Search results: Complaint

I saw this on FoodNavigator–Asia, a newsletter to which I subscribe.

Red yeast rice impact: Kobayashi Pharmaceutical records nearly US$25m losses in Q1: Kobayashi Pharmaceutical reported an “extraordinary loss” of nearly US$25m (JPY$3.86bn) in its Q1 results due to the recall of its contaminated red yeast rice products, raw materials, and compensation of medical expenses. Read more

Red yeast rice is a dietary supplement with a statin-like component observed to reduce blood cholesterol levels, although not nearly to the same extent as statin drugs.  Consumer Lab tests show at least half not to contain what they say they do.

Now, on top of that, the supplements were associated with kidney disease (at least 50 cases) and deaths (at least 2) among takers in Japan.

Comment: Dietary supplements are the wild west of the food supply.  Anyone can make and sell them.  Because they are mainly harmless, nobody much bothers to test them, even major pharmaceutical companies.  Problems with red yeast rice supplements have been known for a long time.  As a result, supplements are risky.  How risky?  Nobody knows.  I don’t recommend them.

A reader who wishes to remain anonymous forwarded this email she received from Kristen Hicks-Roof PhD, RDN, LDN, FAND , Director of Human Nutrition·National Pork Board.

Growing Strong: Animal-Source Foods’ Role in Childhood Development and Sustainable Food Systems

Childhood and adolescence are critically important periods for growth and development. These periods are also key for establishing healthy dietary patterns that can influence eating behaviors and health into adulthood.

During these stages, animal-source foods provide critical nutrients — such as high-quality protein, iron, zinc, choline, and B vitamins — that are not easily replaced from other sources.

In this webinar, Dr. Adegbola Adesogan will:

– Present evidence on the role of animal-source foods in childhood development and impact on future health outcomes

– Review how animal-source foods are a source of key nutrients that support health in children and adolescents

The CPE activity application for this webinar is pending review by the Commission on Dietetic Registration (CDR) and approval for 1.0 CPEU.

Comment

Presumably, the CDR will approve this for continuing education credits required for dietetic licensing.  Also presumably, participants will not learn about the polluting effects of Pork CAFOs or the community lawsuits against them for obnoxious odors and other offenses.  Or the way the pork industry fights back against such complaints.  Or the welfare issues about farrowing crates.  Or complaints about Pork Checkoff programs.

As I’ve noted previously, dietitians are able to fulfill all requirements for continuing education credits from industry-funded courses like this one.

Conflict of interest, anyone?

I subscribe to The Hagstrom Report, not least because Jerry Hagstrom reports on items I might not see otherwise.  Here’s one:

Kroger, Albertsons release list of stores to be sold: The Kroger Co. and Albertsons Companies have released the list of stores they intend to sell if their acquisition plan is approved.

He conveniently provided links to Kroger-Albertsons’ list of stores to be divested, and also to an article about the divestments with a handy map.

From the map, you can see that most stores will be divested in the West: Washington (124 store), Arizona (101), Colorado (91), California (63), and Oregon (62).

One reason why the Federal Trade Commission sued to block the merger is evident: there will be fewer grocery stores available.  Other reasons: less competition between the chains, and more power over employee wages, benefits, and working conditions.

The proposal says 579 stores will be sold to a new owner, C&S Wholesale Grocers.

Kroger’s says: “You’ll see that the 579 stores and other assets to be divested were thoughtfully chosen to allow C&S to succeed in the geographies and maintain – if not increase – the level of competition that consumers benefit from.”

The FTC’s oroginal press release explained why the merger is not a good idea:

The FTC charges that the proposed deal will eliminate fierce competition between Kroger and Albertsons, leading to higher prices for groceries and other essential household items for millions of Americans…lower quality products and services, while also narrowing consumers’ choices for where to shop for groceries. For thousands of grocery store workers…[the merger] would immediately erase aggressive competition for workers, threatening the ability of employees to secure higher wages, better benefits, and improved working conditions…executives for both supermarket chains have conceded that Kroger’s acquisition of Albertsons is anticompetitive, with one executive reacting candidly to the proposed deal: “you are basically creating a monopoly in grocery with the merger.”

Monopolies are never good for consumers.  Let’s hope the FTC holds firm on denying this merger.

The title of this article triggered my usual question: Who paid for this?  I cannot think of any reason other than marketing this supplement for doing a study like this.

Multi-nutrient supplementation of astaxanthin, vitamin E and grape juice improves episodic memory, cognitive performance – RCT:  A study has found that 12 weeks of multi-nutrient supplementation, comprising astaxanthin, vitamin E and grape juice extract, resulted in improved episodic memory and several biomarkers associated with cognitive health…. Read more

The study: Lopresti AL, Smith SJ, Riggs ML, Major RA, Gibb TG, Wood SM, Hester SN, Knaggs HE. An Examination into the Effects of a Nutraceutical Supplement on Cognition, Stress, Eye Health, and Skin Satisfaction in Adults with Self-Reported Cognitive Complaints: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024; 16(11):1770. https://doi.org/10.3390/nu16111770

Method: adults aged 40 to 70 years with subjective memory complaints were randomized to take a supplement containing vitamin E, astaxanthin, and grape juice extract daily for 12 weeks or a matching placebo.

Outcomes:  Changes in cognitive tasks assessing episodic memory, working memory, and verbal memory., speed of information processing, attention, and self-report measures of memory, stress, and eye and skin health.

Results: “Compared to the placebo, nutritional supplementation was associated with larger improvements in one primary outcome measure comprising episodic memory (p = 0.037), but not for working memory (p = 0.418) or verbal learning (p = 0.841). Findings from secondary and exploratory outcomes demonstrated that the nutraceutical intake was associated with larger improvements in the Everyday Memory Questionnaire (p = 0.022), increased plasma brain-derived neurotrophic factor (p = 0.030), decreased plasma malondialdehyde (p = 0.040), and increased skin carotenoid concentrations (p = 0.006). However, there were no group differences in changes in the remaining outcome measures.”

Conclusions: “The results from this 12-week study provide some support for the cognitive-enhancing effects of a nutraceutical containing astaxanthin, vitamin E, and grape juice extract in adults with self-reported memory complaints. This was demonstrated by improvements in one primary outcome measure (episodic memory) but not working memory or verbal learning.”

The Department of Health and Human Service’s Inspector General has reported on its investigation of the FDA’s mis-handling of infant formula shortages a couple of years ago: The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply.

I see this as a direct result of Helena Bottemiller Evich’s reporting in Politico—the power of the press, indeed (she now writes Food Fix, to which I subscribe, and where she discusses this report).

In an earlier report, she detailed the history of FDA’s inspections of the Abbott laboratory and the agency’s surprising delay in getting Abbott to do a “voluntary” recall.

She, justifiably, takes some credit. 

Food safety lawyer Bill Marler also had questions about the quality of production and FDA’s surprising lack of action.

What this is about

Infants who are not breastfed are completely dependent on infant formula. In 2022, contaminated powdered formula from Abbott Labs was associatied with the illness or deaths of several infants,  Despite earlier complaints from whistleblowers about poor sanitation at Abbott plants, the FDA was slow to advise not using this formula.

At the time of the FDA advisory, one infant was ill with Salmonella Newport, and four were ill with Cronobacter sakazakii ); of these, two died—a shocking tragedy.

What the report says

The Inspector General summarizes the findings:

• FDA had inadequate policies and procedures to identify risks to infant formula and respond effectively
• FDA took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. I
• FDA did not escalate an October 2021 whistleblower complaint to senior leadership
• FDA did one inspection 102 days after a whistleblower complaint was received.
• FDA did not initiate an infant formula recall under its FDA-required recall authority.

Why didn’t the FDA act?

One reason was probably because “FDA could not confirm that the Abbott facility’s products caused the infant illnesses or deaths because clinical isolates for the infants were not available or whole genome sequencing was not a match to the Abbott facility Cronobacter investigation findings.”

Another is likely to be inadequate staffing, but a third, I’m guessing, has to do with the culture of the FDA, which increasingly appears captured by the industries it is supposed to be regulating.  The infant formula industry is highly concentrated and Abbott made something like 40% of it—even more reason to make sure the company was taking scrupulous care about safety.

The report instructs the FDA to do better.  Let’s hope.

Last week, the USDA issued new rules for the nutrient content of school meals and also child care programs.

These apply to sugar and sodium (nutrients), whole grains (ingredient or food),  and milk (food).

The New York Times report on this cut right to the chase

The Agriculture Department announced on Wednesday that it had finalized the regulation it had first proposed in February 2023, having weakened several provisions after feedback from food companies, school nutrition professionals and over 136,000 public comments.

The Update to the standards describes the changes and compares them to USDA’s original proposals.

• Sugars: For the first time (I’m not kidding), the USDA set limits on sugars, starting with breakfast cereals (6 grams per ounce), yogurt (12 grams per 6-ounce serving), and milk (10 grams per 8-ounce serving).  This allows chocolate and other flavored milks if companies get the sugar down to 10 grams.
• Sodium: beginning July 2027, sodium will be reduced by 15% for lunch and 10% for breakfast from current limits (USDA proposed 3 consecutive reductions of 10% over the next five years.
• Whole grains: no change from current standard (USDA proposed that 80% of grains be whole).
• Milk: Allows flavored fat-free and low-fat.

Comment: The sugar rule is an improvement, even though products still are sweetened.  The weakening of the sodium proposal is troubling.  We badly need to reduce sodium in processed and restaurant foods and need federal leadership for doing so.  USDA caved to political pressure here.  The USDA has a long history of captivity by Big Ag.  Now it looks captured by Big Food.

The food industry complaint is that its products won’t meet these standards.  The school food complaint is that the standards are too hard to meet, the kids won’t eat the food, and it will be wasted.

I have a lot of sympathy for school foodservice.  It’s the only thing going on in schools that has to be self-supporting, and school food programs are hugely underfunded.  And lots of schools don’t have kitchens to must rely on food products rather than real food.

But from what I’ve observed, two kinds of skills are needed for successful school meal programs: the ability (1) to prepare and serve edible healthy food, and (2) to get the kids to eat it.  I’ve seen every permutation.

1. Good food, kids eat it
2. Good food, kids won’t eat it
3. So-so food, kids eat it
4. So-so food, kids won’t eat it

Whenever I hear “the kids won’t eat it,” I wonder where the adults are. From what I’ve seen, if adults care that kids are fed, the kids will eat the food—not all, necessarily, but most.

School food is not just about the food.  It’s about the interactions of school food personnel, teachers, and the principal with the kids.  If the adults think it important and necessary to feed kids healthy food, the program has a good chance of success.  The new USDA standards are a step in the right direction but still have a way to go.

Wouldn’t it be nice if we had food standards rather than nutrition standards?  How about mandating numbers of servings of real foods instead of worrying about grams of sugar and milligrams of sodium.

A thought,

Additional Resources

• Comparison Chart: 2023 Proposed Standards vs. 2024 Final Standards
• Implementation Timeline – School Meals
• Implementation Timeline – CACFP & SFSP
• Media Toolkit
  • Infographic: Final Rule for School Meal Standards
  • Infographic: Implementation Timeline
  • Infographic: How We Got Here
  • Video: Rule Overview
  • Video: Added Sugars
• Federal Register notice 

Thanks to everyone who flooded my mailbox with this piece from The Guardian: She was fired after not endorsing Splenda-filled salads to people with diabetes. Why?

According to a lawsuit {Elizabeth] Hanna recently filed against the ADA, the organization – which endorses recipes and food plans on its websiteand on the websites of “partner” food brands – tried to get her to greenlight recipes that she believedflew in the face of the ADA’s mission. These included recipes like a “cucumber and onion salad” made with a third of a cup of Splenda granulated artificial sweetener, “autumnal sheet-pan veggies” with a quarter cup of Splenda monk fruit sweetener and a “cranberry almond spinach salad” with a quarter cup of Splenda monkfruit sweetener.

Guess which company gave more than $1m to the ADA in 2022? Splenda.

I also was sent an email from Georgia Warren, the  Guardian’s Interim membership editor: The link between investigative reporting, some nightmarish recipes and the diabetes epidemic.

Why would a public health charity promote a product that its own science shows contributes to the disease it is fighting? Well, as Neil Barsky reported for us this week, the ADA took more than $1m from Splenda in 2022 – and then fired their chief nutritionist when, according to a lawsuit she recently filed, she refused to sign-off on the Splenda-based recipes that her bosses wanted the ADA to publicly endorse.

Neil – creator of our new series ‘Death by diabetes: America’s preventable epidemic’ – told me…“The ADA has bought into a system that requires them to raise money from corporations to fund their research. I don’t for a second doubt that every single person who works there cares about people with diabetes and wants to do the right thing, but being beholden to these groups distorts your judgment.”

..And what else is pharma funding? The ADA. The organization – whose guidance doctors rely on when treating their diabetes patients – boasts a $100m annual budget. Between 2017 and 2024, pharmaceutical and device manufacturers contributed over $134m to the organization – or roughly 20% of its total funding.

Comment: The ADA has long appeared to be in thrall the the drug industry.  I well remember the talk I gave at one of its annual conventions years ago.  I was one of two speakers about diet and diabetes (the other was a session on the role of sugar in diabetes sponsored by Coca-Cola—truly you can’t make this stuff up).  The other talks, hundreds of them, were about drugs.  At that time, the ADA said virtually nothing about diet on its website.

It’s gotten much better.  Here’s what it says about carbohydrates:

• Try to eat less of these: refined, highly processed carbohydrate foods and those with added sugar. These include sugary drinks like soda, sweet tea and juice, refined grains like white bread, white rice and sugary cereal, and sweets and snack foods like cake, cookies, candy and chips.

And here’s what the ADA says about artificial sweeteners:

It’s also important to know that at this time, there is no clear evidence to suggest that using sugar substitutes will help with managing blood sugar or weight or improving cardiometabolic health in the long run. So here’s the bottom line:

• Sugar substitutes are effective alternatives to sugar for some people, but not a perfect fit for all—it’s a personal choice.
• If you’re looking to reduce your intake of sugar or sugar substitutes, start slowly. For example, start by replacing one soda or juice with water or a no-calorie drink at a time.
• Water will always be a great choice! If you start feeling yourself get bored with just water, you can always spruce it up with fruits or herbs like this sparkling strawberry mint infused water.

And, finally for now, here are the ADA’s corporate sponsors, and its national sponsors.

Conflicted?  Sure looks like it.

ProPublica has issued a major and highly importantt investigative report: The U.S. Government Defended the Overseas Business Interests of Baby Formula Makers. Kids Paid the Price.

The report documents how the U.S. has opposed marketing restrictions on infant formula throughout the world.

It refers specifically to what happened in Thailand over attempts to restrict the marketing of toddler formula (an unneccesary product).

In 2017, Thai health experts tried to stop aggressive advertising for all formula — including that made for toddlers. Officials feared company promotions could mislead parents and even persuade mothers to forgo breastfeeding, depriving their children of the vital health benefits that come with it. At the time, Thailand’s breastfeeding rate was already among the lowest in the world.

But the $47 billion formula industry fought back, enlisting the help of a rich and powerful ally: the United States government…U.S. officials delivered a letter to Bangkok asking pointed questions, including whether the legislation was “more trade restrictive than necessary.” They also lodged criticisms in a bilateral trade meeting with Thai authorities and on the floor of the World Trade Organization, where such complaints can lead to costly legal battles…In the end, though, the Thai government backed down. It banned advertising for infant formula but allowed companies to market formula for toddlers like Gustun — one of the industry’s most profitable and dubious products. The final law also slashed penalties for violators.

ProPublica also obtained documents detailing the arguments between trade and health officials over these policies.  See: Documents Show Internal Clash Before U.S. Officials Pushed to Weaken Toddler Formula Rules.

In this case, trade won over health.

The US government role in infant formula marketing goes way back to its opposition to the international code of marketing of breastmilk substitutes.  It is not a nice history and distressing that it continues.

More on infant formula tomorrow…