by Marion Nestle

Currently browsing posts about: FDA

May 18 2021

The FDA needs to take action on food dyes

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,

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.

Apr 28 2021

FDA issues warnings to leafy green growers and their cattle raising neighbors

Leafy greens contaminated with toxic E. coli make eaters very sick (this is an understatement).

Toxic E. coli are excreted by cattle raised in the vicinity of lettuce and spinach fields.

But leafy green safety is overseen by FDA whereas everything having to do with food animals is overseen by USDA.

This is why the latest moves by FDA about leafy green safety are so noteworthy.

  • The FDA is warning leafy green growers that they must take better precautions to prevent E. coli contamination.
  • It also is warning cattle growers that they must prevent wastes from contaminating leafy green fields.

The Big Question: Will—can—the FDA force cattle ranchers and leafy green growers to adhere to food safety precautionary measures?

Let’s hope.

Here are the relevant documents:

FDA statement on release of a report on a 2020 outbreak

The findings of foodborne illness outbreak investigations since 2013 suggest that a likely contributing factor for contamination of leafy greens has been the proximity of cattle. Cattle have been repeatedly demonstrated to be a persistent source of pathogenic E. coli, including E. coli O157:H7.

Considering this, we recommend that all growers be aware of and consider adjacent land use practices, especially as it relates to the presence of livestock, and the interface between farmland, rangeland and other agricultural areas, and conduct appropriate risk assessments and implement risk mitigation strategies, where appropriate.

Report on the 2020 outbreak investigation

The analysis has confirmed a positive match to the outbreak strain in a sample of cattle feces, which was collected during follow-up investigations on a roadside, uphill from where leafy greens or other food identified in the traceback investigation were grown. While the finding does not provide definitive information on how E. coli may have contaminated product during the growing and harvesting season, it does confirm the presence of a strain of E. coli O157:H7 that causes recurring outbreaks in a more narrowly defined growing region and a potential, continued source of contamination.

Leafy Green STEC Action Plan

As outbreaks have continued to occur, despite significant efforts in recent years, greater emphasis will be needed around such complex issues as adjacent land use, agricultural water, and understanding likely routes by which human pathogens may contaminate leafy greens.

Former FDA food safety official Michael Taylor’s comment on these documents

FDA declared the recurring strain implicated in the 2020 outbreak to be a “reasonably foreseeable hazard,” which FDA attributed to the presence of cattle on land adjacent to growing fields.  This finding seems obvious and shouldn’t be surprising. The surprise, however, is that FDA used regulatory language to express its finding and spelled out the implications: farms covered by the FSMA produce safety rule “are required to implement science and risk-based preventive measures” to minimize the risk of serious illness or death from the E. coli hazard…I do not anticipate FDA taking judicial action to enforce its April 6 finding, absent egregious practices or clear negligence in a particular leafy green growing situation. I do see, however, a heightened sense of urgency at FDA and frustration that efforts to date have not solved the leafy greens safety problem. I share that frustration.    

Food safety lawyer Bill Marler’s comment

The FDA took specific aim at California growers as the cause of repeated and ongoing outbreaks, putting the responsibility of combating the outbreaks squarely on the growers.

FDA’s investigations into foodborne illness outbreaks are available from its outbreak page.  These are the ones from 2020.

 

Mar 9 2021

More on toxic metals in baby foods: FDA on the job!

Early in February I wrote about heavy metal toxins in baby foods.  A report, Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury, revealed:

  • Arsenic, led, cadmium, and mercury are present in commercial baby foods at levels much higher than considered safe.
  • Their sources: foods raised on contaminated soil and water, and vitamin/mineral pre-mixes.
  • Baby food companies set their own safety standards for toxic metals.
  • The FDA knows baby foods have high levels of toxic metals but isn’t doing anything about it.
  • Some baby food companies refused to share data on this topic.

Politico has been following this story.  It reports:

In response to the “Tainted” report, the FDA now says it will set standards.

The FDA wrote baby food manufacturers to shape up.  The FDA, it says,

 is taking this opportunity to remind all baby and toddler food manufacturers and processors covered by the preventive control provisions of the rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food…of your responsibility under the rulemaking to consider chemical hazards that may be present in foods when conducting your hazard analysis….FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population.

And the FDA issued a statement to the food industry. 

Toxic elements are in the environment, and therefore in the food supply. The levels of arsenic, lead, mercury, and cadmium in certain foods depends on many factors, including: growing conditions; manufacturing and agricultural processes; past or current environmental contamination; and the genetic capacity of food crops to take up elements. We share the public’s concerns for the health of America’s children, and want to reassure parents and caregivers that at the levels we have found through our testing, children are not at an immediate health risk from exposure to toxic elements in foods. The FDA routinely monitors levels of toxic elements in food, and if we find that they pose a health risk, the FDA takes steps to remove those foods from the market.

Research has shown that reducing exposure to toxic elements is important to minimizing any potential long-term effects on the developing brains of infants and children. As such, this issue is among FDA’s highest priorities and we are actively working to make progress on identifying and implementing impactful solutions to make foods commonly consumed by infants and young children safer.

In the meantime, here’s what Beech Nut says on its website.

Toxic heavy metals are not good for babies’ health.  Baby food companies need to do much better in getting rid of these things if they want anyone to keep buying their products.

What to do in the meantime?  Feed kids small amounts of as wide a variety of foods as possible.  That’s good advice anyway.

Oct 28 2020

The FDA’s limited take on GMOs

The FDA has a new Agricultural Biotechnology Education and Outreach Initiative to teach the public about GMOs.

Its “Feed Your Mind” Initiative  provides webpages, fact sheets, infographics, and videos developed jointly with the USDA and EPA.

What is this about?

in 2017, Congress provided funding for an Agricultural Biotechnology Education and Outreach Initiative, which calls upon FDA to work with EPA and USDA to share science-based educational information about GMOs, beginning with answers to some basic GMO questions.

Some of this is useful.  For example:

If you want details about any of  FDA-authorized GMOs, you have to go to this obscure website on “completed consultations.”

Most GMOs are crops grown for animal feed (or ethanol for cars).

So the only GMO products you are likely to find at supermarkets are papayas, potatoes, squash, and apples.

How can you tell?    If the papayas are from Hawai’i, you can assume they are GMO.

As for the others, you have no way of knowing unless they are labeled, and good luck with that.

GMOs are supposed to be labeled starting in 2020 and definitely by 2022 (unless overturned by litigation).  The label is supposed to look like this:

The FDA website says nothing about GMO labeling.  It also says nothing about GMO monoculture, corporate control of the food supply, pesticide resistance, or pesticide harm.

But it does have all this:

Feb 5 2020

FDA funding for food safety increases, by a little

Thanks to the Hagstrom Report for this item.  It revealed that The Alliance for a Stronger FDA has produced a chart of the changes to the funding levels for the FDA in the Agriculture appropriations bill.

The group reports these increases for food safety funding:

▪ $5 million for innovation and emerging technology
▪ $7 million for advancing FSMA (the Food Safety Modernization Act)
▪ $8 million for strengthening response to foodborne outbreaks
▪ $3 million for dietary supplements
▪ $5 million for imported seafood safety
▪ $2 million for CBD activities
▪ $500,000 for antimicrobial monitoring system
▪ $1 million for standards of identity

These are drops in a very large bucket of need for FDA funding.

Please note that the FDA, a public health agency, gets its funding from agricultural appropriation committees, not health committees.

This is an unfortunate accident of history, but goes a long way to explaining why the FDA is so consistently underfunded.

 

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Jan 15 2020

The new food label kicks in at long last

The FDA released its final guidance on the new food labeling rules late in December.

I have a collection of Kellogg Froot Loop cereal boxes (or facsimiles) going back to its first year.  I’ve been tracking it closely and have just started seeing the new label in stores.

The Spanish translation is optional, but I’m for it.

Industry groups are still complaining that they need more time.  

Really?  Let’s review the history.

  • Between 1993 and 2013: FDA receives 12 citizen petitions calling for changes to the Nutrition Facts and Supplement Facts labels.
  • 2003 to 2007: FDA issues 3 advance notices of proposed rulemaking seeking public comment on issues relevant to updating the Nutrition Facts label.
  • 2014: FDA issues proposed rules.
  • 2015: FDA issues supplemental proposed rule covering added sugars, DV, and footnote text.
  • 2016: FDA issues final rules, expects all companies to comply by 2019.
  • 2017: FDA delays compliance date until 2020.
  • 2019: FDA issues final rules; FDA says it will give six-month leeway for compliance.

I say it’s about time.  Yes!

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Dec 3 2019

The latest Romaine lettuce outbreak: Just say no.

The CDC continues to track the latest outbreak of illnesses caused by eating Romaine lettuce contaminated with E. coli O157:H7.

The outbreak at a glance:

The FDA’s advice:

Consumers should not eat romaine lettuce harvested from Salinas, California. Additionally, consumers should not eat products identified in the recall announced by the USDA on November 21, 2019.

A former FDA official, Stephen Ostroff, says:

With five multistate outbreaks in less than two years, it’s clear there’s a serious continuing problem with E. coli O157:H7 and romaine lettuce. The natural reservoir for this pathogen is ruminant animals, especially cattle. Moreover, one particular strain of E. coli seems to have found a home in the growing regions of central coastal California, returning each fall near the end of the growing season.

It’s not clear where this strain is hiding. Cattle? Water sources? Elsewhere? What is clear is that additional steps must be taken to make romaine safer.

The New Food Economy emphasizes some particularly distressing aspects of this particular outbreak.

  • It is caused by the same strain of E. coli O157:H7 that caused outbreaks linked to leafy greens in 2017 and to Romaine lettuce in 2018.
  • This strain of E. coli seems particularly virulent: 39 of the 67 cases had to be hospitalized.
  • The source has not yet been traced.

Consumer Report’s advice: ”

People should avoid all romaine lettuce and that any currently in refrigerators should immediately be thrown out because of the risk of E. coli contamination…CR’s experts think it is prudent and less confusing for consumers to avoid romaine altogether, especially because romaine is also sold unpackaged and in restaurants, and customers can’t always be sure of the origin that lettuce.  “Much of the romaine lettuce on the market at this time of year is from Salinas,” says James E. Rogers, Ph.D., director of food safety research and testing at Consumer Reports.

Food safety lawyer Bill Marler says enough is enough; It’s time to put warning labels on Romaine lettuce.

Marler’s advice: when in doubt, throw it out.

My comment:  Contamination of vegetables with toxic E. coli means that the vegetables somehow came in contact with waste from farm animals or wild animals or birds.  The most likely suspect is Confined Animal Feeding Operations (CAFOs) or large dairies because they produce so much animal waste.  If one animal is infected under crowded CAFO conditions, other animals also will be infected (but cows don’t show symptoms).

Preventing lettuce contamination means that CAFOs must manage their waste so that it is not infectious (USDA and EPA regulated) and vegetable farms must keep infected water from contaminating their crops (FDA regulated).  All of this means following food safety procedures to the letter, but also in spirit.

Constant Romaine outbreaks are further evidence for the need for consistency in USDA and FDA food safety policies, and a reminder that calls for a single, united food safety agency have been coming for more than 40 years.  Surely, it’s time.

Jul 23 2019

Coca-Cola wants the FDA to let it add vitamins to drinks

Thanks to Elaine Watson at FoodNavigator-USA for writing about Coca-Cola’s efforts to get the FDA to let it put vitamins in its drinks.  OK, its “healthier” drinks.

Historically, the FDA discouraged (putting it mildly) makers of candy and other junk foods from adding vitamins so they could be marketed as “healthy.”  This was known as the “jelly bean rule.”   Vitamins could not be added to jelly beans—or Coca-Cola.

It’s not really a formal rule, but here’s what the FDA says in 21CFR104.20:  ​

The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.

But what about the exceptions?

  • Gummy Bears: vitamins are be added to gummy bears, but these are typically sold as dietary supplements, not foods. They can do this because the Dietary Supplement Health and Education Act of 1994 authorized much looser rules for supplements.  Even though gummy bears are candy, the FDA isn’t going to fight this one.
  • Glaceau Vitamin Water:  Coca-Cola now owns this company. Some Vitamin Waters have as much sugar as a Coke.  They have Nutrition Facts labels and are marketed as foods, and look to me to be in violation of the jelly bean rule,.  The FDA hasn’t done anything about them, even though they are vitamin-enriched sugar water.  If you have any idea why not, please tell me.

For decades, Coca-Cola has tried to get the FDA to ease up on the jelly bean rule.  Now it is trying again.

Its argument?  The rule, by not allowing the addition of vitamins to sugary teas and coffees, stifles innovation.

Its assurance?  It won’t add vitamins to Coke, but will add them to its other, presumably “healthier” (meaning, I suppose, less sugary) beverages.

As I wrote earlier, candy makers are trying this trick too.

I wonder how long the FDA can hold out on this one.  I wish it luck.