Currently browsing posts about: FDA

As I mentioned yesterday, the American Beverage Association represents the interests of soft drink companies that use sugars and artificial sweeteners in their products.  Its goal: to make you think both are just fine for your health.

Today, let’s take a look at a related, but different trade association, this one The Sugar Association.  Its goal: to make you not worry about sugars and to think that they are better for you than artificial sweeteners.

Here, for example, is a press release from this Association from this past summer: New Research Shows Large Majority of Consumers Understand Real Sugar Comes from Plants & That it Can Be Part of a Healthy Diet; Data reveals significant shift in perceptions of sugar and artificial sweeteners.

And here is its infographic showing data on public suspicions of artificial sweeteners.

Now, we have a new campaign from The Sugar Association: The Campaign for Sweetener Transparency.

More than 10,000 consumers across the United States have joined the fight for sweeping reform of the government’s labeling regulations covering the use of alternative sweeteners in packaged food by signing an online petition urging the U.S. Food & Drug Administration (FDA) to require food companies to place clear, complete and accurate information on food labels…it’s virtually impossible for shoppers to know what alternative sweeteners are in which packaged foods because the FDA only requires food companies to list the chemical names of sugar substitutes on food ingredient labels. So, consumers only see names like Xylitol, Hydrogenated Starch Hydrolysates, Saccharin, Acesulfame Potassium, Neotame, Isomalt and Lactitol on ingredients lists without even knowing what they are and why they are used.

The Sugar Association wants artificial sweeteners clearly labeled so customers will switch to products that have sugars instead.

• Products containing artificial sweeteners fall in the category of ultra-processed—foods that should be avoided or eaten in small amounts.
• Products containing added sugars also should be avoided or eaten in small amounts.

That’s why this campaign is about market share, not health.

For a basic guide to what to do about sugars, see this resource guide from Hunter’s Food Policy Center.

Thanks to Tufts Professor Sheldon Krimsky for sending me this gem.

Residues of glyphosate in food and dietary exposure.  John L. Vicini,Pamela K. Jensen,Bruce M. Young,John T. Swarthout, Comprehensive Reviews in Food Science and Food Safety.  First published: 16 August 2021.

The study: A review of existing data on amounts of glyphosate residues in foods as compared to maximum limits or tolerances set by European or American regulatory agencies.  The study also reviewed data on levels of glyphosate in urine samples.

Conclusion: “Exposures to glyphosate from food are well below the amount that can be ingested daily over a lifetime with a reasonable certainty of no harm.”

NutraIngredients.com had an intriguing (to me, at least) article about the latest complaints about FDA’s lack of action on GRAS ingredients—those Generally Recognized As Safe.

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make changes, the authors found.”

The article referred to a this paper, Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

The starting point for this paper is a study done by the Government Accountability Office (GAO) ten years ago: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS)

The new paper argues that ten years later, the FDA has done little to address the GAO’s concerns.

Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. …most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers…FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

This took me right back to a blog post I did in 2016: The FDA’s unfortunate ruling on GRAS regulations.

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.

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.

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:

• The FDA launched a working group on toxic food contaminants in 2017,  partly in reaction to an earlier EPA study that found food to be a source of about half the lead that kids get (see supplementary material in this paper).
• Preventing lead exposure would be good for society as well as for children.

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.

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:

• Two videos
  • Why do we have GMOs?
  • Do GMOs Affect Your Health?
• Four new fact sheets
  • GMO Crops and Food for Animals
  • GMO Crops and Humanitarian Reasons for Development
  • Types of Genetic Modification Methods for Crops
  • Why Do Farmers in the U.S. Grow GMO Crops?
• Spanish translations of the fact sheets and infographics
• High school curriculum Science and Our Food Supply: Exploring Food Agriculture and Biotechnology

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.