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 ConsumerLab.com,
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 ConsumerLab.com 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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