Many supplements contain unapproved, dangerous ingredients: study

U.S. health officials have issued more than 700 warnings during the last decade about the sale of dietary supplements that contain unapproved and potentially dangerous drug ingredients, new research reveals.

16 oct 2018--In nearly all cases (98 percent), the presence of such ingredients was not noted anywhere on supplement labeling, the U.S. Food and Drug Administration found.
From 2007 to 2016, the lion's share of FDA warnings—46 percent—concerned supplements that touted enhanced sexual pleasure, while weight-loss products were cited in 41 percent of the warnings. Most of the remaining warnings (12 percent) concerned supplements marketed as muscle-builders, the findings showed.
The tainted-supplement problem appears to have grown in scope in recent years, with 57 percent of all warnings having been issued since 2012, the researchers said.
"Over the past decade, ever since I first began tracking the problem, I have only seen the number of supplements adulterated with drugs increase rapidly," said Dr. Pieter Cohen. He is a general internist with the Cambridge Health Alliance, and an associate professor at Harvard Medical School in Boston.
"Back in 2009, it appeared that there might be less than 150 brands of supplements that contain drugs," he added. "Now it's clear that there are well over 1,000 brands of supplements that contain active drugs."
Cohen is the author an editorial that accompanies the new analysis, which was published online Oct. 12 in JAMA Network Open. The study was led by Madhur Kumar, of the California Department of Public Health's Food and Drug Branch.
Kumar's team noted that more than half of all American adults routinely take some form of dietary supplement, with estimated annual sales of $35 billion.
The FDA explicitly warns that supplements aren't a replacement for either over-the-counter or prescription medications, and should not be viewed as a way to treat or prevent disease.
The agency classifies dietary supplements—including vitamins, minerals, botanicals, amino acids and enzymes—under the category of food, rather than drugs.
That distinction is important.
"Supplements are handled completely different than either prescription medications or over-the-counter drugs," Cohen explained. "Those two categories are carefully vetted by the FDA. Supplements are not vetted by the FDA, and do not require that any evidence of safety or efficacy is presented to the agency before they are sold to consumers."
The FDA's Dietary Supplement Health and Education Act of 1994 essentially places the burden for evaluating supplement safety, content and labeling primarily on the shoulders of the manufacturers, he said.
Experts point out that this arrangement means that, while the FDA has the authority to remove from the market any supplement reported as causing harm, as a practical matter it does so only after the fact. This raises the risk for a wide range of "serious adverse events" involving tainted supplements—including stroke, kidney failure, liver injuries, blood clots and even death—critics of the arrangement contend.
The study team said prior estimates suggest that such events result in roughly 23,000 emergency department visits and 2,000 hospitalizations in the United States every year.
The new analysis reviewed a decade's worth of information contained in an FDA database titled "Tainted Products Marketed as Dietary Supplements."
Almost 800 tainted warnings were issued during the review period for supplements manufactured by 147 different companies, though some involved multiple warnings about the same supplement, the study authors said.
About 20 percent of the warnings identified products containing more than one unapproved ingredient, the investigators found. Sildenafil (commonly known as Viagra) was the ingredient in nearly half of the warnings concerning sexual enhancement supplements.
Sibutramine—an appetite suppressant taken off the market in 2010 due to cardiovascular risks—was cited in nearly 85 percent of weight-loss supplements, according to the report.
And among muscle-building supplements, synthetic steroids or steroid-like ingredients were the cause for concern nearly 90 percent of the time, the researchers said.
Cohen said any meaningful solution will require a change in the laws that govern the way the FDA monitors supplements. Barring that, you should "ask your doctor if you need to take supplements," he advised.
"If your doctor doesn't advise supplements for your health, then they will likely not help you," Cohen stressed. "However, for my patients who still want to use supplements, I advise them to purchase supplements that list only one ingredient on the label and to avoid any supplement that has a health claim on the label, such as improving immunity or strengthening muscles."

More information: Pieter A. Cohen, M.D., general internist, Cambridge Health Alliance, and associate professor, Harvard Medical School, Boston; Oct. 12, 2018, JAMA Network Open, online

There's more on supplement regulations at the U.S. Food and Drug Administration.

Dietary supplement use among older persons

Many older people are ingesting too much magnesium and vitamin E in the form of dietary supplements. This was discovered by scientists of the Helmholtz Zentrum München in a population-based study; their results have been published in 'The Journal of Nutrition, Health and Aging'.

06 dec 2014--The scientists working with Sigrid Schwab, Priv.-Doz. Dr. Barbara Thorand and Professor Dr. Annette Peters from the Institute of Epidemiology II (EPI II) at the Helmholtz Zentrum München (HMGU) investigated the prevalence of dietary supplement use in the general population and determined daily intake amounts of ingested vitamins and minerals in supplement users.

The data are derived from the KORA-Age Study, which examines the association between lifestyle factors and health status in people aged 65 years or older in the area of Augsburg, Germany. Roughly 54 percent of the women and 34 percent of the men over 64 years of age take dietary supplements or medications containing vitamins, minerals or other substances such as omega-3 fatty acids or coenzyme Q10. In addition to the sex, the frequency of ingestion is associated with the level of education, physical activity, smoking habits and presence of a neurological disease. In women, the most frequently supplemented substances are magnesium and vitamin D, while in men they are magnesium and vitamin E. In both sexes, it was observed that the ingested doses of magnesium and vitamin E frequently exceed the Tolerable Upper Intake Levels established by the European Food Safety Authority. The administered supplement quantities were too high in 20 percent of the female and 33 percent of the male participants regularly taking magnesium and in 8 and 14 percent, respectively, of the participants regularly taking vitamin E. In contrast, vitamin D, whose supplementation is frequently medically recommended in this age group because of its positive effect on bone metabolism, was taken by relatively few older people, the scientists reported.

"Current and population-based data on the intake of supplements in older people are largely missing for Europe. Nevertheless, this population group is of special interest due to the age-related nutrient deficits", says Prof. Peters, Director of EPI II. "Industry and advertising appear to have a large influence on the selection of the preparations. Results such as these are therefore important in order to make it possible to give meaningful recommendations on dietary supplements for older people."

The aim of the KORA-Age Study is to identify factors associated with healthy and contented aging and to support the active participation of older people in social life.

More information: Schwab, S. et al. (2013), The Use of Dietary Supplements among Older Persons in Southern Germany – Results from the KORA-Age Study, The Journal of Nutrition, Health and Aging,DOI: 10.1007/s12603-013-0418-8

Provided by Helmholtz Association of German Research Centres

Many docs don't discuss dietary supplements, study says

Patients need to know more about risks, effectiveness and interactions with conventional drugs.

Patients need to know more about risks, effectiveness and interactions with conventional drugs.

24 july 2013—Doctors do a poor job of providing patients with information about vitamins, minerals, herbs and other dietary supplements, a new study says.

It's an important issue because so many people take these products, which carry risks—including potentially harmful interactions with prescription drugs—and some patients take dietary supplements in place of conventional medicines, the researchers said.

They analyzed transcripts of audio recordings made during office visits by nearly 1,500 patients to 102 primary-care doctors between 1998 and 2010. Of those patients, about 350 had discussions about more than 700 dietary supplements, according to the study, which was published recently in the journal Patient Education and Counseling.

"This is the first study to look at the actual content of conversations about dietary supplements in a primary-care setting," study primary investigator Dr. Derjung Tarn, an assistant professor of family medicine at the David Geffen School of Medicine at the University of California, Los Angeles, said in a university news release.

"The bottom line was that discussions about meaningful topics such as risks, effectiveness and costs that might inform patient decisions about taking dietary supplements were sparse," Tarn said.

The researchers focused on five major topics related to dietary supplements: the reason for taking them, how to take them, potential risks, effectiveness and cost or affordability.

On average, fewer than two of the topics were discussed during the office visits. All five topics were covered during discussions of only six of the more than 700 supplements. None of the topics arose for nearly 300 of the supplements patients told their doctors they were taking.

The researchers did find that discussions about herbal and related supplements were more thorough than those about vitamins and minerals. This is important because herbal and related supplements are more likely to have potentially harmful interactions with conventional medicines.

Both the U.S. Food and Drug Administration and the U.S. National Institutes of Health suggest that patients consult with their doctors before starting to take dietary supplements, the researchers noted.

More information: The U.S. Food and Drug Administration has more about dietary supplements.

Expert advises against high doses of supplements

05 may 2012-- That vitamin D and calcium you're taking could be causing more harm than good, a new article in the Journal of the National Cancer Institute says.

The paper, co-authored by a professor at the University of Arizona's Mel and Enid Zuckerman College of Public Health, cites evidence that high doses of some supplements increase cancer risk.
"You may not need to take supplements if you have a healthy diet," said article co-author Elizabeth Jacobs, a UA associate professor of epidemiology and a researcher at the Arizona Cancer Center. She cited an old phrase: "The dose makes the poison."
"If you are deficient in nutrients, taking a supplement is probably not going to cause any harm, but if you are already adequate in nutrients, then taking a supplement at a minimum has no benefit and in some cases has been shown to cause harm," Jacobs said.
Jacobs said the authors are not trying to say people who take supplements will get cancer. But she cautions about taking megadoses like 10,000 I.U.s of vitamin D per day, for example.
"A lot of literature has shown that often the people who take dietary supplements need them the least, so they already eat a good diet, they have a lot of nutrients in their diet, they exercise, they don't necessarily need extra nutrients," Jacobs said. "And those are the people who tend to take supplements - they are very health conscious, and that's where the danger is because you are already getting enough of these vitamins or minerals in your diet, and then you are adding more."
The article, titled "Dietary Supplements and Cancer Prevention: Balancing Potential Benefits Against Proven Harms," appeared in the April 25 issue of the Journal of the National Cancer Institute. Its lead author is María Elena Martinez of the University of California-San Diego, who is a former UA College of Public Health epidemiology professor.
"Undoubtedly, use is driven by a common belief that supplements can improve health and protect against disease, and that at worst, they are harmless," the scientists write. "However, the assumption that any dietary supplement is safe under all circumstances and in all quantities is no longer empirically reasonable."
In an email, Martinez stressed that the article is not a study but rather an invited commentary that she hopes will "continue to increase awareness among the scientific community, policymakers and relevant government agencies about the scientific evidence on the topic, especially as it relates to harm related to these products."
Nutritional supplements are an estimated $30 billion-per-year industry.
"If you have too much of anything, that is not a good thing," said Cara Welch, vice president of scientific and regulatory affairs for the Washington, D.C.-based Natural Products Association, a nonprofit group representing natural-products retailers and suppliers. "The article was looking at very high doses in particular populations. It is against the law to market your supplement to treat or prevent cancer - at that point it turns into a drug. There's no way around it. You can't imply you prevent cancer."
Both Martinez and Jacobs say there are certainly people who need supplements, such as women of childbearing age who are considering getting pregnant, people who have been diagnosed with a specific nutrient deficiency like anemia and people with food allergies or intolerances, like lactose intolerance.
Folic acid is recommended for women considering pregnancy, but it is an example of a supplement that could be harmful for people who don't need it, Jacobs said.
"When you are older, folic acid is shaking out to be one of the more worrisome supplements," Jacobs said. "It's not natural. It's completely synthetic folic acid, and so your body is getting this new compound and we're just not as efficient at metabolizing folic acid as folate. So that is some cause for concern."
Jacobs said her personal hope is that the article will inspire better regulation and oversight of the supplement industry.
For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to the government's "satisfaction" that the claim is accurate or truthful before it appears on the product, Food and Drug Administration literature says.
Welch said her organization has a research and education arm that works with companies to ensure "truth in advertising."
And the industry is not regulated in the same way as pharmaceuticals for a reason, she said.
"We're not regulated as drugs because we're not drugs," she said.
Welch said a majority of Americans take supplements like multivitamins and Omega-3 to maintain health. "Unfortunately, the standard U.S. diet doesn't give us all the nutrients we need," she said.
None of the article's five scientist authors takes any supplements, not even the much-heralded vitamin D, Jacobs said.
"Eat a variety of food, exercise, don't smoke - that is superior to taking a supplement," Jacobs said. "You aren't supposed to get the recommended dietary allowance (of nutrients) every day. It rarely happens. You are supposed to just average over time. You just do the best you can. But in the U.S. our problem isn't really under-nutrition, it's over-nutrition."
"You aren't supposed to get the recommended dietary allowance (of nutrients) every day. It rarely happens. You are supposed to just average over time. You just do the best you can. But in the U.S., our problem isn't really under-nutrition, it's over-nutrition."
Read more: http://azstarnet.com/news/science/health-med-fit/ua-expert-advises-against-high-doses-of-supplements/article_c3c3c91d-9939-5387-adea-15bea5184f58.html#ixzz1tsvDO4ej
Provided by University of Arizona

Beta-alanine helps seniors stave off fatigue

By Anne Harding
NEW YORK, 15 nov 2008 – Older people taking a sports nutrition supplement favored by Olympic athletes show substantial increases in their ability to withstand fatigue, new research shows.

"We were surprised that it had this kind of impact," Dr. Jeffrey R. Stout of the University of Oklahoma in Norman, who led the study, told Reuters Health. "We weren't sure that this would impact their physical capacity like it did."

Stout and his colleagues found that men and women given a low dose of beta-alanine for 90 days were able to exercise nearly 30 percent more intensely before becoming fatigued.

Beta-alanine increases the amount of carnosine in the muscles, which is key to helping sustain a neutral pH in muscle tissue. When people exercise to fatigue, the muscles become more and more acidic (lactic acid buildup is a byproduct of this process, but not entirely responsible for it), and carnosine is believed to help buffer against this acidity, allowing people to do more without "feeling the burn."

Older people tend to have less carnosine in their muscles, Stout explained, largely because they don't eat as much meat as younger people.

Taking carnosine supplements is useless, Stout said, because the body breaks the protein down immediately. But taking beta alanine, an amino acid that is a component of carnosine, triggers the production of carnosine in muscle tissue, he added.

Stout and his team had previously demonstrated that beta alanine helped young people increase their exercise capacity by 12 percent to 15 percent. In the current study, they recruited 26 men and women, average age about 73, to take 800 mg of beta alanine three times a day or a placebo.

The maker of the supplement, Natural Alternatives International in San Marcos, California, supplied the supplements and placebo but didn't help pay for the study, according to Stout.

Study participants had their exercise capacity tested on a special exercise bike called an ergometer, and the researchers used electrodes to measure electrical activity in their thigh muscle, which signals acid build-up.

The individuals on placebo showed no increase in their ability to withstand fatigue, but those on beta alanine were able to exercise 28.6 percent more intensely, Stout and his colleagues found. The improvement in exercise capacity was similar to that seen in a previous study in which older people underwent 12 weeks of endurance training.

Study participants didn't experience any ill effects while taking the supplement, and the dose was lower than the 6.4 grams daily that Stout and his team gave younger adults, the researcher noted.

Stout says he recommends the supplement to everyone he knows who's over 60. "I know I have my own parents on it," he said.

"It can't hurt and it can only help, but elderly folks must be patient," the researcher added. "It takes a while for the carnosine to increase in the muscle. They probably won't see any benefit for about 4 weeks."

Nevertheless, he added, the patients in his study who were taking the supplement did notice a difference in their ability to go about their daily activities, before they or the researchers were aware that they were in the placebo or supplement group.

"Some of the subjects said I don't care what it is, I want more of it."

SOURCE: Journal of the International Society of Sports Nutrition, November 7, 2008.

Dietary Calcium Superior to Supplements for Protecting Bones

ST LOUIS, June 20 -- Women who got most of their calcium from food had higher bone-mineral densities than patients who relied on supplements, researchers here reported.
Surprisingly, the finding of better bone density at the spine and hip for the milk and cheese eaters held even though women taking supplements had a higher calcium intake, said Reina Armamento-Villareal, M.D., of Washington University, and colleagues, in the May issue of the American Journal of Clinical Nutrition.
In addition, women getting most of their calcium from food had more estrogen metabolites, a shift in the estrogen hydroxylation pathway, which may produce a positive bone-mineral homeostasis and greater bone density, the researcher said.
The results came from a study of 183 postmenopausal white women who were divided into three groups. Thirty-three women who took supplements got at least 70% of their daily calcium from tablets or pills.
Seventy women got at least 70% of their daily calcium from dairy products and other foods.
A diet-plus-supplement group consisted of 65 women whose calcium-source percentages fell somewhere between these ranges.
In addition, the researchers tested urinary concentrations of estrogen metabolites.
The women relying on dietary calcium (primarily dairy sources) took in the least calcium (mean 830 mg/d) yet had higher spine and hip bone-density scores than those relying on supplements who consumed 1,033 mg/d.
Women in the diet-plus-supplement group with the highest calcium intake at 1,620 mg/d tended to have the highest bone mineral density, the researchers reported.
Compared with women taking supplements, adjusted bone mineral density z scores were significantly greater in the women who obtained calcium primarily from food or from both diet and supplements (at the spine, P=0.012, femoral neck, P=0.02, total femur P=0.003, and intertrochanter, P=0.005).
This difference was evident especially in those who obtained calcium primarily from their diet, yet whose total calcium intake was lower than that of the supplement-takers, the researchers said.
Women who obtained calcium primarily from food or from both food and supplements also had significantly (P=0.03) lower ratios of nonestrogenic to estrogenic metabolites (2-hydroxyestrone 1/16 α-hydroxyestrone) than did the women taking supplements, the researchers reported.
This finding, they said, corroborates their earlier report suggesting that calcium may be an important modulator of estrogen hydroxylation favoring the production of active estrogen metabolites.
In contrast, it is possible that nutrients other than calcium, present in calcium-rich foods, cause this shift in estrogen metabolism.
Alternatively, they said, dietary sources of calcium may also contain active estrogenic compounds that can influence bone density and the amount of estrogenic metabolites in the urine.
Another possible explanation, they pointed out is better bioavailability of dietary calcium compared with supplemental calcium.
Calcium salts are available in many over-the-counter supplements, they said, but their solubility and bioavailability are highly variable and may be affected by the presence of other compounds in the supplements or by when the pills are taken.
For example, some supplements must be taken at a meal so that stomach acids can facilitate absorption.
Finally, the researchers said that it is likely that the better bone mineral density in women getting their calcium from food may have resulted from a lifelong healthier diet.
Thus the investigators in this study found that women who consumed a significant amount of calcium from dietary sources, on average, consumed more servings of fruit and fruit juices per week than did the women who consumed calcium primarily from supplements. Also, significantly fewer women who consumed calcium from dietary sources were past smokers.
The study's limitations included its cross-sectional design, which may not have reflected lifelong calcium intakes. In addition, only one seven-day dietary record was used to assess the women's dietary habits.
These results suggest that the type of calcium may be an important determinant in estrogen metabolism and the consumption of dietary calcium should be encouraged in patients at risk of bone loss, the researchers concluded.
No financial disclosures were reported. This study was supported by grants from NIH and the General Clinical Research Center at Washington University. Primary source: American Journal of Clinical NutritionSource reference: Napoli N et al "Effects of dietary calcium compared with calcium supplements on estrogen metabolism and bone mineral density" Am J Clin Nutr 2007; 85:1428 -1433.