Search results: Immunity

A reader, Philly Nassau, sent me the ingredient list of several “immune-boosting” supplements, in quotes because I am a supplement skeptic in general, and of immune supplements in particular (I favor eating healthfully and staying active).

Immune supplements claim to be “Nootropics and Brain Supplement for Memory, Brain Support, Clarity, Focus, Mood Boost, Anti Anxiety & Stress Relief.”  Nootropics?  These are defined as drugs or supplements capable of enhancing memory, concentration, or other cognitive functions and of preventing cognitive decline.  How I wish.

But first, the science.

• Gut-microbiota-targeted diets modulate human immune status.  “The data highlight how coupling dietary interventions to deep and longitudinal immune and microbiome profiling can provide individualized and population-wide insight. Fermented foods may be valuable in countering the decreased microbiome diversity and increased inflammation pervasive in industrialized society.”
• The Stanford press release on this paper. A fermented-food diet increases microbiome diversity and lowers inflammation, Stanford study finds.  Stanford researchers discover that a 10-week diet high in fermented foods boosts microbiome diversity and improves immune responses.
• The New York Times account: How Fermented Foods May Alter Your Microbiome and Improve Your Health.  Foods like yogurt, kimchi, sauerkraut and kombucha increased the diversity of gut microbes and led to lower levels of inflammation.

Beyond eating healthfully and including fermented foods in the diet, here’s what’s being said about diet and immunity.

• Immune health is a marketing opportunity: Given current events, it’s likely that there has been no greater focus on immune health amongst consumers than right now. The market opportunity in this space is staggering, with immunity supplements showing an explosive 72.3% growth in 2020.
• Euromonitor Immunity Report: How to appeal to the holistic health shopper:  As consumers search for holistic and natural ways to improve their immunity, Euromonitor has published a new white paper examining how brands can appeal in a competitive and confusing market…. Read more
• Is immunity really the top functional choice for consumers in a pandemic era?  It sounds pretty logical – the pandemic has prompted increased interest in immunity across F&B. But is it really top dog in the world of functional beverages – or are there other claims consumers are more interested in?… Read more
• Parents are looking for immune-boosting options for school kids. Grocery retailers and packaged food and beverage brands should brace for another significant shift in consumer shopping habits this month as many families with students returning to in-person school after a year or more of distance or hybrid learning look for more on-the-go, budget-conscious and immune-boosting breakfast and lunch solutions.
• Immunity in a glass: Orange juice bioactives may bolster immunity and reduce inflammation:  The micronutrients and other bioactives contained in a glass of orange juice is sufficient enough to shore up the immune response and tackle oxidative stress and inflammation, a review concludes…. Read more  
• Beyond immunity: What ‘superpowers’ do today’s consumers want from their beverages?  The pandemic has propelled immunity to the top of the functional beverage agenda. But that doesn’t mean interest in other functional beverages has disappeared. We ask the experts what trends are bubbling away beneath the pandemic headlines – and will become all the more important to everyday heros in the coming years…. Read more  
• Shiitake happens: Mushrooms to play key role in immunity nutrition and health, concludes report:  Concerns over immune health and the pandemic has thrust the humble mushroom into the spotlight as experts hail the fungi’s ability to interact with gut microbes that influence healthy immune and inflammatory responses…. Read more  

The FTC has imposed new advertising restrictions on Kellogg because of the Immunity claim on Rice Krispies.  The company is not to make claims about “any health benefit of any food  unless the claims are backed by scientific evidence and not misleading.”

Under a previous order dealing with Frosted Mini-Wheats, Kellogg was not supposed to make claims about benefits to cognition on any of its cereals or snack foods unless the company could prove that the claims were backed by real science. This new decision extends that ruling to include any claim at all.

OK, but I’m confused about several aspects of this decision:

• How come the FTC is doing this and not the FDA?  At some point years ago, regulatory responsibility was split between FDA and FTC.  Since then, the FDA regulates claims on food package labels, whereas the FTC regulates advertising claims.  I realize that food labels are a form of advertising, but it’s unusual and surprising for the FTC to get involved in FDA-regulated matters.
• As FoodNavigator also wonders, why didn’t the FTC fine the company and, instead, write a harsh letter? [see update below]
• Why is the FTC doing this?  Kellogg agreed months ago to withdraw its Immunity claim ( see my November 5 post about the withdrawal).  The Immunity boxes gradually disappeared from supermarket shelves and I haven’t seen one for a long time.

So what’s going on here?  Is the FTC getting serious about regulation (and about time, too)?  Or is FDA sitting back and letting the FTC do its enforcement work?

Could this be why the FDA hasn’t sent a warning letter to Mead-Johnson, the maker of the chocolate toddler formula with three health claims aimed at kids ages 1 to 3.  I posted about this product on April 26, but haven’t heard whether the FDA is doing anything about it.  Can the FTC be on this case but waiting for investigations to be completed before taking action?

Kellogg, it seems, is under fire on all fronts.  CSPI’s Margo Wootan sent me the recent decision by the Children’s Advertising Review Unit of the Better Business Bureau that Kellogg must stop advertising Pop-Tarts to kids:

CARU was concerned that the product packaging, which features berries and states “Made with Real Fruit” for several of Kellogg’s Pop-Tarts®  products that have fruit in their names, impliedly represents to children that the products contain substantial amounts of fruit.

In fact, according to CARU, Pop-Tarts contain less than 6% fruit and less than 2% of the fruit shown in the advertising. Kellogg claimed that its marketing was not aimed at kids, but lost that one.

It’s great that regulatory agencies like FTC and FDA (and voluntary agencies like CARU) are regulating but it’s hard to keep track of who is doing what.   Nothing to do but wait and see what happens next.  Stay tuned.

Update, June 8: CSPI’s Margo Wootan writes that FTC can’t impose fines because it does not have the authority to issue civil penalties.  Ted Mermin of Public Good Law concurs.  He says:

Companies fight hard to make FTC (and similar) orders as narrow as possible, in large part to avoid precisely the situation in which they are held responsible for violating an existing injunction/order.  Since (in the Commission’s view, at least) Kellogg hadn’t violated an existing order, the FTC did not have the authority to fine them without first going to the US Department of Justice to get DOJ to take the case (a matter of a 45 day delay, if DOJ takes it at all).  The burden of that delay (and of needing to get authority from DOJ in the first place) is precisely what is driving the congressional charge for enhanced FTC authority as part of the financial reform legislation.

If the House version of financial reform legislation had been in effect, the FTC would have had the authority to seek civil penalties (i.e., fines) and the outcome here might have been different.  As it was, the fact that Kellogg had stopped the practice…kept the Commission (at least the three commissioners in the “majority”) from focusing on any remedy other than injunctive relief–that is, a broadening of the existing order from the Mini-Wheats case, with the threat of that $16,000 per violation (and an expanded area of prohibited activity) running into the future.

Update, June 11: In an editorial titled “Snake oil for breakfast,” the New York Times explains why health claims matter so much.  If you can’t believe health claims, what part of the food label can you believe?:

Businesses have been making dubious claims about their products at least since the 17th century, when the British clergyman Anthony Daffy sold Daffy’s Elixir as a cure for scurvy as well as agues, gout, rheumatism, rickets, worms and other ailments. Hucksterism — no matter how implausible the claim — lives on…[for example] POM Wonderful claimed its pomegranate juice helps treat, prevent or cure hypertension, diabetes and cancer.  This might be par for the course for an era of swift-boating political ads and a torrent of television commercials plumping for myriad wonder drugs (sudden death may result). It leaves the consumer in a quandary: what part of the label can be believed?

My latest column in the San Francisco Chronicle deals with the immunity health claim on boxes of Kellogg Cocoa Krispies (see previous posts).  I’ve been writing the column for the last year at irregular intervals of about once every three weeks.  Beginning in January 2010, it has its own slot and will appear on the first Sunday of the month.  Here’s this one:

Q: It’s great that San Francisco City Attorney Dennis Herrera put a stop to the absurd “immunity” claim on Kellogg’s Cocoa Krispies, but how do companies get away with this?

A: I confess; I’m a health-claims junkie. I snatched up the immunity-claiming box of Cocoa Krispies the minute I saw it in a supermarket last August. I consider it a treasure: “Now helps support your child’s IMMUNITY.”

How does Cocoa Krispies perform this miracle? The cereal contains 25 percent of the daily value of antioxidant vitamins A, B, C and E per serving instead of the old 10 percent. Vitamins, Kellogg points out, play an important role in immunity.

Of course they do. All nutrients are involved in immune function. But is it remotely possible that Cocoa Krispies might protect your child against colds or swine flu? I wish.

Antioxidants present an unparalleled marketing opportunity. Kellogg does not have to prove that its cereals are protective. Immunity claims fall into a Food and Drug Administration regulatory gray area. “Supports immunity” is a “structure-function” claim, so called because it promises to support a structure or function of the human body. However you might interpret such claims, they do not really promise to prevent, treat or cure disease.

Congress expressly authorized structure-function claims when it deregulated dietary supplements in 1994. But that law did not apply to foods. Food companies wanted to use these claims, too. At first the FDA balked. When faced with further legislation and court overturns, the FDA gave up. Now it merely says that structure-function claims on supplements must be truthful and not misleading. The FDA says nothing about structure-function claims on food products. It mostly looks away when they appear.

“Misleading” is inevitably in the eye of the beholder. Herrera turns out to be a skeptic.

“The Immunity claims,” he said, “may falsely suggest to parents that cereals like Cocoa Krispies are more healthy for their children than other breakfast foods … [and] mislead parents into believing that serving this sugary cereal will actually boost their child’s immunity.” Kellogg, he said, must produce the evidence or have the claim subject to “immediate termination or modification.”

Faced with this threat and with ridicule in the press, Kellogg wisely decided to phase out the immunity-labeled Cocoa Krispies packages. Consider them collectors’ items.

Much is at stake. Ready-to-eat cereals produce more than $8 billion a year in sales. Kellogg spent about $32 million in 2008 to promote Rice Krispies cereals, and $4 million of that amount went to advertise Cocoa Krispies alone.

Shoppers care about health. If cereals can be advertised with special health benefits, more boxes will fly off the shelves. Food companies consider health claims essential for marketing their products.

This explains why so many companies are adding omega-3 fats, probiotics and antioxidants to so many foods. These ingredients make foods “functional,” meaning that the foods contain something beyond their usual nutritional value. Although little evidence shows that functional foods make healthy people healthier, companies can use functional ingredients to make health claims, no matter how far-fetched. These days, functional foods are about the only processed foods with increasing sales.

Kellogg has plenty of company with functional ingredients and health claims. See, for example, the claims on Nestlé (no relation) Juicy Juice products targeted to toddlers. One product adds antioxidants to “help support immunity.” The other adds omega-3s to “aid brain development.”

Think about it: Will feeding your toddler a sugary juice product really make her smarter? Face it. You are not supposed to think about it. You are supposed to buy – and feel good about doing so.

Absent the FDA, Herrera stepped into the breach. He does not care whether the claims are on Kellogg cereals or Juicy Juice cartons. If companies make such claims, he insists that they produce the evidence for them.

This will not be easy to do. It is one thing to find evidence that specific nutrients are involved in immune function. It is quite another to show that people who eat sweetened cereals or juices containing such nutrients are healthier than those who do not.

That is why the European Food Standards Agency denied hundreds of company petitions for health claims. The agency cannot find much evidence for the health benefits of foods with added functional ingredients. Its decisions have put European food marketers into crisis. How are they supposed to sell products without health claims?

As I keep saying, health claims are about marketing, not health. If it were up to me, I would remove all health claims from food packages. Foods are not drugs. Health claims cannot help but mislead.

So let’s congratulate Herrera for filling a regulatory gap. His colleagues – and the press – are doing their job on this one. FDA: Get to work!

Kellogg’s says it will phase out boxes of Cocoa and other Rice Krispies cereals with the IMMUNITY claim on them.

Withdrawn, November 4, 2009

The Immunity claim falls into an FDA regulatory grey area.  It is a structure-function claim, meaning that the product is supposed to support a structure or function of the human body – not treat or cure a disease. If Cocoa Krispies were a dietary supplement, the claim would be completely legal because Congress authorized structure-function claims for supplements when it passed the Dietary Supplement Health and Education Act of 1994.

Over the years, food makers complained that if supplements could use such claims, they could too.  At first, the FDA issued warning letters to food companies using structure-function claims.  It stopped after the courts ruled that food companies could make claims for the health benefits of their products on First Amendment grounds.

Now FDA says structure-function claims are OK to use as long as they are truthful and not misleading.  Misleading, of course, is in the eye of the beholder.  Evidently, the San Francisco city attorney thought this claim was misleading and demanded the evidence to back it up.  USA Today wrote about this on the front page (I’m quoted in it).

Wisely, Kellogg’s is going to find another design for its Rice Krispies packages.  Consider this particular box a collector’s item.

The lesson: In the absence of FDA action, food marketing is allowed to run rampant, and city and state attorneys are doing the FDA’s job.  Good for them.  And let’s hear cheers for the power of the press.

The Supreme Court has just handed Bayer, which owns Monsanto, a “landmark victory.”  The decision may well overturn thousands of pending cases of people suing Bayer in the belief that the herbicide glyphosate (Roundup) caused them to develop non-Hodgkin’s lymphoma.

The Supreme Court’s ruling in Monsanto v. Durnell states its premise in the first paragraph:

Monsanto Company manufactures and distributes Roundup, a glyphosate-based herbicide designed to control weeds. The EPA has repeatedly evaluated glyphosate and repeatedly concluded that glyphosate is not likely to cause cancer. EPA’s assessment is shared by many other regulatory bodies around the world. In accordance with EPA’s view that glyphosate is not likely to cause cancer in humans, EPA has not required labels on glyphosate-based pesticides like Roundup to include a cancer warning.

Ergo: If the EPA says glyphosate is not carcinogenic, glyphosate is not carcinogenic.

An advocacy group, Protect Our Care, organized an emergency virtual event in Washington, DC, to condemn this “deeply misguided” decision. 

The Supreme Court ruled in favor of industry and the Trump administration by effectively granting Donald Trump’s big chemical industry donors blanket immunity from state-based liability claims involving the cancer-linked glyphosate chemical found in Roundup pesticides. In the administration’s latest betrayal of the MAHA movement, Trump’s DOJ filed an amicus brief in support of Monsanto – now owned by Bayer — and Trump’s Principal Deputy Solicitor General argued alongside the chemical maker in court. The decision is also a major affront to cancer survivors, now denied a pathway to damages for any injuries and financial costs they may have endured following exposure to glyphosate. 

At the event, Senator Cory Booker said:

Today’s a really a grievous day where the people of the United States saw that their Supreme Court corrupted by massive gifts from billionaires and people of interest in matters before them. A court that takes gifts, from RVs to tuition to lavish gifts, sided with the wealthy, powerful multinational corporation reversing years and years of precedent, dismissing ultimately effectively hundreds and hundreds, in fact 1000s of cases. They sided with the big multinational corporations against the people. Worse than that, compounding that, is a president who said he stood with the MAHA movement has betrayed that movement by now siding with the big corporations and those who are poisoning people in our country.

Why is this infuriating?

(1) The EPA relied on evidence developed by Monsanto: The EPA Relied on an Influential Glyphosate Study Even After Learning Monsanto Was a “Ghost Writer”

The US Environmental Protection Agency has known for nearly a decade that an influential 2013 scientific paper that concluded glyphosate is safe was actually ghostwritten by developer Monsanto. But the agency never informed the public and continued to rely on it, according to an EPA memo obtained by Mother Jones and revealed here for the first time.

(2)  Monsanto created its own evidence for the safety of glyphosate: Merchants of Poison: How Monsanto Sold the World on a Toxic Pesticide.

(3)  The Trump administration’s support of Bayer was aided by officials who came from Bayer’s law firms.

(4)  Getting glyphosate out of the food supply has been a stated objective of the MAHA movement and of HHS Secretary, RFK, Jr (although he later changed his stance)

One more thing: let’s not be taken in by President Trump’s executive order “advancing regenerative agriculture.”  This is really about biofuel production: “The new framework creates significant opportunities for America’s leading biofuel feedstock producers.”

By regenerative, this order refers to “cover crops, improved nutrient management, and conservation tillage—including no-till and reduced tillage.”

This is not my idea of the meaning of regenerative.  I much prefer the approach of Real Organic Project:   “is a farmer-led, soil-grown, pasture-raised WHOLE farm certification with labor protections. “

If a farm uses glyphosate, it’s not regenerative, not matter how much no-till it uses.

This one is not over yet.  At least one lawsuit has been filed to disclose how all this happened.

Stay tuned.

I know I just wrote about botulism in powdered infant formula but it upsets me so much that I have to do it again.

We now have a second outbreak, first ByHeart now Nara, both linked to contaminated organic whole milk from the same German supplier.

Yes, botulism in infant formula is rare, but not nearly rare enough.  You do not want your infant to be one of the unlucky ones.

I’m trying to understand how this could happen and how it can be stopped.

The clearest explanation comes from food safety lawyer, Bill Marler, who represents families of those unlucky babies.

Let me summarize.

• Botulism comes from bacterial spores (“seeds”) that can germinate in an infant’s intestine, releasing botulinum toxin.
• The spores came from Clostridium botulinum in dirt.  Somehow, the dirt got on the cows and the spores got into their milk.
• Spores resist drying and heat; they survive Pasteurization and the drying that happens when milk is turned into powder.
• Spores can germinate in infants’ digestive tracts and produce botulinum toxin (older children and adults have immunity)
• The fat in whole milk may protect the spores (the ByHeart and Nara formulas are whole milk)
• Pasteurized powdered milk is not sterile; it can contain botulinum spores.

What can parents of bottle-fed infants safely feed them?

The only option is an expensive one: Ready-to-feed formula previously sterilized at temperatures high enough to kill spores.

How about preventing spores in the first place?

This is not easy, according to a study of just this question in the International Dairy Journal: Towards low-spore milk powders: A review on microbiological challenges of dairy powder production with focus on aerobic mesophilic and thermophilic spores (Thanks to Kristin Schill for sending).

Here’s what this study says needs to be done to keep spore levels low:

• Membrane filtration or bactofugation
• Validation of cleaning protocols to avoid recontamination
• Sterilisation of heating equipment
• Development of evaporators that are to be sterilised
• Ensure the plant design is hygienic
• Avoid long production cycles for temperature-sensitive steps, i.e., separation, pasteurisation and evaporation
• In other words, prevention requires a clean farm, clean udders, filtration, a clean plant, and quick processing.

What about testing?  It comes too late in the process and can’t always find rare contaminants.

And formula companies would rather not test for pathogens; if they find some, they have to issue recalls.

They also do not like to take responsibility; they would much rather finger point.

; Nara did not want to reveal the name of its European supplier.

The risk of botulinum spores has been known for a long time, at least since 2013.

Marler, who keeps track of all the problems with powdered infant formula in the past few years, thinks Congress needs to pass the Infant Formula Safety Modernization Act of 2026, which requires much, much higher standards for and oversight of infant formula.

Here is Marler’s letter to Congress summarizing the rationale for and evidence in support of this act.

Congress: Please pass this, and right away.  It will force formula companies to do what they should have been doing all along.

Farm Action has joined Vani Hari (the Food Babe) and other groups in this People vs. Poison rally.

Livestream it here.

The “poison” here is glyphosate, the potentially carcinoenic weed killer manufactured by Monsanto (now owned by Bayer) for use with genetically modified crops.

People vs. Poison says, “For decades they poisoned us for profit.  Now the people are fighting back”.

The rally is to let the Supreme Court know that there is widespread opposition to Monsanto’s position in the case, Monsanto v. Durnell.  The Court is hearing that case today.  As People vs. Poison explains,

Bayer – the foreign corporation that bought Monsanto – has paid over $10 billion to cancer victims linked to their weed killer Roundup (glyphosate). And there are still tens of thousands of cases pending.

Now Bayer wants to make sure they never have to pay again.

As described in The New Lede, 

Monsanto specifically is asking the Supreme Court to rule that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), it cannot be held liable for failing to warn of a cancer risk if the Environmental Protection Agency (EPA) has not found such a risk exists and not required such a warning. FIFRA preempts any state requirements for such a cancer warning, the company argues.

Hundreds of groups have filed briefs on both sides of this case.

Trump’s Department of Justice filed one in support of Monsanto/Bayer.

Farm Action says

Monsanto, owned by Bayer, has mounted an aggressive campaign to secure immunity, leveraging its outsized market power to influence policymakers. The company faces thousands of lawsuits alleging its flagship product, Roundup, causes cancer. As Farm Action has documented, threats to pull Roundup from the market are a strategic pressure tactic, not a sign of impending crisis for the food and farm system…The coalition’s brief urges the Court to reject Monsanto’s argument and preserve the right to hold companies accountable when their products cause harm.

The rally is set for 9:00 this morning.  I will be interested to hear how it goes and whether the Supreme Court listens.

Commentary on what the rally is about

• Vani Hari’s video introducing the rally
• Vani Hari on the Reuters poll of public attitudes toward pesticides
• High Wire’s call for participation
• The Florida Surgeon General’s announcement of the rally agenda
• The New York Times’ analysis
• Vani Hari on the background of the Justice Department’s lawyer

Pesticides, herbicides, and other agricultural chemicals in food are of great concern right now, and getting rid of them is high on the agenda of Make America Health Again (MAHA).

This will not be easy.  The chemicals pervade the food supply and Big Ag producers claim that cannot grow food without them.  We have already see how they forced MAHA to retreat on Roundup (glyphosate).

Here’s what’s been happening recently on the chemicals-in-food front.

I.  EWG’s Dirty Dozen: Spinach, it says, ” has more pesticide residues by weight than any other type of produce.”

II.  The Supreme Court case, Monsanto v. Durnell.

Senator Cory Booker has asked the Supreme Court to permit lawsuits against Roundup to proceed.

Vani Hari (aka the Food Babe) approves.

A coalition of groups represented by Center for Food Safety (CFS) has also filed a brief in this case.

For the past decade, state juries across the country have found Monsanto (now Bayer) guilty of failing to warn the public of the cancer risks of its flagship pesticide, Roundup, totaling billions of dollars in damages against the chemical giant. Monsanto is now using the Supreme Court case to seek immunity from any accountability for these harms.

Comment

It’s hard to know how serious a problem these chemicals pose for human health but they cannot possibly be good for us.  I do not want them in my food and drink and support all efforts to reduce their use.  Big Ag is fighting back, of course, which is why this case matters so much.  Let’s hope the Court rules against Monsanto/Bayer.