Currently browsing posts about: Supplements

The FDA has just announced a Qualified Health Claim for Certain Cranberry Products and Urinary Tract Infections.

The U.S. Food and Drug Administration announced today in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.

Huh?

The FDA does not exactly approve health claims that are not backed up by scientific evidence.  It just doesn’t object to them.

This one, no surprise, comes in response to a request by Ocean Spray Cranberries, Inc, which would love to be able to market its products as helping to prevent UTIs (which lots of people believe).

Here’s what the FDA says about the science.

After reviewing the petition and other evidence related to the proposed health claim, the FDA determined that the scientific evidence supporting the claim did not meet the “significant scientific agreement” standard required for an authorized health claim.

Hence, the Qualified health claim.

If Ocean Spray wants to use the claim, it has to put atatements like these on the label:

• For cranberry juice beverages: “Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
• For cranberry dietary supplements: “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”

Why does Ocean Spray want this?  Because believers will ignore the FDA disclaimers.  Ocean spray says:

To that end, Ocean Spray will use its medical attributes in the place they matter most–running a campaign on the WebMD site later this year. “We’re going to be all over WebMD,” he said, noting that the connection between cranberry juice and urinary tract health is the fifth most discussed topic on the influential health site.

Qualified health claims are about marketing, not science.

But I know how you feel.  UTIs are awful.  If all it takes is cranberry juice….

Frauds and fraudulent information are so prevalent that the FDA says what it’s doing about them on its Coronavirus web page.

My email inbox is deluged with marketers claiming that their products boost immune systems in general, and protect against Coronavirus in particular.  Often, they cite evidence but this is highly selective and sometimes based on studies paid for by their sponsors.

The bottom line on keeping immune systems healthy?  Eat a healthful diet, don’t gain excess weight, and get plenty of physical activity.  OK, good luck doing that while you are under lockdown, but you can give it a good try.

Here are some of the items that have ended up in my inbox.

Despite FDA pronouncements, industry coalition action, the coronavirus claims warning letters keep coming:  The US Food and Drug Administration has issued an additional six warning letters in recent days on coronavirus claims. The letters coincide with an industry coalition raising a red flag on the growing flood of such claims on dietary supplement-type products….Read more

Unproven COVID-19 health claims: China’s crackdown on ads for oral sprays, probiotics and anti-hangover tea: The Chinese authorities have named and shamed a string of fake advertisement, mostly surrounding unproven COVID-19 health claims.

Consumers warned of sports nutrition products making coronavirus claims:  The European Specialist Sports Nutrition Alliance (ESSNA) has warned consumers of the increase in companies and individuals making unfounded claims in light of the current coronavirus situation….Read more

Cocoa and the coronavirus: can it boost the immune system?  Cacao beans have been consumed by humans for over 3,000 years and the ingredient is well-known for its wide range of health benefits, recent research suggests it can provide stronger protection against influenza virus infection…. Watch now [but watch critically.  If you even give this a moment’s thought….]

CRN UK highlights why essential nutrients have never been more essential:  The ongoing threat of coronavirus could increase the potential for deficiencies in key micronutrients supporting the immune system, according to The Council for Responsible Nutrition UK (CRN UK). Read more  [How about eating a healthy diet and getting plenty of exercise?].

Could vitamin D play a role in coronavirus resistance? Research thinks so:  Vitamin D supplements may aid in the resistance of respiratory infections such as the coronavirus or limit the severity of the illness in those infected, according to researchers. Read more.  [And what kind of research are we talking about here?  Some of it is industry-funded, as this example demonstrates (thanks to Claudia Santos for sending)].

The study: A Collagen Supplement Improves Skin Hydration, Elasticity, Roughness, and Density: Results of a Randomized, Placebo-Controlled, Blind Study.  Nutrients 2019, 11(10), 2494.

Purpose: “The purpose of this randomized, placebo-controlled, blind study was to investigate the effects of the drinkable nutraceutical ELASTEN^® (QUIRIS Healthcare, Gütersloh, Germany) on skin aging and skin health.”

Conclusions: The test product significantly improved skin hydration, elasticity, roughness, and density…These positive effects were substantially retained during the follow-up.

Funding: This research was funded by Quiris Healthcare, Germany.

Conflicts of Interest: The authors declare no conflict of interest. The sponsor had no influence on execution, analysis and interpretation of the data.

Comment: The funder, Quiris Healthcare, “develops and sells innovative, natural health products. The focus is on effectiveness and special quality.”  What struck me about this particular example is how the authors report no conflict of interest and state that the sponsor had no influence on how the study was conducted, analyzed, and interpreted.  Most research on the influence of industry funding indicates that it most often shows up in the study design.  Research also shows that investigators are unaware of the influence; it occurs at an unconscious level.  I review data backing up these statements in my book Unsavory Truth: How Food Companies Skew the Science of What We Eat.

Double-blind placebo controlled trial of the anxiolyticeffects of a standardized Echinacea extract.  József Haller,| Laszlo Krecsak| János Zámbori.  Phytotherapy Research.2019;1–9.

Conclusion: “These findings suggest that particular Echinacea preparations have significant beneficial effects on anxiety in humans.”

Conflict of interest statement: JH is one of the authors of a US patent on the anxiolytic effects Echinacea preparations.

Comment: I don’t usually bother to write about supplements because so little evidence supports their benefits over placebos.  This study finds small better-than-placebo benefits for this particular Echinacea supplement, presumably the one covered by the first author’s patent.  I’d be happier with independently funded research.  In the meantime, the European Food Safety Authority continues to have doubts.  Will this study make that agency change its collective mind?  We shall see.

For this I must thank NutraIngredients.com: Firm launches glitter-infused multivitamin to add ‘poop-time pizzazz.’ 

I thought that had to be worth a closer look.

It turns out that a company that sells supplements by subscription has invented a multivitamin with edible glitter.

Why?  To “add some pizzazz into poop-time,” of course.

The limited-edition supplement, created and distributed by UK-based WeAreFeel, not only contains glitter made from natural acacia gum (arabic gum) but also 18 key vitamins and minerals.  Being healthy and getting all the nutrients you need shouldn’t be dull and boring, hopefully the prospect of having a glittery toilet will encourage more people to get their daily dose of nutrients!  The product follows hot on the heels of the French firm Lutin Malin, which made available dietary supplements that claim to make flatulence “smell like roses”…

Along with the multivitamin’s use of Arabica gum, the non-toxic glitter combines vitamin A, D3 and folic acid as well as minerals such as magnesium, zinc and iron amongst others. The multivitamins also contain no GMO, anti-adherents, lactose or gluten.

I’m so relieved (as it were).

It looks like a long year coming up.

When I saw this ad in last Thursday’s New York Times, I immediately clipped it out.

What is this?

It is an ad for a dietary supplement, Telos95, with a classic structure/function claim (a type invented for dietary supplements of less-than-established efficacy): “telomere & DNA chromosome health support—-telomere lengthening and lowering cellular age in just 6 months.”

Telos95 is the only plant-based dietary supplement that aids in the chromosome stability during the process of cell replication.  It’s vital that normal cell replicative senescence takes place, so the cells divide in a healthy state and telomeres remain at the same length or lengthen, which biologically ensures a health centrosome matrix and repetitive nucleotide sequence at each end of the chromosome.

Got that?

What’s with telomeres?

All of this refers to work that got a Nobel Prize for Elizabeth Blackburn, Carol Greider, and Jack Szostak in 2009.  They showed that telomeres, caps on the end of chromosomes, protect chromosomes from degradation.  Shorter telomeres are associated with cell aging.

What got my attention in this ad was its report of a 2018 clinical trial finding that this supplement reduced cellular age by more than 7 years.

Really?  I had some immediate questions.

What’s in the supplement? 

The ad doesn’t say anything other than “all natural food grade polyphenols.”  But I managed to find a Supplement Facts Label online.

Highly purified polyphenols extracted from grape and olive leaves?

These, by the way, cost about $100 for 30 capsules.

Whatever.

What’s the study? 

I was able to find it online: A randomized-controlled clinical study of Telos95® , a novel antioxidative dietary supplement, on the shortening of telomere length in healthy volunteers  

It’s in a journal I’ve never heard of previously: HealthMed, published in Bosnia and Herzogovina

The report of the study starts out rather peculiarly:

The objective of this study was to determine the deodorant effectiveness of a dietary supplement to halt the shortening of telomere length as measured through blood samples before and after product use.

Deodorant?  Maybe something is lost in translation here?

Who paid for the study?

The published paper doesn’t say.  It does, however, refer to a Sponsor responsible for the study’s protocols, safety evaluation of the products, and safety indemnification of Princeton Consumer Research Corp (PCR), the group that carried out the study.

PCR’s website, by the way, states that “PRINCETON CONSUMER RESEARCH IS NOT AFFILIATED IN ANY WAY TO PRINCETON UNIVERSITY”.  Whew.

PCR’s press release credits Certified Nutritionals as behind the study.

What is this all about?

The Daily Beast did an investigative report on something similar a couple of years ago.

Obviously, this is about selling a supplement made from rice at profits so great that Longevity by Nature can afford a full-page ad in the Times (these used to run in the $80,000 range, if not more).

It is also about the use of industry-sponsored research to sell products: the sponsored study –> press release –> huge advertisement –> increased product sales.

Will this product keep your telomeres from shortening?  If only.

NutraIngredients.com alerted me to a study by the Council for Responsible Nutrition, the main trade group for the dietary supplement industry.

Its conclusion: 77% of American adults say they take dietary supplements.

Here are selected results.

Who Takes Dietary Supplements? 77 percent of U.S. adults take dietary supplements.

• 79 percent of female adults
• 74 percent of male adults 
• 81 percent of adults 35 – 54
• 79 percent of adults 55+ 
• 83 percent of adults with children under 18 in the household
• 68 percent of adults without employment
• 73 percent of adults who live in the Northeast
• 80 percent of adults who live in the South

Everybody takes this stuff, apparently.  What are they taking?

What to say?

I wish we had better evidence—how about any evidence—that supplements make healthy people healthier, but we do not.

Supplements, as far as I can tell, are about nutritional magic.

Whatever works, I guess.

In the meantime, NutraIngredients cites data that the dietary supplement market was worth nearly $125 bilion in 2018.

Impressive.

For the record: I don’t take supplements.  I prefer my nutrients from food and sunshine.

Addition

A reader, Charlene Elliott, sends her study of supplement marketing to Canadian children.

This study is the first of its kind to examine the nutrient levels of vitamins, minerals and dietary supplements specifically marketed as for children in the Canadian retail environment. On the one hand, the promotion of gummy and chewable supplements using cartoon and licensed characters and claims that the products are “fun to eat” simply extends contemporary strategies found in child-targeted packaged foods. Yet vitamins are not foods, nor are they regulated as foods in Canada, and this study questions the logic of recommending that children consume up to 15 gummy candies per day in order to “improve” their health.  Beyond this, the substantial variation in dosage depending on the supplement is problematic, given that all of these supplements use the same kinds of appeals on the package.

Curcumin is a flavonoid antioxidant isolated from turmeric, the spice used in Indian curries, among other foods.

It is about as overhyped as any ingredient I have encountered lately for its “proven ability” to fight Alzheimer’s, heart disease, cancer, and anything else that ails you.  If only this could be true.  If it were, people in India who use this in their cooking would all live exceptionally long and healthy lives.

But to convince skeptics like me—and to sell curcumin supplements of course—the makers of such supplements fund studies.

I learned about this study from the industry newsletter, NutraIngredients-Latam.

It reported on a an abstract of a clinical trial of a curcumin supplement, Longvida,™ made by Verdure Sciences. 

The study:  This was a double-blind, placebo-controlled, parallel-groups clinical trial in which participants were given Longvida™ (400 mg daily containing 80 mg curcumin) or a matching placebo.

Results: After 12 weeks, the curcumin group did better on memory performance and other tests, and after 4 weeks showed less tension, anger, confusion and total mood disturbance.

Conclusions: “These results confirm that Longvida™ improves aspects of mood and working memory in a healthy older cohort. The pattern of results…may hold promise for alleviating cognitive decline in some populations.”

Funding: Surprise! “This study was funded by a grant from Verdure Sciences.”

Comment: I see three problems here with the Nutraingredients report.

(1) When funders have a vested interest in the outcome of studies, biases tend to creep in.

(2) The report is based on an abstract, not on a complete account of the trial; this makes the methods difficult to assess.

(3) The report did not mention that study was funded by a company with a vested interest in the result; it should have.