Search results: Herbal Supplements

I’m having trouble keeping up with industry-sponsored nutrition research so will use this week’s posts to catch up.  I’ll start with this one.

Nutrition journals often publish supplements on specific themes that are paid for by outside parties, food industry groups among them.  The February 2016 issue of the Journal of Nutrition contains a supplement with the papers from the 2014 International Garlic Symposium: “Role of Garlic in Cardiovascular Disease Prevention, Metabolic Syndrome, and Immunology.”

To distinguish supplement papers from peer-reviewed journal articles, citations give page numbers with the letter S.  The Journal of Nutrition’s exceptionally clear policy on supplement publications explains that organizers are expected to pay page charges of $75 per article and $300 per published page plus additional editorial costs as needed.  It views supplements as paid advertisements and requires full disclosure of funding sources.

Here’s the disclosure for the garlic supplement.

The symposium was sponsored by the University of California, Los Angeles School of Medicine and the University of Florida and co-sponsored by the American Botanical Council; the American Herbal Products Association; the ASN [American Society for Nutrition]; the Japanese Society for Food Factors; the Japan Society for Bioscience, Biotechnology, and Agrochemistry; the Japan Society of Nutrition and Food Science; and the Natural Products Association. The symposium was supported by Agencias Motta S.A.; Bionam; Eco-Nutraceuticos; Healthy U 2000 Ltd.; Magna; Mannavita Bvba; MaxiPharma; Medica Nord A.S.; Nature’s Farm Pte. Ltd.; Nature Valley W.L.L.; Organic Health Ltd.; Oy Valioravinto Ab; Purity Life Health Products L.P.; PT Nutriprima Jayasakti; Vitaco Health Ltd.; Vitae Natural Nutrition; Sanofi Consumer Health Care; Wakunaga Pharmaceutical Co., Ltd.; and Wakunaga of America Co., Ltd. The Chair of the conference and Scientific Program Coordinator for the supplement publication was Matthew J Budoff, Harbor-UCLA Medical Center, Torrance, CA. Scientific Program Coordinator disclosures: MJ Budoff has been awarded research grants from Wakunaga of America Co., Ltd., and received an honorarium for serving as Chair of the conference. Vice-Chair and Supplement Coordinator for the supplement publication was Susan S Percival, University of Florida, Gainesville, FL. Supplement Coordinator disclosures: SS Percival has been awarded research grants from Wakunaga of America Co., Ltd., and received an honorarium for serving as Vice-Chair of the conference. Publication costs for this supplement were defrayed in part by the payment of page charges. This publication must therefore be hereby marked “advertisement” in accordance with 18 USC section 1734 solely to indicate this fact. The opinions expressed in this publication are those of the authors and are not attributable to the sponsors or the publisher, Editor, or Editorial Board of The Journal of Nutrition [my emphasis].

Comment on scoring: Because they were presented at a symposium sponsored by food and supplement companies, all papers raise questions about industry sponsorship.  That is why the Journal requires every paper in the supplement to repeat this funding disclosure in its entirety.

But for this particular symposium, some of the papers report additional funding by Wakunaga of America, a company that, no surprise, manufactures garlic supplements.

All of the papers produced results useful to the sponsor.  Some of them, however, were independently funded and the authors report no links to the sponsor other than having given a talk at the meeting.  They did not disclose who paid for travel and hotels and without any way to check, I must assume that they paid their own expenses to the meeting in San Diego.  For the purposes of scoring, I’m not counting them as industry-funded, even though their presence at the symposium made it seem more scientifically credible.

Garlic Lowers Blood Pressure in Hypertensive Individuals, Regulates Serum Cholesterol, and Stimulates Immunity: An Updated Meta-analysis and Review.  Karin Ried.  J Nutr. 2016; 146:389S-396S doi:10.3945/jn.114.202192.

• Conclusions: Our review suggests that garlic supplements have the potential to lower blood pressure in hypertensive individuals, to regulate slightly elevated cholesterol concentrations, and to stimulate the immune system. Garlic supplements are highly tolerated and may be considered as a complementary treatment option for hypertension, slightly elevated cholesterol, and stimulation of immunity.
• Author disclosures: K Ried, no conflicts of interest. K Ried received travel sponsorship from Wakunaga of America Co. Ltd. to attend the 2014 International Garlic Symposium.
• Score: industry-positive

Chemical Assignment of Structural Isomers of Sulfur-Containing Metabolites in Garlic by Liquid Chromatography−Fourier Transform Ion Cyclotron Resonance−Mass Spectrometry.  Ryo Nakabayashi, Yuji Sawada, Morihiro Aoyagi, Yutaka Yamada, Masami Yokota Hirai, Tetsuya Sakurai, Takahiro Kamoi, Daryl D Rowan, and Kazuki Saito.  J. Nutr. 2016; 146:397S-402S doi:10.3945/jn.114.202317.

• Conclusion: The ability to discriminate between such geometric isomers will be extremely useful for the chemical assignment of unknown metabolites in MS-based metabolomics.
• Supported, in part, by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan; Japan Advanced Plant Science Network; Japan Science Technology Agency (JST), Strategic International Collaborative Research Program (SICORP); and JST, Strategic International Research Cooperative Program (SICP).
• Score: industry-neutral

Garlic-Derived Organic Polysulfides and Myocardial Protection.  Jessica M Bradley, Chelsea L Organ, and David J Lefer.  J. Nutr. 2016; 146:403S-409S doi:10.3945/jn.114.208066.

• Conclusion: The beneficial health effects of garlic on cardiovascular health are dependent on multiple mechanisms. Furthermore, the mechanisms of action may be mediated by the active components in garlic.
• Supported by grants from the National Heart, Lung, and Blood Institute (1R01 HL092141, 1R01 HL093579, 1U24 HL 094373, and 1P20 HL113452; to DJL) and by the Louisiana State University Health Foundation in New Orleans.
• Score: Industry-neutral

Aged Garlic Extract Inhibits Human Platelet Aggregation by Altering Intracellular Signaling and Platelet Shape Change.  Khalid Rahman, Gordon M Lowe, and Sarah Smith.  J. Nutr. 2016; 146:410S-415S doi:10.3945/jn.114.202408

• Conclusion: These results indicate that AGE [Aged Garlic Extract] inhibits platelet aggregation by increasing cyclic nucleotides and inhibiting fibrinogen binding and platelet shape change.
• Funding: Supported by a grant from Wakunaga of America Co. Ltd.  K Rahman and GM Lowe were in receipt of a grant from Wakunaga of America Co., Ltd. S Smith, no conflicts of interest.
• Score: industry-positive

Garlic and Heart Disease.  Ravi Varshney and Matthew J Budoff.  J. Nutr. 2016; 146:416S-421S doi:10.3945/jn.114.202333

• Conclusion: We conclude that garlic supplementation has the potential for cardiovascular protection based on risk factor reduction (hypertension and total cholesterol) and surrogate markers (CRP, PWV, and CAC) of atherosclerosis.
• Disclosures: The authors report no funding received for this study.  R Varshney, no conflicts of interest. MJ Budoff receives funding from Wakunaga of America Co., Ltd.
• Score: industry-positive

The Role of Adiponectin in Cardiometabolic Diseases: Effects of Nutritional Interventions.  Patricio Lopez-Jaramillo.  J. Nutr. 2016; 146:422S-426S doi:10.3945/jn.114.202432

• Conclusions: Recently, it was reported that the administration of aged garlic extract and a single food intervention with pistachios can increase adiponectin concentrations in individuals with metabolic syndrome. Moreover, the Mediterranean diet is associated with higher adiponectin concentrations. Additional studies are needed to evaluate the potential benefits of increasing adiponectin by nutritional interventions in the treatment and prevention of cardiometabolic diseases.
• Funding: The author reports no funding received for this study.
• Score:  Industry-neutral

Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study.  Suguru Matsumoto, Rine Nakanishi, Dong Li, Anas Alani, Panteha Rezaeian, Sach Prabhu, Jeby Abraham, Michael A Fahmy, Christopher Dailing, Ferdinand Flores, Sajad Hamal, Alexander Broersen, Pieter H Kitslaar, and Matthew J Budoff.  J. Nutr. 2016; 146:427S-432S doi:10.3945/jn.114.202424

• Conclusions: This study indicates that the %LAP [Low Attenuation Plaque] change was significantly greater in the AGE group than in the placebo group. Further studies are needed to evaluate whether AGE has the ability to stabilize vulnerable plaque and decrease adverse cardiovascular events.
• Disclosures: While the study was funded by Wakunaga of America Co., Ltd., the authors are solely responsible for the design, all study analyses, the drafting and editing of the paper and its final contents…S Matsumoto, R Nakanishi, D Li, A Alani, P Rezaeian, S Prabhu, J Abraham, MA Fahmy, C Dailing, F Flores, S Hamal, and A Broersen, no conflicts of interest. PH Kitslaar is employed by Medis Medical Imaging Systems and has a research appointment at the Leiden University Medical Center. MJ Budoff receives funding from Wakunaga of America Co., Ltd.
• Score: industry-positive

Aged Garlic Extract Modifies Human Immunity.  Susan S Percival.  J.  Nutr. 2016; 146:433S-436S doi:10.3945/jn.115.210427

• Conclusions: These results suggest that AGE supplementation may enhance immune cell function and may be partly responsible for the reduced severity of colds and flu reported. The results also suggest that the immune system functions well with AGE supplementation, perhaps with less accompanying inflammation.
• Funding: Support for this research was provided by Wakunaga of America Co., Ltd.  Author disclosures: SS Percival received travel expenses to the conference where this work was presented.
• Score: industry-positive

Bioavailability of Alfrutamide and Caffedymine and Their P-Selectin Suppression and Platelet-Leukocyte Aggregation Mechanisms in Mice.  Jae B Park.  J. Nutr. 2016; 146:437S-443S doi:10.3945/jn.114.202473

• Conclusions: These data show the adequate bioavailability of alfrutamide and caffedymine and their different mechanisms of suppressing PSE and PLA: alfrutamide exerts its effects only via COX inhibition, whereas caffedymine works through both COX inhibition and cAMP amplification.
• Funding: Supported by the USDA (project 8040-51000-057-00).
• Score: Industry-neutral

Garlic Influences Gene Expression In Vivo and In Vitro.  Craig S Charron, Harry D Dawson, and Janet A Novotny.  J. Nutr. 2016; 146:444S-449S doi:10.3945/jn.114.202481

• Conclusion: Measuring mRNA gene expression in whole blood may provide a unique window to understanding how garlic intake affects human health.
• Support: CSC, HDD, and JAN were supported by the USDA.
• Score: Industry-neutral.

Development of an Analytic Method for Sulfur Compounds in Aged Garlic Extract with the Use of a Postcolumn High Performance Liquid Chromatography Method with Sulfur-Specific Detection.  Toshiaki Matsutomo and Yukihiro Kodera.  J. Nutr. 2016; 146:450S-455S doi:10.3945/jn.114.208520

• Conclusion: We developed a rapid postcolumn HPLC method for both qualitative and quantitative analyses of sulfur compounds, and this method helped elucidate a potential mechanism of cis-S1PC and SAMC action in AGE.
• Acknowledgment: The authors thank Takami Oka of Wakunaga Pharmaceutical Co., Ltd. for his kind guidance for this study and critical review of the manuscript.
• Score: Industry-positive

Pharmacokinetics of S-Allyl-L-cysteine in Rats Is Characterized by High Oral Absorption and Extensive Renal Reabsorption.  Hirotaka Amano, Daichi Kazamori, and Kenji Itoh.  J. Nutr. 2016; 146:456S-459S doi:10.3945/jn.114.201749

• Conclusion: The pharmacokinetics of SAC in rats were characterized by high oral absorption, limited metabolism, and extensive renal reabsorption, all of which potentially contribute to its high and relatively long-lasting plasma concentrations.
• Acknowledgment: We thank Takami Oka of Wakunaga Pharmaceutical Co. for his valuable advice, critical reading of the manuscript, and helpful suggestions.
• Score: Industry-positive

Aged Garlic Extract Suppresses the Development of Atherosclerosis in Apolipoprotein E–Knockout Mice.  Naoaki Morihara, Atsuko Hino, Takako Yamaguchi, and Jun-ichiro Suzuki. J. Nutr. 2016; 146:460S-463S doi:10.3945/jn.114.206953

• Conclusion: These data suggest that the antiatherosclerotic activity of AGE is at least partly due to the suppression of inflammation and lipid deposition in the vessels during the early stage of atherosclerotic development in ApoE-KO mice.
• Acknowledgment: We thank Takami Oka of Wakunaga Pharmaceutical Co., Ltd., for his helpful advice, encouragement, and critical reading of this manuscript; Yukihiro Kodera of Wakunaga Pharmaceutical Co., Ltd., for the preparation of AGE; and Tadamitsu Tsuneyoshi of Wakunaga Pharmaceutical Co., Ltd., for his technical advice.
• Score: Industry-positive

This makes 8 industry-positives from this journal supplement.

But let me add one more on this topic, sent by a reader:

The effect of aged garlic extract on blood pressure and other cardiovascular risk factors in uncontrolled hypertensives: the AGE at Heart trial.  Karin Ried Nikolaj Travica, Avni Sali.  Integrated Blood Pressure Control, 27 January 2016.

• Conclusion: Our trial suggests that aged garlic extract is effective in reducing peripheral and central blood pressure in a large proportion of patients with uncontrolled hypertension, and has the potential to improve arterial stiffness, inflammation, and other cardiovascular markers in patients with elevated levels. Aged garlic extract was highly tolerable with a high safety profile as a stand-alone or adjunctive antihypertensive treatment.
• Funding: This trial was supported by a grant from Wakunaga of America Co Ltd, who sup­plied trial capsules and provided funding for costs of tests and research assistance. Wakunaga of America was not involved in study design, data collection, analysis, or prepa­ration of the manuscript…The authors report no conflicts of interest in this work.
• Score: industry-positive, of course.

This brings the score since last March to 119 industry-positives/11 industry-negatives.

Ebola is much in the news, and for good reason.  It is highly contagious, difficult to contain, and deadly.

In food studies, we say that food is a lens through which to view the most important problems of society.  Here are some thoughts on the food politics of Ebola.

Dietary Supplements for Ebola Prevention or Treatment

The Council for Responsible Nutrition, the trade association for supplement manufacturers, has found it necessary to issue an advisory on use of dietary supplements to prevent or treat Ebola infections.

The American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the United Natural Products Alliance (UNPA) are therefore endorsing the following unified advisory for marketers and retailers, as well as for consumers of dietary supplements:

• Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing Ebola virus disease, or preventing Ebola virus infection.
• Marketers and retailers should refrain from promoting any dietary supplement as a cure or treatment for Ebola virus disease.
• Anyone who believes they may have Ebola virus disease or may have come in contact with the Ebola virus should contact a healthcare professional immediately. The Centers for Disease Control and Prevention has more information on Ebola virus disease and the proper actions to take if you suspect you are ill.

The knowledge that no known treatment exists for Ebola has not stopped supplement manufacturers from advertising the benefits of their products for this infection.

FDA Warning Letters

The FDA has stepped in and issued warning letters to three manufacturers marketing their products as possible treatments or cures.  The FDA letters, which make interesting reading, went to:

• Natural Solutions Foundation
•  Young Living
• dōTERRA International LLC

Marketing of Nutritional Supplements

A simple Google search of “supplements Ebola” turned up this kind of information this morning:

The Ebola virus can be destroyed naturally – despite what you’ve been told To date, not a single virus has been tested that is not inactivated (killed) by a large enough dose of vitamin C (ascorbic acid). Many other antioxidants have similar virucidal effects, but vitamin C appears uniquely to be of greatest potency and clinical efficacy, as its simple chemical structure allows for it to be disseminated throughout the body with little restriction… Vitamin C is both very potent and optimally bioavailable in accessing any viral infection.

And this:

The substances in the Natural Allopathic protocol for Ebola offer a power unequalled in the world of medicine that we can harness to save many lives of people infected with Ebola…. Magnesium salts, sodium bicarbonate (baking soda), iodine, selenium and vitamin C are concentrated nutritional medicinals that have been used in the direst of medical circumstances…The core of the Natural Allopathic protocol redefines the way emergency room and intensive care should be practiced on Ebola patients with proven fast-acting, safe, concentrated and mostly injectable nutritional medicines. If the Ebola infection truly gets out of hand, it is comforting for parents to know that they can legally administer these same medicinals if infected people are treated at home. All of the Natural Allopathic Medicines can be also taken orally or used transdermally (topically) to almost the same effect if treatment is started early enough.

How Can Supplement Makers Do This?

The ability of supplement manufacturers to claim health benefits for their products, and mostly get away with it, is a result of congressional action in passing the Dietary Supplement Health and Education Act of 1994 (DSHEA), which essentially deregulated these products.

Twenty years later, the supplement industry is deeply divided between responsible and irresponsible manufacturers, both allowed by law.

As the president and CEO of one supplement company puts it,

The industry of 1994, roughly $8 billion in sales, has experienced compounded double-digit growth every year since DSHEA became law…DSHEA opened the door to growth, innovation, new science, new discovery and a nation of wanting consumers enchanted with the thought that there are natural solutions to their individual health needs…20 years later, it’s time to take a hard look at what DSHEA doesn’t provide to the industry today. The barrier to entry into this industry continues to have no hurdles; DSHEA does not define the boundaries of consumer trust… The generations of today, and the generations of tomorrow will demand transparency, they will demand efficacy, and they will demand quality and safety from all of us.

Clearly, they aren’t getting that now.

Other Connections to Food Politics

Chocolate

Politico writes:

EBOLA THREATENS WORLD’S CHOCOLATE SUPPLY:  Ivory Coast, the world’s largest producer of cacao, the raw ingredient in M&Ms, Butterfingers and Snickers Bars, has shut down its borders with Liberia and Guinea, putting a major crimp on the workforce needed to pick the beans that end up in chocolate bars and other treats just as the harvest season begins… the outbreak already could raise prices…Prices on cocoa futures jumped from their normal trading range of $2,000 to $2,700 per ton, to as high as $3,400 in September over concerns about the spread of Ebola to Côte D’Ivoire.

Food safety

Food safety lawyer Bill Marler points out that Ebola started out as a foodborne illness.    Its most likely source was infected bushmeat that transferred the virus to human handlers.

Following standard food safety procedures is always a good idea while hoping that health officials get this epidemic under control.

 

People who consume caffeinated energy drinks may be dying right and left (Because of the caffeine?  The drinks?  Hard to say) but that isn’t stopping food manufacturers from adding it to everything: Cracker Jacks, jelly beans, Gummi Bears, brownies, mints, and maple syrup.

The FDA has just released its data on problems reported among users of three caffeinated energy drinks.

According to the New York Times,

The three products involved in the release — Rockstar Energy, 5-Hour Energy and Monster Energy — are all marketed as dietary supplements. Other energy drinks like Red Bull, NOS and AMP are marketed by their producers as beverages. There is not a mandatory reporting requirement for beverages, though makers can do so voluntarily.

In releasing the filings, the F.D.A. said it thought that even with the mandatory reporting requirement for dietary supplements, “only a small fraction of adverse events associated with any product is reported.”

…The records related to Monster Energy and 5-hour Energy came to light because they were released by the F.D.A. under the Freedom of Information Act.

The choice of labeling these products as foods or supplements deserves scrutiny.  By an act of Congress, dietary supplements do not have to meet the same standards for content and health claims as foods, and the FDA cannot do much to regulate them unless the products are demonstrably harmful.

Even though people died after drinking these products does not necessarily mean that the products caused the deaths.  Even this number of deaths could be a coincidence.

But earlier, the Times reported that

Since 2009, 5-Hour Energy has been mentioned in some 90 filings with the F.D.A., including more than 30 that involved serious or life-threatening injuries like heart attacks, convulsions and, in one case, a spontaneous abortion….

Some lawmakers are calling on the F.D.A. to increase its regulation of the products and the New York State attorney general is investigating the practices of several producers.

I looked up the Supplement Facts label for 5-Hour Energy.

According to statements given to Beverage Daily, 5-Hour Energy says there isn’t any evidence that its products cause deaths.  Its shots contain no more caffeine than a cup of coffee, and do not contain herbal ingredients.

But the product label does not list caffeine content.  The FDA does not require companies to disclose caffeine levels.

It allows them to market the products as drinks or as dietary supplements. Monster Energy contains 240 mg caffeine in 24 ounces.  It has been associated with the deaths of five people so far.

The Times points out that healthy adults can consume large amounts of caffeine with no evidence of harm but that caffeine can be risky for people with underlying conditions like heart disorders.  How much is risky?  It’s hard to say.

Most adults know how much caffeine they can handle without getting shaky or sleep-deprived.  But kids don’t, necessarily.

Consumer Reports tested products and found that some energy drinks contained more than 240 mg per serving, but notes that packages sometimes contain more than one serving.

The FDA considers caffeine to be safe.  But in an opinion last updated in 2011, FDA’s Select Committee on GRAS Substances found that “it is inappropriate to include caffeine among the substances generally recognized as safe (GRAS). At current levels of consumption of cola-type beverages, the dose of caffeine can approximate that known to induce such pharmacological effects as central nervous system stimulation.”

The Times notes that sales of energy drinks in the U.S. are booming, growing by about 16% last year and bringing in nearly $9 billion.

What to do?  A lawyer for the parent of one of the teenagers who died after drinking Monster Energy is urging the FDA to ban the drinks to minors.

The FDA should investigate the cases, for sure.

And how about adding amounts of caffeine to labels.  That seems like a no brainer while the investigations are in progress.

Concerns that highly caffeinated Monster Energy drinks might be responsible for the recent deaths of at least five young adults are, as I see it, a direct result of deregulation of food oversight.

Here’s my version of the history leading up to the present situation:

• In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which in essence deregulated dietary supplements, permitted them to be labeled and regulated as supplements, not foods, and removed much of FDA’s authority over their contents and health claims.
• The dietary supplement industry, as I explain in Food Politics, wrote much of the key language of this law.
• When the FDA tried to enforce its food rules for supplements, the courts ruled in favor of manufacturers on First Amendment grounds.
• Because rules for supplements are less restrictive than those for foods, some manufacturers prefer labeling their products as supplements.
• Monster Energy drinks are labeled as supplements, removing them from much of FDA’s authority.

The results of DSHEA, in this case, are explained by the New York Times:

But while the F.D.A. regularly makes adverse event reports about drugs and medical devices publicly available, it does not do so for dietary supplements like energy drinks. Because of that policy, consumers had no way of knowing of the complaints about Monster Energy drinks before incident reports were released by the F.D.A. in response to a formal Freedom of Information Act request.

Also, while supplement makers have been required since late 2007 to alert the F.D.A. to possible product-related deaths and injuries, Monster Beverage submitted just one such report to the agency over the last four years, agency officials said.

Most likely because of their high caffeine content, sales of energy drinks are rising rapidly, as shown in this graphic from the Times:

Booming sales means booming profits, and the makers of energy drinks are under pressure to cash in.  That sometimes means cutting corners or not always matching contents to labels.

For example, a Consumer Reports investigation of the caffeine content of energy drinks identified some discrepancies.

Caffeine levels per serving ranged from about 6 milligrams to 242 milligrams per serving—and some containers have more than one serving. The highest level was in 5-hour Energy Extra Strength; the lowest in the seemingly oxymoronic 5-hour Energy Decaf…By comparison, an 8-ounce cup of coffee has about 100 milligrams; a 16-ounce Starbucks Grande, 330 milligrams.

Consumer Reports noted one other key point: the FDA considers caffeine as GRAS (Generally Recognized As Safe) and does not require amounts to be listed on labels.

A representative of the Monster Beverage Corporation explained that his company does not list caffeine levels “because there is no legal or commercial business requirement to do so, and also because our products are completely safe, and the actual numbers are not meaningful to most consumers.”

Consumer Reports points out that Monster drinks—like those of 16 other products—warn against use by children, pregnant or nursing women, and people sensitive to caffeine, and recommend a daily limit.

Whether the Monster Energy drinks are really responsible for the reported deaths will not be easy to establish.  One victim, age 14, is said to have consumed two 24-ounce Monster drinks containing 240 mg caffeine each within a day or two.

That energy drinks are labeled as supplements ties the FDA’s hands in dealing with such products.

Here are some suggestions to consider:

• Label energy drinks with standard Nutrition Facts panels.
• Require amounts of caffeine to be stated on the label.
• Limit the amount of caffeine that can be included in soft drinks.

Two Senators (Durban and Blumenthal)—not for the first time—are pushing the FDA to investigate.  Good idea.  I can only speculate about why the FDA isn’t responding, but I’m guessing that this issue, like so many others, is too controversial to take up during an election campaign.

Soon, please.

Thanks to Anita Laser Reutersward in Sweden for forwarding the most recent decisions of the European Food Safety Authority (EFSA) on  petitions for health claims.

Health claims are vitally important to food marketers.  Evidence: they have filed 44,000 petitions with EFSA to date.  EFSA consolidated these into 4,185 claims.  It is dealing with them in batches.

EFSA did not approve many of the 416 petitions in this latest batch :

Experts issued unfavourable opinions on most of the claims in the second series due to the poor quality of the information provided to EFSA including:

• Lack of information to identify the substance on which the claim is based, e.g. “probiotics”
• Lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”)
• Lack of human studies with reliable measures of the claimed health benefit

Its decisions about antioxidants are especially interesting in light of claims on products in American supermarkets.  Under EFSA rules, this Kellogg package would not be allowed.

In its decision, EFSA said:

“On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and (1) a beneficial physiological effect related to antioxidant activity, antioxidant content, or antioxidant properties, and (2) the protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage.”

My translation: EFSA panels took a good hard look at the science and could not find evidence for benefits at the physiological or molecular levels from taking antioxidant supplements or eating foods with antioxidants.

I can’t wait to see how food manufacturers respond.

March 1 update: here come the comments.  According to FoodNavigator.com, EFSA rejected health claims for:

vitamin D, probiotics, green tea, black tea, lutein, beta glucans, meso-zeaxanthin, alpha-lipoic acid, melatonin, peptides, xanthan gum, sugar-free gum, guar gum, gamma-linolenic acid (GLA), fermented whey and linoleic acid.

These decisions “came as a massive blow to the European and international functional foods and nutraceuticals industries, especially the herbal antioxidant and probiotic sectors, which have yet to see a positive NDA opinion.”

The FDA has its hands full these days, what with peanut butter, no commissioner, and Daschle withdrawing for consideration as secretary of Health and Human Services (the FDA’s parent agency).  Even so, the FDA is concerned about weight loss supplements that it considers fraudulent, and has now gone after 70 of them.  The FDA has a lot on its plate, as it were, and let’s hope the new administration figures out a way to make oversight of the food supply a priority.

February 10 update: the New York Times has a long piece on this problem.  Turns out that a lot of these so-called herbal products actually contain weight loss drugs of one kind or another.  They are not supposed to.