January,
2007
Shaping
Up the Dietary Supplement Industry
By Sharon Palmer, RD
Today’s Dietitian
Vol. 9 No. 1 P. 34
With public safety at stake, some organizations
are developing initiatives to better protect consumers from
false claims and potentially dangerous products.
The dietary supplement industry seems to be
a magnet for controversy. It’s not uncommon to find your
e-mail inbox flooded with spam on supplements claiming to enlarge
choice body parts or spy best-selling diet books peddling an
array of dietary supplements aimed at weight loss, antiaging,
and beauty. What’s a soul to do but cave in and pop a
few pills? And this is just what people are doing. The Office
of Dietary Supplements reports that in 2004, consumers spent
$20.3 billion on dietary supplements.
Daniel Fabricant, PhD, vice president of scientific
affairs at the Natural Products Association, says in defense
of dietary supplements, “A smart buyer doesn’t confuse
the e-mail spammers making egregious claims with the legitimate
dietary supplement industry [any] more than they would confuse
the spammers claiming to give away cars with the legitimate
automotive industry.”
Sure, smart consumers could simply install a
better spam protector to fend off spurious supplement e-mails
or ignore ads promoting dubious products, but there will be
a certain number of people suckered into wasting their cash
on products with little scientific evidence to support them.
And of greater concern is the potential for people to be harmed
due to fraudulent supplements. When it comes to life-threatening
diseases such as cancer, even one consumer who falls prey to
a supplement suggesting that it cures cancer in lieu of traditional
treatments such as chemotherapy and radiation is too many.
In a study published in Family Medicine in 2002,
researchers from the Scripps Center for Integrative Medicine
in La Jolla, Calif., conducted Internet searches using the linked
terms herb and cancer, resulting in matches for each of the
six primary search engines of between 11,730 and 58,605. Further
cross matching with the three master search engines revealed
that prevention, treatment, and cure were discussed at rates
of 92%, 89%, and 58%, respectively. Researchers concluded that
although the Dietary Supplement Health and Education Act of
1994 (DSHEA) was enacted to decrease unlawful claims of disease
prevention, treatment, and cure, such claims on commercial Internet
sites are prevalent.1
“The Internet has had a mixed effect on
the supplement industry. It has allowed a lot of bad and misleading
products to be promoted very effectively through spam e-mails
or professional-looking Web sites. People tend to believe what
they see and are trying products that don’t have much
evidence behind them,” says Tod Cooperman, MD, president
of ConsumerLab.com, a Web site that provides independent testing
and reviews of dietary supplements.
The Upside of the Supplement
Biz
In the midst of today’s concern over questionable dietary
supplements comes a wave of health professionals speaking out
on behalf of supplements, reminding us that not all are created
equally. Complementary nutrition is growing, with a number of
studies being funded and published that address efficacy of
various herbs and supplements.
Take omega-3 fatty acid supplements. Research
has supported the heart-healthy benefits of omega-3 fatty acids
in supplemental form, suggesting that it may not be possible
to get adequate amounts of the omega-3 fatty acids docosahexaenoic
acid (DHA) and eicosapentaenoic acid (EPA) necessary to effect
health change in those with coronary heart disease through diet
alone. In addition, some supplement manufacturers remove heavy
metals and other contaminants from fish oil, which increases
purity, potency, and safety of the product compared with dietary
sources of DHA and EPA.2 Even heart health guru Dean Ornish,
MD, recommends omega-3 fatty acid supplements in his Lifestyle
Program.
And let’s not forget that good, old-fashioned
multivitamin and mineral preparations fall under the dietary
supplement category. What dietitian hasn’t recommended
a standard multivitamin and mineral supplement for a patient
with less than desirable nutrient intake? “We don’t
have a problem with vitamins and minerals in general, but they
are lumped in with the herbal and other questionable products
used in the United States,” says Ilene Ringel Heller,
senior staff attorney at the Center for Science in the Public
Interest (CSPI).
The National Center for Complementary and Alternative
Medicine (NCCAM) is busy funding studies on a number of supplements
such as echinacea and glucosamine/chondroitin. The NCCAM’s
position is that there is scientific evidence for the effectiveness
of some complementary and alternative medicine treatments, but
for most, there are key questions yet to be answered through
well-designed scientific studies, such as whether they are safe
and work for the diseases or conditions for which they are used.
Consumer Perceptions
Surrounding Supplements
Consumer attitudes are all over the place when it comes to dietary
supplements, but one thing is for sure: people are using them.
Fabricant reports that more than 70% of American consumers use
dietary supplements and that these consumers are typically well-educated,
both in general and about the products they’re buying.
Douglas S. Kalman, PhD candidate, MS, RD, FACN,
director of nutrition and applied clinical research at Miami
Research Associates and chair of the Nutrition in Complementary
Care Dietetic Practice Group (NCC-DPG), says, “Customers
believe in the industry. A recent study found that 34% of consumers
looking to lose weight first turn to a dietary supplement as
their adjunct in the battle against obesity.”
But consumers are also confused. According to
a recent national survey, American adults believe weight-loss
supplements are safer and more effective than they really are.
More than 60% of 1,444 telephone respondents in the survey,
all of whom had made significant efforts to lose weight, said
weight-loss supplements have been tested and proven safe and
effective. More than one half stated that these supplements
are approved by the FDA.3
“Things are really out of control,”
says Heller, who reports that some customers don’t notice
the FDA disclaimer required on dietary supplements (stating
that the FDA has not reviewed the statements made) and interpret
it as an FDA approval for the product. Other consumers band
together in groups such as Save Our Supplements to rail against
further regulation of the dietary supplement industry.
“Over the last five years, it seems that
consumers have become more interested in information about dietary
supplements as opposed to taking promotional material at face
value. It seems that more people are realizing that this industry
is not well-regulated by the government, although many still
think supplements are as well-regulated as prescription medications
and over-the-counter medicines,” says Cooperman.
The Regulatory
Backdrop for Dietary Supplements
So how did an environment evolve that allowed dubious supplements
such as breast enhancers to flourish? Flash back to the enactment
of DSHEA in 1994. Dietary supplements were defined as products
intended to supplement the diet; containing one or more dietary
ingredients (including vitamins, minerals, herbs or other botanicals,
amino acids, and other substances) or their constituents; intended
to be taken by mouth as a pill, capsule, tablet, or liquid;
and labeled on the front panel as being a dietary supplement.4
Dietary supplements are regulated by the FDA
but differently than other foods and drugs. A dietary supplement
cannot claim on its label that it will diagnose, cure, mitigate,
treat, or prevent a disease. The label of a dietary supplement
may contain one of three types of claims: a health claim, nutrient
content claim, or structure/function claim. Health claims describe
a relationship between a food, food component, or dietary supplement
ingredient and reducing risk of a disease or health-related
condition. Nutrient content claims talk about the relative amount
of a nutrient or dietary substance in a product. And structure/function
claims are statements about how a product may affect the organs
or systems of the body without mentioning a specific disease.
The latter claims do not require FDA approval, but the manufacturer
must provide the FDA with the text of the claim within 30 days
of putting the product on the market. Product labels containing
such claims must also include a disclaimer that reads, “This
statement has not been evaluated by the FDA. This product is
not intended to diagnose, treat, cure, or prevent any disease.”
The label of a dietary supplement product is required to be
truthful and not misleading. If the label does not meet this
requirement, the FDA may remove the product from the marketplace
or take other action.4
Supplement ingredients sold in the United States
before October 15, 1994, are not required to be reviewed by
the FDA for their safety before they are marketed because they
are presumed to be safe based on their history of use. For a
new dietary ingredient (not sold as a dietary supplement before
1994), the manufacturer must notify the FDA of its intent to
market a dietary supplement containing the new dietary ingredient
and provide reasonable evidence for safe human use of the product.4
Dietary supplement makers do not have to provide
the FDA with evidence that dietary supplements are effective
or safe. Once a dietary supplement is marketed, the FDA has
to prove that the product is not safe to restrict its use or
remove it from the market. The quality control of dietary supplements
depends on the manufacturer, supplier, and production process.4
A Whole Batch of Problems
“There are lots of problems with dietary supplements.
There are no regulations that dictate appropriate serving recommendations.
There is no organized collection of adverse events so that safety
problems can be spotted early,” says Cooperman. “The
area that we focus most on is product quality. We are seeing
one fourth of the products that we select for testing to have
a quality problem. We find products with none or little of their
claimed ingredients, products contaminated with lead or pesticides,
[and] tablets that won’t break apart to release their
ingredients. Many products don’t even specify a dose that
is known to work.” Cooperman gives an example of zinc
lozenges for colds. Three fourths of the products that ConsumerLab.com
tested did not have or suggest the amount of zinc that has been
shown to be effective.
So what happens to all the products that don’t
contain what they are supposed to contain? Cooperman reports,
“It is very rare that a manufacturer recalls a supplement,
even after a report comes out on a product. The retailer is
not required to recall the supplement. Only when people are
really being hurt does [the] FDA take serious action against
a manufacturer.”
Heller agrees: “[The] FDA does not have
recall authority over supplements. If there are fly-by-night
supplements being made, they are not going to get off the market
or off of shelves.” Heller also believes the structure/function
claims allowed on dietary supplements are close to disease claims
and that many dietary ingredients in supplements on the market
are grandfathered in, so there’s a presumption of safety
rather than the actual determination of safety.
Protecting Consumers
A movement is growing aimed at better protecting consumers.
One leader of the pack is Sen Richard J. Durbin (D-Ill.), who
introduced legislation to require dietary supplement manufacturers
to ensure their products are safe before they are sold.
“Sen Durbin has orchestrated the adverse
effects reporting legislature,” says Heller, who reports
that this legislature would obligate of dietary supplement manufacturers
to report adverse effects. “This goes back to the ephedra
case in which there were about 16,000 adverse effects, but the
manufacturers had no obligation to turn them over to [the] FDA.
One percent of all adverse events are reported to [the] FDA
under the current voluntary system,” adds Heller. Dietary
supplements containing ephedra have been banned in the United
States since April 2004.
Edward Blonz, PhD, FACN, FNAASO, a newspaper
nutrition columnist and author, has also taken up the cause.
Blonz reports, “I now have three cases with the Federal
Trade Commission [FTC], and I work for a group of 11 DAs [district
attorneys] in California. All these efforts involve issues of
questionable advertising claims being made for dietary supplements.”
Blonz also teaches a class at the University of California,
Berkeley titled “Dietary Supplements: What Every Health
Professional Needs to Know” and is seeking funding for
a stand-alone nonprofit organization that will aim to analyze
dietary supplement advertising claims to provide information
about products and their associated claims to consumers.
CSPI has worked extensively on making dietary
supplements safe and honestly labeled. Quackwatch, Inc. is a
nonprofit corporation whose purpose is to combat health-related
frauds, myths, fads, fallacies, and misconduct that often involve
dietary supplements. Founded by Stephen Barrett, MD, in 1996,
Quackwatch, Inc. works to investigate questionable claims, advise
quackery victims, report illegal marketing, and attack misleading
advertising on the Internet. ConsumerLab.com includes review
articles on various supplements to help educate consumers and
healthcare professionals. Many NCC-DPG members work on forwarding
progress in manufacturing practices, clinical research, and
open communication with the FTC, the FDA, and other agencies.
Numerous credible Web sites (see sidebar) offer scientific information
on herbs and supplements.
Tired of suffering a tarnished reputation at
the hands of shady supplement makers, those in the dietary supplement
industry are also banding together to clean up the industry.
“The supplement industry has had bad press in recent years.
Some of the industry supports adverse event reporting as a way
of repairing that image,” says Heller. The Natural Products
Association, along with several other dietary supplement organizations
and consumer groups, is supporting legislation in both the House
and Senate that would require the reporting of serious adverse
experiences for dietary supplements and over-the-counter drugs.
(The Senate recently passed this legislation.) Kalman, who performs
clinical trails for the food and supplement industry, also finds
more and more companies working on independent research for
supplements.
The American Herbal Products Association, the
Consumer Healthcare Products Association, the Council for Responsible
Nutrition, and the Natural Products Association recently announced
a voluntary industrywide protocol, Standardized Information
of Dietary Ingredients, to facilitate the exchange of information
between ingredient suppliers and finished product manufacturers
to help identify and qualify supplement ingredients from trustworthy
sources.
Good Manufacturing Practices
One action eagerly awaited is Good Manufacturing Practices (GMP)
for supplements. The FDA is authorized to create GMP regulations
describing conditions under which dietary supplements must be
prepared, packed, and stored. The FDA published a proposed rule
in March 2003, but until this proposed rule is finalized, dietary
supplements must comply with food GMPs that are primarily concerned
with safety and sanitation rather than quality.
“It’s been 12 years since they have
been promised, and there are still no established GMPs for supplements.
There is a lot of talk about them coming out this year, but
they say that every year. If GMPs are approved, manufacturers
will be required to make the products the same way from lot
to lot. This would be a step in the right direction,”
says Cooperman. “To be even more meaningful, GMPs would
include standards around what is supposed to be in the product.
For example, what levels of specific plant chemicals should
be in a product claiming to be gingko, garlic, or ginseng.”
Fabricant reports that rather than waiting for
the federal GMPs to be issued, his association developed its
own GMP certification program in 1999. The Natural Products
Association has certified nearly 60 companies and provided education
for representatives from more than 350 dietary supplement companies.
Their standard is used by other organizations as the basis of
their dietary supplement GMP program. “GMPs mean understanding,
analyzing, controlling, and documenting the manufacturing process.
It is a third party audit system,” says Fabricant.
Dietary Supplement Certification
Voluntary certification can offer supplement consumers some
quality assurance. ConsumerLab.com, which offers a voluntary
certification program, is finding more and more manufacturers
interested in certification. They allow manufacturers and distributors
to use specific “CL Seals” to identify products
that have met ConsumerLab.com standards based on its product
reviews.
NSF International, a public health and safety
company, also developed an independent product evaluation program
to address dietary supplements. Their voluntary testing and
certification program verifies the identity and quantity of
dietary ingredients listed on the product label; ensures the
product does not contain undeclared ingredients or unacceptable
levels of contaminants; and demonstrates conformance to currently
recommended industry GMPs for dietary supplements.
Enforcement Action
“There is a little bit of action, a joint program between
[the] FTC and FDA, to go after products on the Web,” says
Heller. “[The] FDA is increasing enforcement on dietary
supplements, but it’s not at the level it should be.”
The FTC and FDA work together against fighting
dietary supplement fraud. The FDA has primary responsibility
for claims on product labeling and the FTC has primary authority
over advertising claims. The FDA can identify fraudulent products
through market surveys, inspections, Internet searches, adverse
event reports, consumer complaints, informants, and referrals
from other government agencies. The highest priority for the
FDA are products that pose direct health hazards to consumers.
When a problem arises with a supplement, the FDA can act by
working with the product’s marketer to correct the problem
voluntarily. If that doesn’t work, the FDA may bring a
lawsuit to seize the product and enjoin the firm marketing it.
The FDA can also seek criminal penalties against parties breaking
the law.
Although it may seem like a drop in the bucket,
many examples do exist in which the FDA and FTC went after supplement
makers that broke the law. Recently, it made news when the FDA
and FTC sent warning letters to dozens of U.S.- and foreign-owned
Web sites selling or advertising dietary supplements that claimed
to cure, treat, or prevent diabetes. These were discovered through
an Internet sweep for fraudulent sites and products.
Finding a Safe Place
for Complementary Nutrition
While fraudulent dietary supplements may sully the industry’s
reputation, it’s important for dietitians to be objective
and equip themselves with knowledge to better guide their patients.
After all, many of your patients are probably taking supplements,
whether or not they tell you. Numerous reputable sources of
information on dietary supplements are available to guide your
patients to making safe choices.
“Our goal is to educate dietitians about
complementary nutrition. Some of our members have written articles
in USA Today. There is good, solid information out there,”
says Kalman. “Unfortunately, a lot of dietitians’
quest for information is limited to what they are exposed to.
They are unaware of academic, NIH [National Institutes of Health]-approved
nutrition education on complementary nutrition.”
In today’s world of healthcare, there
is room for both traditional and alternative therapies. For
cancer patients visiting the Duke Center for Integrative Medicine
in North Carolina, the health team may recommend specific vitamins,
Chinese herbs, and acupuncture in addition to chemotherapy.
The healthcare team takes into consideration the whole person,
including support systems, spiritual practices, and stress reduction
in an effort to help patients better tolerate chemotherapy.
Integrating complementary and alternative therapies
seems to be the wave of the future. Perhaps dietitians can help
their patients wade through the sea of supplements to find the
true treasures.
— Sharon Palmer, RD, is a contributing
editor at Today’s Dietitian and a freelance food and nutrition
writer in southern California.
References
1. Bonakdar RA. Herbal cancer cures on the Web: Noncompliance
with The Dietary Supplement Health and Education Act. Fam Med.
2002;34(7):522-527.
2. Kris-Etherton PM, Harris WS, Appel W, et
al. AHA Scientific Statement: Fish Consumption, Fish Oil, Omega-3
Fatty Acids, and Cardiovascular Disease. Circulation. 2002;106:2747.
3. Americans Fall Prey to Weight-Loss Supplement
‘Hype.’ HealthDay. October 27, 2006. Available at:
http://www.nlm.nih.gov/medlineplus/news/fullstory_40638.html
4. Dietary Supplement Health and Education Act
of 1994. FDA, Center for Food Safety and Applied Nutrition,
December 1, 1995. Available at: http://www.fda.gov/opacom/laws/dshea.html#sec3
Safe and Sound Dietary Supplement
Resource Guide
American Dietetic Association
American
Pharmacists Association
Center for
Science in the Public Interest
ConsumerLab.com
Federal Trade Commission
Medline
Plus, Dietary Supplements
National
Center for Complementary and Alternative Medicine
Nutrition
in Complementary Care, American Dietetic Association Dietetic
Practice Group
Office
of Dietary Supplements
Quackwatch
SupplementWatch.com
USDA,
Food and Nutrition Information Center, Dietary Supplements
U.S.
FDA/Center for Food Safety and Applied Nutrition, Dietary Supplements
