Last week I did a post on the FDA’s reorganization.   I should have made one other point: the long-standing inadequacy of FDA funding.  For decades, Congress has assigned tasks to the FDA but provided inadequate funding to do those tasks adequately (hence 1% of imported foods are inspected).  Congress also assigns the funding for specific purposes.

Yes, FDA ought to be doing more, but it is not up to the agency to decide how to deploy its funds.

One more point: For long-standing historical reasons, FDA funding comes from congressional Agriculture committees, even though it is an agency of the Public Health Service.  That is one reason why USDA’s food safety programs are funded at so much higher a level than FDA’s.

With that said, the FDA has come out with some recent initiatives of interest.

I.  Front-of-Package labels.  The FDA is proposing to research a front-of-package symbol: “an easy-to-understand, standardized system that is 1) mandatory, 2) nutrient-specific, 3) includes calories, and is 4) interpretive with respect to the levels of added sugars, sodium, and saturated fat per serving.”

It is doing this in response to a petition from the Center for Science in the Public Interest.

The comments that have come in so far are here.

It is examining the use of front-of-pack symbols in other countries.

It also plans to conduct research on consumer understanding of multiple designs.  Here are the prototype packages on which the designs will be tested.

None of these is likely to be as effective as the ones used in other countries.

Here is one of the better options, in my opinion.

To file comments, go here.  It’s important to do this because the Consumer Brand Association (formerly the Grocery Manufacturers Association) and other industry groups are unlikely to accept any labeling scheme that might discourage you from buying a product.

II.  Qualified health claim: cocoa flavanols.  The FDA has approved a qualified health claim for cocoa flavanols and reduced risk of cardiovascular disease.

This was in response to a petition from the Swiss chocolate company, Barry Callebaut.

Here’s what the FDA will allow.  Yes, this is absurd (look at what the FDA has to go through to get to this), but companies must think statements like this will sell their products.

• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that there is very limited scientific evidence for this claim.”
• “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease. FDA has concluded that there is very limited scientific evidence for this claim.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease.”
• “Very limited scientific evidence suggests that consuming cocoa flavanols in high flavanol cocoa powder, which contains at least 4% of naturally conserved cocoa flavanols, may reduce the risk of cardiovascular disease. This product contains at least 4% of naturally conserved cocoa flavanols. See nutrition information for_____ and other nutrients.”

III.  GRAS panels.  The FDA has issued final guidance on best practices for panels deciding which ingredients can be Generally Recognized as Safe.

This lays out the guidelines for

• Identifying GRAS panel members who have appropriate and balanced expertise.
• Steps to reduce the risk of bias, or the appearance of bias, that may affect the credibility of the GRAS panel’s report, including assessing potential GRAS panel members for conflict of interest and the appearance of conflict of interest.
• Limiting the data and information provided to a GRAS panel to publicly available information.

A lot of this is headache-inducing.  FDA rulemaking takes forever.  Can’t wait to see how all this turns out.

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And don’t miss Food Corps‘ gift of Veggie Valentine cards.  Here’s an example:

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Astaxanthin is the dye used by growers of farmed salmon to give the fish a pink color.  They do this by matching the desired amount of the dye to this SalmoFan template.

Astaxanthin, claim its makers, is an antioxidant and, therefore, good for you.

First the public relations: Screen shot: Astaxanthin reduces work-induced visual stress in people aged over 40 – BGG trial: Astaxanthin supplementation has been found to reduce visual display terminal (VDT) work-induced visual stress in people aged over 40, according to a new Japan trial sponsored by supplier BGG Japan. Read more

As for the actual research:

The study: Effects of diet containing astaxanthin on visual function in healthy individuals: a randomized, double-blind, placebo-controlled, parallel study.  Takahiro Sekikawa, Yuki Kizawa, Yanmei Li, Naoki Miura. J Clin Biochem Nutr.  https://doi.org/10.3164/jcbn.22-65.

Results:  In participants aged ≥40 years, corrected visual acuity of the dominant eye after visual display terminal work at 6 weeks after intake demonstrated a higher protective effect of astaxanthin in the astaxanthin group vs the control group (p<0.05). In participants aged <40 years, no significant difference was seen between the astaxanthin and control groups. Moreover, no significant difference was found in functional visual acuity and pupil constriction rate between the astaxanthin and control groups [my emphasis].

Conclusion: These results suggest astaxanthin reduces oxidative stress caused by visual display terminal work. Age-related reduction in ciliary muscle strength is likely the main detractor of visual acuity. Correspondingly, astaxanthin reduced visual display terminal work-induced visual stress in the middleaged and elderly.

Conflict of interest: This trial was sponsored by BGG Japan Co., Ltd., which provided all costs for the implementation of the trial. TS and YK are employees of BGG Japan Co., Ltd. YL is an employee of Beijing Gingko-Group Biological Technology Co., Ltd., which belongs to the same company group as BGG Japan Co., Ltd. NM received funding from BGG Japan Co., Ltd. to provide medical services to the trial participants.

Comment: BGG makes astaxanthin products.  This is a company-sponsored study conducted by researchers employed or paid by the company.  It is an excellent example of interpretation bias—putting a positive spin on results that are marginally significant in some groups but not others, or null.

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Oh no!  US Snack Index reveals consumers’ fear of running out of snacks during the Super Bowl

This has to be a commentary on where we are as a food nation.

This survey of Super Bowl fans found that a whopping 49% “would rather see their team lose than have to sit through the game without snacks.”

OK.  The survey was conducted by Frito-Lay, a not exactly disinterested observer, but still.

It makes clear that the Super Bowl is only peripherally about sports.  It is about eating junk food.

You don’t believe me?  Try:

• Super Bowl foods better than a touchdown
• 7% of all chicken wings are consumed during the Super Bowl: 1.42 billion
• So are 300 million gallons of beer, 28 million pounds of chips
• 139.4 million pounds of avocados, 3.8 Million Pounds of popcorn

As for Super Bowl food politics, try getting your head around the danger Mexican truckers face bringing avocados North for your guacamole.

Enjoy the game!

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Thanks to Lisa Young for this:

The average price of a dozen eggs goes up and up.   It now averages $4.25 a dozen, and that’s for the cheapest kinds.

The New York Times explains

• Inflation
• The war in Ukraine
• Higher feed costs
• Higher energy costs (those hens have to be kept warm)
• Avian flu (44 million hens died or were killed)
• Higher-than-normal demand

It could get worse.  Avian flu infects animals as well as birds and could infect us.

How’s that for a cheery thought.

Small egg farms, anyone?

Or chickens as art, per National Geographic?

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So many readers have asked me to comment on the American Academy of Pediatrics’ Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity that I thought I ought to say something about it.

The guideline report is so long and detailed that I cannot imagine anyone actually reading it.  I started with the introduction, which summarizes basic facts.

• 14.4 million children and adolescents are affected by obesity.
• Obesity is a chronic disease with potentially serious health consequences
• Childhood obesity is strongly affected by social determinants of health (poor education, poverty, racism, exposure to toxins, etc)
• Childhood obesity is stigmatized in ways that fail to acknowledge social determinants.

What got press attention—and the attention of readers of this blog—is the AAP’s endorsement of drug and bariatric surgical treatment of obese children.

I cut right to the chase and looked at Appendix I, which gives the AAP’s algorithm for deciding on treatment options.  

The report’s major conclusions expand on this chart (the report does not define KAS, but I think it means Knowledge, Attitudes, and Skills):

KAS 9.  Pediatricians and other PHCPs should treat overweight (BMI ≥ 85th percentile to <95th percentile) and obesity (BMI ≥ 95th percentile) in children and adolescents, following the principles of the medical home and the chronic care model, using a family-centered and nonstigmatizing approach that acknowledges obesity’s biologic, social, and structural drivers.

KAS 10.  Pediatricians and other PHCPs should use motivational interviewing (MI) to engage patients and families in treating overweight (BMI ≥ 85th percentile to <95th percentile) and obesity (BMI ≥ 95th percentile).

KAS 11.  Pediatricians and other PHCPs should provide or refer children 6 y and older (Grade B) and may provide or refer children 2 through 5 y of age (Grade C) with overweight (BMI ≥ 85th percentile to <95th percentile) and obesity (BMI ≥ 95th percentile) to intensive health behavior and lifestyle treatment. Health behavior and lifestyle treatment is more effective with greater contact hours; the most effective treatment includes 26 or more hours of face-to-face, family-based, multicomponent treatment over a 3- to 12-mo period.

KAS 12.  Pediatricians and other PHCPs should offer adolescents 12 y and older with obesity (BMI ≥ 95th percentile) weight loss pharmacotherapy, according to medication indications, risks, and benefits, as an adjunct to health behavior and lifestyle treatment.

KAS 13.  Pediatricians and other PHCPs should offer referral for adolescents 13 y and older with severe obesity (BMI ≥ 120% of the 95th percentile for age and sex) for evaluation for metabolic and bariatric surgery to local or regional comprehensive multidisciplinary pediatric metabolic and bariatric surgery centers.

What is not in this guideline is anything that addresses the social determinants of childhood obesity.  What we have here is a focus on treating the symptoms, but getting nowhere near the cause.

It is difficult for someone like me who is not affected by those determinants to even imagine how drugs and surgery could be thought even remotely acceptable for children, even those over the age of 12, but I am not treating these kids.

Providers who do treat obese children tell me they are relieved to be able to offer options that might help kids achieve healthier weights.

As I see it, these should be absolute last resorts if used at all. And this is without even getting into issues of cost or our dysfunctional health care system.

In public health terms, drugs and surgery are “downstream” solutions to a problem that began way upstream with all those societal determinants.

If ever we needed upstream approaches, chldhood obesity is a prime example.

Upstream means policy changes that make healthy eating more appealing, accessible, and affordable  That’s what pediatricians need to be calling for.

This AAP report deliberately separates treatment from prevention.  It promises a discussion of prevention in a subsequent report.  I hope it is as hard hitting as any AAP report has ever been.

If childhood obesity teaches us anything, it is that our society needs to change in ways that are healthier for our children.

Additional supporting documents

• Executive Summary: Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity
• Appraisal of Clinical Care Practices for Child Obesity Treatment. Part I: Interventions
• Appraisal of Clinical Care Practices for Child Obesity Treatment. Part II: Comorbidities

Thanks to all the people who wrote me about this.  Much appreciated.

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Last week, the FDA announced its proposed Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities.   You can also watch this announcement on video.

This action comes in the wake of:

• The infant formula crisis [Contaminated formula made babies sick. The FDA was warned about food safety concerns at an Abbott plant but took no action.  Abbott recalled formulas,shut down the plant.  This led to empty shelves.  Abbott is now under criminal investigation].
• The FDA’s evaluation of its performance during the crisis [this didn’t say much about accountability]
• The evaluation of the FDA by the Reagan-Udall Foundation [it called for major structural changes]
• The resignation of Frank Yiannas, deputy FDA commissioner [which made clear needed changes were not going to happen]
• Bipartisan pressure from members of Congress to enact major reforms
• Pressure from Senators DeLauro and Durbin to enact reforms
• The Washington Post editorial calling for breaking up the FDA
• Pressure from food safety lawyer Bill Marler to put food back into the FDA and to make fundamental changes

The FDA proposal comes with a vision of how the redesign would work.

The complaints and pressures argued for appointing a senior FDA official in charge of all FDA food programs and units.  Instead, the FDA proposes to create a Human Foods Program encompassing some, but not all, FDA food units.

Most prominently missing is the Center for Veterinary Medicine which deals with food for farm animals and pets.  These, however, fully participate in the food system for humans; they eat most of US corn production and loads of byproducts of human food production.  The systems for humans and animals are inextricably linked.

The organizational chart will look like this.  It splits the food units and connects them with dotted lines.  Good luck with that.  That was precisely the problem with the previous organization.

This looks better than the previous organization chart but falls far short of the authority needed to solve the nation’s food safety problem.

What’s needed?

• Unification of food safety under a central authority that unites the functions of USDA and FDA (the Government Accountability Organization has been calling for that for decades).
• Short of that, high-level FDA authority over the entire food supply under its jurisdiction.
• And much more FDA attention to its public health as well as its safety functions.  It should be taking the lead on actions to prevent diet-influenced chronic diseases.

Hey, I can dream.

In the meantime, let’s see how the FDA’s new structure goes and who it hires into that key position in charge of human foods.

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I saw this on NutraIngredients.com, one of those newsletters I read regularly: Study: Mulberry extract shrinks blood sugar spike by 40%.  

That headline was all I needed: Who paid for this?

Fortunately, the study was readily available: Mulberry leaf extract improves glycaemic response and insulaemic response to sucrose in healthy subjects: results of a randomized, double blind, placebo‑controlled study.  Pariyarath Sangeetha Thondre Helen Lightowler, Lis Ahlstrom,  Andrew Gallagher.  Nutr Metab (Lond). .2021 Apr 15;18(1):41.   doi: 10.1186/s12986-021-00571-2.

Conclusion: “Mulberry leaf extract can be used as part of lifestyle changes that may lead to healthy blood glucose levels.”

Acknowledgements:  The authors would like to thank Dr Chen Xie (CX) and Mrs Hongwen Yu (HY) for technical input during the conceptualization of the study and editorial commentary on the draft publication. CX and HY are both employees of Phynova Group Limited.

Funding: The work in this study was funded by Phynova Group Ltd, a privately held company that is the developer of Reducose® mulberry leaf extract. Phynova was involved in the study design and manuscript preparation but had no role in data collection and analysis.

Competing of interest: AG is an employee of Phynova Group Limited, the funder of the study. He was involved in the development of the product, design of the study and drafting of the manuscript, but was not involved in the collection, analysis or interpretation of data. PST, HL, and LA have declared they have no conflicts of interest.

Comment:  This degree of industry involvement turns this study into industry-funded marketing research, no matter how beautifully the science is conducted.  Please refer to my book, Unsavory Truth, for references to the studies backing up that statement.

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