C supplements may raise cataract risk. (#09-52 December 24, 2009)
A study of women who were followed over an 8-year period has found that vitamin C supplementation, particularly in high dose and long duration, may increase the risk of age-related cataracts. The study included 24,593 women aged 49-83 years from the Swedish Mammography Cohort (follow-up from September 1997 to October 2005). The researchers used a self-administered questionnaire to collect information on dietary supplement use and lifestyle factors.
[Rautiainen S and others. Vitamin C supplements and the risk of age-related cataract: a population-based prospective cohort study in women. American Journal of Clinical Nutrition, Nov 18, 2009. Epub ahead of print] http://www.ncbi.nlm.nih.gov/pubmed/19923367.
The study does not prove cause-and-effect, but because high-dose vitamin C provides no proven benefit for the general population, the findings provide further reason to avoid vitamin C megadosage.
found ineffective for weight loss. (#10-28, July 15th, 2010)
At the International Congress on Obesity (ICO 2010) in Stockholm, two research teams reported on studies that found that many popular dietary supplement ingredients are not effective for weight control. One study found that L-carnitine, polyglucosamine, cabbage powder, guarana seed powder, bean extract, konjac extract, fiber, sodium alginate, and selected plant extracts were no more effective than placebos over an 8-week period. The other study was a literature review that summarized the state of evidence from clinical trials involving chromium picolinate, Ephedra, bitter orange, conjugated linoleic acid (CLA), calcium, guar gum, glucomannan, chitosan and green tea. [New research finds no evidence that popular supplements facilitate weight loss. ICO news release, July 2010] http://www.dietscam.org/reports/ico.shtml.
Company settles FTC charges. (#11-01,
January 6th, 2011)
The Dannon Company, Inc. has agreed to stop making unsubstantiated claims about its Activia yogurt and DanActive dairy drink, which contain potentially beneficial bacteria known as probiotics. [Dannon agrees to drop exaggerated health claims for Activia yogurt and DanActive dairy drink. FTC news release, Dec 15, 2010] http://www.ftc.gov/opa/2010/12/dannon.shtm Under the settlement:
**Dannon is prohibited from claiming that any yogurt, dairy drink, or probiotic food or drink reduces the likelihood of getting a cold or the flu, unless the claim is approved by the FDA.
**Dannon may not claim that any other yogurt, dairy drink, or probiotic food or drink will relieve temporary irregularity or help with slow intestinal transit time unless the claim is substantiated by at least two well-designed human clinical studies.
**Dannon may not make any other claims about health benefits, performance, or efficacy of any yogurt, dairy drink, or probiotic food or drink, unless the claims are true and backed by competent and reliable scientific evidence.
The FTC worked in close coordination with 39 state attorneys general, who are simultaneously announcing the resolution of their own inquiries into Dannon's advertising of DanActive and Activia. Dannon has agreed to pay the states $21 million to resolve these investigations. Dannon has also settled a class-action suit by agreeing to create a $35 million fund to reimburse consumers for up to $100 for products purchased. http://www.casewatch.org/civil/dannon/settlement.pdf.
manufacturer settles FTC charges. (#11-20 July 7, 2011)
Beiersdorf, Inc. has signed a consent agreement under which it will pay $900,000 and stop claiming that using its Nivea My Silhouette! skin cream can significantly reduce the user's body size. The FTC's administrative complaint charged Beiersdorf with falsely claiming that consumers could slim down by regularly applying Nivea My Silhouette! cream to their skin. http://www.ftc.gov/os/caselist/0923194/110629beiersdorfcmpt.pdf .
Beiersdorf touted the cream's "Bio-slim Complex," a combination of ingredients that includes anise and white tea. The proposed settlement (a) bars Beiersdorf from making unsubstantiated claims that any product applied to the skin causes substantial weight or fat loss or a substantial reduction in body size and (b) requires that any claim about health benefits of any drug, dietary supplement, or cosmetic be backed by competent and reliable scientific evidence. The FTC advises consumers to be suspicious of any claim that body size can be significantly reduced by applying a cream. [FTC settlement prohibits marketer from claiming that Nivea Skin Cream can help consumers slim down. FTC news release, June 29, 2011] http://www.ftc.gov/opa/2011/06/beiersdorf.shtm.
questions vitamin E safety. (#11-34
October 13, 2011)
A major clinical trial has found that dietary supplementation with vitamin E appears to increase the risk of prostate cancer among apparently healthy men. [Klein EA and others. Vitamin E and the risk of prostate cancer: The Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA 306:1549-1556, 2011] http://www.ncbi.nlm.nih.gov/pubmed/21990298
The study, which spanned more than seven years, followed what happened to more than 35,000 men who received either 400 IU of vitamin E, vitamin E plus selenium, selenium, or a placebo. The group that received vitamin E alone had a 17% higher incidence of prostate cancer. The researchers warned:
"The observed . . . increase in prostate cancer incidence demonstrates the potential for seemingly innocuous yet biologically active substances such as vitamins to cause harm. The lack of benefit from dietary supplementation with vitamin E or other agents with respect to preventing common health conditions and cancers or improving overall survival, and their potential harm, underscore the need for consumers to be skeptical of health claims for unregulated over-the-counter products in the absence of strong evidence of benefit demonstrated in clinical trials."
warns of supplement risks. (#12-18
May 24, 2012)
The United States Anti-Doping Agency has launched the Supplement 411 Web site to warn about the danger of dietary supplements marketed to athletes. http://www.usada.org/supplement411 The site features the stories of prominent athletes who were disqualified from competition after illegal substances (originating from supplements) were found in their urine. The site also reports news about supplement hazards.
finds little evidence that sports performance products are useful.
Researchers who reviewed performance-enhancing claims for sports drinks, supplements, clothing, footwear, and devices have concluded that they were not adequately supported by scientific evidence. The investigators viewed 1035 web pages, identified 431 performance-enhancing claims for 104 different products, asked the marketers for additional information, and evaluated 146 references that supposedly underpinned the advertised claims. They found that half of the sites cited no references and that among those that did, nearly all of the studies were inadequately designed. [Heneghan C and others. The evidence underpinning sports performance products: A systematic assessment. BMJ Open 2:e001702, 2012] http://bmjopen.bmj.com/content/2/4/e001702.full.
Prizewinner warns that antioxidants may cause cancer. (#13-3 January 17, 2013)
Geneticist James Watson, Ph.D., who won the Nobel Prize for discovering the structure of DNA, has noted that clinical trials of antioxidant supplements beta-carotene, vitamin A, vitamin C, vitamin E, and selenium have shown no obvious effectiveness against common cancer and may shorten the life of cancer patients who use them. In a highly technical paper, he says that instead of doing more such trials, future research should focus on innovative anti-metastatic drug development, including drugs that inhibit antioxidant activity. [Watson J. Oxidants, antioxidants and the current incurability of metastatic cancers. Open Biology 3:120144, 2013].
C supplements linked to kidney stones. (#13-7 February 14, 2013)
An 11 year study of more than 48,000 men has found that those who took vitamin C (ascorbic acid) supplements were twice as likely to develop kidney stones than those who did not. The dominant component in these stones was calcium oxalate. The association does not prove cause-and-effect, but the authors note: "Currently there are no well-documented benefits of high-dose ascorbic acid supplement use, and, therefore, it seems prudent to advise that high-dose preparations be avoided, particularly by those with a history of kidney stones." [Thomas L and others. Ascorbic acid supplements and kidney stone incidence among men: a prospective study. JAMA Internal Medicine, Feb 4, 2013] An accompanying editorial notes that causation is biologically plausible because ascorbic acid is partly metabolized to oxalate and is excreted in the urine. [Fletcher RH. The risk of taking ascorbic acid. JAMA Internal Medicine, Feb 4, 2013] The full text of these articles is available free online.
use blasted. (#13-48
- December 19, 2013)
The Annals of Internal Medicine has published the results of three studies which found no benefit from taking multivitamins:
The U.S. Preventive Services Task Force updated its evaluation of vitamin supplements for primary prevention in community-dwelling adults with no nutritional deficiencies. After reviewing 3 trials of multivitamin supplements and 24 trials of single or paired vitamins that randomly assigned more than 400,000 participants, the authors concluded that there was no clear evidence of a beneficial effect on all-cause mortality, cardiovascular disease, or cancer. [Fortmann SF and others. Vitamin and mineral supplements in the primary prevention of cardiovascular disease and cancer: An updated systematic evidence review for the U.S. Preventive Services Task Force. Annals of Internal Medicine 159:824-834, 2013 (link)]
Another team evaluated the use of a daily multivitamin to prevent cognitive decline among 5947 men physicians aged 65 years or older participating in the Physicians' Health Study II. After 12 years of follow-up, there were no differences between the multivitamin and placebo groups in overall cognitive performance or verbal memory. [Grodstein F and others. Long-term multivitamin supplementation and cognitive function in men: A randomized trial. Annals of Internal Medicine 159:806-814, 2013 (link)] The full text is available online free-of-charge.
Another team assessed the potential benefits of a high-dose, 28-component multivitamin supplement in 1708 men and women with a previous heart attack who participated in the Trial to Assess Chelation Therapy. After a median follow-up of 4.6 years, there was no significant difference in recurrent cardiovascular events with multivitamins compared with placebo, although, as the authors noted, the significance of this study was limited by high rates of nonadherence and dropouts. [Lamas GA and others. Oral high-dose multivitamins and minerals after myocardial infarction: A randomized trial. Annals of Internal Medicine 159:717-804, 2013 (link)]
An accompanying editorial, which considered the gamut of previously published studies drew a very harsh conclusion that generated headline news throughout the United States:
Beta-carotene, vitamin E, and possibly high doses of vitamin A supplements are harmful. Other antioxidants, folic acid and B vitamins, and multivitamin and mineral supplements are ineffective for preventing mortality or morbidity due to major chronic diseases. Although available evidence does not rule out small benefits or harms or large benefits or harms in a small subgroup of the population, we believe that the case is closed supplementing the diet of well-nourished adults with (most) mineral or vitamin supplements has no clear benefit and might even be harmful. These vitamins should not be used for chronic disease prevention. Enough is enough. [Gualler E and others. Enough Is enough: Stop wasting money on vitamin and mineral supplements. Annals of Internal Medicine 159:850-851, 2013 link]
Quackwatch has suggestions about the rational use of dietary supplements (link). Among other things, it recommends that people who wish to take multivitamins should do so only every 2 or 3 days and spend no more than $1 per month.
supplement product triggers call for greater regulation (#14-14 April 20, 2014)
Nearly 100 cases of hepatitis (liver inflammation) and liver failure have been linked to the use of OxyElite Pro, a dietary supplement intended for muscle-building or weight loss. In response, Pieter A. Cohen, M.D., has pointed out:
- Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves.
- Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.
- Although OxyElite Pro was recalled, nothing has been done to prevent another supplement from causing organ failure or death. Nor have any changes been made to improve the FDA's ability to detect dangerous supplements.
- More than 500 supplements have already been found to be adulterated with pharmaceuticals or pharmaceutical analogues, including new stimulants, novel anabolic steroids, unapproved antidepressants, banned weight-loss medications, and untested analogues of sildenafil (the active ingredient in Viagra).
- If consumers and physicians are to have confidence that all supplements are safe, the laws regulating supplements must be reformed so that every ingredient is required to undergo rigorous safety testing before marketing.
[Cohen P. Hazards of hindsight: Monitoring the safety of nutritional supplements. New England Journal of Medicine 370:1277-1280, 2014]
company settles FTC charges. (#14-24
- July 6, 2014)
L'Oréal USA, Inc. has agreed to settle Federal Trade Commission charges of deceptive advertising about its Lancôme Génifique and L'Oréal Paris Youth Code skin-care products. According to the FTC's complaint, L'Oréal made false and unsubstantiated claims that its Génifique and Youth Code products provided anti-aging benefits by targeting users' genes. Under the proposed administrative settlement, the company is prohibited from making unsubstantiated claims that any Lancôme or L'Oréal Paris facial skin-care product targets or boosts the activity of genes to make skin look or act younger, or respond five times faster to aggressors like stress, fatigue, and aging. [L'Oréal settles FTC charges alleging deceptive advertising for anti-aging cosmetics. FTC news release, June 20, 2014]
Agency warns athletes about dietary supplements (#14-29 - August 10, 2014)
The United States Anti-Doping Agency (USADA) maintains a Web site that challenges myths about dietary supplements and discourages their use. Among other things, the site warns:
Navigating the supplement marketplace and supplement issues is difficult. No one person or organization can provide all the answers.
Many people have hastily jumped to the conclusion that supplements are safe, effective, and a necessary part of being an elite athlete.
It is very unlikely that healthy people will be unable to get the nutrients they need from diet alone. There is simply no substitution for eating a proper diet.
The majority of supplements have not been proven to improve performance.
Certain dietary supplements contain exorbitant amounts of nutrients that are unnecessary, unusable by the body, or even potentially harmful.
The best option may be to not take dietary supplements.
The site also contains the Supplement 411 High Risk List of products that have been found to contain substances that are banned in high-level athletic competition. The list is accessible free of charge but requires viewers to register.
products associated with liver toxicity (#14-38 - October 12, 2014)
The Drug-Induced Liver Injury Network has reported that about 15% of the cases that it studied involved herbal and dietary supplement products. The organization was established in 2003 to identify and study cases of drug-induced liver injury attributable to medications (excluding acetaminophen [APAP]) and supplements. The 130 patients with liver injury from supplements consisted of 45 (35%) who had taken bodybuilding products and 85 (65%) who had taken non-bodybuilding products. The report noted the problems attributable to bodybuilding products were relatively mild but severe outcomes (deaths and liver transplants) were more frequent among users non-bodybuilding products than among medication users. [Navarro VJ and others. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology 60:1399-1408, 2014]
Many herbs and dietary supplements fail ingredient tests (#15-28 - July 19, 2015)
ConsumerLab.com, which has tested over 4,500 products since November 1999, has found that, through July 2015, 20% of the vitamins and minerals, 43 percent of the herbals, 21% of other supplements, and 24% of nutritional powders and drinks failed their evaluations. The most common problem was too little or none of the main ingredient. The other problems included too much active ingredient; the wrong ingredient; potentially dangerous or illegal ingredients; contamination with heavy metals; "spiking" with unexpected ingredients; poor disintegration (which affects absorption); and misleading or incomplete product information.
Herbal products blasted (#15-45 - November 15, 2015)
Donald M. Marcus, Professor of Medicine and Immunology Emeritus at Baylor College of Medicine in Houston, has severely criticized the use of herbal products and the loose way in which they are regulated. [Marcus DM. Dietary supplements: What's in a name? What's in the bottle? Drug Testing and Analysis, Nov 2, 2015] He concludes:
The Dietary Supplement Health and Education Act of 1994 (DSHEA), which arbitrarily classified herbals and other medicinal products as dietary supplements, obscured fundamental differences between two classes of products. Authentic supplements to the diet, such as multivitamins or calcium, have nutritional value and are safe. Herbals are used worldwide as medicines, they do not supplement the diet, they may cause severe adverse events, and they should be regulated as medicines. DSHEA also prevented the FDA from effectively regulating herbal supplements as medicines. One consequence of weak FDA regulatory oversight is the poor quality of herbals. FDA inspections of manufacturing facilities have revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications. Moreover, many "all natural" herbals marketed for weight loss, enhancement of sexual health and improving sports performance are adulterated with prescription and over-the-counter medications that have caused adverse cardiovascular events. New procedures to authenticate the identity of plants used in herbals will neither detect adulteration by medications nor provide assurance of appropriate pharmacological activity or safety. Nonvitamin, nonmineral "supplements" should be regulated as medicines, but revision or repeal of DSHEA faces strong opposition in Congress. The marketing of botanical supplements is based on unfounded claims that they are safe and effective. Health professionals need to inform patients and the public that there is no reason to take herbal medicines whose composition and benefits are unknown, and whose risks are evident.
The full text of the article is accessible free of charge.
Frontline report blasts dietary supplement industry (#16-05 - January 31, 2016)
Frontline, The New York Times and the Canadian Broadcasting Corporation have co-produced a 55-minute video report that examines problems in the marketing and regulation of vitamins, herbals, and other supplement products. The report spotlights (a) contaminated products that have caused severe harm, (b) irresponsible promotion, (c) regulatory weaknesses, and (d) industry denialists. [Supplements and Safety. Frontline, Jan 19, 2016]
FTC attacks "natural" claims (#16-14 - April 17, 2016)
Four companies that market skin care products, shampoos, and sunscreens online have agreed to settle FTC charges that they falsely claimed that their products were "all natural" or "100% natural," despite the fact that they contain synthetic ingredients. [Four companies agree to stop falsely promoting their personal-care products as "all natural" or "100% natural"; fifth is charged in Commission complaint. FTC news release, April 12, 2016] Under the proposed settlements, each of the four companies is barred from making similar misrepresentations in the future and must have competent and reliable evidence to substantiate any ingredient-related, environmental, or health claims it makes. The Commission has issued a complaint against a fifth company for making similar claims. Jessica Rich, Director of the FTC's Bureau of Consumer Protection, said that "all natural" and "100% natural" mean that the product must not contain artificial ingredients. In response to a citizen petition, the FDA is reviewing the use of "natural" claims in labeling.
Tanning bed use declining but still of concern (#17-10 - March 5, 2017)
USA Today has published an excellent review of the status of tanning bed use in the United States today. [Painter K. Home tanning beds: convenient but dangerous, health experts say. USA Today, Feb 26, 2017] The article notes that more than 10,000 of the 18,000 tanning salons operating in 2010 have closed, but unknown numbers of people continue to use tanning beds in private homes. Behavioral psychologist Sherry Pagoto, PhD, is taking part in a campaign to encourage colleges to reduce easy access to tanning beds on or near college campuses. In 2014, she authored a study which found that 48% of U.S. News and World Report's 125 top colleges had indoor tanning facilities either on campus or in off-campus housing surrounding the schools and that 14% allowed campus cash cards to be used to pay for tanning. In a 2015 interview, she said that these circumstances create a perception among students that colleges endorse tanning despite its association with a greatly elevated cancer risk. An estimated 450,000+ cases of nonmelanoma skin cancer and 10,000+ cases of melanoma each year have been attributed to indoor tanning in the United States, Europe, and Australia. [Weiner MR and others. International prevalence of indoor tanning A systematic review and meta-analysis. JAMA Dermatology 150:390-400, 2014].
Kidney failure after high-dose vitamin D reported (#19-15 - April 4, 2019)
A 54-year-old man developed kidney failure after: (a) being advised by a naturopath to take 8 drops daily of a brand of vitamin D that contained 500 international units (IU) per drop and, (b) unknowingly obtaining another vitamin D preparation containing 1,000 IU per drop. The resultant total 8,000 to 12,000 IU daily for 2.5-years, during which he was not counseled about toxicity risks. A year after his kidney failure was diagnosed and treatment was initiated for his elevated blood levels of vitamin D and calcium, he was left with stage 3B chronic kidney disease. [Auguste BL and others. Use of vitamin D drops leading to kidney failure in a 54-year-old man. CMAJ 191:E390-E394, 2019]
A 2014 review of hundreds of studies concluded that highly convincing evidence of a clear role of vitamin D does not exist for any health outcome. [Theodoratou E. and others. Vitamin D and multiple health outcomes: umbrella review of systematic reviews and meta-analyses of observational studies and randomised trials. BMJ 348:g2035, 2014]
Last year, the U.S. Preventive Services Task Force recommended against daily supplementation of 400 IU or less of vitamin D and 1000 milligrams or less of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. It also concluded that current evidence is insufficient to assess the balance of the benefit and harms of:
- daily supplementation with doses greater than 400 IU of vitamin D and greater than 1000 mg of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women
- vitamin D and calcium supplementation, alone or combined, for the primary prevention of fractures in men and premenopausal women.