I learned about the new civil and criminal actions against makers of dietary supplements from a press release from US Senator Claire McCaskill, ranking member of the US Senate Special Committee on Aging. The dietary supplement industry, she says, “continues to resemble the Wild West.”
The Department of Justice, Food and Drug Administration (FDA), and Federal Trade Commission (FTC) have initiated enforcement actions against USPlabs, which makes muscle and weight loss supplements such as Jack3d and OxyElite Pro. The charge:
USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.
The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. In fact, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.
The FDA’s statement says that it has warned consumers not to use certain USPlabs products containing a synthetic alkaloid, aegeline, which is so toxic that it induces liver problems so severe that they caused several victims to need liver transplants and one died (the New York Times says more about this).
The FDA says it:
continues to warn consumers about the risks associated with some over-the-counter products, falsely marketed as dietary supplements, which contain hidden active ingredients that could be harmful. In the last year, the agency has warned of more than 100 products found to contain hidden active ingredients. These products are most frequently marketed for sexual enhancement, weight loss, and body building.
wrote FDA Acting Administrator Stephen Ostroff to request that the FDA take appropriate action to suspend sales of any supplement containing picamilon, a product that FDA has determined is not a dietary ingredient. McCaskill also asked for any documents submitted to the FDA as a part of the New Dietary Ingredient notification process that confirm the ingredient’s safety, and for any cases in which picamilon had caused ‘adverse events’ in consumers. After the FDA failed to respond, McCaskill asked retailers to voluntarily remove products containing picamilon from their shelves—an action that many took.
Wild West indeed. The supplement industry brought this on itself when it convinced Congress that its products were so safe and so much more effective than prescription drugs that regulations were unnecessary. In 1994, Congress agreed and passed the Dietary Supplement Health and Education Act, which essentially deregulated dietary supplements and, except for egregious instances like this one, forced the FDA to leave supplements pretty much alone.
The industry argues that there are just a few bad apples like these. But how would we know?
Conclusion: Maintaining energy balance at a higher caloric intake and expenditure should be a more successful long-term strategy for weight maintenance than reduced consumption or extreme caloric restriction at a low level of energy expenditure (a low energy flux) and improve intervention effectiveness for sustainable methods for body weight stability. [Implication: eat more to lose weight?]
Funding: GA Hand received non-restricted research funding and travel grant from The Coca Cola Company and a travel grant from International Life Sciences Institute. RP Shook received a travel grant from the Coca Cola Company. JO Hill received research support from the Coca Cola Company and the American Beverage Association. JO Hill is on the advisory board for McDonalds, General Mills, Curves, Consumer Goods Association, Calorie Control Council, International Food Information Council and McCormick Science Institute. JO Hill is a consultant for Walt Disney, has equity in Gelesis and Active Planet and is on the Board of Directors for International Life Sciences Institute and Livewell Colarado. SN Blair is the principal investigator on projects supported by unrestricted research grants from The Coca Cola Company to the University of South Carolina.
Comment: Some of these investigators were among those highlighted in the New York Times article revealing Coca-Cola’s funding of research demonstrating that physical activity is more important than diet in weight maintenance.
Conclusion: If the physical inactivity industry could commit to increasing physical activity by 78 calories a day per person, we would begin seeing some real success…we need innovative thinking, recognition that both food and physical activity are important, and open minds about how to engage all of society in making changes.
Disclosure: Dr. Hill reports personal fees from Coca-Cola, personal fees from McDonald’s, grants from American Beverage Association, personal fees from Walt Disney Company, personal fees from General Mills, personal fees from Calorie Control Council, other from International Life Sciences Institute, and other from Retrofit outside the submitted work. In addition, Dr. Hill has a patent Energy Gap issued. Dr. Blair reports grants from Technogym and grants from Coca-Cola. Dr. Peters has no competing interests to disclose.
Comment: same investigators as in previous example.
Conclusion: Soy isoflavones, although not as potent as risedronate [a drug used to treat osteoporosis], are effective bone-preserving agents in postmenopausal women regardless of their equol-producing status, and mixed isoflavones in their natural ratios are more effective than enriched genistein. [Equol is an isoflavone produced by intestinal bacteria]
Conflicts: CMW is on the scientific advisory board of Pharmavite [the maker of SoyJoy]. SB has a US patent on the use of conjugated isoflavones and the prevention of osteoporosis.
Conclusions: Agave inulin supplementation shifted the gastrointestinal microbiota composition and activity in healthy adults. Further investigation is warranted to determine whether the observed changes translate into health benefits in human populations. [Note: Agave inulin is a prebiotic, a fiber that can be metabolized by intestinal bacteria. The study reports enrichment of fecal Bifidobacterium (the good kind)].
Funding: Supported in part by Global Nutrition R&D, Ingredion Incorporated, Bridgewater, NJ. V Gourineni and CL Pelkman are employees of Global Nutrition R&D, Ingredion, Incorporated. [Ingredion manufactures prebiotic fibers]
As always, please send examples, particularly of industry-funded studies that do not produce results in the sponsor’s interest.
Earlier this week, President Obama announced a plan to reduce toxic emissions from coal-burning power plants. The purpose of the EPA’s Clean Power Plan is to reduce greenhouse gases that contribute to climate change.
But from the standpoint of food politics, the new rules do something really important. They will force coal-burning power plants to further reduce emissions of mercury.
In 2005, the EPA promulgated a rule to control mercury emissions from fossil fuel-fired power plants under section 111(d): the Clean Air Mercury Rule (CAMR). The EPA established a nationwide cap-and-trade program that took effect in two phases: In 2010, the cap was set at 38 tons per year, and in 2018, the cap was lowered to 15 tons per year. The EPA expected, on the basis of modeling, that sources would achieve the second phase, 15-ton per year cap cost-effectively by choosing among a set of measures that included shifting generation to lower-emitting units.
Mercury from coal-burning power plants is the largest human-induced source of methymercury in the fish food chain, accounting for 40% of the amount that gets into oceans (most of the rest comes from underseas volcanos). Mercury is converted to toxic methylmercury in seawater, and the toxin moves up the fish food chain as bigger fish eat smaller fish. Methylmercury does very bad things to the nervous system of the growing fetus (recall the mass poisonings in Minamata, Japan in the 1950s and the shocking photos of the victims).
Fish advisories
Large, predatory fish have the most methymercury and should not be eaten in large amounts, or at all by pregnant women.
Wouldn’t it be better to prevent mercury from getting into seawater in the first place?
I like to use eliminating methylmercury as an example of why public health (“upstream”) approaches work better than personal responsibility (“downstream”) approaches.
An exceptionally clear example is how to avoid toxic levels of methylmercury in fish. We can teach pregnant women to recognize which fish are high in methylmercury and hope this works well enough so they will avoid buying such fish (personal responsibility) or we could–as a society–require coal-burning power plants to scrub their emissions so mercury doesn’t get into ocean or lake waters in the first place (public health).
The basics of the Clean Power Plan are fairly simple. The EPA is giving each state an individualized goal for reducing emissions from their electric power plants. States can then decide for themselves how to get there…. Power plant emissions have already dropped 15 percent between 2005 and 2013, thanks to a brutal recession, cheap natural gas pushing out coal, the rise of wind power, and improved efficiency. So with this new plan, EPA is expecting a further 20 percent cut in power-plant emissions from 2013 levels by 2030.
But hold the celebration. Politico Pro Energy reports that Republicans in Congress view the rule as a key component of the administration’s “war on coal” and will try to block it or sue to stop it. The Supreme Court says that the EPA has the authority to issue this rule, but “Challengers are expected to argue that the rule is invalid because it exceeds EPA’s authority, contradicts a Clean Air Act provision meant to avoid duplicative rules, and violates the 5th and 10th Amendments to the Constitution.” And, of course, a post-Obama president could undo the whole thing, as it is an executive branch action, not a law passed by Congress.
Yesterday’s New York Times had a front-page story on how coal lobbyists and corporate lawyers started organizing more than a year ago to fight this plan.
An important ally in the effort was the American Legislative Exchange Council, or ALEC, a conservative advocacy group that pushes policy through state legislatures. Typically, the council’s committees of corporate members will craft a model bill designed to push through policies it supports, such as rolling back environmental regulations.
The Clean Power Plan deserves massive support.
This may be a climate-change plan, but it is also a critically important public health measure.
Anyone who likes eating fish should do everything possible to support this measure.
Ordinarily I don’t pay close attention to early congressional legislative initiatives until they seem likely to be passed by both houses and signed by the President.
Rep. Peter DeFazio, D-Ore: if a U.S. company or subsidiary labels a product as containing GMOs in any foreign country, it must label the equivalent product the same way in the United States. (Defeated 122 to 303)
Rep. Jared Huffman, D-Calif: ensures tribal sovereignty to prohibit or restrict the cultivation of GMOs on tribal lands. (Defeated 196 to 227)
Rep. Rosa DeLauro, D-Conn: prohibits use of the term “natural” on GMO foods. (Defeated 163 to 262)
Rep. Chellie Pingree, D-Maine: strikes the entire bill and creates a USDA non-GMO certification program and label. (Defeated by voice vote)
In an op-ed in the Boston Globe, Reps. Chellie Pingree and Jim McGovern say “Let consumers decide for themselves.”
Americans want more information, not less. What we need is one law that makes GMO labeling mandatory across the country and establishes a single national standard that eliminates confusion and puts consumers in charge.
This debate isn’t about the safety of GMOs. It’s about consumers’ right to know what’s in the food they put on their tables. We ought to give them that right.
Even if the House passes the bill, nobody in the Senate seems interested in it as yet. So maybe this is all just theater.
But I read it as acknowledgment by the GMO industry and its food product supporters that the labeling issue is not going to go away. Therefore, they had best try to preempt it by passing a law they can live with and making sure that states do not pass their own, stronger bills.
Stay tuned.
*Addition: I received a request to unpack the bill and state its terms. HR 1599:
Calls for premarket notification of new GMOs introduced into the food supply.
Says the process of GMO is not sufficient to require labeling.
Says non-GMO labeling cannot imply that non-GMO is safer.
Blocks voluntary non-GMO labeling.
Prevents states from requiring GMO labeling.
Allows the term “natural” on labels of GMO foods.
Establishes a non-GMO certification program requiring process controls and preemption of state laws.
Update, July 27: According to OpenSecrets.org, representatives who voted against GMO labeling received three times as much money from agribusiness as those who did not. OpenSecrets calls this a “cash crop.”
Use and enjoy the list of media resources—links to videos, audios, songs, movies, infographics, commercials—keyed to illustrate the text.
This book:
Answers the question, how did what is essentially flavored sugar-water come to mean so much and to have such devastating health and food policy consequences?
Is the first to focus on the history, politics, nutrition, and health of soda, integrating public health science with historical and cultural research
Helps readers understand how we created this food system, what its problems are, and what we can do to fix these problems
Is illustrated with 70 figures and 50 tables
Comes with a Foreword by Mark Bittman, food journalist and columnist for The New York Times
Comes with an Afterword by Dr. Neal Baer, pediatrician and television writer and producer
Here are the book’s blurbs:
“The soda industry is a powerful economic operator. Economic power readily translates into political power. Soda Politics is exactly the kind of carefully-researched investigative reporting needed to open the eyes of the public and parliamentarians to the health hazards of what is, as the author rightly notes, essentially liquid candy in a bottle.” –Dr. Margaret Chan, Director-General, World Health Organization
“No book in history has so completely laid bare the soda scourge that touches every corner of the world. Marion Nestle shows how this happened, its impact on human health and well-being, who the players are, and, most importantly, what might be done. This is the right book at the right time.” –Dr. Kelly Brownell, Dean, Sanford School of Public Policy, Duke University
“Marion Nestle is one of the greatest muckrakers of our time, and what she does is vitally important-for our health, our environment, and for future generations. Here, she wages war against the soda titans with such piercing clarity and so many irrefutable truths that all other arguments crumble.” –Alice Waters, Founder and Proprietor of Chez Panisse
“Comprehensive and well-written, this book will help frame a thoughtful public policy debate about nutrition and the societal impacts and costs of obesity.” –Ann M. Veneman, Former US Secretary of Agriculture and Former Executive Director of UNICEF
“What happens when the food industry’s most insightful critic turns her sights on soda? This razor-sharp, fun to read, plan-of-battle for one of the greatest public health fights of our time. Big soda may have all the money, but those who would enter this fray, as we all should, now have their champion.” –Michael Moss, Author of Salt Sugar Fat: How the Food Giants Hooked Us
“For decades, soda companies have amassed fortunes off drinks that are making us sick. It took someone like Marion Nestle to cut through the spin and uncover the high cost of cheap sodas.” –Robert Kenner, Director/Producer, Food Inc. and Merchants of Doubt
“Long recognized as an important and informed voice in our national and international discussions on nutrition and health, Marion Nestle has written another book that will keep us talking. With an impressive combination of scholarship and advocacy, Dr Nestle takes an unflinching look at the soda industry, its products and the impact on health. Soda Politics deserves the attention of the public and policy makers, and should make us all think more carefully about choices we can make to improve health and well-being.”–Margaret Hamburg, M.D., Former Commissioner, U.S. Food and Drug Administration
REVIEWS
Here’s the first review from the August 2015 Library Journal:
Nestle (nutrition, New York Univ.) once again exposes the dark side of the food business. As in her 2007 Food Politics: How the Food Industry Influences Nutrition and Health, the author examines the soft drink industry, demonstrating how products that are basically flavored water with added sugar contribute to obesity, type-2 diabetes, and metabolic syndrome. She discusses the composition and production of soda, the adverse effects of excess sugar consumption, and product marketing. The companies’ targeting of children, low-income, and minority communities; lobbying of Congress to prevent legislation that would impact profits; funding of research to produce results that obscure the facts about soda; and donations to health organizations and charities in order to be portrayed as socially responsible corporations make it difficult for citizens to act. Nestle reveals what can be done and how to do it, providing relevant data, analyzing that information, and illustrating its difficulties. She then advocates for smaller portions, taxing sugary drinks, and excluding soda from the Supplemental Nutrition Assistance Program (SNAP) and provides examples of successful campaigns, a list of groups advocating for healthy beverage choices, and extensive notes. VERDICT An outstanding manual for health educators, activists, and anyone seeking information about the soda industry and its impact on health.— Barbara Bibel, formerly Oakland P.L.
For me, the single most stunning and appalling revelation comes in the section about environmental impact and industry responses to it. It is that between 340 and 620 litres of water are used for every litre of soft drink produced, about 20% of that related to packaging. Despite such disturbing revelations,Soda Politics is not discouraging…Throughout the book, Nestle provides tactics for practical, local advocacy, such as working with school wellness committees and engaging local policymakers. And since 2002, the proportion of US citizens who say that they avoid soft drinks has risen by 20%, reaching nearly two-thirds of the population…For public health to prevail over soda politics as usual, we have miles to go. This book is the richly drawn map of how to get there, from here.
The standard operating practices of companies like Coca-Cola and PepsiCo demand the same level of scrutiny as cigarette companies, and for many of the same reasons, argues Marion Nestle in the introduction of her new book, Soda Politics. What follows is a thorough and unflinching look at the soft-drink industry’s role in promoting the consumption of sugary drinks despite growing evidence that they are detrimental to our health. The book begins with a basic primer of the range of health problems that have been linked to soda consumption, from tooth decay to obesity and diabetes, hitting its stride with an eviscerating assessment of the industry’s marketing and advocacy practices.
For those readers who share Nestle’s critical perspective on the food industry, it is obvious that this book would be informative. But here is the greater surprise: this solid book is by far the best source on this topic for any reader, with any perspective on economics or politics. If I worked for a trade association, or an industry front group, or an esteemed professional association that relies on soda industry funding, or the House Agriculture Committee, or a sugar manufacturer, or a high-powered corporate law firm, I might store this book in my desk drawer rather than my book shelf … yet I would read it word for word.
In Soda Politics (OUP, £19.90), Dr Marion Nestle does us all a great service by spelling out clearly and authoritatively the dreadful price we are paying for guzzling gallons of sugared water – Coke and Pepsi by any other name. Big Soda, as Dr Nestle calls the billion-dollar corporate giants behind this poison, know exactly how bad their products are for us but are so powerful no one takes them on. Rise up and rebel, Nestlé urges.
Nestle writes like an investigator hunting every possible scrap of damning material for a prosecutorial brief, which will no doubt make her book an excellent resource for activists and reformers seeking remedies in Washington, in the courts, and, perhaps, in the aisles of the local supermarket.
Fortunately, so does Marion Nestle. The nutrition professor, advocate and investigator best known for “Food Politics” profiles the soft drink industry in her expansive, superbly researched new book, “Soda Politics: Taking On Big Soda (and Winning).” It isn’t so much a narrative as a well-organized barrage of facts, some eye-popping (the world’s soda companies produce nearly two trillion 12-ounce servings annually), others banally incriminating. They come off the page like jabs in a sustained pummeling lasting more than 400 pages. Even if Nestle is only half right, it’s still a total knockout.
Nestle is foremost an educator and an activist, and Soda Politics is worth its price alone for the chapters on advocacy, from recruiting public health leaders and working from within to protecting public water resources…In other words, we can change things, one Big Gulp at a time.
Sabnavis M. Bitter fizz. Financial Express (India), March 20, 2016: A book that exposes that there’s more ill in a cola bottle than mere sugar—environment costs, high water use and pure politics.
Vermont has issued GMO labeling rules. They seem straightforward. Here are the ones that I think matter:
1. Unpackaged GMO foods must post labels
Raw: “produced with genetic engineering.”
Processed: “produced with genetic engineering,” or “may be produced with genetic engineering.”
2. Packaged GMO foods must be labeled by the manufacturer
Raw: “produced with genetic engineering”
Processed: “produced with genetic engineering,” or “partially produced with genetic engineering” (<75% GMO) or “may be produced with genetic engineering (if they aren’t sure).”
3. If the food is GMO, it cannot be labeled “natural”
4. The font can’t be any smaller that of Serving Size in the Nutrition Facts label
It’s hard for me to imagine why the biotechnology industry, Grocery Manufacturers Association, and so many food companies think that saying “may be produced with genetic engineering” means the end of civilization as we know it, so much so that they pour millions of dollars into fighting it.
Now they are taking Vermont to court to try to block implementation of these rules.
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 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.
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.
I am increasingly concerned about the proliferation of research studies sponsored and funded by food, beverage, or supplement companies with a vested interested in the outcome. These almost invariably come to conclusions in favor of the sponsor’s food product.
You must understand that I am not searching for sponsored studies in any systematic way. They just appear in the tables of contents of journals I typically read and are easily identified by their titles.
My plan is to post a list of sponsored research studies every time I accumulate 5 examples. My first post in this series appeared March 16.
Conclusion: Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL.
Sponsor: Tersus Pharmaceuticals (maker of Provinal palmitoleic acid). Dr. Roizen is chair of the Scientific Advisory Board of Tersus Pharmaceuticals and chair of the Cleveland Clinic Wellness Institute.
Conclusion: We conclude that whey protein supplementation attenuated the decline in postprandial rates of MPS [Myofibrillar Protein Synthesis] after weight loss, which may be of importance in the preservation of lean mass during longer-term weight loss interventions.
Sponsor: The Dairy Research Institute through the Whey Protein Research Consortium.
Conclusion: High egg consumption did not have an adverse effect on the lipid profile of people with T2D [type 2 diabetes] in the context of increased MUFA [monounsaturated fatty acid] and PUFA [polyunsaturated fatty acid] consumption. This study suggests that a high-egg diet can be included safely as part of the dietary management of T2D, and it may provide greater satiety.
Conclusion: Milled flaxseed lowers total and LDL cholesterol in patients with PAD [peripheral artery disease] and has additional LDL-cholesterol–lowering capabilities when used in conjunction with CLMs [cholesterol-lowering medications].
Sponsor: Flax2015, the Canola Council of Canada, and others.
Fish advisories
