Editor's note: In January 2007 the publication of Dan Hurley's book, Natural Causes: Death, Lies, and Politics in America's Vitamin and Herbal Supplement Industry,1 was accompanied by a high-profile public relations campaign, which included the author's being inter-viewed on a two-part segment on CBS Evening News as well as an essay by the author in the New York Times.2 Unfortunately, some of the erroneous information in the book was repeated in both venues, e.g., the author's statement that the US Poison Control Center's database for adverse event reports on drugs and dietary supplements contains over 1.6 million case reports of adverse reactions to dietary supplements from the years 1983-2004, an egregious error that was eventually corrected by the New York Times after it received numerous letters exposing that error and other mistakes and misinterpretations in Mr. Hurley's essay.3 (The database records "exposures,” many or most of which are not neces-sarily adverse reactions.)
Annette Dickinson, PhD, a scientist and formerly a longtime staff member and officer of the Council for Responsible Nutrition (CRN), a lead-ing dietary supplement industry trade association, has submitted the following review of this book. Due to the extensiveness and critical nature of this review, we have decided to publish it as both a book review and guest editorial. As with other guest editorials, Dr. Dickinson's views do not necessarily reflect the views of HerbalGram or the American Botanical Council.
Dan Hurley has written a book that he obviously hopes will be the springboard for a new and more stringent approach to regulating dietary supplements. From the prologue to the conclusion, and all 11 chapters in between, its tone reeks of classic muckraking-colorful, horrific tales liberally laced with cries of outrage and calls to action. However, it is as singularly biased on the negative side as he claims dietary supplement promotion to be on the positive side, as outrageous in its overall message as the most egregious claims of the most inventive snake-oil peddler. Some readers may find Hurley's diatribe to be reminiscent of the writings of that longtime critic of dietary supplements, Stephen Barrett, MD, of Quackwatch, and for good reason. In the notes, Hurley asserts that although Barrett is never mentioned in the book, he was "indispensable” in providing information and reviewing the manuscript.
In his book, Hurley repeatedly demands to know why consumers are so devoted to dietary supplements, despite the defects he identifies regarding the scientific underpinnings of research, the credibility of the industry, and the quality and safety of some products. He will probably never understand the deep and lasting appeal of dietary supplements, because his entire context for thinking about them is based on erroneous premises and assumptions. Hurley insists on viewing the industry and the whole dietary supplement phenomenon as if it were part and parcel of the pharmaceutical world and therefore controlled by the same rigid requirements that apply there. Yet he also seems to recognize that dietary supplements are not part of that world and eloquently enumerates the many ways in which the two worlds differ, but he somehow cannot let go of the conviction that supplements ought to be drugs.
Hurley traces the development of dietary supplements back to patent medicines, but this is a bogus parentage. Patent medicines evolved into over-the-counter (OTC) drugs, not into dietary supplements (although some nutrients were then used for drugs and are now approved for drug uses). The true conceptual and practical origin of dietary supplements emerges from the world of food, which also has its share of eccentricity and in some respects is just as obsessed with concerns about health and disease. Food habits and some specific foods have enjoyed a special place in every culture as preventatives or cures, apart from their everyday appeal as part of the traditional diet. Carrots are good for eyesight, fish is brain food, and chicken soup is good for what ails you. These were bywords in American households when today's baby boomers were toddlers. The ancient Greeks said food is medicine, and scientists as well as ordinary folks still believe that "we are what we eat."
People tend to choose foods because they are delightful and gorgeous and tasty, not primarily because of their relative effectiveness in sustaining life and growth and reproduction. Most of us know in our hearts-and it is documented in national surveys- that we don't eat perfect diets and often fall short of getting all the nutrients we need. It logically follows that we can improve this situation by taking a few supplements of the nutrients we know we are missing from our diets. It's not just about scientific proof of benefit or rigorous demonstration of preventive powers-it's about the reasonable expectation that if we get all the nutrients we need, we will be better off than if we don't.
The dietary supplement industry as we know it in the United States actually started when vitamins were discovered in the first few decades of the 20th century. As soon as these seemingly miraculous substances were isolated and identified, they appeared in the marketplace, and the vitamin industry was off and running. Vitamins appeared in the form of tablets and were also added to foods, cosmetics, and chewing gum. According to business reports of the day, retail sales of vitamin supplements grew four-fold from 1925 to 1927, tripled again by 1929, then increased almost ten-fold by 1939.4 Clearly, the intensity of consumer interest in supplements is not a new phenomenon. The American Medical Association was already complaining in an article published in 1938 that the public was "vitamin crazy.”5
When the "new” 1938 Food, Drug and Cosmetic Act was passed (replacing the original 1906 Act), legislators were well aware of the phenomenon of vitamin supplements, and the rightful legal classification of these products got serious consideration. In the end, the legislators created a special provision for "foods for special dietary use.” Those uses, as defined by the Food and Drug Administration (FDA) in regulations promulgated in 1941, specifically included supplementing the diet.6 Thus, the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994 did not break new ground in classifying dietary supplements as foods. Rather, it established a specific definition for dietary supplements and reconfirmed that this class of products belonged in the food category, where it had already been placed more than 50 years earlier by the 1938 Act.
When FDA made its first sweeping attempt to limit the potencies and formulations of vitamin and mineral supplements in a rule finalized in 1973, it was not for reasons of safety but in order to impose "rationality” as dictated by the conventional medical view of nutrition. Hurley writes on page 268 that "Senator Proxmire's 1976 bill to prohibit the FDA from setting maximum safe doses of vitamins and minerals was wrong then, and it is wrong now.”1 But he mistakes the reasoning behind FDA's action and fails to mention that the vitamin regulations were overturned twice by the courts, in addition to being firmly rejected by Congressional action.7,8,9 Dietary supplement consumers then and now want their supplements to be safe and believe they are safe when used with reasonable judgment, but they feel no obligation to toe the line on nutritional orthodoxy where their food and supplement choices are concerned.10 As Hurley recognizes, many supplement users in the 1970s were also forging their own path in supporting organic food production and vegetarianism, at a time when both-like the use of vitamin supplements-were considered somewhat kooky rather than positively mainstream, as they are today.
Twenty years after its first attempt to limit vitamins and minerals, FDA again threw down the gauntlet. FDA Commissioner David Kessler convened an internal task force to make recommendations about how supplements should be regulated (commonly referred to as the "Dykstra Report,” named for the FDA official Gary Dykstra who headed the task force). The task force findings were the basis for an Advance Notice of Proposed Rulemaking in June 1993.11 Hurley mistakes the date and misses the critical importance of this report, which concluded that limits should be put on vitamins and minerals, that amino acids should be banned from supplements as illegal food additives, and that herbs were unsafe and frequently used for therapeutic purposes and therefore should be regulated as drugs. This proposal reeked of the same authoritarian arrogance that had doomed the 1973 regulations, and it galvanized the final passage of DSHEA.
Hurley devotes an entire chapter called "Kessler vs. Kessler” (pages 72-103)1 to the events surrounding the passage of DSHEA, but it is wildly incomplete. The trade associations that spent untold time and effort in the lobbying campaign for DSHEA must be surprised, if not shocked, to find that Hurley gives them no credit (or blame, as he would see it) for the success. Instead he attributes the entire victory to the efforts of Gerald Kessler, who was and continues to be a wild card within the industry. Kessler is the founder and owner of the dietary supplement company called Nature's Plus, and he's the founder of a relatively small, single-interest industry-consumer group, the Nutritional Health Alliance (NHA), which was a vocal participant in the lobbying effort to pass DSHEA. Perhaps the literary allure of posing the legislative effort as a battle between FDA's David Kessler and the industry's Gerry Kessler was simply too tempting, and Hurley gave in to it, but the challenge of getting two thirds of the Senate and over half of the House to sign onto the legislation as cosponsors was a major feat and definitely not accomplished single-handedly by any one person or group. The full story of the passage of DSHEA has yet to be told.
It is true, as Hurley claims, that a major factor in the passage both of the 1976 vitamin bill and of DSHEA in 1994 was the phenomenal outpouring of consumer support, as demonstrated by sustained avalanches of letters, phone calls, and personal visits to Congress by citizens demanding that senators and representatives protect the consumer's right to choose the supplements they wanted and needed to preserve their own health. Gerry Kessler's NHA was one of the groups-but not the only one-that worked at the grassroots level in the 1990s, whereas others, including the National Health Federation, had taken on that role in the 1970s. However, the passion and persistence of that consumer outpouring cannot be dismissed as the mere product of an industry campaign. That kind of intensity can be effectively utilized as part of an industry effort, but it cannot be created from scratch, as many other industries with deeper pockets have discovered. That kind of intensity can only come from a deep well of genuine consumer devotion to a product category combined with real outrage against restrictions threatened by a government out of touch with reality.
Hurley asserts on page 102 that DSHEA was responsible for the "breathtaking”1 elimination of the simple food/drug dichotomy that had long been a fundamental premise of food and drug law, but in fact that particular feat had already been accomplished by the Nutrition Labeling and Education Act of 1990 (NLEA). Until 1990, FDA had enforced a bright line between food and drug claims, vigorously prohibiting any disease-related claims for foods. For the first time, NLEA created a category of disease claims (called "health claims”) that would be permitted for foods, including dietary supplements. These claims were defined as statements about the association between a substance in food and a disease or health-related condition, and the law allowed such claims to be authorized by FDA only after a stringent review of the scientific evidence. NLEA was a giant step onto a slippery slope, because once it was accepted that disease claims legally could be made for foods, it became difficult or impossible to keep those claims within the corral initially envisioned by the law. The courts ruled against FDA's denial of some health claims on First Amendment grounds, thus creating a new category of "qualified health claims” that must include language attempting to explain to consumers how much or how little evidence exists for the claim. The later provisions of DSHEA regarding "statements of nutritional support” (including claims about the effect of a substance on the structure and function of the body) pale in comparison to the NLEA breakthrough allowing health claims for foods and would not have been politically feasible without that precedent.
Hurley's book contains an abundance of cautionary tales about the horrific effects of some extreme treatments, and he appears to believe that these tales should deter reasonable consumers from ever taking so much as a vitamin again. But the horrific effects are not all due to dietary supplements, and frankly some of the stories are too bizarre to serve as a deterrent to reasonable people making generally rational choices. His opening story is about a woman (a nurse, no less!) who seeks out several extreme topical treatments for a lesion on her nose. (Topical products are by definition applied to the skin, are not ingested, and are therefore not legally classified as dietary supplements. One of the topical treatments contained the highly potent root of the American medicinal plant bloodroot [Sanguinaria canadensis, Papaveraceae]). After persisting with the treatment way beyond the point where she should have realized something was terribly wrong, she discovered the stuff had basically eaten her nose off. Nobody in their right mind is going to identify with this story as having any relationship to ordinary dietary supplements or to the usual choices made by reasonable consumers.
Hurley does cite some well-known examples of serious problems in the dietary supplement industry, including (1) the tryptophan disaster in 1989 in which a manufacturing error by a Japanese supplier resulted in contaminated tryptophan (an essential amino acid) in dietary supplements that caused an outbreak of serious muscle and neurological symptoms and caused a number of deaths, and (2) the ephedra (Ephedra sinica, Ephedraceae) controversy that extended over a full decade before FDA banned the product in 2004. Hurley insists on treating these examples as being typical of the consumer experience with dietary supplements, but in fact neither is characteristic of the dietary supplement industry as a whole, any more than contaminated spinach or the current craze for extreme energy drinks are characteristic of the food industry as a whole.
There is a larger problem that Hurley lays at the door of the dietary supplement industry (page 187 and following),1 but in reality the phenomenon he identifies is a fraud perpetrated against the industry as well as against vulnerable consumers. It is the marketing of street drugs under the guise of dietary supplements, despite the fact that these products are clearly not intended "to supplement the diet” but are intended for use as recreational drugs. It is unfortunate but true that many young people appear to be driven to discover and abuse the latest "upper” or "enhancer” on the market, and FDA's lax enforcement permits pushers of recreational drugs to masquerade the latest fad product as a dietary supplement. This problem can be addressed only through persistent enforcement efforts on the part of FDA and the Drug Enforcement Agency, and such enforcement is strongly supported by the mainstream dietary supplement industry.
Referring to some of the key figures in the ephedra controversy or in the promotion of street drugs, Hurley marvels that so many "leading figures” of the dietary supplement industry are "convicted felons,” but the people and companies he cites are in no way leaders or even genuine members of this industry. They play in another game entirely: the game of manufacturing and marketing illicit drugs, and they are interlopers in the dietary supplement industry. They are the "black knights” so rightly abhorred by Dan Hurley's good industry friend, "Mitchell” Balbert, the founder and former CEO of what has become a large supplement company, known to the rest of us by his real name of Elliott. It would probably be a cheap shot to suggest that the depth of Hurley's understanding of the industry is approximately equal to his accuracy in recording Balbert's name, but it's hard to resist.
Hurley makes other false assertions-so many that it is difficult to know how to address them all in a commentary shorter than his book. For example, contrary to his claim that FDA's efforts to finalize Good Manufacturing Practices (GMPs) for dietary supplements have been shot down by industry, the fact is that the industry trade associations support the need for these GMPs and celebrated publication of the Final Rule on June 25, 2007. In fact, it was the industry that submitted a GMP proposal to FDA within a year after the passage of DSHEA. That document was published by the agency in 1997 as an Advance Notice of Proposed Rulemaking, followed in 2003 by a Proposed Rule.12,13 By the time the Final Rule was published, many companies had already implemented new GMPs that met or exceeded the official requirements.
Hurley deplores a court decision overturning an FDA rule that would have required unit-dose packaging for high-dose iron products and wrongly concludes that there are no special packaging rules to protect children against accidental overdoses of iron (page 178).1 The fact is that child-resistant closures have been required for iron-containing dietary supplements since 1978, under rules promulgated by the Consumer Product Safety Commission (CPSC).14 The court later ruled against an additional FDA requirement for unit-dose packaging for some products, not because it was a bad idea, but because it is the CPSC-not FDA-that has primary authority in the area of protective packaging.15 The bottom line is that, contrary to Hurley's belief, iron-containing dietary supplements are required to have child-resistant closures under CPSC rules and are also required to bear a black-box warning about the dangers of accidental childhood poisoning under more recent FDA rules.16
Dan Hurley appears to believe that the dietary supplement industry's "expansion” into pharmacies is a new and ominous development, intended as a stealth move to increase the credibility of dietary supplements, but this reflects a fundamental misunderstanding of the structure and history of the business. The dietary supplement marketplace has always included a mass market segment as well as a specialty market segment, with different companies supplying each distribution system. In fact, in the 1930s and 40s there was an effort on the part of pharmacies to obtain a monopoly on the sale of vitamin supplements, but it failed, and thus the products continued to be available not only in pharmacies but also in health food stores, grocery stores, convenience stores, and gas stations, as well as by mail order and multilevel marketing (aka network marketing) companies. Nevertheless, pharmaceutical companies were early and successful competitors in the vitamin market. An article in Fortune in 1945 listed some of the leading companies in the mass market at that time, including Upjohn, Mead Johnson, Squibb, Abbott, and Eli Lilly.17
Hurley preaches ad nauseum about the virtues of relying on scientific evidence as the major (or sole) basis of consumers' decision-making about supplements, yet he shows the classic journalist's tendency to take the latest research article as the final word, without putting the findings in the overall context of all the available information on a particular subject. For example, an abundance of evidence exists regarding the benefits of supplemental calcium and vitamin D in increasing bone density during the growing years and in slowing the rate of bone loss during aging, and no less than three NIH (National Institutes of Health) consensus conferences have confirmed this. Yet Hurley is prepared to toss all of that evidence out as irrelevant and accept the highly controversial findings of the massive but flawed Women's Health Initiative as the final word (page 174).1 In contrast, most calcium researchers share the opinion of the Surgeon General of the United States, who affirmed in a recent report that calcium and vitamin D supplements can be bone-savers for people who are not getting enough in their diets.18
Another example is the long held theory that vitamin E may help protect against heart disease (and other diseases),19 and in 1993 two large cohort studies from Harvard showed that people who took more than 100 IU of vitamin E for at least 2 years in the form of supplements had about a 40% reduction in risk of heart disease.20,21 As Hurley points out, most of the controlled clinical trials of vitamin E have been disappointing, but it is also true that most of them have been done in people who already had heart disease. Such trials are testing vitamin E as a treatment, not really as a preventive agent. It is notable, however, that one of those trials did find that vitamin E dramatically reduced the risk of having a second heart attack.22 In a study in 40,000 healthy women, vitamin E reduced heart disease mortality by 24% in women over 45 and by 49% in women over 65.23 Thus, the evidence is not as uniformly bleak as Hurley suggests, and researchers in the antioxidant field remain convinced that generous intakes of vitamin E have benefit.24 When vitamin E is supported by some major studies and by key researchers, it cannot be viewed as anti-scientific for consumers to continue to believe in its likely benefits.
Hurley accepts without question the astounding hypothesis (page 171),1 put forward in one meta-analysis,25 that high doses of vitamin E may increase overall mortality. He ignores the many flaws in that statistical analysis. He also appears to be unaware that the comprehensive safety report prepared for the NIH multivitamin conference in 2006 by Johns Hopkins University debunked the meta-analysis, saying that based on a review of the data "along with consideration of biological plausibility, we find no convincing evidence to suggest vitamin E supplement use increases risk of death per se.”26,27
Multivitamins also receive their share of criticism in this book. Hurley claims that in general "our trust in vitamins and minerals has been misplaced.” In a colorful if incomprehensible turn of phrase, he says on page 181, "The very bedrock of the dietary supplement industry turns out to be a swamp where the facts go to die.”1 In fact, many of the most respected nutritional experts in the country firmly endorse the notion that it would make sense for most adults to take a multivitamin daily. Harvard's Walter Willett in his book Eat, Drink, and Be Healthy even proposes a revised Food Pyramid that includes a sidebar recommending "Multiple Vitamins for Most.”28 UCLA's David Heber suggests adopting the "basic four” supplements to go along with the basic 4 food groups; these would include a multivitamin, extra calcium, extra C, and extra E.29 Dr. Bernadine Healy, MD, who was the first woman to be appointed as director of the NIH and later served as head of the American Red Cross, said in an editorial in U.S. News and World Report on March 12, 2007, that common sense suggests that people should avoid smoking, eat lots of fruits and vegetables, decrease saturated fats, "enjoy fish and maybe even fish oil tablets,” take supplements of calcium and vitamin D, and "add on a multivitamin.”30 These and other experts provide ample support for consumers who choose to adopt the sensible habit of taking a multivitamin daily as part of a healthy lifestyle.
If Hurley is hard on vitamins, that's nothing compared to the vitriol he heaps on herbal products. Leaving aside his lengthy rehashing of the ephedra issue, he dwells on problems with the sourcing and potential contamination of herbs, especially those imported from Asia. He highlights a case of kidney failure in a woman taking herbs contaminated with the Chinese herb fang chi (Aristolochia fangchi, Aristolochiaceae) that contained nephrotoxic and carcinogenic aristolochic acid. He also cites cases of heavy metal poisoning from the use of Ayurvedic products and tells of products labeled as herbs that were found to contain potent pharmaceutical ingredients. These are genuine problems that are taken seriously by responsible elements within the herb industry as well as the government-problems new GMPs will be very helpful in addressing. He lampoons the National Center for Complementary and Alternative Medicine (NCCAM) at NIH, saying it had become "a haven for witch doctors doing voodoo science” (page 245)1; that is, before the previous NCCAM director, the late Stephen Straus, MD, cleaned house and began producing sound scientific results, most showing that various herbal treatments- including St. John's wort (Hypericum perforatum, Clusiaceae), echinacea (Echinacea spp., Asteraceae), and saw palmetto (Serenoa repens, Arecaceae)-failed to perform up to expectations, at least as measured within the limited design of the particular trials. In fact, recently published controlled clinical trials on various preparations made from these 3 herbs have shown positive results, and systematic reviews and meta-analyses of multiple randomized clinical trials on each have concluded that despite mixed results from various trials, some preparations made from each of these herbs do provide clinically-documentable benefits.31,32,33
Had Mr. Hurley taken the time to really comb through the wealth of published randomized controlled clinical trials on these three herbs (and others), abstracts for which are available on Medline and other accessible databases, as well as systematic reviews and meta-analyses from the Cochrane Collaboration, he would have discovered, as various reviewers and meta-analyzers have, that despite mixed results, there is substantial evidence supporting the therapeutic benefits of numerous clinically-studied herbs and phytomedicines. In other words, the potential therapeutic benefits of these herbs cannot be easily dismissed.
Hurley seems ready to write off the whole category of botanicals, yet the World Health Organization recognizes the value of herbal medicine, which is relied upon almost exclusively by a large part of the world's population, particularly in developing countries. In the United States, the NIH has funded at least 6 centers of excellence in botanical research at major universities. In many European countries, botanical treatments are approved for many uses and are respected by the medical community as well as by consumers, so there is clearly a more promising side of the story, as documented in numerous publications of the American Botanical Council, as well as elsewhere. But we get not a glimpse of that more positive, evidence-based story in Hurley's book.
Proving that a little learning is a dangerous thing, Hurley dips into the reports compiled by the National Association of Poison Control Centers and comes up with the false notion that tens of thousands of people are being poisoned by vitamins, herbs, and other dietary supplements every year. It is true that the Poison Control Centers receive an enormous number of calls from consumers, but it is not true that each of those calls represents a case of harm. If Aunt Alice finds little Johnny in the middle of the living room floor gleefully waving around a bottle of vitamins and calls the Poison Control Center to find out what she should do, that counts as a report-even though the child never actually got his hands on one of the tablets and no event of any kind occurred. In the 2004 annual report tabulating almost 2.5 million calls received by Poison Control Centers in that year, tables show the products most frequently involved in "exposures.”34 These include cosmetics, cleaning products, analgesics, toxic ornamental houseplants, and vitamins-the types of products most likely to be present in a household and thus the most readily accessible to young children, who account for fully half of all exposures. For 2004, there were 126,507 calls to Poison Control Centers about vitamins, minerals, herbs, and other supplements. Only 326 of these (0.3%) are identified as involving serious effects-a matter for concern but not the epidemic that Hurley would have us believe is occurring.
Hurley ends with a "baker's dozen” list of 13 actions that should be taken to improve the state of the dietary supplement industry and to protect consumers. Some of these actions would be endorsed not only by consumer and health groups but also by leading trade associations in the industry, including my own alma mater, the Council for Responsible Nutrition. Hurley calls for "seed to shelf” quality control of products (page 264),1 a concept described and supported by CRN some years ago.35 Such control is precisely the goal of the new dietary supplement GMPs, which are supported by all the major dietary supplement industry associations as well as numerous other nonprofit advocacy groups allied with the industry. He also calls for mandatory reporting of serious adverse events by companies in the industry (page 265),1 and I am glad to report that Congress recently enacted a law, with the support of the trade associations as well as many other groups, that now requires such reporting. The law was introduced into Congress by long-time supplement industry allies Senators Tom Harkin [D-IA] and Orrin Hatch [R-UT]. Hurley calls for better labeling and more safety testing and higher funding for FDA (pages 265-268).1 He suggests that NCCAM be eliminated. In its place, he urges that an expert review be conducted by the National Academy of Sciences, resulting in monographs describing those dietary supplements considered to be safe and effective for specific uses. He further suggests that reimbursement by Medicare, Medicaid, and health insurance be allowed for products found to be effective in the expert review.
But Hurley's true agenda is not the accomplishment of finite achievable goals such as those mentioned above. It is much broader and, frankly, more sinister. His true agenda appears to be to control the flow of information, so that people learn only what he believes they should know.
Hurley says the media should be held accountable for the information they provide and should be responsible for not running false advertising (page 270).1 This sounds like a good start, doesn't it? On the same page, he says the media should do a better job of informing people about supplements. Again, this sounds reasonable. He even provides an example of something specific the media should do to accomplish this: "For one, they should stop routinely quoting the Council for Responsible Nutrition, which is merely a trade group promoting their members' products, despite its attempts to position itself as a purveyor of the 'science behind the supplements.'1 Really? Muzzling CRN is his number one idea? Does he imagine that reporters from the major newspapers and TV stations don't know that CRN is a trade association? The fact is, reporters go to CRN and other associations for comment precisely in order to get the industry view and thus provide the critical "balance” editors demand in a story-or the added element of controversy that makes an article more interesting. Even if CRN's scientists weren't sought out specifically because of their industry affiliation, on what grounds should they be prevented from commenting on the hot scientific findings of the day?
But it isn't only CRN that Hurley would like to muzzle. He goes on to say that the media should be cautious in general about covering good news about supplements, because their coverage may lead consumers to rely on the stories and buy "products that have undergone no serious scientific or regulatory scrutiny” (page 271).1 We can only be grateful that the likes of Hurley were not in control of our Constitution and our Bill of Rights, or else the Founding Fathers could never have created our democratic form of government or given us the precious guarantee of freedom of speech.
In Senator Barack Obama's book, The Audacity of Hope: Thoughts on Reclaiming the American Dream (Crown 2006), he tells the story of a confrontation between the late Senator Patrick Daniel Moynihan and another colleague, a disagreement they ultimately failed to resolve. The other senator said he supposed he was entitled to his own opinion on the matter. Senator Moynihan responded, "You are entitled to your own opinion, but you are not entitled to your own facts.”36
Dan Hurley is entitled to pontificate about dietary supplements as much as he likes, but he is not entitled to make up his own facts. I have tried in this commentary to correct at least some of the erroneous statements that abound in his astonishing book.
Annette Dickinson, PhD, is a consultant on dietary supplement regulation and food and nutrition policy. She worked in Washing-ton, DC, for over 30 years for the Council for Responsible Nutri-tion (CRN), a trade association of the dietary supplement industry. She was responsible for regulatory and scientific affairs and served as CRN's president prior to her retirement in 2005. Dr. Dickinson was appointed in 2002 to serve a 3-year term on the FDA's Food Advisory Committee and was appointed by President Clinton to the Commis-sion on Dietary Supplement Labels (1995-1997). She earned her PhD in nutritional science from the University of Maryland.
- Hurley D. Natural Causes: Death, Lies, and Politics in America's Vita-min and Herbal Supplement Industry. New York: Broadway Books; 2006. [ISBN 0-7679-2042-2; $23.95.]
- Hurley D. Diet Supplements and Safety: Some Disquieting Data. New York Times. January 16, 2007; F1:5.
- Revisiting a poison control database on supplement risks. New York Times. February 6, 2007; F3:6.
- Vitamins Go To War. Business Week. July 10, 1943:57-68.
- Miller LM. The Vitamin Follies. Hygeia. November 1938:10041005,1045.
- Food and Drug Administration. Definition of "special dietary uses” and label regulations for food represented for special dietary uses. Federal Register, 1941;6:5921.
- National Nutritional Foods Association v FDA, 504 F2d 761 (2d Cir 1974), cert. denied, 420 US 946 (1975).
- National Nutritional Foods Association v Kennedy, 572 F2d 377 (2d Cir 1978).
- Pub L No. 94-278, Title V, sections 501-502, 90 Stat. 410-413 (1976). [The vitamin bill, adding a new Section 411 to the FD&C Act.]
- CRN Consumer Confidence Survey, 2006. Washington, DC: Council of Responsible Nutrition; 2007.
- Food and Drug Administration. Advance Notice of Proposed Rulemaking Regarding Dietary Supplements. Federal Regis-ter.1993;58:33690.
- Food and Drug Administration. Advance Notice of Proposed Rulemaking, GMPs for Dietary Supplements. Federal Regis-ter.1997;62:5700.
- Food and Drug Administration. Proposed Rule, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements. Federal Regis-ter.2003;68:12158.
- Consumer Product Safety Commission. Poison Prevention Packaging. Substances requiring special packaging.16 CFR 1700.14(a)(13).
- Nutritional Health Alliance v FDA, 318 F3d 92 (2d Cir 2003).
- Food and Drug Administration. Labeling of dietary supplements containing iron. 21 CFR 101.17(e).
- The Vitamin Business. Fortune Magazine. May 1945:140.
- Surgeon General of the US. Bone health and osteoporosis: A report of the Surgeon General. Published July 1994. Available at http://www. surgeongeneral.gov/library/bonehealth/chapter_5.html. Accessed February 22, 2008.
- Shute WE. Vitamin E for Ailing and Health Hearts. New York, NY: Pyramid Books; 1972.
- Stampfer MJ, Hennekens CH, Manson JE, Colditz GA, Rosner B, Willett WC. Vitamin E consumption and the risk of coronary disease in women. N Engl J Med. 1993;328:1444-1449.
- Rimm EB, Stampfer MJ, Ascherio A, Giovannucci E, Colditz FA, Willett WC. Vitamin E consumption and the risk of coronary heart disease in men. N Engl J Med. 1993;328:1450-1456.
- Stephens NG, Parsons A, Schofield PM, Kelly F, Cheeseman K, Mitchinson MJ. Randomized controlled trial of vitamin E in patients with coronary disease: Cambridge Heart Antioxidant Study (CHAOS). Lancet. 1996;347:781-786.
- Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005;293:1338-1347.
- Traber MG. How much vitamin E?...Just enough! Am J Clin Nutr. 2006;84:959-960.
- Miller ER, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: High-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2004;142:37-46.
- NIH State-of-the-Science Conference on Multivitamin/Mineral Supplements and Chronic Disease Prevention. May 15-17, 2006. NIH Web site. Available at: http://consensus.nih.gov/2006/ 2006MultivitaminMineralSOS028html.htm. Accessed March 30, 2007.
- Huang HY, Caballero B, Chang S, et al. Multivitamin/mineral supplements and prevention of chronic disease. Evidence report technology assessment no. 139. (Prepared by The Johns Hopkins University Evidence-based Practice Center under Contract No. 290-02-0018.) AHRQ Publication No. 06-E012. Agency for Healthcare Research and Quality, Rockville, MD, May 2006.
- Willett WC. Eat, Drink, and Be Healthy: The Harvard Medical School Guide to Healthy Eating. New York, NY: Simon & Schuster Source; 2001.
- Heber D. What Color Is Your Diet? New York, NY: Regan Books; 2001.
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