The Safety of Nutritional Supplements

An article in the New England Journal of Medicine warns about the dangers of nutritional supplements.  There is an increasing market of supplements, and unfortunately, the system for ensuring the safety of those supplements is inadequate.

These supplements are marketed to people looking to loose weight, to be more energetic, or to be less depressed, however, there have been instances where these supplements have been deadly or caused severe damage including liver failure.  Many of us buy into the notion that a pill can fix our issues.

We also overuse many of our normal vitamins and supplements often without the scientific evidence to support such claims.  In some cases, overuse can do more harm than good.

In a related case, there are parents who look to improve the health of their children through 'juicing'.  An article in Medical Daily shows there is a trend for children to take 'detox juice blends".  What works in adults may not be as good for children.


New England Journal of Medicine
http://www.nejm.org/doi/full/10.1056/NEJMp1315559
Perspective
Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements
Pieter A. Cohen, M.D.

N Engl J Med 2014; 370:1277-1280April 3, 2014DOI: 10.1056/NEJMp1315559

Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.1 Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. This dietary supplement was recalled, but 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.
The FDA's delayed response — with its life-threatening consequences — is attributable to our woefully inadequate system for monitoring supplement safety. 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.

And the agency has its work cut out for it: potentially dangerous supplements are widely available. 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 sildenafil analogues.2 In 2013 alone, researchers discovered two new stimulants in widely marketed supplements. My colleagues and I identified a new analogue of methamphetamine, N,α-diethyl-phenylethylamine (N,α-DEPEA), in a popular sports supplement.3 FDA scientists discovered another stimulant, β-methylphenethylamine (β-MePEA) — a novel analogue of amphetamine — in nine supplements.4 N,α-DEPEA and β-MePEA have never been studied in humans, and their adverse effects are entirely unknown; yet they are sold as “natural” products without having undergone any premarketing testing for safety. (Although supplements containing N,α-DEPEA were voluntarily withdrawn from the market, supplements containing β-MePEA remain widely available.)

Rapid detection of harm from these and other supplements is essential to minimizing risks to consumers. The FDA currently relies on MedWatch (https://www.safetyreporting.hhs.gov), the FDA's online portal for clinicians to voluntarily report adverse events associated with prescription drugs, medical devices, or dietary supplements. MedWatch suffers from significant underreporting and incomplete reports, which hamper its ability to detect harms even from prescription medications. It is even less effective in detecting adverse effects of supplements, a more complicated task because supplements are sold directly to consumers, often contain multiple active ingredients, and are too often inaccurately labeled.

MedWatch reports have rarely provided sufficient and adequately timely data to permit detection of clusters of serious adverse effects from supplements. Instead, local public health departments, the CDC, or the Department of Defense have often been the first to detect harm from supplements. The recent cluster of patients with liver failure in Hawaii is a case in point: MedWatch reports were submitted only after the local department of public health was already investigating supplement use among affected patients. Similarly, in 2008, when a poorly manufactured multivitamin was responsible for more than 200 cases of selenium poisoning — with symptoms including diarrhea, fatigue, hair loss, and joint pain — local health departments cracked the case linking the illness to the multivitamin; MedWatch reports were irrelevant. More recently, in 2011, the Department of Defense removed supplements containing the stimulant 1,3-dimethylamylamine (DMAA) from military bases because of safety concerns. It took the FDA an additional 16 months after the military ban to gather sufficient safety data from MedWatch to alert consumers about DMAA's risks. Despite a concerted effort by the FDA to remove the stimulant, DMAA remains in dozens of supplements. During the 2014 Winter Olympics, three Olympians were banned for using DMAA — all three reported inadvertently consuming it in supplements.

MedWatch also lacks the capacity to provide clinical advice to providers caring for affected patients. Clinicians are often unfamiliar with supplement ingredients and may turn to poison centers, which offer free medical advice after any type of poison exposure. An investigation by the Government Accountability Office revealed that between 2008 and 2010, more than 1000 supplement-related adverse events were reported to poison centers but not reported to the FDA. Because data are not routinely shared between the centers and the agency, the FDA did not have access to any of these reports.

What can be done? A bill currently being reviewed by committee, the Dietary Supplement Labeling Act, sponsored by Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT), would require supplement manufacturers to register their products with the FDA and to provide more safety information, such as information about known adverse effects, to consumers (see tableExamples of Potential Adverse Reactions to Legal Ingredients and Adulterants in Dietary Supplements.). The bill is a step toward ensuring that vitamins, minerals, botanicals, probiotics, and other supplement ingredients are accurately labeled, but it would not improve the FDA's ability to detect and remove dangerous supplements from store shelves.

Sweeping changes would be needed to create an effective surveillance system capable of rapidly detecting supplement-related adverse events in the United States. I believe that accurate information on every supplement sold in this country should be incorporated into databases maintained by both the FDA and poison centers. Appropriate public health responses would be expedited if all key organizations, including the poison centers, the Defense Department, local departments of public health, and manufacturers, shared reports of serious supplement-related adverse events with the FDA in real time. A supplement response team could be created, made up of expert clinicians, toxicologists, pharmacologists, and chemists. The team could be based at the CDC, the FDA, the poison centers, or an academic institution. When consumers or physicians report a serious adverse event, the supplement response team could be alerted immediately. The multidisciplinary team could then offer clinical advice to physicians as they cared for patients, provide detailed reports to the FDA, and analyze patients' unused supplements for labeled and unlabeled ingredients. Supplement manufacturers could be required to provide complete manufacturing details and additional samples as requested. These changes would ensure not only that the FDA received accurate and timely reports, but also that clinicians received expert clinical advice as they cared for affected patients.

A pilot project incorporating several of these principles has already shown that active surveillance of poison-center reports can result in rapid identification of potentially harmful products.5 This successful pilot was terminated, however, because of a lack of funding. With more than half of U.S. adults taking supplements every year, at a cost of billions of dollars, consumers deserve a well-funded surveillance program capable of rapidly detecting hazardous supplements.

But even these ambitious changes would not prevent dangerous supplements from reaching consumers. If consumers and physicians are to have confidence that all supplements are safe, the law regulating supplements must be reformed. Every supplement ingredient should undergo rigorous safety testing before marketing. Until that happens, consumers and physicians cannot be assured that the pills, powders, and potions labeled as dietary supplements are safe for human consumption


Medical Dailyhttp://www.medicaldaily.com/kids-are-now-doing-juice-cleanses-doctors-concerned-about-dangers-childrens-detox-trend-274302

Kids Are Now Doing Juice Cleanses: Doctors Concerned About The Dangers Of Children’s ‘Detox’ Trend
By Lecia Bushak | Apr 3, 2014 01:22 PM EDT


Though there’s an obesity epidemic in the U.S. and serious concern about childhood obesity, there are also a fraction of kids out there who are beginning to pick up on their parents’ “green” habits and become hooked on juice cleanses. And doctors say this may not be the best trend.

Juice cleanses are often five-day affairs (or two-week ones) that involve consuming nothing but liquid juices supposedly packed with nutrients, antioxidants, and fiber. The idea is to “clean” out your system and jump-start a weight loss program, though people on juice cleanses are advised not to do any intense workouts during that time — not eating real food can leave you pretty weak and exhausted.

Sofia Davella is an example of a child who’s become addicted to stealing her mother’s juices from the fridge. At 6 years old, Sofia enjoys drinking her mom’s concoctions, labelled “Fountain of Youth” and “Glo.” Her mother, Sandra Davella, is a 44-year-old banker who gets upset because the kale products are expensive — up to $80 a day. “I have to buy extra because I know she’s going to take it,” Davella told the New York Post. “She’s not a French fry kid.”

Most of the companies that create these weight loss potions aim their products at adults; besides, children do need proper nutrition during their integral developmental years. But many of these companies seem to think it’s OK for kids to start juice cleansing at a young age. “For adults and kids alike who are trying to lose weight, these raw and organic drinks are a great kick-starter,” Stephanie Walczak, founder of the health food company called Rawpothecary, told the New York Post. On its website, Rawpothecary describes its juices as a blend of greens and fruits. “Leaving our fruit, veggies, and seeds in their purest, unprocessed state allows your body to absorb all the benefits that Mother Nature intended us to have with each ingredient we use… most importantly the FIBER,” the website says, adding that fiber can help lower cholesterol and monitor blood sugar level. Another company called Dherbs.com actually targets their juices for kids, touting a product called “Children’s Cleanse.”

Indeed, these fancy juice cleanses may have their short-term benefits: making you feel lighter, and seemingly healthier, for a few days at least. But to what extent is it necessary for a child to be on any sort of regiment like this? Walczak says that these products can be meal replacements or supplements for children: “It’s complete nutrition.”


Huffington Post
http://www.huffingtonpost.com/2012/05/13/do-vitamins-and-supplements-actually-work_n_1510985.html?ncid=dynaldusaolp00000255
Do Vitamins And Supplements Actually Work?
Posted: 05/14/2012 12:17 am EDT

Vitamins and dietary supplements are big -- more than 110 million Americans forked over a collective $28 billion in 2010 on little bottles of would-be health magic. Research is unclear, however, on whether shoring up your diet with extra vitamins, minerals, and other supplements helps or hurts -- in the short run or in reaching for the century mark.

For more than a decade, for example, researchers followed more than 35,000 men enrolled in SELECT, a clinical trial designed to see whether taking selenium and vitamin E might help prevent prostate cancer. In 2008, study participants received phone calls and letters: Stop the pills. Not only was the answer "no," but vitamin E apparently increased the chance of prostate cancer, if very slightly, and selenium seemed to do the same to diabetes risk. Later the same year, researchers from the Physicians' Health Study-II reported that neither vitamin E nor vitamin C reduced the chances of major cardiovascular problems or cancer as hoped.


That so many people seem to believe they need to boost their intake of vitamins and supplements is a triumph of marketing. Most Americans are well-nourished (besides being amply fed). Because much of our food is fortified with nutrients, once-common deficiency diseases such as scurvy and rickets, caused by inadequate vitamin C and D, respectively, have nearly disappeared in this and other developed countries. Researchers generally believe that with a few exceptions, like pregnant women or the elderly, most people don't need supplements. Over the 22-year course of the Iowa Women's Health Study, supplemental vitamin B6, folic acid, iron, magnesium, and zinc were associated with a slightly higher risk of premature death, copper to an 18 percent increased risk. Findings were published last year in the Archives of Internal Medicine. The study authors highlighted concerns about the long-term use of supplements and vitamins among those who do not have severe nutritional deficiencies. The pills, they concluded, are best used when recommended by doctors -- not for general prevention.

A 2009 editorial in the Journal of the National Cancer Institute, meanwhile, warned that most vitamin studies show no cancer benefits, and that some found unexpected harm. Two studies of supplemental beta carotene, for example, found higher lung cancer rates, and folic acid research suggested a higher risk of colon polyps among those taking supplements than among those in a placebo group.

Still, some researchers maintain that the diets of many Americans fall somewhat short on certain key nutrients -- not enough to threaten a return of those debilitating deficiency diseases, but perhaps enough to call for a little extra help. What follows is the current thinking -- pro and con -- on popular key supplements that have been well-studied.

Multivitamins. The U.S. Preventive Services Task Force neither recommends nor advises against multivitamins (or other supplements) for preventing cancer or cardiovascular disease. Yet many researchers say a multivitamin has a role as "a very inexpensive insurance policy," says David Schardt, senior nutritionist at the Center for Science in the Public Interest, a nutrition advocacy group in Washington, D.C. There's no need for anything fancy that claims "heart health" or "prostate health" benefits, he says; an inexpensive, basic brand is fine. In 2008, Harvard Men's Health Watch newsletter editor Harvey Simon recommended against multivitamins. His chief worry was that on top of already fortified foods, the folate in a multi could spur cancer. But a study since then showed that cancer was not increased in women at risk for heart problems who were given folic acid supplements. Simon is now less concerned about breast cancer risk, but prostate cancer still worries him.


Calcium and vitamin D. Thumbs up. Extra calcium to protect bone health is safe and routinely prescribed for adults who get too little from food. In one study, men who consumed the most calcium (about 2,000 mg. a day) were 25 percent less likely to die over the next decade than their peers who got the least, according to findings published in 2010 in the American Journal of Epidemiology. The Iowa Women's Health Study also found that calcium supplements were associated with reduced risk of death over nearly two decades.

And consensus is building that Americans need more vitamin D to promote calcium uptake. It is produced by sun-exposed skin and is difficult to get from unfortified foods -- fatty fish is the only major food source. Studies suggest vitamin D also may help fend off cancer and ward off infections. Still, no large-scale randomized controlled clinical trials prove vitamin D supplements offer benefits beyond bone health. Researchers are hungry for more evidence.

In 2010, the Institute of Medicine released new recommendations for daily calcium and vitamin D intake. Between 600 and 4,000 international units of vitamin D are advised, depending on age and gender, and between 700 and 2,500 milligrams of calcium.

Fish oil. New findings are at odds with past evidence for the worth of the omega-3 fatty acids in fish oil, especially for heart-related conditions. An April analysis published in the Archives of Internal Medicine found that fish oil may not do much to ward off heart attacks and strokes in people who already have heart disease. Those taking fatty acid pills had about the same rates of heart disease, death from heart attacks, congestive heart failure, and stroke as those on placebo pills. But the findings don't necessarily mean that fish oil supplements are useless in heart patients. The study participants were all taking statins, powerful cholesterol-lowering medications, which could have trumped any benefits from fish oil.

The American Heart Association continues to recommend fish oil supplements for those at high risk of a heart attack. Simon, no fan of nutrients in pill form, says that, for those with heart risks who don't eat fatty fish like tuna and salmon twice a week, taking 1,000 mg or so is a good idea.

Antioxidants. The glowing promise of antioxidants remains elusive. These substances, among them selenium and vitamins A, C, and E, are believed to help sop up molecules called free radicals. These react with other molecules in the body and promote oxidative damage -- another name for cellular wear and tear. "There's a lot of data supporting the idea that oxidation, over time, has a role in chronic illnesses," says J. Michael Gaziano, a chronic disease epidemiologist with Brigham and Women's Hospital and coauthor of the Physicians' Health Study-II papers.

Many observational studies suggest that people who gobble antioxidant-laden fruits and veggies or supplements have a reduced risk of some forms of heart disease and cancer. Most clinical trials, however, do not support this. Some research, in fact, has shown that supplemental vitamin E may actually increase the risk of lung cancer among smokers, as has been found with beta carotene, as noted above. Vitamin E may do the same. And cancer patients shouldn't add more vitamin C than the amount in a multi; research suggests that too much of the vitamin helps cancer cells withstand treatment.

Researchers are still studying whether supplemental antioxidants might slow the progression of age-related macular degeneration and perhaps prevent noise-related hearing loss. But "no doctor would recommend them for the prevention of cancer, of cardiovascular disease, or of dementia," says Simon.

What about you? Nutritional profiles are not all the same. Recommended intake varies by age, gender, and even race. And genetic differences mean everyone utilizes or responds to vitamins differently, says K. Simon Yeung, a research pharmacist in the Integrative Medicine Service at Memorial Sloan-Kettering Cancer Center. Diet preferences, such as a low-fat or vegetarian regimen, will alter the mix of nutrients taken in. Moreover, lab tests that analyze the nutrients in your system and indicate which ones might need boosting or trimming are, with a few exceptions, not readily available and not often performed. "You can get your cholesterol checked, but not your niacin levels," says Thomson. However, keeping tabs on your dining habits for a few days with SuperTracker, a U.S. Department of Agriculture tool, will give you a sense of whether you're on the right course. (It helps you plan, analyze, and track your diet and physical activity.)

Alice Lichtenstein, a professor of nutrition science and policy at Tufts University's Friedman School of Nutrition, worries that supplements give Americans license to continue their unhealthful ways so long as they pop a pill after the steak and hot fudge sundae. A balanced diet is still the best source of nutrients. Adding supplements -- or fruits and veggies, for that matter -- to a high-calorie diet is not going to work magic. Good health begins with physical activity and a balanced diet that is heavy on fruits, veggies, whole grains, "good" fats, and fish and light on red meat, "bad" fats, and processed food -- and not too high in calories. "Nature," says Lichtenfeld, "is probably better than our manufacturers."