Friday, April 26, 2013

10 things vitamin makers won’t say

1. “We overwhelm you with choices.”
There are more than 54,000 dietary supplements on the market, sold under 1,000 different brands, according to consumer groups. Indeed, the Food and Drug Administration defines a supplement broadly, as an ingestible product containing a “dietary ingredient,” which may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars and metabolites. And the industry is growing. Sales hit more than $30 billion in 2011, according to a report released last month by the Government Accountability Office, up from about $25 billion in 2009.

Faced with so many choices, how can consumers find a safe product? Heather Mangieri, a registered dietitian in Pittsburgh and a spokesperson for the Academy of Nutrition and Dietetics, a trade group representing food and nutrition professionals, gives her clients tips on navigating this fragmented market. Look for supplement makers that have scientific advisory boards listed on their websites, she says.
Another good sign is a gold “USP Verified” stamp on the label, showing the product has the approval of the U.S. Pharmacopeial Convention, an organization that tests supplement quality. (The absence of a USP mark doesn’t necessarily mean the product isn’t up to snuff, she notes, since some companies may choose not to pay for the verification process.)
When in doubt, call the manufacturer. It’s a red flag if you can’t reach a human being who can answer questions, experts say, and an even bigger one if there’s no contact information on the packaging. 

2. “Medications can’t be sold without FDA approval, but our products can.”
The FDA regulates supplements, but differently than prescription and over-the-counter drugs. Manufacturers of the latter must prove safety and efficacy before new products reach the market. By contrast, manufacturers generally do not need FDA approval before producing or selling dietary supplements, as long as the ingredients they’re using were marketed in a dietary supplement in the U.S. before the Dietary Supplement Health and Education Act of 1994 was passed. Manufacturers using “new dietary ingredients” not marketed before that law passed must notify (but not necessarily get approval from) the FDA before selling the product, and must submit materials showing the ingredient is “reasonably expected to be safe” — according to the manufacturer’s own assessment.
The FDA oversees supplements after they hit the market, and the government requires manufacturers to report all serious adverse events like a heart attack or stroke associated with the use of their supplements. Consumers can search the FDA website for warning letters it has sent to supplement makers in violation of its regulations, but there’s no searchable database for adverse event reports.

Critics say FDA regulation falls short: “Consumers are playing roulette with their health because we don’t have adequate regulation of dietary supplements,” says Chuck Bell, programs director at Consumers Union, the consumer group that publishes Consumer Reports magazine. “The state of FDA regulation is illustrative of how safe the industry is,” counters Steve Mister, president and CEO of the Council for Responsible Nutrition, a dietary supplement trade group. “We do see the FDA flex its muscle where there is a problem.” FDA spokeswoman Tamara Ward says that the FDA regulates these products according to the 1994 law, which dictates that manufacturers are responsible for marketing a safe product. While the FDA does not review most supplements for safety or effectiveness prior to marketing, she says, “if a safety issue arises, the FDA can investigate and take the necessary steps to have the product removed from the market.” Indeed, earlier this month, the FDA issued warnings about DMAA, a substance commonly used in weight-loss and muscle-building supplements, saying the agency has received 86 reports of illness and death associated with supplements containing DMAA; the FDA says it is using all tools at the agency’s disposal to ensure that supplements containing DMAA are removed from the marketplace. 

3. “Good luck judging a supplement by its label.”
Federal law requires supplement ingredients to be listed on the supplements’ packaging in descending order of predominance by weight. Yet for competitive reasons, the FDA doesn’t require manufacturers to list the exact amounts of ingredients in a “proprietary blend” in the “Supplement Facts” box on the label. The words “blend” and “formula” can also be used by manufacturers to fudge the exact amounts of expensive ingredients like chondroitin, a component of cartilage that’s used in joint supplements, says Dr. Tod Cooperman, president of, an independent supplement testing firm. His recommendation: When reading labels, focus on the ingredient you want, and make sure it’s listed alone as a discrete ingredient in the list of ingredients, not followed by the word “blend” or “formula.”

The most common quality breach that finds when testing supplements is products that list more of an ingredient than they actually contain. For example, a supplement’s facts box might say that a pill contains 100 milligrams of a given nutrient when it really has 20, Cooperman says. The second most common breach is the reverse: supplements that list less than they actually contain of a given ingredient. This type of mislabeling happens even in mainstream products, he says. Mister, of the Council for Responsible Nutrition, says this type of mislabeling isn’t prevalent.
While labels are supposed to accurately reflect the amount of a given nutrient in a supplement, the FDA doesn’t commonly pursue these types of infractions, says Bell, of Consumers Union; it’s more common to see the FDA go after claims that a supplement helps cure or prevent diseases, he notes. 

4. “The health benefits are debatable.”
On packaging, the FDA allows supplement manufacturers to make so-called structure-function claims, which describe how a nutrient is intended to affect the structure or function of the human body. One example: “Curbs appetite to help with weight loss.” Manufacturers cannot, however, claim that their product cures, treats or prevents disease, as with a statement like “Aids weight loss to treat obesity.” However, in a 2012 analysis of 127 supplements by the Office of Inspector General of the Department of Health and Human Services, 20% of dietary supplements did make such claims. The FDA responded to the report by saying the agency would consider whether to seek explicit authority to review substantiation for structure-function claims beyond what the law currently allows.

While the FDA’s guidelines require that manufacturers have “competent and reliable scientific evidence” to show their claims are truthful, Dr. Margery Gass, a gynecologist and executive director of the North American Menopause Society, says most supplement claims don’t have the same science behind them that drugs do. For instance, she says, reputable studies are large scale and double-blind, meaning that neither the subjects nor the researchers know who is getting the supplement and who is getting a placebo. These types of studies are rare in the supplement industry, according to the Inspector General report. Furthermore, many supplements don’t even have human studies to support their evidence, says Bell.
Mister says this criticism misses the point: Supplements cannot be tested exactly like drugs. New drugs are “something no one has ever had in their body before,” whereas researchers can’t test the immune-boosting effects of vitamin C on a control group of individuals who have no vitamin C in their systems. “You cannot do the kinds of randomized clinical trails for vitamins that you can do for drugs,” Mister says. Even so, he notes, “Our industry doesn’t think for a minute that we can do without scientific rigor.” 

5. “No pill is a substitute for a healthy diet.”
A sensible approach to supplements looks something like this, says Mangieri, the registered dietitian: You start with a healthy, balanced diet, then work with a doctor or dietitian to fill in any missing nutrients, if necessary, with supplements. “I’m always pushing, ‘food first,’” she says. Most people can and should get their daily dietary requirements from food alone, she says, although it can take some effort. One exception is her weight-loss clients on a diet of 1,600 calories or less — it can be tough for them to get all the nutrients they need through food, so she often recommends they take a multivitamin.

Indeed, vitamins and minerals alone can’t replicate the effects of a balanced diet, says Dr. Gary Deng, attending physician at the Integrative Medicine Service at Memorial Sloan-Kettering Cancer Center. The best diets have “a little of this and a little of that,” and the combination of all the nutrients is more effective than those in isolation, he says, noting that studies have tried and failed to replicate the same positive impact with supplements alone. 

6. “You may need a magnifying glass to read our disclaimers and warnings.”
On supplement packaging, each structure-function claim must be accompanied by a disclaimer saying that the claim hasn’t been evaluated by the FDA (and again that the product is not intended to diagnose, treat, cure or prevent any disease). Good luck finding these, though: Disclaimers are often in tiny font on the bottom of the bottle or package. Mister says that rather than a deliberate obfuscation, this usually represents manufacturers’ attempt to create an attractive, uncluttered label.

You have to look even harder to find certain other warnings. The law requires that supplements be safe for “normal conditions of use,” and many manufacturers interpret that to mean they should warn consumers if their product isn’t for everyone, Mister says. For example, many glucosamine supplements are made with the shells of shrimp, crab and lobster, so people with shellfish allergies are advised to avoid them. Yet some manufacturers aren’t so clear with their warnings, if they offer them at all, Bell says. He once found a warning on the opposite side of an iron supplement label — the side that faces the bottle — saying that the product shouldn’t be taken within two hours of oral tetracycline antibiotics, since it interferes with their absorption. “There’s a limited amount of real estate on the label,” Mister says, noting that such peel-back labels are perfectly legal. 

7. “There’s no magic weight-loss pill.”
Clients at Mangieri’s dietitian practice fill out a form at their first visit that asks them what supplements they’ve taken. The list of weight loss products that she’s seen on those forms is long, she says. “People are desperate,” she says. “It’s a shame that so much money goes into products that don’t work.” Of course, not all weight-loss supplements are the same and some may be more or less helpful than others. And while weight-loss supplement makers often recommend that their product be taken as part of a larger program of diet and exercise, some in the industry doubt the necessity of taking pills. “What will cause the weight loss is the diet and exercise,” not the supplement, Mangieri says.

Mister says certain weight loss supplements, alongside diet and exercise, can make a difference. Some bulk fiber products can contribute to a feeling of satiety, he says, and cause people to eat less, while other supplements might boost a person’s metabolism a bit. 

8. “ ‘Natural’ isn’t the same as ‘safe.’ ”
Arsenic, poisonous mushrooms, tobacco: Plenty of products found in nature can be dangerous. Some of the most prominent supplements to come under scrutiny in the past decade contained ephedra, an Asian herb that raises blood pressure and stresses the heart. The supplements were marketed for weight-loss and athletic performance, but after several reports of deaths and other bad health outcomes among ephedra users, the FDA found they presented an unreasonable risk of illness and injury and banned them in 2004.

Even vitamins and minerals may be harmful in excess, recent studies have suggested. Often, people think that if they take more than the recommended dose, they’ll reap even more benefits, says Dr. Gass of the North American Menopause Society. That’s not the case. A study last year out of the University of Copenhagen, for instance, found that there might be such a thing as too much vitamin D. Researchers studied blood samples from nearly 250,000 Danes and found higher mortality rates in those with low levels of vitamin D — and those with high levels of vitamin D. While the research isn’t conclusive, it does argue against overdoing it. A simple blood test can reveal a person’s vitamin D levels and show whether supplements might be needed, experts say. Research has also suggested that excess calcium can lead to an increased risk of heart disease and death. 

9. “Enhanced effectiveness may be due to pharmaceuticals.”

It’s illegal to try to pass off prescription drugs as dietary supplements, but that hasn’t stopped some manufacturers from trying. Some examples: Supplements to enhance male sexual performance have been found to contain sildenafil citrate, an active component of Viagra, while weight loss supplements have been found to be tainted with the prescription drug sibutramine, an ingredient found in an FDA-approved drug that was removed from the market in 2010 because it caused heart problems and stroke. In most cases, this contamination is deliberate, experts say, and the FDA has been active in trying to prevent this practice.
Mainstream manufacturers don’t spike their products with prescription drugs, Mister says. To avoid potential problems, he says, “don’t buy from an Internet company you’ve never heard of, that only has a P.O. box.”

10. “Your doctor needs to know what you’re taking.”

While patients often tell their doctors what prescription drugs they’re taking, they often neglect to mention the supplements. This is a mistake, experts say. Many herbal supplements interact with prescription drugs people are taking. For example, St. John’s wort, a supplement that has been shown to be effective in cases of mild depression, should not be taken alongside prescription antidepressants, says Dr. Reid Blackwelder, president-elect of the American Academy of Family Physicians and a practicing doctor in Kingsport, Tenn. Blackwelder sometimes recommends the herb to patients in lieu of drugs, along with exercise and other nonmedical therapies. Other herbal products can lessen the effectiveness of chemotherapy or radiation in cancer patients, says Barrie Cassileth, chief of the integrative medicine service at Memorial Sloan-Kettering Cancer Center in New York City: “They can create serious problems for people already very sick.”

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