1. Supplements are not risk-free
More than 6,300 reports of serious adverse events associated with dietary supplements, including vitamins and herbs, streamed into the FDA from supplement companies, consumers, health-care providers, and others between 2007 and mid-April of 2012. The reports by themselves don’t prove the supplements caused the problems, but the raw numbers are cause for some concern. Symptoms included signs of heart, kidney, or liver problems, aches, allergic reactions, fatigue, nausea, pains, and vomiting. The reports described more than 10,300 serious outcomes (some included more than one), including 115 deaths and more than 2,100 hospitalizations, 1,000 serious injuries or illnesses, 900 emergency-room visits, and some 4,000 other important medical events.
The FDA gets far more reports about serious problems with prescription medication than about supplements. But there’s a big difference between the two, notes Pieter Cohen, M.D., an internist at Cambridge Health Alliance in Massachusetts with a special interest in supplements. “These powerful medications with powerful side effects are actually saving lives when used appropriately,” he says of prescription drugs. “But when healthy consumers use supplements, there’s rarely, if ever, a powerful lifesaving effect.”
The FDA suspects most supplement problems never come to its attention, says Daniel Fabricant, Ph.D., director of the agency’s Division of Dietary Supplement Programs. But those that do are still useful because they can raise red flags about a developing problem. For instance, last year the agency noted seven reports of serious health problems regarding consumers who took Soladek vitamin solution, marketed by Indo Pharma of the Dominican Republic.
When the FDA learned that tested samples contained vitamins A and D at concentrations many times the recommended daily allowances, it issued a consumer warning. Why not simply order a problem product off the market? Current laws make that so difficult for the FDA that to date it has banned only one ingredient, ephedrine alkaloids. That effort dragged on for a decade, during which ephedra weight-loss products were implicated in thousands of adverse events, including deaths.
Type the name of the supplement you’re interested in into the search box at www.fda.gov to see whether it has been subject to warnings, alerts, or voluntary recalls. If you suspect you’re having a bad reaction to a supplement, tell your doctor. You can also report your problem to the FDA at 800-332-1088 or www.fda.gov/medwatch.
I have a hard time believing that supplements cause some much problems, but given the fact that the vast majority of supplements are manufactured using food grade manufacturing processes rather than much higher standard of pharmaceutical grade manufacturing process, some of the issues with off the shelf supplements have to stem from toxins or impurities from the manufacturing.
2. Some supplements are really prescription drugs
Fabricant has said that dietary supplements spiked with prescription drugs are “the largest threat” to consumer safety. Since 2008 there have been recalls of more than 400 such products, mostly those marketed for bodybuilding, sexual enhancement, and weight loss, according to the FDA. We’ve seen many recalled products that have contained the same or similar active ingredients as prescription drugs, such as sildenafil (Viagra), tadalafil (Cialis), and sibutramine (Meridia, a weight-loss drug that was withdrawn from the market in 2010 because of evidence that it increased the risk of heart attacks and strokes). Others contained synthetic steroids.
Those adulterated products can cause some of the same side effects and interactions that consumers may have been trying to avoid by choosing supplements over drugs. The FDA has received reports of strokes, acute liver injury, kidney failure, pulmonary embolism (blood clots in the lung), and death associated with drug-tainted supplements. “A number of the spiked sexual enhancement products claim to work within 20 to 45 minutes,” Fabricant said on the FDA’s website. “When we see a product that makes claims above and beyond what a dietary supplement might do—above supporting health—and within a time frame of a few minutes, it tips us off that we might have a spiked product.” Slim down with diet and exercise.
Build muscles by weight training. And consult a doctor if you need help in the bedroom, since it could indicate an underlying health problem. If you suspect you’ve purchased a product that is tainted with undeclared prescription drugs or steroids, send an e-mail about it to the FDA, at taintedproducts@fda.hhs.gov.
More than half of American adults take vitamins, minerals, herbs, or other nutritional supplements. Some of those products aren’t especially helpful, readers told us in a recent survey, but that aside, don’t assume they’re safe because they’re “all natural.” They may be neither. Here are 10 hazards that we’ve distilled from interviews with experts, published research, and our own analysis of reports of serious adverse events submitted to the Food and Drug Administration, which we obtained through a Freedom of Information Act request. Read and be warned.
There it is again, the low, non regulated food grade manufacturing process. Ask the Olympic Committee why they don't recommend their athletes taking OTC supplements. Ask the Olympic Committee which Pharmaceutical grade supplements sponsors many of their athletes. Plus there are certainly many professional athletes coming up "hot" on banned substances who claim to be taking OTC supplements.
3. You can overdose on vitamins and minerals
Unless your health-care provider tells you that you need more than 100 percent of the recommended daily intake of a particular nutrient, you probably don’t. “It doesn’t make sense to me to take huge doses of vitamins and minerals unless there’s a diagnosed problem, because there is so little evidence that they do good and sometimes a possibility that they might do harm,” says Marion Nestle, M.P.H., Ph.D., a professor of nutrition, food studies, and public health at New York University.
I know who I won't be asking nutritional advice from. The proof's in the pudding Marion, that 1- you cannot get all your required nutrients from today's food supply and 2 - there is an undenible link of nutritional deficiencies to the long list of degenerative diseases affecting us. And these degenerative diseases are hitting us when we are younger and younger,....is that because we are producing weaker humans? It is much more likley to be linked to terrible foods that we commonly consume today.
4. You can’t depend on warning labels
For one thing, the FDA doesn’t require them on supplements. There is an exception: Supplements that contain iron must warn about accidental overdosing and fatal poisoning in children.
Not only does the FDA not require warning labels on supplements, they donlt require food grade supplements to be produced to any guaranteed quality.
5. None are proved to cure major diseases
If you’re surfing the Internet for dietary supplements and find a site that claims its products can diagnose, cure, mitigate, treat, or prevent a disease, surf right off to another site. Such claims are off-limits to supplements, according to the FDA. “We’d like to see those things go away,” Fabricant says. “Those are a direct threat to public health.” Since 2007, the agency has sent dozens of warning letters to companies telling them to stop making those types of claims about their supplement products.
Earlier this year, for instance, the FDA sent a warning letter to BioAnue Laboratories of Rochelle, Ga., when these statements and others were spotted on websites: “Formula CX will reverse wasting disease,” and “Bovine cartilage stops tumor growth.” (The FDA said it’s still reviewing the company’s response. The president of BioAnue Laboratories told us it “complies with all U.S. laws.”)
We're not going to see any FDA sponsored or approved message concerning supplements and degenerative disease. If they did it would put a whole in the wallets of the drug companies.
6. Buy with caution from botánicas
???? I'm only buying pharmaceutical grade products. I'm not buying from Botanicas, the local Vitamin Shop, nor from the Voodoo lady on the corner.
7. Heart and cancer protection are not proved
Omega-3 pills and antioxidants are widely thought to reduce the risk of heart disease and cancer, respectively, and millions of women take calcium to protect their bones. But recent evidence casts doubt on whether those supplements are as safe or effective as assumed. Calcium.
The latest blow against calcium supplements was a report by German and Swiss researchers who followed almost 24,000 adults for an average of 11 years. They found that regular users of calcium supplements had an 86 percent increased heart-attack risk compared with those who didn’t use supplements, as reported in the June 2012 issue of the journal Heart. On the other hand, there was a statistically significant 30 percent reduction of heart-attack risk among adults with a moderately high intake of calcium from food itself.
Omega-3 fish oil. The widely held view that fish-oil pills help prevent cardiovascular disease hit a snag when a study of 12,500 people with diabetes or prediabetes and a high risk of heart attack or stroke found no difference in the death rate from cardiovascular disease or other outcomes between those given a 1-gram fish-oil pill every day and those given a placebo, according to a June 11, 2012, New England Journal of Medicine online report. But the results may be clouded by the fact that participants were already taking other heart medication. Most people can get enough omega-3s by eating fatty fish at least twice a week.
The American Heart Association says that people who have coronary artery disease may want to talk to their doctor about omega-3 supplementation. Antioxidants. Far from reducing cancer risk, as a lot of people believe, high doses of some antioxidant supplements may actually increase it, evidence suggests. The discouraging news appeared in the May 16, 2012, issue of the Journal of the National Cancer Institute.
Based on current evidence, vitamins C and E haven’t been found to shield people from cancer; vitamin E, beta-carotene, and vitamin C don’t seem to protect against getting or dying from cancer; selenium doesn’t prevent prostate cancer; and there’s no convincing evidence that beta-carotene or vitamin A, C, or E supplements prevent gastrointestinal cancers. Still worse, the researchers wrote, “Some clinical trials show that some of these antioxidant nutrients may increase cancer risk.”
What skews these reports is the facts that people are consuming real crappy supplements. There is no doubt in my mind there would be a vastly different outcome reported if the testing and consuming was with quality supplements.
8. Pills can irritate the esophagus
Really? Then take them with water.
9. Some ‘natural’ products are anything but
Vitamin pills can be synthetically, and legally, produced in a lab. Synthetic ingredients are even allowed in multivitamins that bear the Department of Agriculture’s “Organic” seal. But the FDA has said that synthetic copies of botanicals don’t qualify as dietary-supplement ingredients at all. “Vitamins can be synthetic because, by definition, a vitamin doesn’t have to come from nature,” says Fabricant at the FDA. They just have to perform the biological activity of vitamins, he added, whereas a “botanical” means that it was alive at some point. In other words, botanicals and their extracts must come from actual living plants, not a test tube.
Some nutrients are best in a synthetic form. And there are some, like Melatonin for instance, which the body produces, but the form we take as a sleeping aid is synthetic. This reminds me of a gent I was talking to about his sleeping problems. He said he never gets more than 3 hours at night. He also drank three Monster Energy drinks through the day. He could not see the link between his energy drink consumption and his lack of ability to sleep, so he was seeking a sleeping aid. I told him about a pharmaceutical grade Melatonin that worked for several of my clients. He asked me if it was "natural" because we would not take anything "synthetic" (although he could pump massive amounts of Monster!). I told him "No, this Melatonin was farmed from dead bodies,......just kidding, of course, it is synthetic." He ended up declining to try it. Last thing I heard is that he went to a tarot card reader to see what his sleeping problem was all about.
10. You may not need supplements at all
If you are already getting the recommended amount of nutrients by eating a variety of fruit, vegetables, cereals, dairy, and protein, there’s little if any additional benefit from ingesting nutritional supplements.
Ok, I'll take Consumer Reports word that they may not need supplements, but at 53 years old with no more knee and back pain, 140 cholesterol level, BP at 118/82, fasting blood sugar at 80 or less, I'll stick to taking quality supplements.
Read the original, and long, Consumer Reports article here.
Here is an intelligently thought-out and written RESPONSE by Citizens For Health Vice President James Gormley to Consumer Reports:
ReplyDeleteAn Open Letter to Consumer Reports: 10 Misinformation Hazards in Your “10 Surprising Dangers of Vitamins and Supplements” Article.
http://www.citizens.org/?p=3091
Yes, before going to use any supplement whether it is a sport or bodybuilding supplement we should consult to a doctor or to a sports trainer whom under you are working. I have taken previously some supplement without consulting to anyone then I got some negative result but now I am fit and always take doctor advice before using compound 20 usp labs supplement after consulting with my instructor.
ReplyDeleteRead the response letter from BioAnue to the FDA here
ReplyDeletehttp://bioanuelabs.com/pdf%20files/BioAnue%20Reply%20to%20FDA.pdf
It looks to me like the FDA is attacking a company because of what someone else wrote about their products. Can they do that?