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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The Federal Trade Commission has issued a Health Products Compliance Guide.

This amazing publication takes on the Dietary Supplement Health and Education Act of 1994.  That act effectively removed the FDA from regulating dietary supplements.  It also allowed supplement labels to make “structure/function” claims that the supplement supported some structure or function of the body, whether or not there was much in the way of scientific evidence to back up those claims (in contrast, FDA-authorized claims must be scientifically substantiated).

Now the FTC is saying:

Marketers of health-related products, including dietary supplements, should be familiar with the requirements under both FDA law and FTC law that labeling and advertising claims be truthful, not misleading, and substantiated.  The FTC approach generally requires that health-related claims be backed by competent and reliable scientific evidence substantiating that the representations are true.

Marketers cannot suggest unsubstantiated benefits, safety, or other characteristics.

Example 4:  An ad for an infant formula states that an ingredient added to the formula can reduce the symptoms of colic.  The ad includes an unrelated chart from a pediatric journal showing that, as a general principle, the length of time that colicky babies cry tends to decrease over the first 12 weeks of life…Using the graph in an ad for the infant formula likely implies that the formula, rather than the babies’ ages, causes the decrease in crying time.

Claims have to be qualified.

Example 10:  An energy drink contains an ingredient that, when consumed daily over an extended period, can result in a significant increase in blood pressure.  Even absent any representation about the product’s safety, the marketer should disclose this potentially serious risk.

Qualifying information must be clear and straightforward.

Example 13:  A company has results from two studies suggesting that its supplement helps to maintain healthy cholesterol levels.  There are, however, significant limitations to each of the studies… The company makes a claim in advertising that “promising, preliminary scientific studies show that our product may be effective in reducing cholesterol.”  The use of the words “promising,” “preliminary,” and “may” is unlikely to sufficiently convey the limitations of the science.

Assertions about the strength of evidence must be accurate.

Example 16: An ad for a supplement includes the statement “Scientists Now Agree!” in discussing the product’s benefit.  This statement likely conveys to consumers that the state of science supporting the benefit has reached the level of scientific consensus.  Unless the advertiser possesses evidence demonstrating that scientists have reached that consensus, the claim is false.

Marketers must consider the totality of the science.

Example 30:  An advertiser wants to claim that a supplement will substantially reduce body fat.  The advertiser has two controlled, double-blind studies showing a modest but statistically significant loss of fat at the end of a six-week period.  However, there is an equally well-controlled, double-blind 12-week study showing no statistically significant difference between treatment and control groups.  Assuming other aspects of methodology are similar, the studies taken together suggest that, if the product has any effect on body fat, it would be very small and may not persist over time.  Given the totality of the evidence, the claim is unsubstantiated.

Here’s the press release. 

The bottom line:  The FTC is requiring evidence for health claims on supplements.

This will affect claims for thousands of supplement products.

Enforcement anyone?  This should be fun to watch.

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I don’t care what the arguments are about plant-based meats (see Deena Shanker’s riveting piece in Bloomberg News), they and other plant-based alternatives to animal foods still look like a hot trend to me.   I base this on what pours into my inbox.

One view of the trends:

• Traditional and cultured meat: The trends to look out for in 2023:  As the world emerges into 2023 following a year of perma-crisis, Food Manufacture explores what the coming 12 months have in store for the meat industry and what role cultivated animal proteins have supporting the industry and the growth of plant-based alternatives. Read more

The new products:

• Plant-based product launches for Veganuary 2023:  As the plant-based community celebrates another Veganuary, we take a look at some of the new launches from the sector in this round-up of plant-based new product development…. Read more
• Vegan baby formula: Exploring the plant-based potential in ‘one of the most strictly regulated’ categories: Why does bovine milk dominate the infant formula category, when plant-based is booming in adult nutrition? FoodNavigator speaks with lawyer Jessica Burt from Mills & Reeve, as well as brands Aptamil and Sprout Organic to discuss the plant-based potential in baby formula…. Read more
• How an Israeli start-up developed fish-free tinned tuna with the ‘complete sensory experience’ of taste, texture and smell: In Israel, Vgarden Ltd. has developed what it claims is ‘game-changing’ vegan tinned tuna. Omer Eliav, chief of R&D and Vgarden co-founder runs us though the most challenging aspects of replicating the kitchen staple, fish-free…. Read more

Funding and expansions:

• Businesswire No Meat Factory secures $42 million series B funding: With this latest funding round, No Meat Factory plans to expand its production footprint in North America and build out its manufacturing capabilities to service the global market, increasing access…Read More
• Aqua Cultured Foods begins buildout on fungi-based alt seafood factory: The maker of mycoprotein-based seafood alternatives has begun buildout of a new facility in the US, from where it will produce products for the European market…. Read more

Marketing innovations:

• ‘Plants don’t get the flu…’ Plant-based eggs in the spotlight as egg prices surge: While chicken egg prices were up a staggering 59.9%* year-on-year in December 2022, refrigerated liquid plant-based alternatives have come down in price, with unit sales (+14.2%) outpacing dollar sales (+8.4% to $35.52m) in the year to Dec 4, 2022, according to SPINS data shared with FoodNavigator-USA…. Read more

Even so, the criticisms continue:

• Meat substitutes contain ‘antinutrients’ that inhibit absorption of iron and zinc: ‘The industry needs to think about the nutritional value of these products’: New research out of Sweden has found that while many meat substitutes are high in micronutrients like iron they are often found in a form that cannot be absorbed by the body…. Read more

I am ever fascinated by all this. You too?  Stay tuned.

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All of this is enough to make me want to run out and eat some M&Ms.

You can’t make this stuff up.

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When I saw this tweet from Tom Philpott, I knew immediately what it was about.

I had seen Deena Shanker’s investigative report in Bloomberg News, not least because I’m quoted in it: Fake Meat Was Supposed to Save the World. It Became Just  Another Fad.

The article’s subtitle: “Beyond Meat and Impossible Foods wanted to upend the world’s $1 trillion meat industry. But plant-based meat is turning out to be a flop.”

And then I saw this ad in the January 22 New York Times.

Anonymous Reddit writers saying things like “I suspect it’s coming form [sic] a news outlet paid money to write an article by people who make money from meat sales.”

A badge of honor for Deena Shanker indeed.  Clearly, she hit a nerve.

Meat alternatives still have their fans and I’m not ready to write off fake meat just yet.   But this ad makes me much less sympathetic to this particular Cause.

Ironic addition, January 30: Impossible Foods to lay off 20% of its staff.

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I was interested to come across this paper: Conflict of Interests in the Scientific Production on Vitamin D and COVID-19: A Scoping Review.   Front Public Health. 2022 Jul 11;10:821740.   doi: 10.3389/fpubh.2022.821740. eCollection 2022.

Results and conclusions: 

• Studies were funded by companies in the diagnostics, pharmaceutical and food sectors.
• Conclusions favorable to vitamin D supplementation were more prevalent in papers where COI was identified (9/13, 69.2%) than among papers where COI was not found (4/16, 25.0%).
• Omissions of disclosure of COI, funding source, and sponsor functions were observed.
• The identification of possible corporate political activities in scientific papers about vitamin D published during the COVID-19 pandemic signals a need for greater transparency and guideline development on the prevention of COI in scientific production.

Comment:  Not many studies look at disclosure issues this closely.  This is a welcome addition to the genre.  It reminds me of this especially entertaining report: “COVID-19 and misinformation: how an infodemic fuelled the prominence of vitamin D.”  Papers on vitamin D and COVID-19, it seems, are not only influenced by corporate interests; they are also occasionally fraudulent, if viral.

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The Access to Nutrition Initiative (ATNI) published a report, Spotlight on Lobbying 2022 just in time for Christmas.  I am just getting to it.

ATNI has been commissioned to benchmark the world’s 25 largest F&B companies’ lobbying-related commitments, management systems, and disclosure against the Responsible Lobbying Framework (RLF). The RLF was developed to help organizations adopt corporate practices that ensure their lobbying activities are legitimate, transparent, consistent, and accountable, while providing the opportunity for other, more resource-constrained groups, to lobby in the public
interest.

Note that this report focuses on corporate promises and internal practices.  It does not evaluate what the companies are actually doing to influence nutrition policy.

The results?  No surprise, “current practice is far from the standard set in the RLF.”

Of course it is.  Why would companies want to stop lobbying when it is so effective in protecting their profits.

The report mentions the major issues:

• Taxes on unhealthy foods
• Marketing restrictions, particularly to children
• Mandatory front-of-package labels
• Food-based (rather than nutrient-based) dietary guidelines.

I hope its next lobbying report will document how these companies are fighting every one of these public health initiatives.

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