administration Gives to Consumers On the Impact of These Dyes on the Behavior of Some Children, and to Require Neurotoxicity Testing of New Food Additives and Food Colors.

And now here’s another reason not to use it, even though it doesn’t do this in people, apparently.  Our skin is too thick.

Addition

A reader points out that tartrazine is on the list of food dyes now banned in California.  Good idea.

The FDA says it is proposing to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food.  In  transslation from FDA-speak, the agendy now intends to ban BVO.

This is the second time I have written an RIP for BVO.  The first was in 2013—ten years ago!— when PepsiCo said it no longer use BVO in Gatorade in response to a petition from a teenage influencer.

BVO, a flame retardent, is made by adding bromine to vegetable oil.  Studies for years have found BVO to cause neurological and other health problems.  The FDA says:

In our 2014 review, we identified four unresolved safety questions with respect to the use of BVO in food: the potential for thyroid toxicity, bioaccumulation, developmental neurotoxicity, and reproductive toxicity. We determined that the safety data and information available did not provide evidence of a health threat resulting from the limited permitted use of BVO as a flavoring stabilizer in fruit-flavored beverages,…We concluded that high-quality data from contemporary studies, performed under current guideline standards, were needed to address the knowledge gaps regarding the safety of BVO …. The rodent safety studies…confirmed previous reports that dietary exposure to BVO is toxic to the thyroid and results in bioaccumulation of lipid-bound bromine in the body at doses relevant to human exposure.

OK, but this FDA action has an even longer history, and shockingly so.

In 1970, the FDA ruled that BVO could no longer be considered “Generally Recognized as Safe” (GRAS), but took no further action saying removing it was not much of a priority.

The UK banned it isoon after; the European Union got rid of it in 2008.  But the FDA did not.

In summary, the FDA has been worried about BVO since 1970 but is only just now getting around to banning it.

Why?  I can only speculate.

• The soft drink industry is losing power now that people view it as producing unhealthy products.
• California recently took the lead and banned BVO along with three other questionably safe additives.
• Or maybe it just didn’t judge the evidence for harm as adequate.

Better now than never.

Resources

• Constituent Update: FDA Proposes Rule to Revoke Regulation Allowing the Use of Brominated Vegetable Oil in Food
• FDA Voices: How FDA’s New Approach to Reviewing Chemicals Added to Food Will Strengthen Food Safety
• Constituent Update: FDA Update on Post-market Assessment of Certain Food Ingredients
• Lists of Select Chemicals in the Food Supply Under FDA Review
• Food Chemical Safety
• The full list of products containing BVO

California’s AB 418, the California Food Safety Act,  is now law.

The bill addresses additives banned in Europe on the basis of various health concerns.  Originally it also included titanium dioxide, but that got dropped when candy makers protested and framed the bill as a “Skittles ban.”   Fighting words, apparently.

In his statement on signing the bill, Governor Newsom implied that the ban is temporary, pending the FDA’s setting safe levels for these additives.  He also said the ban would not need to be implemented until 2027.https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/

These additives—and titanium dioxide—have been the subject of heath concerns for years.  The Center for Science in the Public Interest has been pushing for bans for decades.  It reviewed some of this history in a statment:

The FDA learned Red 3 was a carcinogen in the 1980s and declared it as such in 1990. For that reason, the agency eliminated Red 3 from cosmetics and drugs applied to the skin. That same year, the FDA said it would “take steps” to ban the use of Red 3 in foods, ingested drugs, and dietary supplements. With inaction in the intervening decades, the Center for Science in the Public Interest last year petitioned the FDA to finally eliminate the carcinogenic dye from the food supply.  CSPI says it hopes the California legislation will inspire similar efforts around the country and prompt the FDA to eliminate the four additives.

According to Bakery & Snacks, the ban could affect 12,000 products.  A ban in California is a call for reformulation with with safer substances.

It’s now time for the FDA to act, and the sooner the better.

Of course, not everyone agrees.  Take the National Confectioners Association, the trade association for candy makers, for example.  It issued a statement, “California is once again making decisions based on soundbite rather than science,” and also wrote the FDA to protest.

The gist of the letter is that candy makers have limited alternatives to the banned additives and “the cost of reformulation will be substantial and ultimately passed on to consumers in the form of higher prices.”

Really?  These additives are banned in Europe yet the last time I looked there was still plenty of candy on sale.

You might think candy makers would be proud to replace potentially harmful additives with healthier alternatives and advertise accordingly, but that’s not how the system works, alas.

As I keep saying, food companies are not public health or social service agencies.  They are businesses prioritizing profits to stockholders and compensation to executives.  Ther job is to sell you candy, lots of it, and at the lowest possible cost.  [Oops.  A reader points out I should have said at the highest possible cost.  Of course.  I stand corrected].

Note: we are talking candy here, not health foods.

A review article finds it nontoxic.You may recall that on June 17,  Daily Harvest issued a recall of its frozen vegan Crumbles product  after 500 or so adverse event reports, many of  severe liver damage among the 28,000 customers who ordered it.

Here’s what the front of the package looked like.

This product has lots of ingredients:

organic butternut squash, organic hemp seeds, organic cauliflower rice, organic extra virgin olive oil, organic french lentils, organic red lentils, organic tri-colored quinoa, organic cremini mushrooms, organic tara flour, organic leeks, organic parsley, water, organic cassava root flour, organic flax seeds, organic sacha inchi powder, chia seeds, organic porcini powder, himalayan sea salt, organic apple cider vinegar, organic onion powder, nutritional yeast, organic garlic powder, organic tomato powder, organic white pepper, organic coriander seeds, organic mustard powder, organic thyme.

As food safety lawyer Bill Marler predicted, tara flour has been identified as the ingredient at fault.

• Tara is only in Crumbles and Crumbles is the only product that made people sick.
• Tara is also in another company’s product, Revive smoothies, that made people sick.

I had never heard of tara and had to look it up.  Since then, I’ve gotten curious and did some quick research.

Tara is a legume—a bean plant—grown in Peru and other Latin American countries.

Tara is grown for several purposes:

• Pod tannins for industrial leather, keeping ships free of marine animals, and preparing textiles to accept dyes
• Cosmetics (polysaccharides isolated from the seeds)
• Food additives—protein flours and gums (from the endosperm)

The research literature on tara is remarkably extensive (Who knew?).

On the tannins:

• Anything you want to know about tara tannins (from a doctoral dissertation)
• Use of tara tannins to prevent ship fouling

On cosmetics:

• Tara is safe as used in cosmetics.

On tara as a food ingredient:

• An overview from the International Food Additive Council implies that it’s safe
• A major safety evaluation in 1993 says it’s safe.
• It’s not toxic as used in traditional Peruvian medicine
• Another review article finds it nontoxic.
• It is neither mutagenic nor genotoxic
• It may have anti-cancer properties

From everything previously reported about tara over the past 20 years, there is no reason to think it might be unsafe.

So what’s going on?  How to explain “only” hundreds of cases of severe liver injury when 28,000 Crumbles meals were shipped during the time when cases were reported.

Possibilities:

• Some toxic ingredient accidentally or deliberately got into the tara flour (similar to melamine being substituted for wheat gluten in pet food in 2006 and in infant formula in China in 2008).
• Toxic tannins from other parts of the tara plant got into the endosperm flour.
• Some people have unusual sensitivities to tara proteins or digestive products of tara proteins (similar to what happens when people with coeliac disease eat gluten from wheat or other gluten-containing grains)
• Some people have inborn errors of metabolism that cause acute reactions to tara proteins (similar to what happens when people with deficiency of the enzyme glucose-6-phosphate dehydrogenase ingest fava beans)
• Others?  Could be, but I can’t think of any.

To prevent this from happening again, it’s necessary to identify the toxin.  I hope that happens soon.

The watchdog Environmental Working Group has analyzed the approval process for new food chemicals.  Its disturbing conclusions:

Nearly 99 percent of all food chemicals introduced since 2000 were greenlighted for use by the food and chemical industry,…not by the Food and Drug Administration, the agency responsible for ensuring food is safe.

That’s because food and chemical companies exploited a loophole in the law allowing them to decide which chemicals are safe to consume, contrary to what Congress intended when it enacted food chemical laws in 1958….for 756 of 766 new food chemicals added to the food supply since [2000], or 98.7 percent, these companies have exploited a loophole for substances that are “generally recognized as safe,” or GRAS. The loophole lets them – not the FDA – decide a substance is safe.

The data:

Do we care?  I think we should.

EWG deserves thanks for keeping an eye on this issue.

Bettina Siegel’s Lunch Tray blog had an item recently about a new report on the effects of food dyes on children’s behavior (her blog is behind a Substack paywall, but well worth the subscription).

This report makes it time to talk about food dyes again.  For starters, they have only one purpose: to sell ultra-processed (junk) foods.  Research shows that brightly colored candy, snacks, and sodas are perceived as tasting better than the grey alternatives.  The food industry needs cosmetic food dyes.  We don’t, especially if they are harmful.

The 311-page peer-reviewed report, from the California Environmental Protection Agency’s Office of Environmental Health Hazards Assessment (OEHHA), is a meta-analysis of animal studies and 27 human clinical trials dealing with the neurobehavioral effects of seven synthetic food dyes on children.

Its conclusion:

The scientific literature indicates that synthetic food dyes can impact neurobehavior in some children… current ADIs [FDA’s Acceptable Daily Intakes] may not provide adequate protection from neurobehavioral impacts in children. For some of the dyes… updated safe levels of exposure would be much lower.

The idea that synthetic food dyes are associated with adverse neurobehavioral outcomes in children, but that children vary in their sensitivity to these dyes, is hardly new information.

In the mid-1970s, the physician Ben Feingold associated food dyes with hyperactivity in children and developed the Feingold Diet to improve kids’ behavior.

Much of the evidence for the “Feingold hypothesis” rested on anecdotal reports by parents,

Scientists’ attempts to study the effects of food dyes gave mixed results.  For example, as I wrote in a blog post on March 31, 2011, consider two studies published by Science magazine in 1980:

• Researchers 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 (Science 1980;207:1485-87).  But this study used pills rather than foods, mixed additives, and used questionable methods for evaluating hyperactive behavior.
• Researchers attempted to correct for such problems by using two drinks that looked and tasted the same—one contained seven food colors while the other did not.   The study was designed carefully such that neither the kids, parents, or observers knew what the kids were drinking.  The result:  Twenty of the 22 kids showed no reaction to the dyes.  One child reacted to the dyes every time (Science 1980;207:1487-89).

The interpretation?  Some kids may react to food dyes.

This gave the FDA an excuse to do nothing.  But then,

• In 2007, a study in England associating food dyes with hyperactivity revived the issue.
• In 2008, the Center for Science in the Public Interest (CSPI) petitioned the FDA to bad food dyes associated with behavioral problems in children.
• In 2009, CSPI updated its Diet, ADHD & Behavior: A Quarter-Century Review
• In 2010, CSPI published Food Dyes: A Rainbow of Risks.
• In 2016, CSPI published Seeing Red: Time for Action on Food Dyes.

Today, the FDA says this about color additives in food:

FDA on color additives in food (2007):

So how safe are they? “Color additives are very safe when used properly…There is no such thing as absolute safety of any substance. In the case of a new color additive, FDA determines if there is ‘a reasonable certainty of no harm’ under the color additive’s proposed conditions of use.”

FDA on whether color additives are safe to eat (2018):

Yes, color additives are safe when they are used in accordance with with FDA regulations…our regulations specify:

• the types of foods in which it can be used,
• any maximum amounts allowed to be used, and
• how the color additive should be identified on the food label.

FDA on whether color additives affect the behavior of children (2018)

The FDA has reviewed and will continue to examine the effects of color additives on children’s behavior. The totality of scientific evidence indicates that most children have no adverse effects when consuming foods containing color additives, but some evidence suggests that certain children may be sensitive to them…Parents who wish to limit the amount of color additives in their children’s diet may check the food ingredient list on labels. Parents should also discuss any concerns with their family physician.

Well good luck with that.  The FDA can and should do better.

The bottom line: Food dyes have no health benefits.  Kids don’t need to be eating ultra-processed foods anyway.  They will not be harmed by avoiding food dyes.

CSPI has produced a lengthy and comprehensive comment on the new report. 

Given all of this, it’s surely time for the FDA to take some action.

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.

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.