UNICEF does not want its statements to be compromised by conflicted interests with food and beverage companies that make formula or foods for children.

Here’s how UNICEF will be dealing with the food and beverage interests.

This publication explains just how UNICEF intends to avoid conflicts of interest with companies making products that do not promote childrens’ health.

The practices and products of a subset of the F&B industry whose primary business is the production, distribution, marketing and retailing of ultra-processed foods and beverages (UPF) pose particular concern. The companies producing these unhealthy, nutrient-poor UPF – rich in sugar, salt, trans-fats and food additives and preservatives – are major drivers of today’s broken food system and the global epidemic of childhood overweight and obesity and diet-related non-communicable diseases…It is now widely accepted that the practices and products of the UPF industry harm children’s and adolescents’ lives and have become the main commercial determinant of childhood malnutrition and disease.

Evidence shows that direct partnering with the UPF industry (i.e., working with) and voluntary UPF industry initiatives do not translate into large-scale sustainable results in transforming food systems for children. Further, direct funding engagements with UPF industry stakeholders pose a significant reputational risk to the credibility of UNICEF programming and independence as governments’ trusted advisor for policy formulation, normative guidance and programme scale-up for children and adolescents.

UNICEF says it will, among other measures (my emphasis):

• Continue to advocate for the F&B industry not to be included in public policy making.
• Continue avoiding all partnerships with F&B industries that violate the Code.
• Avoid all partnerships with ultra-processed food and beverage (UPF) industries.
• Exclude Code violators and UPF industries in UNICEF-led business platforms.
• Engage responsibly with the F&B industry in humanitarian response.

These commitments are a major public health advance.  Let’s hope UNICEF sticks with them.

I was deluged with interview requests last week over the rumor that the World Health Organization will soon release reports stating that the artificial sweetener aspartame is “possibly” carcinogenic.

I say rumor, because the reports will not be released until July 14.

According to Reuters—Exclusive: WHO’s cancer research agency to say aspartame sweetener a possible carcinogen -sources—two sources leaked the conclusion.

Aspartame, used in products from Coca-Cola diet sodas to Mars’ Extra chewing gum and some Snapple drinks, will be listed in July as “possibly carcinogenic to humans” for the first time by the International Agency for Research on Cancer (IARC), the World Health Organization’s (WHO) cancer research arm, the sources told Reuters…. Last month, the WHO published guidelines advising consumers not to use non-sugar sweeteners for weight control. The guidelines caused a furore in the food industry, which argues they can be helpful for consumers wanting to reduce the amount of sugar in their diet.

From what I hear from my own sources, everyone involved in the forthcoming reports is bound by confidentiality agreements.  They suspect that food industry representatives did the leaking.

This gives the industry plenty of time to complain and lobby.  As one report has it, “Industry experts and trade groups are decrying the World Health Organization’s International Agency for Research on Cancer’s pending addition of aspartame to a list of possible carcinogens for humans as unscientific and politically motivated.”

Aspartame has been under scrutiny for its potential harm to health practically from the time it first appeared. (see Laura Reiley in the Washington Post on how aspartame has come under scrutiny lately).

Center for Science in the Public Interest has long said of aspartame, Avoid.

Aspartame (sometimes marketed under the brand names Equal, NutraSweet, or AminoSweet) is a chemical combination of two amino acids and methanol. Questions of cancer and neurological problems, such as dizziness or hallucinations, have swirled around aspartame for decades…In 2005, researchers at the Ramazzini Foundation in Bologna, Italy…found that rats exposed to aspartame starting at eight weeks of age and continuing through their entire lifetimes developed lymphomas, leukemias, and other tumors, including kidney tumors, which are extremely rare in the strain of rat used. In 2007, the same researchers published a follow-up study that exposed rats to aspartame beginning in the womb and continuing through their entire lifetimes. That study, too, found that aspartame caused leukemias/lymphomas, as well as mammary (breast) cancer. Then in 2010, they published a study that exposed mice to aspartame, starting in the womb and continuing throughout their entire lifetimes. That third study found that aspartame caused liver and lung cancer in male mice.

US Right to Know says of Aspartame, “Decades of Science Point to Serious Health Risks.”

But the FDA says “aspartame is safe for the general population when made under good manufacturing practices and used under the approved conditions of use.”

And the American Cancer Society says you would have to drink 36 cans of diet soda a day to excede the Acceptable Daily Intake level.

Rumors and concerns about aspartame causing a number of health problems, including cancer, have been around for many years. Some of the concerns about cancer stem from the results of studies in rats published by a group of Italian researchers, which suggested aspartame might increase the risk of some blood-related cancers (leukemias and lymphomas). However, later reviews of the data from these studies have called these results into question. The results of epidemiologic studies (studies of groups of people) of possible links between aspartame and cancer (including blood-related cancers) have not been consistent.

A recent review says “The consumption of ASBs [artifically sweetened beverages] was associated with a higher risk of obesity, type 2 diabetes, all-cause mortality, hypertension, and cardiovascular disease incidence.”

As I mentioned a month or so ago, artificial sweeteners are taking a big hit these days and it looks like they are about to take another one.

In my intereviews, I pointed out that what’s news here is the level of authority.  It’s a big deal that WHO is saying this.

Two other points.

• Aspartame is not essential in the diet.  Nobody (except soft drink companies) need it.
• It and other artificial sweeteners are artificial and, therefore, ultra-processed.
• I’m already seeing “no aspartame” labels on soft drinks and food products.

I am looking forward to seeing the data when the reports are published.

The FDA is asking for public feedback on an updated research study to decide which front-of-package labeling design will work best to help the public choose healthy fpackaged foods.

To submit comments, go here.  They are due by July 17.

I’ve written about this issue previously.

The FDA tried to do this a decade ago.  But the Grocery Manufacturers Association (now Consumer Brands Association) did an end run and volunteered to use Facts Up Front/Guideline Daily Amounts, which nobody understands or pays attention to.  The FDA caved in and let that happen.

Now countries all over the world are putting warning labels on foods high in calories, fat, salt, and sugar, most of them ultra-processed.

The FDA says it will  test 8 front-of-package label designs to see which work best in conveying healthfulness. The study materials are here and here.

Earlier, if those links don’t work, it proposed to test all of these designs.

I don’t think any of the choices is as compelling as Chile’s warning labels, which can be understood easily by children and people who cannot read.

Among the FDA’s choices, here’s my preference (it’s most like the labels from Canada and Brazil).

This still requires people to figure out what it means if the colors differ, as they do here, but surely everyone will understand that the more red boxes, the worse.

One other complaint: Since this effort started, the concept of ultra-processed has become much more prominent and is backed up by a tremendous amount of research.

Avoiding ultra-processed foods is the key message needed now.

The FDA’s proposals will take care of most ultra-processed foods, but miss the point.  Whatever the FDA chooses will be out of date no matter when it appears.

Never mind.  This is a step in the right direction.  Food industry opposition to any of it is strong.

It’s important to tell the FDA to get busy on this, and to strengthen the warning.

Write the FDA NOW!

I’m always looking for food ideas for July 4th and thought this one looked just about perfect.  Have a happy and safe holiday!

I learned about this one as I often do from reading NutraIngredients’ daily newsletter:  RCT: Grape and blueberry extract improves cognitive health in ageing consumers.

This sounds great!  I went right to the article.

The study:  Effects of a polyphenol-rich grape and blueberry extract (Memophenol™) on cognitive function in older adults with mild cognitive impairment: A randomized, double-blind, placebo-controlled study   Adrian L. Lopresti, Stephen J. Smith, Camille Pouchieu Line Pourtau, David Gaudout, Véronique Pallet⁴ and Peter D. Drummond.  Front. Psychol., 29 March 2023.  Volume 14 – 2023 | https://doi.org/10.3389/fpsyg.2023.1144231

Background: Polyphenols are naturally occurring organic compounds found in plants. Research suggests that their intake reduces the risk of cognitive decline and related dementias. Grapes and blueberries are polyphenol-rich foods that have attracted attention for their potential cognitive-enhancing effects.

Purpose: Examine the effects of supplementation with a standardized and patented polyphenol-rich grape and blueberry extract (Memophenol™) on cognitive function in older adults with mild cognitive impairment.

Study design: Two-arm, 6 month, parallel-group, randomized, double-blind, placebo-controlled trial.

Methods: One hundred and forty-three volunteers aged 60 to 80 years with mild cognitive impairment were supplemented with either 150 mg of Memophenol™, twice daily or a placebo. Outcome measures included computer-based cognitive tasks, the Behavior Rating Inventory of Executive Function (BRIEF-A), the Cognitive Failures Questionnaire, and the CASP-19.

Results: Compared to the placebo, Memophenol™ supplementation was associated with greater improvements in the speed of information processing (p = 0.020), visuospatial learning (p = 0.012), and the BRIEF-A global score (p = 0.046). However, there were no other statistically significant between-group differences in the performance of other assessed cognitive tests or self-report questionnaires. Memophenol™ supplementation was well-tolerated with no reports of significant adverse reactions.

Conclusion: The promising results from this trial suggest that 6-months of supplementation with Memophenol™ may improve aspects of cognitive function in adults with mild cognitive impairment. Further research will be important to expand on the current findings and identify the potential mechanisms of action associated with the intake of this polyphenol-rich extract.

Funding: This study received funding from Activ’Inside. The funder was not involved in data collection, interpretation of data, or the decision to submit it for publication.

Conflict of interest: AL is the managing director of Clinical Research Australia, a contract research organization that has received research funding from nutraceutical companies. AL has also received presentation honoraria from nutraceutical companies. SS is an employee of Clinical Research Australia and declares no other conflicts of interest. PD and VP declare no conflicts of interest. DG, CP, and LP are employed at Activ’Inside and provided the Memophenol™ and placebo capsules.

Comment: Guess what Activ’Inside makes.  This study is not only funded by the maker of the supplement, but three of the authors work for the company.  This is contract research.  How can they say the funder was not involved?  The authors may not recognize it, but the funder was involved, and deeply.  How could it not be if the authors work for the company?

Earlier this week I wrote about the UNICEF-WHO meeting I went to in Geneva on implementing the 1981 International Code governing marketing of infant formulas.

UNICEF has just issued an update: What I [meaning you] Should Know about the Code

This new publication—a one-stop shopping guide to the issues—summarizes UN resolutions on the Code since 1981 as well as subsequent research on breastfeeding and infant formula marketing, most notably the Lancet Commission reports I wrote about earlier.

Incontrovertible evidence demonstrates how inappropriate marketing of infant formulas undermines breastfeeding and can harm children, especially in places that do not have clean water to dilute formulas.

Every country in the world has committed to the Code—the United States was the last holdout.  We do not seem to pay much attention to the Code’s provisions.

Here is one example.  The Code says:I’m not sure how to interpret the “except” phrase, except that our FDA must think that the health claims on a product like this are entirely acceptable, whereas they would not be allowed in many other countries.  [Reference 23 refers to UN General Assembly Resolution 63.23.]

The Code states that infant formulas should not be labeled in any way that suggests formula might be superior to breast milk.  This and the accompanying statement on the product website, would appear to violate that guideline.

Infant formulas do a good job of substituting for the nutrients in breast milk.  Because the FDA tightly regulates their ingredients, they are all pretty much alike, although they vary in price enormously.

The infant formula industry deserves close scrutiny of its marketing practices and this UNICEF publication is an excellent place to begin.

I have been asked to comment on the American Medical Association’s resolution to stop using the BMI as the sole criterion for diagnosing obesity [To find this resolution, click on CCSPH Report(s) #07: Support Removal of BMI as a Standard Measure in Medicine and Recognizing Culturally-Diverse and Varied Presentations of Eating Disorders].

The BMI—Body Mass Index—defined as weight in kilograms divided by height in meters squared—is a quick way to categorize the relationship of weight to height and does a better job of identifying people with excessive body fat than most other simple and inexpensive measures.

Unfortunately, not everyone demonstrates a close correlation of BMI to body fat and those who don’t may well find themselves discriminated against in the health care system.

The BMI is also an imperfect measure of health risk:

The current BMI classification system is also misleading regarding the effects of body fat mass on mortality rates. Numerous comorbidities, lifestyle issues, gender, ethnicities, medically significant familial-determined mortality effectors, duration of time one spends in certain BMI categories, and the expected accumulation of fat with aging are likely to significantly affect interpretation of BMI data, particularly in regard to morbidity and mortality rates…[This report] outlines the harms and benefits to using BMI and points out that BMI is inaccurate in measuring body fat in multiple groups because it does not account for the heterogeneity across race/ethnic groups, sexes, and age-span.

The resolution recommends:

(1) greater emphasis in physician educational programs on the risk differences among ethnic and age within and between demographic groups at varying
levels of adiposity, BMI, body composition, and waist circumference and the importance  of monitoring these waist circumference in all individuals with BMIs below 35 kg/m2;

(2) additional research on the efficacy of screening for overweight and obesity, using different indicators, in improving various clinical outcomes across populations, including morbidity, mortality, mental health, and prevention of further weight gain; and

(3) more research on the efficacy of screening and interventions by physicians to promote healthy lifestyle behaviors, including healthy diets and regular physical activity, in all of their patients to improve health and minimize disease risks.

My translation: Keep using the BMI as an indicator, but also pay attention to body composition and waist circumference as better measures of body fat.

The AMA is not minimizing the importance of excess body fat as a disease risk factor.  It is saying that only using the BMI to evaluate the risk itself risks stigmatizing patients, especially those of non-majority race, ethnicity, and gender conformation.

This resolution ought to further sensitize physicians to such issues.  If it does, it could not come a better time.

Resources

• Stat News on the resolution
• Ancel Keys et al’s original paper on the BMI: Indices of relative weight and obesity.

I am putting the Keys’ paper into this discussion to demonstrate that Keys was quite well aware of the strengths and weaknesses of the BMI, which was intended mainly to identify groups and populations at risk of undernutrition.

Guided by the criteria of correlation with height (lowest is best) and to measures of body fatness (highest is best), the ponderal index is the poorest of the relative weight indices studied.  The ratio of weight to height squared, here termed the body mass index, is slightly better in these respects than the simple ratio of weight to height. The body mass index seems preferable over other indices of relative weight on these grounds as well as on the simplicity of the calculation and, in contrast to percentage of average weight, the applicability to all populations at all times.

Once again I am indebted to Bill Marler for keeping me informed about items related to food safety: Publisher’s Platform: The House Appropriations Committee Directs the FDA to Restructure – will it be Ignored? 

He points to this item on page 79 of the House Agriculture Appropriations bill.

I’ve written about problems with the FDA’s oversight of food and food safety previously (see this for example).

Food has always been a stepchild at the FDA, getting much less attention than drugs or medical devices.  When I was on the FDA’s Food Advisory Committee in the early 1990s, the FDA seemed to be trying to do better but that committee did not last long.  In any case, we were not advising the FDA on what it was proposing to do; we were giving the FDA a notion of the response to decisions it had already made.

What’s needed now is to unite the three units of FDA that deal with food: the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine’s food oversight programs, and the office that overseed food regulations.

And bring back the Foods Advisory Committee and listen to its advice.

The FDA commissioned a report on what it should do (see Reagan-Udall Foundation report and my comments on it).

What will happen now?  As Bill Marler puts it, “Grab the popcorn.”

Here’s what the FDA says it’s doing (thanks to Jerry Hagstrom’s Hagstrom Report for the links)

• FDA — Proposed Human Foods Program Organization Chart 
• Updates to FDA Proposal to Unify Human Foods Program / Create New ORA Model
• Proposed Office of Regulatory Affairs Organization Chart

This does some of what’s needed but the organization charts still look complicated, and the more complicated an organization chart, the least likely it is to work.

Will this work?  Bill Marler says it might.  Grab the popcorn indeed.