Search results: Complaint

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if:

• the first two digits of the code are 22 through 37; and
• the code on the container contains K8, SH or Z2; and
• the expiration date is 4-1-2022 (APR 2022) or later.

The FDA and CDC are investigating.

[They have received] four consumer complaints of infant illness…All of the cases are reported to have consumed powdered infant formula (IF) produced from Abbott Nutrition’s Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.

Bill Marler’s Food Poison Journal has more about Cronobacter sakazakii (formerly known as Enterobacter sakazakii) in infant formula.

The FDA reports:

On 2/17/2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries as well. Canadian health officials have also issued a recall warning.

Helena Bottemiller Evich, writing in Politico, is right on top of this situation.

The FDA first received a report of a foodborne illness suspected to be linked to infant formula in September — four months before issuing a recall of three major brands this week after four babies were hospitalized and one died, according to a state agency.

The [recall]…comes after reports of illnesses came to FDA and the Centers for Disease Control and Prevention between September and January. The Minnesota Department of Health investigated a case of an infant who was sickened by Cronobacter sakazakii in September 2021, the state agency told POLITICO.

She also Tweeted:

I’ve gotten a bunch of reports that the formula recall includes these (often unsolicited) packs that formula companies send new parents. So check those, too!

Warning to parents: if you are using any Abbott formula products, check the labels.  Do not feed recalled products to your infant.

Comment: Anything wrong with infant formula is a terrible problem because that’s all infants are fed and they are completely dependent on those products.  We will have to wait and see why the FDA:

• Did not push Abbott to recall these products four months ago.
• Did not mention the gift pack of formula given to new mothers.

And Bill Marler writes: “I have some questions about the Cronobacter and Salmonella infant formula outbreak: Why are illnesses not universally reportable and why was there a two year gap in FDA inspections at plant?”

Also worrying is that the FDA still does not have the authority to demand immediate recalls of potentially harmful products.

The Food Safety Modernization Act gave the FDA recall authority, but tied its hands.

FSMA’s mandatory recall authority allows the FDA to mandate a recall when a responsible party chooses not to conduct a voluntary recall when the criteria under section 423 of the FD&C Act are met. The FDA can use its mandatory recall authority when the FDA determines that there is a reasonable probability that an article of food is adulterated under section 402 of the FD&C Act and/or misbranded under section 403(w) of the FD&C Act and where there is a reasonable probability that the use of or exposure to such food would cause SAHCODHA.

You will be amused to know that SAHCODHA stands for Serious Adverse Health Consequences or Death to Humans or Animals.

On January 1, the USDA’s useless rules for labeling bioengineered (BE) foods, those formerly known as genetically modified (GMOs), went into effect.

Will the new rules help you figure out which items in the produce section or anywhere else in the store have been genetically engineered?

Not a chance.

I am particularly curious about what’s in the produce section.  It’s easy enough to know which genetically modified foods have been approved by the FDA; the FDA has a website for this purpose.

But just because they’ve been approved does not necessarily mean they are in production and in your supermarket.

To know which ones are genetically modified, it would be nice to have labels.

Instead, we have the results of USDA’s obfuscation, as I discussed in a blog post two years ago: Goodbye GMO, Hello Bioengineered: USDA publishes labeling rules.  It’s worth repeating:

Priya Fielding-Singh.  How the Other Half Eats: The Untold Story of Food and Inequality in America.  Little, Brown Spark, 2021.

I did a blurb for this book (some of it ended up on the cover)

How the Other Half Eats is a must-read for anyone who has ever wondered why Americans don’t eat more healthfully. Fielding-Singh achieved something remarkable in gaining the trust of families who then let her observe their daily food choices. Her book is a thoughtful, riveting, compassionate, and utterly compelling account of why eating healthfully is so difficult, especially for the poor. What’s more, she offers a superb example of why on-the-ground field research is invaluable for gaining a deep and nuanced understanding of the ways that our industry-driven and highly inequitable food environment affects real people on a daily basis.

What I found so amazing about this book was that Fielding-Singh actually talked to people about how they feel about their diets—and listened.  Her analysis is exceptionally thoughtful.  Some examples:

From page 253

It is one thing to be able to find and afford a head of cauliflower.  But it is another to want to buy that cauliflower, to choose to spend one’s money on that cauliflower (at the expense of other purchases), to have the time and tradition to cook that cauliflower, and to possess the patience to weather one’d child’s complaints and pleas for macaroni and cheese and soldier on to feed that cauliflower to one’s child.  Only a handful of parents I met had all of these things.

From page 255

Personal responsibility has never solved a public health problem or remedied an inequity.  Food is no exception…Many of the families I met had either done so or were trying to figure out how to eat more nutritiously with the resources they had.  But, largely due to the structures implemented by the food industry and federal government, most felt like they were fighting an uphill battle—and losing.

Page 259

Banning marketing to kids would give moms a fighting chance of being able to feed their kids what they want rather than what corporations push on them.  Currently, only those families with the most money, time, and bandwidth have a shot at prevailing against the industry—and even those families often struggle and even fail.  Protection from the food industry should be right granted to all families, not a privilege reserved for the few.

I am not a litigious person and much prefer to stay out of the legal system.

But I am a big fan of Bill Marler, who represents victims of food poisonings, not least because his lawsuits against companies with sloppy food safety procedures should encourage them to clean up their processes.

I’m not sure what to think of NPR’s account of Spencer Sheehan’s 400 or so lawsuits against food companies for misleading labeling.

The one that triggered off the article is on behalf of a woman suing Kellogg over the number of strawberries in Strawberry Pop-Tarts.

Enriched flour (wheat flour, niacin, reduced iron, vitamin B1 [thiamin mononitrate], vitamin B2 [riboflavin], folic acid), corn syrup, high fructose corn syrup, dextrose, soybean and palm oil (with TBHQ for freshness), sugar, bleached wheat flour. Contains 2% or less of wheat starch, salt, dried strawberries, dried pears, dried apples, leavening (baking soda, sodium acid pyrophosphate, monocalcium phosphate), citric acid, gelatin, modified wheat starch, yellow corn flour, caramel color, xanthan gum, cornstarch, turmeric extract color, soy lecithin, red 40, yellow 6, blue 1, color added.

Some of his other cases:

Keebler and Betty Crocker and others over “fudge” cookies and baking mixes that contained no milkfat.

Frito-Lay alleging it didn’t use enough real lime juice in its “hint of lime” Tostitos.

Coors suggesting its pineapple-and-mango-flavored Vizzy Hard Seltzers are sources of Vitamin C “nutritionally-equivalent” to actual pineapples and mangos.

Snack Pack pudding — advertised as “made with real milk” — actually made with fat-free skim milk.

Many cases targeting vanilla products — soda, soy milk, yogurt, ice cream — that use synthetic vanilla or other flavors alongside or in place of the more expensive natural vanilla.

NPR says

Most of Sheehan’s suits, including the strawberry Pop-Tart cases, allege damages based on the so-called “price premium theory,” which says that products are sold at higher prices than they would have otherwise commanded had the companies marketed them honestly.

Are these cases frivolous or in the public interest?

I’m for anything that gets the makers of ultra-processed foods to advertise them for what they are, not for what they aspire to be.

Hat tip to Lisa Young for sending this one.

The White House issued a fact sheet on promoting competition in several business areas, one of them agriculture.

Over the past few decades, key agricultural markets have become more concentrated and less competitive. The markets for seeds, equipment, feed, and fertilizer are now dominated by just a few large companies, meaning family farmers and ranchers now have to pay more for these inputs. For example, just four companies control most of the world’s seeds, and corn seed prices have gone up as much as 30% annually. Consolidation also limits farmers’ and ranchers’ options for selling their products. That means they get less when they sell their produce and meat—even as prices rise at the grocery store…Overall, farmers’ and ranchers’ share of each dollar spent on food has been declining for decades. In short, family farmers and ranchers are getting less, consumers are paying more, and the big conglomerates in the middle are taking the difference.

In the Order, the President:

• Directs USDA to consider issuing new rules under the Packers and Stockyards Act making it easier for farmers to bring and win claims, stopping chicken processors from exploiting and underpaying chicken farmers, and adopting anti-retaliation protections for farmers who speak out about bad practices.
• Directs USDA to consider issuing new rules defining when meat can bear “Product of USA” labels, so that consumers have accurate, transparent labels that enable them to choose products made here.
• Directs USDA to develop a plan to increase opportunities for farmers to access markets and receive a fair return, including supporting alternative food distribution systems like farmers markets and developing standards and labelsso that consumers can choose to buy products that treat farmers fairly.
• Encourages the FTC to limit powerful equipment manufacturers from restricting people’s ability to use independent repair shops or do DIY repairs—such as when tractor companies block farmers from repairing their own tractors.

According to Politico

The rules seek to make it easier for the agency to challenge unfair and deceptive practices by meat processors and would allow farmers to more easily file complaints with USDA or sue under the Packers and Stockyards Act. People familiar with the order said it would also tighten the rules for so-called poultry grower tournament systems, in which contract farmers are paid more or less than their peers in the same area depending on how closely they meet buyers’ standards.

The agency is also moving forward with rules that seek to increase food access through alternatives to supermarkets, like local farmer’s markets, and increase consumer transparency about where meat is raised.

Lest anyone think these are trivial measures, take a look at the reactions.

The North American Meat Institute:

President Biden’s executive order calling for USDA to change the Packers and Stockyards rules will have unintended consequences for consumers and producers…Government intervention in the market will increase the cost of food for consumers at a time when many are still suffering from the economic consequences of the pandemic. These proposed changes will open the floodgates for litigation that will ultimately limit livestock producers’ ability to market their livestock as they choose. These proposals have been considered and rejected before and they are counter to the precedent set in eight federal appellate circuits.

Zephyr Teachout in The Nation:

He ordered the Department of Agriculture to use its full power under the Packer and Stockyards Act to break the stranglehold of distributors and other corporate giants that crush farmers and farmworkers…Biden has a chance to be the first trust-busting presidency in over 50 years—and we keep getting strong signals that he’s got it in his sights. That’s great news for workers, for small businesses, and for the small communities that have been left out in the collapsing concentration of our country for the last 50 years.

USDA Vilsack announces plans to boost competition:

Secretary Tom Vilsack said USDA will offer $500 million in grants, loans, and other assistance to help new meat and poultry processors enter the market, along with $150 million to support small plants that are already operating. The department will also move forward with a series of regulations to protect farmers and ranchers who work with large agribusinesses.

The National Sustainable Agriculture Coalition applauds Vilsack’s action:

NSAC is also pleased to see that USDA will issue new rules under the Packers and Stockyards Act. As directed in the Executive Order, this new rule will make it easier for farmers to bring and win claims, stopping chicken processors from exploiting and underpaying chicken farmers, and adopting anti-retaliation protections for farmers who speak out about bad practices.

Will Biden’s USDA follow through?  That would be real progress.

A press release from The Center for Food Safety announces that the agribusiness giant Corteva is dropping its “Plant-Killing Pesticide Dicamba Amid Legal Battles, Drift Concerns.”

Dicamba, like glyphosate, is a controversial herbicide widely used in conjunction with crops genetically modified to resist it.  Why controversial?

• It is potentially toxic to adults, children, and pets.
• It drifts long distances and kills “non-target” crops that are not genetically modified—those that are organically grown, for example.

National Pesticide Information Network Fact Sheet on Dicamba has a Q and A.

What are some signs and symptoms from a brief exposure to dicamba?

Pure dicamba is low in toxicity if breathed. If inhaled, people may experience dizziness, and irritation of the nose, resulting in coughing. If you get pure dicamba on your skin, it is low in toxicity, however skin irritation may develop. If you get dicamba in your eyes, it is moderately toxic. If dicamba is swallowed, people have reported symptoms such as vomiting, loss of appetite and muscle spasms. If a large amount is swallowed, diarrhea and abdominal pain have been reported.

Pets may be exposed to dicamba if they come into contact with plants that have been treated with dicamba, either by eating the plants or walking through an area where dicamba was applied. Signs that a dog or a cat may have been exposed to dicamba include shortness of breath, muscle spasms and the animal may produce a lot of saliva. Birds may also be exposed to dicamba by eating dicamba granules and signs include wing drop, a loss of controlled movements, and weakness.

The Missouri Department of Agriculture also has a Fact Sheet.  It reviews damages caused by this herbicide and complaints about it.

Dicamba is a highly volatile chemical that can damage non-target plant species through spray drift and/or volatilization (vapor drift). Misuse of dicamba products may cause serious damage to non-dicamba-tolerant soybeans, sensitive crops, non-crop plants, and endangered species.

The Center for Food Safety press release explains some history:

In June 2020, a federal appeals court prohibited the spraying of dicamba on GE crops, in response to a lawsuit brought by farming and environmental groups led by Center for Food Safety (CFS). The Court ruled that EPA had failed to estimate the “enormous and unprecedented damage” caused by dicamba drift, which triggered strife that “has torn apart the social fabric of many farming communities.” Just a few months later, Trump’s EPA re-approved the dicamba products, made by Bayer and BASF. CFS and allies are back in court challenging this unlawful decision. Press reports suggest Biden’s EPA will allow continued use for at least a year, permitting a fifth year of devastating dicamba drift damage.

In another landmark lawsuit against Monsanto (now owned by Bayer) and BASF, Missouri farmer Bill Bader was awarded $75 million for dicamba drift damage that devastated his peach orchard.

As Bill Freese, the Center’s director, points out, “If even an agrichemical giant like Corteva is dropping dicamba to avoid liability from the enormous, widely-documented drift damage it causes, what will it take for the Biden Administration to end the use of these hazardous products on America’s croplands for good?”

I’ve written previously about the alarming findings of toxic heavy metals in baby foods.  These toxins are in all foods, but are particularly harmful to infants and young children, a situation that calls for immediate FDA action to set limits on the amounts these foods contain.

The FDA has a Q and A on this issue.  It has also issued previous guidance.

• Metals and Your Food
• What FDA is Doing to Protect Consumers from Toxic Metals in Foods
• What You Can Do to Limit Exposure to Arsenic
• Arsenic in Food and Dietary Supplements
• FDA Makes Available Results from Testing of Infant Rice Cereal for Inorganic Arsenic

In response to many complaints, the FDA has now issued a plan for action:  “Closer to Zero.”

Translation: the agency will propose action levels (limits on allowable amounts), consult with stakeholders, finalize the limits, and then evaluate how the whole thing works to reduce intake levels.

Timeline: It plans to do this starting now, with the aim of finishing the process by 2025.

The FDA must not consider limiting toxic metals in baby food to be urgent.

No wonder some members of Congress have introduced la bill to force the FDA to set limits for the most common toxic metals within a year.  It suggests what those limits should be: 10 parts per billion for inorganic arsenic in baby food (15 ppb for cereal); 5 ppb for both cadmium and lead (10 ppb for cereal); and 2 ppb for mercury.

While all this is going on, what are parents to do?

Suggestions from Harvard Health

The FDA is working on doing better monitoring and regulation of heavy metals in commercial baby foods. In the meantime, it’s nearly impossible to know which are completely safe and which aren’t. Babies don’t need solid foods until 6 months of age. At that time it’s perfectly fine to give them soft table foods instead of baby foods. You can also make your own baby food, using steamed or naturally soft foods and a blender. (Storage tip: you can pour a homemade puree into an ice cube tray and freeze it, and then just grab the cubes you need each time.)

Suggestions from Healthy Children

• Give your child a wide variety of different foods (the more natural colors, the better).
• Vary the grains. As mentioned above, it’s best to limit rice and rice products (check labels — rice is in a lot of foods marketed for babies, like “puffs”). Try barley, oats, and other grains. When cooking rice, it’s best to cook it in extra water and drain that water off, and to use white basmati and sushi rice, which have less arsenic.
• Check your water. Old pipes can contain lead, which can leach into drinking water.
• Avoid fruit juices. Not only can they increase the risk of cavities and obesity, but many commercial juices also contain heavy metals.
• Make healthy fish choices. Fish contains nutrients that are very healthy for the developing brain, but some fish can contain unhealthy amounts of mercury. Stay clear of big, predatory, long-living fish like swordfish, shark, or albacore tuna; it’s better to choose fish like cod, light tuna, salmon, or pollock.

In the meantime…

• The lawsuits!  At least 69 had been filed as of April 29.
• The New York Attorney General is also looking into this.

Some parts of government are still functioning the way they are supposed to.

The U.S. Office of the Special Counsel (OSC) says USDA Secretary Sonny Perdue has violated the Hatch Act and has to repay the US Treasury.

In letters to Citizens for Responsibility and Ethics and to Representative Marcia Fudge,  the OSC says

Secretary Sonny Perdue violated the Hatch Act on August 24, 2020, when he spoke in his official capacity at an event in Mills River, North Carolina (the “August 24 event”)…The event generally related to USDA’s Farmers to Families Food Box Program…Because he was on taxpayer-funded travel when he engaged in the political activity at issue, the U.S. Treasury must be reimbursed for the costs associated with his political activity.  Provided that immediate corrective action is taken and the U.S. Treasury is reimbursed for such costs, OSC will decline to pursue disciplinary action and instead consider this file closed with the issuance of the cure letter.

As the letter explains,

The Hatch Act restricts certain political activities of federal executive branch employees, except for the President and the Vice President.  As the Secretary of Agriculture,
Secretary Perdue is covered by the Hatch Act and prohibited from, among other things, using his official authority or influence for the purpose of interfering with or affecting the result of an election.  Under this provision, Secretary Perdue may not use his official title while engaging in political activity or his official position to advance or oppose candidates for partisan political office.

In his speech at the event, Perdue congratulated President Trump for authorizing an additional billion dollars to the Farmers to Families Food Box Program

you just authorized another billion dollars for the hungry people of this country and to keep our farmers there. And we’ve never seen an outpouring of compassion like that for people who matter, because people matter to you. And that’s what’s important to me. And that’s what’s going to continue to happen—four more years—if America gets out and votes for this man, Donald J. Trump.

This is a particularly clear violation of the Hatch Act.  The OSC is right to call Perdue on it and insist that he repay taxpayers.

This is also yet another example of how the Farmers to Families food box program, about which I have written repeatedly, is more about politics than feeding the hungry.

The OSC investigation resulted from a complaint from Representative Fudge and several colleagues in Congress.   It’s also good to see them doing their job.