Search results: Herbal Supplements

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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Today’s New York Times has a front-page story about how the FDA knew that certain weight-loss supplements contained unlabeled amphetamine-like substances but did nothing about it, perhaps because its head supplement official came from the industry (and has since returned to it).

Let’s start with the science.

In 2014, Pieter Cohen and his colleagues noted that several athletes had been disqualified from competition after tests found evidence of a methamphetamine analog (N,α-diethyl-phenylethylamine) in their urine.  The athletes said that the chemical must have come from their workout supplements.  Cohen et al. tested the supplements and identified the analog as one with entirely untested stimulant, addictive, or other adverse effects in humans.  They recommended its immediate removal from all dietary supplements.

Earlier that year, the FDA reported that 9 of 21 supplements containing Acacia rigidula to test positive for varying amounts of another methamphetamine analog, β-Methylphenethylamine (BMPEA).   The FDA investigators said this compound could be misidentified as amphetamine during certain kinds of analyses, but did not identify the products found to contain BMPEA.

Cohen et al. then did their own tests of the kinds of supplements the FDA had tested.  

The stimulant was present at quantities such that consumers following recommended maximum daily servings could consume a maximum of 93.7 mg of BMPEA per day. Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans. The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements.

The New York Times explains the context:

The controversy comes at a time when the supplement industry is under increased scrutiny. Last week, 14 state attorneys general, led by Eric T. Schneiderman of New York, called on Congress to provide the F.D.A. with more power to regulate supplements. Mr. Schneiderman’s office in February accused four major retailers of selling contaminated herbal supplements, and one of the companies, GNC, has agreed to extensive new testing and quality control procedures for its store-brand herbal products.

This brings us to the politics.

The supplement industry, of course, is doing everything it can to oppose and stop Schneiderman’s work.

Recall that Congress passed the Dietary Supplement Health and Education Act in 1994, essentially deregulating the industry.  The act allowed absurd health claims for supplements and essentially removed much of the FDA’s authority to regulate these products.

The result was an increase in sales despite remarkably little evidence for efficacy.

As for conflicts of interest at FDA:

• Daniel Fabricant, the head of the FDA’s dietary supplement division at the time this was happening, came to the agency from the Natural Products Association, “Over 75 years of serving the natural products industry.” He has since left the FDA and now heads the NPA.
• The NPA spent nearly $1.5 million on lobbying in 2013 and 2014.
• The current head of the FDA’s dietary supplement division, Cara Welch, also came to FDA from the NPA.

Since DSHEA, the dietary supplement industry has gotten a pass.  Suggestions:

• Congress should rescind DSHEA and give the FDA the authority to regulate supplements as it does food.
• The FDA should appoint officials who are independent of the industries they are supposed to regulate.

Front-of-Package Labels: The FDA is hard at work trying to do something about public understanding of food labels.  What with the fuss about the Smart Choices program (now withdrawn), FDA wants to get the front-of-package labeling under control.  It is considering various formats for giving a quick overview of the nutritional quality of food products.  FDA is asking for public comment on the various formats (see Federal Register notice).

The FDA chose five versions (plus variations) for comment:

1. A mini Nutrition Facts version called Nutrition Tips
2. A UK traffic lights version
3. A version like Hannaford’s Guiding Stars
4. A version like the discontinued Smart Choices
5. One that just highlights calories/servings

I rather like this one, a variation of #1 (colorful, easy to understand, not too cluttered, and makes calories clear).

The Nutrition Facts Panel: The FDA also is taking another look at the Nutrition Facts panel on the back of food packages.  It is seeking public comment on  a plan for consumer research to test understanding of elements on the Nutrition Facts panel.  Here’s the Federal Register notice with all the information about what’s going on and where to file comments.

What’s interesting about this is that the FDA has great social science researchers on staff.  They’ve been kept under wraps the last eight years and apparently are being let loose again.  Even so, they don’t get to just go out and do studies like we academics do (with human subjects approval, of course).  Oh no.  First, they have to announce that they plan to do the studies (which they did some time ago) and get comments on the idea.  Then they do the research plan and have to ask for further comments on the research design.  That’s what this notice is about.  Once they deal with these comments, they can finally get to work.    It’s a miracle if they do anything at all.  Keep them busy: send comments!

Agency Transparency: The Association of Health Care Journalists (ACHJ) and ten other journalism organizations have filed a complaint.  The FDA, they say, is still requiring journalists to obtain permission from an agency official in order to conduct interviews with staff members.  This is a leftover from the Bush administration.  Time to get rid of it.

Blogging: It is especially time to open up to reporters because Michael Taylor, who is now senior advisor to the FDA commissioner, is now blogging on the Atlantic Food Channel (which also reprints my posts).  If he can blog, FDA staff can talk to reporters.

Addendum: Beverages pretending to be dietary supplements: The FDA has just issued guidance to the beverage industry to stop putting herbal supplements into beverages and calling them dietary supplements so they can get around food rules on health claims.  If a beverage is consumed as a food, it should be labeled as a food.  Guidance, of course, is non-binding but I see this as a warning that the FDA is going to be enforcing its own rules.  Good show!

I see stores selling Kratom all over my downtown Manhattan neighborhood and am curious about it (no, I have not tried it, nor do I intend to).

I took a look at the websitesof the American Kratom Association (AKA) and the FDA’s Kratom page.

The AKA describes itself as “a consumer-based, nonprofit organization, focuses on setting the record straight about kratom and gives a voice to those who are suffering by protecting their rights to possess and consume safe and natural kratom.” It says:

Natural kratom comes from the mitragyna speciosa, a tropical evergreen tree in the coffee family native to Southeast Asia…Naturally occurring Kratom is a safe herbal supplement that behaves as a partial mu-opioid receptor agonist and is used for pain management, energy, even depression and anxiety that are common among Americans. Kratom contains no opiates, but it does bind to the same receptor sites in the brain. Chocolate, coffee, exercise and even human breast milk hit these receptor sites in a similar fashion.

Thus, according to the AKA, Kratom is something like chocolate or breast milk.

The FDA, in fact, defines Kratom in much the same way:

Kratom is a tropical tree (Mitragyna speciosa) that is native to Southeast Asia…Kratom is often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. An estimated 1.7 million Americans aged 12 and older used kratom in 2021, according to the Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.

So far so good.

But the AKA is calling on the FDA to regulate Kratom.  This may sound highly responsible, but the AKA is doing this because the FDA refuses to have anything to do with this product and warns against its use.

The FDA says:

• Kratom is not an approved drug: “There are no drug products containing kratom or its two main chemical components that are legally on the market in the U.S.
• Kratom is not an approved dietary supplement: “FDA has concluded from available information, including scientific data, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.’
• Kratom is not an approved food additive: “FDA has determined that kratom, when added to food, is an unsafe food additive.”
• Therefore, kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.

The FDA’s Q and A:

• What can happen if a person uses kratom?  FDA has warned consumers not to use kratom because of the risk of serious adverse events, including liver toxicity, seizures, and substance use disorder (SUD). In rare cases, deaths have been associated with kratom use…However, in these cases, kratom was usually used in combination with other drugs, and the contribution of kratom in the deaths is unclear.
• How is FDA protecting the public from the risks of kratom?   FDA has also taken steps to limit the availability of unlawful kratom products in the U.S. We will continue to work with our federal partners to warn the public about risks associated with use of kratom.

The AKA says its mission is to

• Support Consumers. The FDA does everything it can do to interfere with the right of consumers to make informed choices about products they use for their health and well being, and their war on kratom includes distributing disinformation on kratom that materially misleads consumers and policy makers. Our goal is to change that.
• Educate. Kratom is a natural plant that helps consumers improve their health and well being for centuries. Our goal is to educate all Americans with the truth about kratom — from potential consumers to regulators and everyone in between.
• Speaking the Truth on Kratom. We represent millions of Americans that each have a story to tell. The FDA wants to drown out the individual voices, but we will raise those voices and together we will be heard across America.
• Global Awareness. Anti-kratom detractors are trying to expand kratom bans across the world. We hope to demonstrate responsible use and the health benefits of kratom will convince other countries to responsibly regulate kratom, not ban it.
• Protect Natural Resources. Kratom is a precious natural resource that is an important part of our global ecosystem. We support and advocate for sustainable harvesting techniques and reforestation protecting existing kratom forests to protect the climate and the invaluable carbon exchange kratom trees contribute to the environment.

Oh dear.  While this disagreement continues, Kratom is readily available in shops that sell CBD and other cannabis derivatives.

What’s especially interesting about this difference of opinion is that the FDA usually keeps hands off —says not one word about—products sold as dietary supplements.  It stays quiet about them as a result of court decisions following passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which essentially deregulated herbal supplement products.

But the FDA has plenty to say about Kratom.  That the agency argues that Kratom is not a drug, supplement, or food additive, means that it views Kratom as demonstrably harmful.

In situations like this, I tend to invoke the precautionary principle: see proof of safety before using it.  I prefer to head off trouble whenever possible.

But this situation raises an interesting question.  If the FDA thinks Kratom is all that bad, why isn’t it acting to take it off the market?  Or stating that it wishes it could but DSHEA won’t let it.  When the FDA tried to ban potentially harmful supplements, the makers of those supplements took the FDA to court.  The courts generally ruled in favor of the supplement makers.  Go figure.

Caveat emptor.

Really, I can’t make this stuff up.

Thanks to Jim Krieger of HealthyFoodAmerica.org for sending me to Food Navigator-USA: Post launches the first-ever cereal designed to promote sleep.

A cereal meant to be consumed at bedtime?  I wanted it for my cereal box collection, and there hasn’t been a good one like this for a long time since the FDA started discouraging ridiculous health claims.  I went straight to the Ithaca Walmart and scored a box.

Sweet Dreams, the box tells you, is “part of a healthy sleep routine.”

The front-of-package claims:

• Made with whole grains
• Supports natural melatonin production with zinc, folic acid, and B vitamins
• Excellent source of Vitamin E for neuroprotection

The back-of-package claims:

• Sleep…We want to help you enjoy it.  With delicious wholesome ingredients, curated vitamins and minerals, and a specially formulated night-time herbal blend, our dreamy cereal is part of a healthy sleep routine.
• Made with a night-time herbal blend containing a touch of lavender and chamomile

I looked up the website:

For 130 million American adults, a good night’s sleep is elusive. You deserve good sleep, and we want to help you enjoy it! So, we made Sweet Dreams cereal, the first ready-to-eat cereal specially designed to support a good sleep routine and a fresh start to the next day…Available in Blueberry Midnight and Honey Moonglow flavors, make Sweet Dreams cereal a part of your bedtime routine and enable a better sleep cycle while satisfying those nighttime food cravings.

Comment:

I hardly know where to begin: “curated vitamins and minerals”?  “Supports natural melatonin production”?

This last is a structure/function claim like those for supplements.  It requires only the barest hint of scientific substantiation.

Reader, I ate it.

The cereal is crunchy, with occasionally visible almonds, but is cloyingly sweet (to my taste): A cup of cereal has nearly a tablespoon (13 grams) of added sugar– 24% of a day’s total sugar allowance.

No wonder it’s so sweet.  Sugars appear seven times on the ingredient list.

Whole Grain Wheat, Rice, Cane Sugar, Almonds, Whole Grain Rolled Oats, Canola and/or Soybean Oil, Flavor Clusters (Sugar, Corn Syrup, Degermed Corn, Palm Oil, Natural Flavor, Cocoa (processed with alkali)(for color), Blueberry and Carrot Concentrates (for color)), Salt, Honey, Corn Syrup, Barley Malt Extract, Molasses, Tocopherols (Vitamin E) to maintain freshness, Natural Flavor.

Post must be trying to sell more cereal.  Eat cereal at night?  Well, if you have sleep problems I suppose you can give it a try.

I ate this cereal in the morning.  It did not make me feel sleepy.

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Selenium, antioxidants, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials. David JA Jenkins, David Kitts, Edward L Giovannucci, Sandhya Sahye-Pudaruth, Melanie Paquette, Sonia Blanco Mejia, Darshna Patel, Meaghan Kavanagh, Tom Tsirakis, Cyril WC Kendall, Sathish C Pichika, and John L Sievenpiper.  The American Journal of Clinical Nutrition, Volume 112, Issue 6, December 2020, Pages 1642–1652

Background: “Antioxidants have been promoted for cardiovascular disease (CVD) risk reduction and for the prevention of cancer. Our preliminary analysis suggested that only when selenium was present were antioxidant mixtures associated with reduced all-cause mortality.”

Results: No association of selenium alone or antioxidants was seen with CVD and all-cause mortality. However, a decreased risk with antioxidant mixtures was seen for CVD and all-cause mortality when selenium was part of the mix.

Conclusion: The addition of selenium should be considered for supplements containing antioxidant mixtures if they are to be associated with CVD and all-cause mortality risk reduction.

Comment: The results are statistically significant, but not by much (RR: 0.90; 95% CI: 0.82, 0.98; P = 0.02); the Confidence Interval reaches 0.98, which is very close to 1.00, which would show no difference.  But that’s not the real reason for my interest in this one.  The real reason in this astounding conflicts-of-interest statement and the disclaimer that follows it.

Conflicts of interest

DJAJ has received research grants from Loblaw Companies Ltd, the Almond Board of California, Soy Nutrition Institute (SNI), and the Canadian Institutes of Health Research (CIHR). He has received in-kind supplies for trials as a research support from the Almond Board of California, Walnut Council of California, American Peanut Council, Barilla, Unilever, Unico, Primo, Loblaw Companies, Quaker (Pepsico), Pristine Gourmet, Bunge Limited, Kellogg Canada, and WhiteWave Foods. He has been on the speakers’ panel, served on the scientific advisory board, and/or received travel support and/or honoraria from the Loblaw Companies Ltd, Diet Quality Photo Navigation (DQPN), Better Therapeutics (FareWell), Verywell, True Health Initiative (THI), Heali AI Corp, Institute of Food Technologists (IFT), Soy Nutrition Institure (SNI), Herbalife Nutrition Institute (HNI), Herbalife International, Pacific Health Laboratories, Nutritional Fundamentals for Health (NFH), the Soy Foods Association of North America, the Nutrition Foundation of Italy (NFI), the Toronto Knowledge Translation Group (St. Michael’s Hospital), the Canadian College of Naturopathic Medicine, The Hospital for Sick Children, the Canadian Nutrition Society (CNS), and the American Society of Nutrition (ASN). He received an honorarium from the USDA to present the 2013 W. O. Atwater Memorial Lecture. He is a member of the International Carbohydrate Quality Consortium (ICQC). His wife, Alexandra L Jenkins, is a director and partner of INQUIS Clinical Research for the Food Industry; his 2 daughters, Wendy Jenkins and Amy Jenkins, have published a vegetarian book that promotes the use of the plant foods advocated here, The Portfolio Diet for Cardiovascular Risk Reduction; and his sister, Caroline Brydson, received funding through a grant from the St. Michael’s Hospital Foundation to develop a cookbook for one of his studies. CWCK has received grants or research support from the Advanced Food Materials Network, Agriculture and Agri-Foods Canada (AAFC), Almond Board of California, American Peanut Council, Barilla, Canadian Institutes of Health Research (CIHR), Canola Council of Canada, International Nut and Dried Fruit Council, International Tree Nut Council Research and Education Foundation, Loblaw Brands Ltd, Pulse Canada, and Unilever. He has received in-kind research support from the Almond Board of California, American Peanut Council, Barilla, California Walnut Commission, Kellogg Canada, Loblaw Companies, Quaker (PepsiCo), Primo, Unico, Unilever, and WhiteWave Foods/Danone. He has received travel support and/or honoraria from the American Peanut Council, Barilla, California Walnut Commission, Canola Council of Canada, General Mills, International Nut and Dried Fruit Council, International Pasta Organization, Loblaw Brands Ltd, Nutrition Foundation of Italy, Oldways Preservation Trust, Paramount Farms, Peanut Institute, Pulse Canada, Sun-Maid, Tate & Lyle, Unilever, and White Wave Foods/Danone. He has served on the scientific advisory board for the International Tree Nut Council, International Pasta Organization, McCormick Science Institute, and Oldways Preservation Trust. He is a member of the International Carbohydrate Quality Consortium (ICQC), is Executive Board Member of the Diabetes and Nutrition Study Group (DNSG) of the European Association for the Study of Diabetes (EASD), is on the Clinical Practice Guidelines Expert Committee for Nutrition Therapy of the EASD and a director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. JLS has received research support from the Canadian Foundation for Innovation, Ontario Research Fund, Province of Ontario Ministry of Research and Innovation and Science, Canadian Institutes of Health Research (CIHR), Diabetes Canada, PSI Foundation, Banting and Best Diabetes Centre (BBDC), American Society for Nutrition (ASN), INC International Nut and Dried Fruit Council Foundation, National Dried Fruit Trade Association, The Tate and Lyle Nutritional Research Fund at the University of Toronto, The Glycemic Control and Cardiovascular Disease in Type 2 Diabetes Fund at the University of Toronto (a fund established by the Alberta Pulse Growers), and the Nutrition Trialists Fund at the University of Toronto (a fund established by an inaugural donation from the Calorie Control Council). He has received in-kind food donations to support a randomized controlled trial from the Almond Board of California, California Walnut Commission, American Peanut Council, Barilla, Unilever, Upfield, Unico/Primo, Loblaw Companies, Quaker, Kellogg Canada, WhiteWave Foods, and Nutrartis. He has received travel support, speaker fees, and/or honoraria from Diabetes Canada, Dairy Farmers of Canada, FoodMinds LLC, International Sweeteners Association, Nestlé, Pulse Canada, Canadian Society for Endocrinology and Metabolism (CSEM), GI Foundation, Abbott, Biofortis, ASN, Northern Ontario School of Medicine, INC Nutrition Research & Education Foundation, European Food Safety Authority (EFSA), Comité Européen des Fabricants de Sucre (CEFS), and Physicians Committee for Responsible Medicine. He has or has had ad hoc consulting arrangements with Perkins Coie LLP, Tate & Lyle, Wirtschaftliche Vereinigung Zucker e.V., and Inquis Clinical Research. He is a member of the European Fruit Juice Association Scientific Expert Panel and Soy Nutrition Institute (SNI) Scientific Advisory Committee. He is on the Clinical Practice Guidelines Expert Committees of Diabetes Canada, European Association for the Study of Diabetes (EASD), Canadian Cardiovascular Society (CCS), and Obesity Canada. He serves or has served as an unpaid scientific advisor for the Food, Nutrition, and Safety Program (FNSP) and the Technical Committee on Carbohydrates of the International Life Science Institute (ILSI) North America. He is a member of the International Carbohydrate Quality Consortium (ICQC), executive board member of the Diabetes and Nutrition Study Group (DNSG) of the EASD, and director of the Toronto 3D Knowledge Synthesis and Clinical Trials foundation. His wife is an employee of AB InBev. DK, ELG, SS-P, MP, SBM, DP, MK, TT, and SCP have no conflicts of interest to declare.

Disclaimer: The authors have no relevant conflicts of interest over the past 4 y. DJAJ has received funds for dietary studies from Loblaws, which, during the course of his funding, acquired Shopper’s Drugmart, which is a pharmaceutical company that also sells supplements.

Comment: Here’s one reason why I am not a fan of dietary supplements.  Most independently funded studies show no significant benefit when they are given to healthy people.  The industry needs studies like these for marketing purposes.  I’m not, but if you are worried about selenium, try food.

Food connects to everything, even to Covid-19.  Here’s how.

The New York Times says “Open Windows. Don’t Share Food.”  It reports the latest advice from Vice President Pence’s office, summarized in a flyer.  The not-sharing-food advice refers to schools.

The Los Angeles Times asked for a comment of sharing food.  Here’s what I told the reporter (the article quotes some of this):

Depends on how paranoid you are.  So far, there is no evidence that Coronavirus can be transmitted by food but I suppose it is theoretically possible.  Someone who has the virus but doesn’t show symptoms could cough or sneeze or handle raw foods.  If you handle the foods before cooking them, you could pick up the virus.

Cooking should kill the virus (don’t re-use the bag the foods came in).  Salad greens should always be washed, even prewashed, even salads that come pre-bagged.

As for salad bars: they usually have glass or plastic screens and long handled spoons.  Again, contamination is possible but unlikely.  If such things worry you, the remedy is easy: cook the food and eat it while it’s hot.

Some of the CDC’s advice about Coronavirus relates to food.

• Wash your hands often with soap and water for at least 20 seconds, especially after blowing your nose, coughing, or sneezing; going to the bathroom; and before eating or preparing food.
• If you are sick with COVID-19, avoid contact with your pet, including petting, snuggling, being kissed or licked, and sharing food.

CDC’s advice about preparedness [link no longer available] says what to do if you are ill.  Basically, stay home.

• Consider ways of getting food brought to your house through family, social, or commercial networks
• Monitor food and other medical supplies (oxygen, incontinence, dialysis, wound care) needed and create a back-up plan.
• Stock up on non-perishable food items to have on hand in your home to minimize trips to stores.

General information about Coronavirus also is available from the World Health Organization.  It doesn’t say anything about sharing food but recommends standard hygiene procedures for food handling and preparation—wash hands, cook meat thoroughly, and avoid cross-contamination between cooked and uncooked foods (see WHO website).

The European Food Safety Authority (EFSA) says there is no evidence that that food is a source or transmission route for Coronavirus.

• EFSA’s chief scientist, Marta Hugas, said: “Experiences from previous outbreaks of related coronaviruses, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), show that transmission through food consumption did not occur. At the moment, there is no evidence to suggest that coronavirus is any different in this respect.”

The FDA has issued warnings to individuals and companies making unsupported claims for Covid-19 cures, one of them to the TV evangelist Jim Bakker (he hawks supplements of colloidal silver).  Warning letters went to the Jim Bakker Show, as well as Vital Silver, Quinessence Aromatherapy Ltd., Xephyr, LLC doing business as N-Ergetics, GuruNanda, LLC, Vivify Holistic Clinic, Herbal Amy LLC.

Finally, a survey finds that one-third of shoppers in the U.K. are stockpiling food in preparation for siege by Coronavirus.

Enjoy your meals while all this is going on!

NutraIngredients-USA.com has posted a set of articles celebrating the 25th anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which effectively deregulated the supplement industry.  The articles that follow are from the perspective of that industry.

Personally, I’m not a fan of DSHEA, and view deregulation of dietary supplements as a mistake for the industry as well as for the public.  Strong regulation inspires trust.  Weak regulation encourages distrust of supplement products and the entire industry.  When I see a Supplement Facts label, I have no reason to trust that the label reflects the contents of the package.  Until supplements are subjected to the same level of regulation as food products, caveat emptor.

Special Edition: DSHEA at 25

The Dietary Supplement Health and Education Act of 1994 created the framework for the modern supplement industry. In 1994, the industry was worth $4 bn. Now it is estimated to be worth over $40 bn.

In this special edition we will talk to some of the industry legends who helped to craft the law, we’ll learn about NPQAA, we’ll hear from the head of the FDA’s Office of Dietary Supplement Programs on the need to modernize the law, get the views of some of the industry association leaders, and look to the future.

• DSHEA at 25: In conversation with Scott Bass and Loren Israelsen: The brilliant strategy of Sen. Orrin Hatch, the upswell of grassroots consumer pressure, and the ‘highly unusual’ personal intervention of an FDA Commissioner: The development and passage of the Dietary Supplement Health and Education Act is a fascinating story….. Read
• What was NPQAA and what role did it play in the successful passage of DSHEA?  While much of the focus around DSHEA was on Capitol Hill and the machinations of government, an important behind-the-scenes contribution came from the short lived Natural Products Quality Assurance Alliance. But what was NPQAA and how did it help?.. Watch now
• FDA’s Tave: ‘Opportunity to strengthen regulatory framework couldn’t come at a more pivotal time’: With scientific advances and the growth of the dietary supplements industry on one hand, and the proliferation of adulterated and misbranded products on the other, the opportunity to modernize DSHEA couldn’t come at a better time… Read
• DSHEA Was Not Carved in Stone: Want to spark controversy? Just suggest to some audiences that it’s time to amend DSHEA… Read
• Balancing consumer access and safety: Looking back 25 years, there are several remarkable aspects of the Dietary Supplement Health and Education Act (DSHEA) amendments to the Food Drug and Cosmetic Act (FD&C Act), which transformed how dietary supplements are regulated… Read
• Fabricant on DSHEA: ‘Why are we talking about modernizing something that has never been fully implemented?’  As talk in the industry and at the FDA continues around the modernization of DSHEA, not everyone thinks big changes are needed. “The best thing the Agency does is inspect and test,” says NPA’s Dr Daniel Fabricant… Watch now
• Critic says FDA’s slow enforcement makes ‘DSHEA 2.0’ a side issue: Industry critic Dr Pieter Cohen, MD, said FDA’s enforcement is overly deliberate, making any discussion about revisions to DSHEA more or less moot… Read
• Bodybuilding.com VP on DSHEA: What changes could improve the regulation of dietary supplements: Bodybuilding.com’s John Venardos shares some of his ideas to improve the regulation of the dietary supplements industry, from better transparency to greater FDA staff accountability, and how to level the playing field… Watch now
• If botanicals don’t fit easily under supplement heading, why not try to fix that?  Should the creation of a new herbal medicine category be one of the goals of the upcoming discussions about a new regulatory framework? If it were possible, such a change could clear up many of the ambiguities surrounding the marketing of these products as dietary supplements… Read
• What should DSHEA 2.0 look like? Here are a couple of suggestions: On Monday FDA Commissioner Scott Gottlieb put forward some ideas about where the regulation of dietary supplements should go in the coming years. This is an opportunity that should not be missed. What should be tops on the industry’s wish list?.. Read