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I received an email from the American Kratom Association, an organization I did not know existed. (now, I do).

Landmark Bipartisan Bill Regulating Kratom in the United States Introduced in Congress

Bill will ensure consumers have continued access to safe, regulated kratom products

The American Kratom Association is elated to announce Federal Kratom Consumer Protection Act legislation has been filed in both the Senate and House. This is a monumental moment for kratom consumers and a significant step towards protecting the rights of millions of Americans. The fight is far from won, but we are only arriving at this exciting event because of the support of so many amazing advocates.

What is kratom?  It depends on whom you ask.

The American Kratom Association says:

Kratom is a plant that has been used safely for centuries in Southeast Asia and in the United States since the early 1970s. ..for a variety of health and wellness purposes, including for an energy boost, increased focus, reducing anxiety, and as a personal harm reduction tool for managing acute and chronic pain.   [see KratomAnswers.org for details]

The U.S.  Drug Enforcement Administration agrees that Kratom has a long history of use in Southeast Asia.   But, it says,

Consumption of its leaves produces both stimulant effects (in low doses) and sedative effects (in high doses), and can lead to psychotic symptoms, and psychological and physiological dependence….In the U.S., the abuse of kratom has increased markedly in recent years…The FDA has not approved Kratom for any medical use. In addition, DEA has listed kratom as a Drug and Chemical of Concern.

The FDA says kratom is an unapproved drug and writes cease-and-desist letters to its sellers.

This begins to sound  just like what’s going on with hemp and marijuana in New York State (see yesterday’s post).

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Happy new year to all.!

And now, back to my Monday postings of industry-funded studies.  Today’s is about the popular herbal supplement, ashwagandha.   This is typically taken to reduce stress and improve a wide variety of health problems, but little science backs up those contentions.  Hence, this study, which I learned about from reading an account of it: Single ashwagandha dose may exert cognitive performance: Study.  That headline was all it took to get me to ask my usual question: Who paid for this?

The study: Effects of Acute Ashwagandha Ingestion on Cognitive Function. Int. J. Environ. Res. Public Health 2022, 19(19), 11852; https://doi.org/10.3390/ijerph191911852

Methods: The study assessed performance on the Berg–Wisconsin Card Sorting (BCST), Go/No-Go (GNG), Sternberg Task (STT), and Psychomotor Vigilance Task (PVTT) tests.   Participants took a placebo or ashwagandha (ASH) extract (NooGandha^®, Specnova Inc., Boca Raton, FL, USA).

Conclusions: Acute supplementation with 400 mg of ashwagandha improved selected measures of executive function, helped sustain attention, and increased short-term/working memory.

Funding: “This study was funded as a fee-for-service project awarded to the Human Clinical Research Facility at Texas A&M University from Specnova, Inc. (Boca Raton, FL, USA)…Specnova was not involved in any way in data collection, analysis of the data, or the writing of the manuscript.”

Comment: Specnova, you will not be surprised to learn, is a supplier of supplement ingredients.  The company ordered the study to its specifications.  It got the result it wanted, as funders almost invariably do.  Despite booming sales of ashwagandha, so little is known about its properties that the National Center for Complementary and Integrative Medicine does not even have a fact sheet for it among its reviews of herbal supplements.  Industry-sponsored research to the rescue!  And of course it “was not involved in any way…”  It didn’t have to be.  Funding is usually enough to induce unconscious bias on its own.

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Much is happening in the plant-based food sector.  I love trying to keep up with it.

First, the bad, or somewhat bad, news:

• SPECIAL REPORT: Plant-based dairy and meat by numbers; declining trends continue, but pockets of growth remain: New data from IRI and SPINS shows continued steep declines in sales of refrigerated meat alternatives but pockets of growth in frozen products and some plant-based milk, cheese, and yogurt subcategories, which do not all behave in the same way (spoiler alert: oatmilk is hot, oat yogurt is not)…. Read more
• 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 
• Business Insider A food fight is raging over what we can and can’t call ‘meat’:  Startups that make plant-based foods are battling the meat lobby for the right to describe their products as bacon, burgers or steak. Read More

Next, the new product launches:

• The latest food and drink plant-based product launches: Food Manufacture looks at some of the latest food and drink product launches in the plant-based and vegan category, including Meatless Farm, Seabloom, Richmond, Innocent and Sheese. Read more
• Voie gras: Nestlé develops plant-based foie gras alternative for European markets: Just six months on from inception, Nestlé’s vegan foie gras alternative is launching into Swiss and Spanish markets under its Garden Gourmet bran. Read more
• Plant-based butter set to revolutionise the art of pastry with low environmental impactBe Better My Friend is a Dutch company set up by chef Marike van Beurden, food scientist Pere Castells and global food strategist Joost Lindeman with a vision to end the bakery sector’s dependency on animal-derived ingredients…. Read more
• Creamy without the cow: ChickP releases plant-based ice cream with ‘a truly rich’ texture: ChickP Protein’s chickpea-based ice cream prototype boasts dairy-like creamy texture and fewer additives…. Read more
• Philadelphia Cream Cheese launches plant-based spread: The product, which is available at select retailers in the Southeastern U.S., is Kraft Heinz’s second non-dairy launch under one of its flagship brands in the last two months.

And where the industry might be headed:

• Food companies invited to collaborate on plant-based research: Plant2Food, a science platform from the Novo Nordisk Foundation, is inviting UK food companies to collaborate on plant and food science and share new knowledge. Read more

Comment: Despite the current drop in sales, I don’t see these products disappearing off the shelves.  There is a demand or them among people who do not want to eat meat or dairy foods for reasons of health, animal welfare, or the environment.  The products need to taste good if they are going to continue to sell.  And they need to become more food-based rather than ingredient-based if they are to overcome concerns about their meeting definitions of ultra-processed.

I will keep following this sector with great interest.  Stay tuned.

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Healthy People 2030 has released its latest set of tracking data.  This, you will recall, is the latest of the US Public Health Service’s 10-year plans for improving the health of Americans.  The agencies involved set specific, measurable objectives and track progress toward achieving them.

You can browse the full set of objectives here.

The objectives for overweight and obesity are here.  Three have tracking data available.  Of these,

One shows no change: Reduce the proportion of children and adolescents with obesity — NWS‑04

Two are getting worse

• Reduce the proportion of adults with obesity — NWS‑03
• Increase the proportion of women who had a healthy weight before pregnancy — MICH‑13

The objectives for Nutrition and Healthy Eating are here.

Of the objectives with data available, two showi improvement!

As regular readers know, I subscribe to the weekly newsletter, Obesity and Energetics Offerings, and particularly enjoy its section on Headline vs Study.

Here’s a particularly amusing example, which right away triggers my question: Who paid for this?

Headline vs Study

• Headline: Snacking on Almonds Can Help People Reduce Calorie Intake: Study.  
• Press Release: Believe It or ‘Nut’, Almonds Can Help You Cut Calories, Study Finds.  
• Study: “There was no significant difference in total energy intake ([…] p = 0.286) or energy from core ([…] p = 0.860) or discretionary foods ([…] p = 0.158) between [almonds and an isocaloric carbohydrate-rich snack bar].”

Let’s take a look.

Headline: Snacking on Almonds Can Help People Reduce Calorie Intake: Study.

A handful of almonds may be the latest weight loss hack, new research suggests.

A new study from the University of South Australia found that eating 30 to 50 grams of almonds could regulate appetite, leading to less calories consumed each day.

The research, which examined both the hormones that regulate appetite and how almonds could aid in controlling hunger, discovered that the consumption of the nut ultimately led to about 300 fewer calories [sic*]consumed at the following meal.

Press Release: Believe It or ‘Nut’, Almonds Can Help You Cut Calories, Study Finds.

Examining how almonds can affect appetite, researchers found that a snack of 30-50 grams of almonds could help people cut back on the number of kilojoules they consume each day.

Published in the European Journal of Nutrition, the study found that people who consumed almonds — as opposed to an energy-equivalent carbohydrate snack — lowered their energy intake by 300 kilojoules (most of which came from junk food) at the subsequent meal.

Study:  Acute feeding with almonds compared to a carbohydrate-based snack improves appetite-regulating hormones with no effect on self-reported appetite sensations: a randomised controlled trial. Carter, S., Hill, A.M., Buckley, J.D. et al.Eur J Nutr (2022). https://doi.org/10.1007/s00394-022-03027-2

Results: “…Cholecystokinin, ghrelin, glucagon-like peptide-1, leptin and polypeptide YY AUCs were not different between groups. Self-reported appetite ratings and energy intake following the buffet did not differ between groups.”

Conclusion: “More favourable appetite-regulating hormone responses to AL did not translate into better self-reported appetite or reduced short-term energy consumption. Future studies should investigate implications for longer term appetite regulation.”

Funding: “This work was funded by the Almond Board of California. This funding source had no role in the design of this study or the analysis and interpretation of the data.”

Conflict of interest: “AMC has consulted for Nuts for Life (an initiative of the Australian Tree Nut Industry). S-YT has previously been involved in studies funded by the Californian Walnut Commission. AMC, JDB and S-YT have previously been involved in studies funded by International Nut and Dried Fruit Council.”

*Comment: How could the headline get it so wrong?  The authors write: “Although not significant, the AL group consumed 300 kJ less energy in the meal challenge than the SB group, 270 kJ of which came from discretionary foods, which may be a clinically important benefit in weight management.”  The sic partly explains the problem.  The 300 refers to kilojoules (kj), not calories.  300 kj = 72 calories, not 300.  No wonder the result wasn’t statistically significant.

But the press release and resulting headline explain why the nut industry funds studies like this.  Even when the result shows no difference, the PR people can spin the data to produce the expected favorable result.

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The Expert Committee tasked with evaluating the FDA’s human foods program has released its report.

The Committee begins by pointing out that to do its job, the FDA needs adequate resources, sufficient authority, and a structure and culture that breeds success.

In its judgment, the FDA has none of those.  Instead, it is an agency in “constant turmoil.”

The report focuses on lack of leadership.

A leadership skill set, it says, should include:

• Expertise and knowledge in food safety and/or nutrition
• Ability to make decisions in a complex regulatory environment
• Ability to lead in a complex work environment
• Strong demonstrated management capability
• Superb communication skills
• Ability to identify and nurture talent

Instead, the FDA is risk averse, which it admits is “not surprising in a program subject to significant external criticism.”

The committee makes many (too many) recommendations:

Identify vision and mission.

Change the agency’s culture.

Give it more resources.  Food programs are under-resourced; budget and staffing have been flat for at least a decade.

Expand user fees.  [Uh oh.  Bad idea.  The committee even explains why, but ignores the hazard.]

There is also significant skepticism in the public interest community about the potential for “industry capture” of the Human Foods Program if FDA is overly reliant on industry fees.  Efforts to establish structures to secure additional industry funding, such as enhanced registration fees, may address these concerns. While the Panel acknowledges these concerns, the Panel recommends that FDA explore whether common ground can be found on this issue.

Reinstate the Food Advisory Committee.  [I was on the first one in the early 1990s, but our job was to react to decisions the agnecy had already made, not advise it about tough issues].

Reorganize the agency to give the food programs more visibility, integrate them, and give them clear lines of authority [Note: one big weakness of this project is that the committee was instructed not to include the Center for Veterinary Medicine, as if food for pets and food animals has nothing to do with the human food supply, which of course it does].

The report gives five options for reorganization, all of them complicated and undoubtedly politically difficult.  It lists their strengths and weaknesses, but does not state a preference.

• Create a separate food administration within HHS
• Create a Deputy Commissioner for Foods
• Put CFSAN in charge of human food programs
• Puts Commissioner in charge of human food programs
• Create a Deputy Commissioner for Foods

Do more about nutrition labeling, research on consumer behavior.  [Really?  That’s all?]

Comment: The committee only had a couple of months to pull this together and was required to leave out the Center for Veterinary Medicine.  Even so, the report makes it clear that the FDA is in serious trouble, so much so that the committee did not even get into what the FDA ought to be doing about about taking steps to prevent diet-influenced chronic disease.  This, of course, would require it to take on the food industry—an unlikely scenario given everything else that’s not happening.

The next step is to see what the Commissioner does with the report, if anything.  And whether Congress will appropriate more funding.

The report did not say a word about what I see as a major political handicap for the FDA; it’s funding comes from congressional agriculture committees, not health committees, even though FDA is an agency of the public health service.   That too needs to change.

What the press is saying:

• Washington Post: Scathing report recommends major changes at FDA, including possibly breaking up agency
• Bloomberg:  FDA’s Food Program Needs Strong Leader, Outside Reviewers Find
• USA Today:  Report finds FDA’s food regulatory agency lacks leadership, is in ‘constant turmoil’
• Politico:  ‘Constant turmoil’ at FDA’s food regulatory agency, report says

Anda quote from a colleague:

“While we appreciate the Panel’s thoughtful attempt to dig into complicated food issues and their recommendation to elevate nutrition/chronic food illness, creating a seperate, unfunded, nutrition center would have the opposite effect. That’s unacceptable.” Jerold Mande CEO Nourish Science

The meat industry is hard at work these days to overcome concerns about the effect of high-meat diets on health and the climate.  Here are two recent examples.

I.  Early Life Beef Consumption Patterns Are Related to Cognitive Outcomes at 1-5 Years of Age: An Exploratory Study.  Victoria C Wilk, Michelle K McGuire, Annie J Roe.  Nutrients.  2022 Oct 26;14(21):4497.   doi: 10.3390/nu14214497.

II. Approximately Half of Total Protein Intake by Adults Must be Animal-Based to Meet Nonprotein, Nutrient-Based Recommendations, With Variations Due to Age and Sex.  Florent Vieux, Didier Rémond, Jean-Louis Peyraud, Nicole Darmon.  The Journal of Nutrition, Volume 152, Issue 11, November 2022, Pages 2514–2525, https://doi.org/10.1093/jn/nxac150

• Background: Shifting towards a more plant-based diet, as promoted in Western countries, will reduce the animal protein contribution to total proteins. Such a reduction may not only impair protein adequacy, but also the adequacy in other nutrients.
• Conclusions: “this study showed that for this French adult population, the lowest animal protein contributions to total proteins that are compatible with nutritional adequacy, affordability, and eating habits vary from 45% to 60%, depending on age and sex, with the highest contributions needed for older populations and young women.”
• Funding: “MS-Nutrition and MoISA received financial support from the French National Interprofessional Association of Livestock and Meat (Interbev)…Interbev had no role in the design, implementation, analysis, or interpretation of the data.”
• Author disclosures: “The authors report no conflicts of interest.”

Comment: These are classic examples of article titles that make me immediately ask: Who paid for this?   Bingo!   They are also classic examples of studies with conclusions that can easily be predicted if you know who funded them.  The authors may believe that they have no conflicts of interest but it sure looks like they do.

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Chloe Sorvino.  Raw Deal: Hidden Corruption, Corporate Greed, and the Fight for the Future of Meat.  Atria Books, 2022.  

This is the first analysis I’ve seen of the meat industry from a business perspective.  Corvino is a business reporter from Forbes and did an amazing research job to do this book, including visiting CAFOs, slaughterhouses (she doesn’t say how she talked her way into it), chicken houses, and alternative meat places.  She also talked to a vast number of experts on all sides of the meat issue.  Full disclosure: she interviewed me and quoted me in the book in a couple of places.

I was happy to do a blurb for it.

Raw Deal is Chloe Sorvino’s deeply reported, first-hand account of how business imperatives drive the meat industry to mistreat workers, pollute the environment, fix prices, bribe, and manipulate the political process, all in the name of shareholder profits.  She argues convincingly for holding this industry accountable and requiring it and other corporations to engage in social as well as fiduciary responsibility.   Raw Deal is a must read for anyone who cares about where our food comes from.

On meat substitutes

I have yet to meet anyone in this industry who says they do not care about climate change.  In fact, many say they are personally driven by their product’s sustainability and environmental potential.  But it’s still all to a certain point.  There’s a reason Impossible Foods is preparing for a potentially $10 billion public listing, and that neither Impossible nor Beyond Meat is registered as public benefit corporations a move that would legally inhibit the companies from putting profit over their environmental mission.  Half of Impossible’s investors come from venture capital firms and the roster even includes a hedge fund, Viking Global Investors. Backers are no doubt ready for an exit, and they want to get Impossible the best deal.  A sustainability halo helps the cause (pp. 169-170).

On support for small local meat producers

Local infrastructure for livestock producers to cook and package products is a key missing link in making local food systems profitable and viable.  Creating lasting impacts wouldn’t cost much.  “We have the information and we have the evidence.  FaWhat we don’t have are the facilities and shared space where multiple people can leverage that at their business’s scale,” Mickie told me.  “It’s just crazy to me to be in a space where we’re trying to meet so many intersecting issues of inequity, and have to prove it one hundred percent, and then in another realm, people are playing with stem cells and getting two hundred million dollars.  We literally feed people and want to do it better )p. 257).

Chloe Sorvino has also published:

• An adapted essay in the Los Angeles Times on universal food access
• An excerpt in Fast Company about whether good meat exists

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