by Marion Nestle

Currently browsing posts about: Supplements

Apr 17 2023

Industry-funded study of the week: whey and muscle strength

I give high praise to NutraIngredients.com for doing full disclosure in the title of an article: “Industry study concludes whey promotes muscular strength and endurance, independent of diet.”

Whey protein supplementation promotes muscle mass increase and selective increases in muscular strength and endurance from resistance exercise, independent of dietary influence, according to a new industry-funded study.

I looked up the study.

The Study: Effects of Whey Protein Supplement on 4-Week Resistance Exercise-Induced Improvements in Muscle Mass and Isokinetic Muscular Function under Dietary ControlChae-Been Kim Jong-Hoon Park Hyoung-Su Park 2Hye-Jin Kim 2Jung-Jun Park   Nutrients.  2023 Feb 16;15(4):1003.   doi: 10.3390/nu15041003.
Purpose: to investigate the effect of whey protein supplementation under dietary control on improvements in muscle mass and function following resistance exercise training.
Method: Thirty-two men were randomly assigned to a whey protein supplementation group taking whey protein isolate (PSG, n = 17) and a placebo group (CON, n = 15). Participants were provided with three meals per day corresponding to the estimated individual daily energy intake. The supervised resistance exercise program was conducted 60 min per day, six days per week, for four weeks.
Conclusion: whey protein supplementation enhances resistance exercise-induced increase in muscle mass and overall muscular strength and endurance, independent of dietary influence.
Funding: This research was funded by Maeil Health Nutrition Co., Ltd.
Conflicts of Interest: The authors declare no conflict of interest.
Comment:  Maeil Health Nutrition is a Korean company which makes and sells dairy-based sports supplements like the one used in this study.  Two of the authors (the ones with 2 ) work for this company.  They have obvious conflicts of interest.  
I won’t bother to dissect the details of the study except to note that the placebo group was taking a supplement with 20 fewer grams of protein per day.
Feb 3 2023

Weekend reading: the FTC wants science to back up supplement health claims. What a concept!

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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Jan 5 2023

A bill to legalize kratom? What’s up with this?

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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For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

 

Jan 2 2023

Industry-funded study of the week: Ashwagandha

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 202219(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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For 30% off, go to www.ucpress.edu/9780520384156.  Use code 21W2240 at checkout.

 

 

Aug 11 2022

More FDA educational initiatives: Supplements this time

The FDA’s food operations are under siege over problems with infant formula, the Fresh Harvest recall, and all its other food safety and regulatory problems.

As you saw yesterday, it has plenty of time for educational initiatives.

This one is called “Supplement Your Knowledge.”  Its purpose is to help inform health care professionals, consumers, and educators about the hazards of dietary supplements.

How is the FDA helping with this?

The FDA is worried about harm from thousands of products that are largely unregulated, thanks to the Dietary Supplement Health and Education Act of 1994 (DSHEA).  This act took the FDA out of the business of regulating supplements, allowed supplement manufacturers to claim pretty much anything they want about supplements (regardless of evidence), and left ghe matter of what’s actually in the bottles as a matter of faith.

More than half of American adults take supplements of one kind or another, despite lack of evidence that they do any good at all for reasonably healthy people.  Fortunately, most are harmless.

The FDA wants to encourage supplement users to report adverse effects from the ones that aren’t.

I’m guessing the AMA wants to discourage physicians from inappropriately suggesting supplements and encourage them to recognize adverse events when they see them.

Congress passed DSHEA.  It will take another act of Congress to  protect the public from supplements that contain what they shouldn’t, don’t contain what they should, and otherwise mislead the public about what they can do.

Related Information

Jun 16 2022

Annals of research: Vitamin C and colds

I found this discussion on David Allison’s remarkably useful weekly collection of articles about obesity and energetics.  His listings include articles in categories, one of them “Scientific Rigor & Scholarly Dialogue.”

I was particularly interested in this example:

This took me back to one of my all-time-favorite research studies: Ascorbic Acid for the Common Cold: A Prophylactic and Therapeutic Trial.  JAMA;1975;231:1038-1942.

Linus Pauling wrote Vitamin C and the Common Cold in 1970.  NIH investigators wondered if there was anything to it.  They got 300 volunteers to take vitamin C or a placebo and measured the number of colds and their duration in both groups.

When they first looked at the data, it looked like the volunteers who were taking vitamin C had fewer and shorter colds.   Exciting!

But these were highly rigorous investigators.

They examined the data closely and noticed that an unusually large number of participants had dropped out of the trial, especially those in the placebo group (44%).  They guessed that participants thought they knew what they were taking and dropped out if they “knew” they were taking the placebo.

They reanalyzed the data to account for participants thought they were taking.

The final result: volunteers who thought they were taking vitamin C reported fewer and shorter colds, regardless of whether they were taking vitamin C or the placebo.

Those who thought they were taking the placebo had more and longer colds, regardless of whether they were taking the placebo or vitamin C.

Comment: This study provides compelling evidence for the placebo effects of vitamin C.  Placebo effects are powerful. I’m all for them.  The authors of the recently retracted study should have read this one first.

Jun 6 2022

Oops: Sports supplements with doping drugs.

I am not much of a fan of dietary supplements and have to admit to confirmation bias; I collect studies that provide evidence for skepticism about how well they work.

So when a reader, Arya Afrashteh, sent this study, I gave it some attention.

The study:  Dietary Supplements as Source of Unintentional Doping.  Vanya Rangelov KozhuharovKalin Ivanov, and Stanislava Ivanova.  Biomed Res Int. 2022; 2022: 8387271. Published online 2022 Apr 22. doi: 10.1155/2022/8387271

The rationale:  Athletes are not supposed to take performance-enhancing drugs but they are permitted to take dietary supplements.  Are these safe?

Method: A review of the literature on unapproved substances found in dietary supplements.

Results: 875 of 3132 supplements contained undeclared substances.

Conclusion: ~28% of the analyzed dietary supplements pose a potential risk of unintentional doping.

Comment:  Between one-quarter and one-third of dietary supplements taken for performance enhancement contained unlabled substances that could test as unapproved drugs.

This is a result of the Dietary Supplement Health and Education Act of 1994 (DSHEA) that basically deregulated dietary supplements.  It took supplements out from under the control of the FDA.

All the FDA can do is write warning letters, which it occasionally does.

But unless the FDA is checking, you cannot be sure that what is in the supplements is accurately reflected by their labels.  Sports supplements, it seems, are prime examples of why this is a problem.

Caveat emptor.

 

May 3 2022

RIP Senator Orrin Hatch

The New York Times’ obituary for the late Utah Senator Orrin Hatch, “Orrin Hatch, Seven-Term Senator and a Republican Force, Dies at 88,” filled an entire page of the newspaper.  That’s how important he was.

I was surprised that the obituary said not one word about Senator’s Hatch’s responsibility for the Dietary Supplement Health and Education Act of 1994 (DSHEA, pronounced d’shay).  The purpose of this act was to boost the supplement industry, which is well represented in Utah, by taking it out from under the regulatory authority of the FDA.

As a reminder, DSHEA:

  • Assumed that dietary supplements were safe.
  • Essentially deregulated them by weakening the FDA’s regulatory power.
  • Permitted structure/function health claims on supplements, (e.g., supports a healthy immune system), regardless of level of scientific substantiation.
  • Labeled supplements with Supplement Facts rather than Nutrition Facts.
  • Forced the FDA to take manufacturers to court if agency regulators had concerns about safety, misleading claims, or inconsistent contents.
  • Caused the FDA to lose court cases on First Amendment grounds.

The results:

  • The supplement industry expanded rapidly, achieving DSHEA’s purpose.
  • You cannot be sure that what you are buying is actually waht the label says you are buying.
  • You cannot be sure that claimed benefits have any science behind them.
  • Food manufacturers demanded the right to make struture/function claims.
  • Use of the First Amendment to protect commercial (rather than personal, political, or religious) speech has gotten stronger.

We have Orrin Hatch to thank for turning the supplement industry into one based on faith, not science.

Why would he do this?

The obituary suggests one possibility:

During the opioid crisis in 2015, he introduced a bill to narrow the authority of government regulators to halt the marketing of drugs by predatory pharmaceutical companies. It later emerged that he had received $2.3 million in donations from the drug industry over 25 years.

For a more direct explanation, check out this article about Senator Hatch from the New York Times in 2011, “Support Is Mutual for Senator and Utah Industry.

“Senator Hatch — he’s our natural ally,” said Marc S. Ullman, a lawyer for several supplement companies. Mr. Hatch, who credits a daily regimen of nutritional supplements for his vigor at 77, has spent his career in Washington helping the $25-billion-a-year industry thrive….Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home.  His family and friends have benefited, too, from links to the supplement industry.

Hatch’s efforts to deregulate supplements did no good for public health or trust in science.  As the obituary said,

But there were no political repercussions. The senator was re-elected in 1982, 1988, 1994, 2000, 2006 and 2012, averaging nearly 65 percent of the vote.

Requiescat in pace.