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Regulation of herbal supplements

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Regulation of herbal supplements

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REGULATION OF HERBAL SUPPLEMENTS

by

Wafa Iqbal Unus

A Project Presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
In Partial Fulfillment of the
Requirements for the Degree
MASTER OF ARTS
(SPECIALIZED JOURNALISM)

May 2009

Copyright 2009 Wafa Iqbal Unus

ii

Table of Contents

Abstract…………………………………………………………………………………iii

Introduction…………………………………………………………………………..……1

Choosing Herbal Supplements………………………………………………………..…..3

“Natural” Medicine………………………………………………………………….....…8

Safety………………………………………………………………………………….…10

Regulation…………………………………………………………………………….….16

Manufacturer Responsibility……………………………………………………………..21

Conclusion……………………………………………………………………………….23

iii

Abstract
Regulation of Herbal Supplements

Herbal supplement use is a growing trend in the United States. As more and more
people turn to supplements there is increased concern over the safety of herbal products.
However, regulation of herbal supplements is challenging to enforce because of the
diversity of supplements and the various forms in which they are taken. Many
supplements come from international sources making their ingredients and production
standards difficult to track. Used as a primary source of treatment for a large population,
herbal supplements are being dissected by the western medical world as it searches for
proofs of its efficacy as well as its interaction with pharmaceuticals.

1

Introduction
We are becoming a drugged-crazed, pill-popping nation.

Not the back alley, dirty dealing kind of drug-crazed, but the back pain, migraine,
obesity-stricken, fad-diet-obsessed nation that is ready to try just about anything in some
medicinal pursuit of happiness, including becoming our own physicians.

A growing number of people in the United States are acting as their own doctors and
pharmacists by diagnosing and treating themselves through unregulated, over the counter
herbal supplements.

Despite the apparent danger, millions of Americans are snatching herbal treatments off
the shelves at increasing rates.

The average amount Americans spend on herbal supplements reached over 22 billion
dollars in 2008, an 83% increase over the past decade.

Growing trends in supplement use have raised eyebrows in the medical community yet
many people continue to use them because they insist they are natural. Even if they don’t
do good, they at least don’t do harm.

However, some physicians say the harm can be severe indeed.

2

Dr. Daniel Wu is a Chicago physician who’s adamantly against the use of herbal
supplements without physician oversight. The death of one of his patients was a wake-up
call to the dangers that can come with irresponsible use of alternative medicine.

She was an elderly patient who frequented Dr. Wu’s Chicago Chinatown office, tucked
away between little shops in a small two-story strip mall littered with an eclectic
collection of mom and popshops that advertised everything from inexpensive Chinese
souvenirs to “cures” for colon cancer.

“I told her she had cervical cancer,” he said. “I told her she should have surgery.”

She said she’d think about it and left his office. Two weeks later Dr. Wu called her house
to discuss scheduling an appointment to treat the cancer. The patient’s daughter picked up
the phone and spoke with Dr. Wu. He informed her that her mother’s procedure had a
high success rate because her mothers’ cervical cancer was at such a primary stage.

The patient’s daughter informed him that her mother had gone to see an herbal medicine
practitioner and would not be returning to Dr. Wu’s office for the surgery.

“She died.” Dr. Daniel Wu said. “She died [from the cancer] eventually.”

It wasn’t the herbal medicine that killed his patient, Dr. Wu said. In fact, he said that the
herbs helped in some ways. But while the herbs calmed her symptoms and relieved some
3

of the pain, they probably gave her a false sense of hope. The fact that the body is not in
pain does not mean that the problem is gone. Even without noticeable symptoms, cancer
could be growing and spreading.

Like Dr. Wu’s patient, a growing number of people are finding herbal treatments more
appealing than pharmaceuticals without fully understanding what they do.

Choosing Herbal Supplements
Many people are turning to herbal supplements due to increased frustration with the
western health system. Left feeling thwarted by the “one-size-fits-all” aspect of western
medicine, patients are finding solace in herbal medicine.

Though standardization and regulation define western medicine and legally allow it to
claim cures, biomedicine is seriously lacking in the most attractive quality of herbal
treatments: personalization.

Pharmaceuticals are the staid old-standbys of the drug world, mundane, commonplace
clean-shaven, creased-slacks, nine-to-five working gentlemen. Herbal treatments are their
motorcycle-riding, sweet-talking, ‘this is just for you, baby,’ younger brothers that know
exactly what you want.

Bryan Able, the founder and primary herbology practitioner at Thumos Health Center in
Pacific Palisades, California, became a firm believer in the power of personalized herbal
4

medicine at a young age. As a child he was plagued with digestive problem. He suffered
from painful and sometimes debilitating stomach pains.

After visiting doctor after doctor and never feeling as though his illness was being
alleviated, the twelve-year-old Abel became increasingly frustrated, particularly when his
pain began to interfere with his studies of Kung Fu.

His Kung Fu instructor Keun Joo Kim noticed the effect the pain was having on Abel.
Kim decided it was time to introduce Abel to the health aspect of Kung Fu, herbal
healing. Along side the art of martial defense, Abel was slowly taught the benefits of
alternative medicine and herbal remedies. Abel said it was a complete lifestyle change to
which he quickly adapted. Suddenly he was no longer a kid learning how to defend
himself; he was his own herbal healer and a devoted student of herbal medicine.

Kim offered herbal medication that Abel describes as life altering. Finally his pain was
gone. An herb had solved what frequent visits to a western physician and numerous tests
had not.

Abel was drawn to herbal medicine because he was frustrated with his western medicine
doctors and their treatments. Others are motivated by financial concerns.

With rising insurance costs many people find themselves turning to herbal supplements.
According to the National Coalition on Health Cares, as of 2007, nearly 50 million
5

people in the United States are walking germ-infested streets, being slowly covered in
bacteria without a penny of insurance money for medication should they fall ill. Even
those who are insured find that pharmaceuticals can take a toll on their pocketbooks and
see herbal medicines as a more affordable way to stay healthy.

Celebrex, a popular drug used to treat arthritis can run more than four dollars a day. Its
herbal counterpart, ginger, a supplement commonly recommended by herbologists to
reduce inflammation, costs only about 38 cents a day. Over a year, that’s a $1,321 cost
difference. It seems like a sweet deal for those who can’t get insured because of their
medical backgrounds, simply can’t afford insurance or realize how much money they can
keep in their pockets by avoiding pharmaceuticals. He says he worries that the herbal
supplements won’t be inexpensive for long. Deforestation is threatening regions rich with
medicinal herbs. Abel traveled to the Amazon in 1997 in hopes of studying herbs before
deforestation possibly wiped them out completely.

He spent a few months with a medicine man in a small village, searching through forests
for rare herbs and studying their medicinal properties. He was amazed to find what he
calls a “pharmacopoeia” of botanicals, but deforestation was threatening many of them.

“They were cutting down things that might one day have a cure for cancer or malaria,” he
said.

6

Herbs being destroyed by deforestation are becoming increasingly harder to find and as
such the poorer regions in these already poor countries are facing higher prices in the
marketplace.

It’s a simple case of supply and demand. If the herbal supplement industry in the U.S. is
affected by deforestation in countries that are large exporters or herbal supplements, costs
could rise and the alternative natural treatment may see similar price tags as
pharmaceuticals.

Few insurance companies cover alternative treatments since they are not regulated and
thus considered much more risky to insure than well known, standardized and regulated
treatments. Because the effects of most herbal supplements have not been clinically
tested or peer-reviewed, their credibility in the scientific world remains uncertain and as
such, chances of acceptance in the insurance industry are slim

But will consumers still choose herbal supplements if prices increase?

Chicago-based alternative medical practitioner Long Huynh believes that even if patients
have to pay more, they’ll still move toward herbal supplements over pharmaceuticals.

“Why don’t they mind? Because it works,” Huynh said.

7

Despite the growing technological advancements in western medicine in the U.S., people
are drawn to nature, he said, and ancient treatments will not be overshadowed by
technology.

“In this country we all believe in the technology. We are able to diagnose everything. We
are able to see inside of a person. We spend so much money doing all that, thinking we
can get rid of all this old age, ancient, out of date [ways of treatment],” Huynh said.

Frustration and finances aside, Abel believes part of the growing trend toward herbal
supplement use is as simple as the inherent human desire to return to nature.

“It’s the emotional and psychological effects of alternative medicine that draw followers.
There’s a lot more to taking an herbal supplement than taking a pharmaceutical drug,” he
said.

Abel, who holds degrees in both biochemistry and eastern medicine, encourages a
lifestyle change when he prescribes herbs to his patients. Sometimes he’ll encourage
patients to take the herbs in the form of a tea simply so they are forced to slow down and
relax while they take their medication as opposed to popping a pill on the go.

Herbal teas that require that the patient sit down and drink a warm soothing drink
encourage healing simply in the way they are ingested, he said.

8

“Just telling your body that you’re going to relax is going to have an effect,” Abel said.

He believes the fast-paced, instant-gratification culture is causing bodies to be pushed
into constant overdrive. Allowing the body to relax is critical to good health. His
confidence in herbal supplements is largely based on the way interact people with them,
treating them more as a lifestyle choice than a drug.

“Natural” Medicine
As America becomes more “health-conscious” Abel feels as though people are becoming
more aware of what’s synthetic and what’s not. “Going green,” has had its impact in the
food and drug industry as well. Recent trends toward organic foods and organic products
have further defined a dichotomy between the natural and unnatural that clearly places
synthetic products on the opposite spectrum of organic or natural products.

“The more we get away from [the natural], we go more toward the synthetic things,” he
said. Because synthetic products such as sugars and high-fructose corn syrup are leading
causes of diabetes and obesity many fear synthetic drugs have the potential to cause harm
as well. Thus, people consider natural herbal supplements as safer than pharmaceuticals
just as they consider natural foods to be better for the body than processed foods.

Huynh confidently tells his patients he has a way to avoid taking synthetic medications
entirely. He has “natural antibiotics,” he said. “Herbs.”

9

However, using herbs in place of pharmaceuticals raises many concerns for safety and
consumers aren’t always aware of what they should be conscious of in the first place. For
most, the understanding of herbal supplements begins and ends after a quick glance
through drug store shelves, picking up a package, reading “gingko’ and “100 percent
natural,” thinking “Hm, does it really do that?”

All too often the unspoken answer is, “I guess I’ll try it and find out.”

Because herbal supplements do not require a prescription, many perceive them as being
somehow less potent or dangerous to share with or purchase for others.

A woman in a health foods store was paying for her items. As the customer handed the
cashier a small rectangular box, she asked, “What do you think of these pills?” The
cashier said something to the effect of, ‘I think they’re great. All natural herbs.” The
customer then replied, “Great. I’m going to get them for my mother. She’s not a big fan
of these pills but they’re just herbs.”

These pills were easily available with little to no explanation about use and without
guidance regarding side effects or possible drug interactions, which can be particularly
dangerous for anyone taking multiple pharmaceutical or herbal medicines.

Regardless of how natural an herb, the way it’s used determines how it affects the body.
There is such a thing as “too much of a natural thing.” Not only can natural medicines
10

have dangerous interactions with pharmaceuticals and other herbs, they can also have
adverse effects if taken incorrectly or in the wrong amounts. An obvious example is the
use of marijuana. It’s an herb and the more pure or “natural” it is the more potent it is.
Used irresponsibly, it results in serious inhibitive chemical reactions in the body. Used
responsibly however, some scientists believe it holds powerful medicinal properties.

Safety
Informing the public of safe herbal supplement use is an ongoing battle where east meets
west, technology wrestles tradition and both come out swinging not knowing they’ve
been fighting on two inherently different battlefields all along.

Culture clashes of east and west have long been documented in history and romanticized
through literature and film. Add opinions of science and healing into the mix and the plot
thickens. Putting together two independent ways of treating illness with little knowledge
and understanding of their separate properties is much like mixing two unmarked
chemicals in a lab.

Herbal supplements can create a chemical reaction in the body just as a synthetic drug
might and these interactions can sometimes negate the effectiveness of drugs entirely,
pharmaceutical or natural. Individuals could be inhibiting the effects of necessary
medications without even knowing it. USC Pharmacy professor Roger Clemens says we
simply don’t know enough about it to ensure safe practices.

11

“One of the challenges is that we don’t know the interface or interaction with the herbal
supplements and their impact on western medicine,” Clemens said.

There are inherent dangers in science not yet knowing how herbal supplements interact
with the already highly drugged sect of America. Mixing herbal supplements with
pharmaceuticals brews danger.

A study by the Department of Health and Human Services found that at least half of all
Americans take one prescription drug and approximately one in every six people is taking
more than one.

Whether it’s for controlling blood pressure, or diabetes or even attempting to curb the
effects of depression, Americans are taking pharmaceutical drugs for almost every
ailment they’re diagnosed with. This is particularly true for elderly Americans. Clemens
believes that because Americans are already so drugged, adding unregulated herbal
supplements to the mix creates major dangers. It’s not necessarily that the supplements
that are dangerous but rather, the interactions they can have with a belly full of
pharmaceuticals.

We have a trend that warrants a, “Consumer, beware [warning],” Clemens said.

As western science grabbles to scientifically understand the effects herbal supplements
have on the human body and their interaction with pharmaceuticals today, Clemens
12

believes that a tradition thousands of years in the making is hardly going to be able to be
understood by the west overnight.

Able feels it’s the responsibility of the herbal medicine provider to fill in the knowledge
gap and keep those who wish to take herbal supplements safe by taking responsibility for
the supplements he or she hands out. However, his efforts to keep his patients safe from
the dangers of drug interaction can only go so far as many people choose to purchase
supplements through independent vendors, at stores or online and without consultation.

With the internet making supplements available through an international host of venders
requiring little more than a click, consumer safety is an even bigger challenge than if the
products were available in store only. The need for those seeking herbal remedies to visit
a practitioner is nonexistent.

When bypassing people versed in the qualities of clean and effective herbs, consumers
run the risk of unknowingly ingesting harmful, and sometimes deadly, toxins into their
bodies.

“As a practitioner I kind of take responsibility. I want to know that if I give something
that it is the safest product available,” Abel said. This includes checking what other drugs
his patient might be taking or what health conditions they may have and finding herbs
that have the least known reaction.

13

“You need to go to some sort of resource that gives you the knowledge [about what]
you’re taking,” Abel said.

Gaining the necessary knowledge takes time and extensive research. Clemens travels
around the globe each year to visit herbal supplement production centers. Though many,
he said, are exceptionally rigorous, and increasingly so, when it comes to ensuring the
safety of their products, there are some that slip through the cracks. Major suppliers of
herbal supplements like China and India, sometimes face issues of contaminated water
and unregulated agricultural practices, both of which can have substantial effects on the
herbs that are being grown.

If the herbs are grown in soil with high levels of lead, there are serious dangers of lead
contamination. Arsenic in water supplies in India has been a concern in regions of the
country. Dangerous toxins in fertilizers can also lead to the contamination of herbs.

Agricultural conditions affect herbs the same way they affect more common “herbs” that
are widely used, such as coffee. The process of creating a great cup of coffee is much the
same as the process of creating a great herbal supplement. Its taste is affected by how it’s
brewed. Its quality depends on how it’s grown, the quality of the soil it’s grown in and
where it was grown. The value of the coffee completely changes depending on all of
these factors just as the value of an herb would.

14

Consumers consider where coffee beans are cultivated and are willing to pay high prices
for the most pure and elite of beans to ensure the best beverage quality, yet they don’t use
the same consideration in the use of herbal supplements. A bad cup of coffee is easy to
taste but it’s not as easy for consumers to taste a bad herb.

An herb is only as natural as the way it’s grown. The U.S regulates agriculture, setting
standards for soil safety, water purity and toxins in fertilizers. These standards are not
necessarily the same in countries that many imported herbal supplements come from.

India, one of the largest exporters of herbal medicines, came under fire recently after a
study published in the Journal of the American Medical Association found that nearly 21
percent of its herbal supplements contained dangerous levels of lead, mercury or arsenic.
The case raised the question of how “natural” herbal supplements actually are.

The studies’ designers purchased the medicines online, without any guidance from a
physician or herbal practitioner and without a prescription, just as many consumers
might.

Because of this growing danger, slowly more and more medical schools are recognizing
the need to move toward a more dynamic curriculum that can prepare their students for
issues regarding the interactions of herbal supplements.

15

At the forefront of the effort to incorporate herbal supplement education into medical
education is the Feinberg School of Medicine at Northwestern University. Feinberg
works with the National Center for Complementary and Alternative Medicine, a division
of the National Health Institute based in Maryland, to educate medical students about the
possible interactions between drugs they may prescribe and the various herbal
supplements that their patients are likely to use as the trend explodes across the U.S.

However, most medical schools are resistant to including alternative medical practices as
a part of the medical school curriculum, arguing that there just isn’t enough room to fit
another requirement into a already jam-packed four-year program.

However, while physicians may not be learning about herbal supplements in medical
school, pharmacy schools are becoming increasingly serious in engaging their students
with issues of herbal supplement interactions with they pharmaceuticals they’ll one day
provide.

“The pharmaceutical schools are much more open to having classes or electives than the
medical schools,” said Clemens.

Several decades ago the Keck School of Medicine and School of Pharmacy held a
discussion about altering the curriculum of the medical school to fit the growing need for
physicians to be trained specifically in nutrition due to an increase in the number diet-
16

related illness. The institution stuck to its age-old curriculum while the pharmacy school
required a minimum of forty hours of course work in herbal studies.

While academic health institutions struggle to meet the challenges brought forth by the
growing trend of herbal supplement use, the Food and Drug Administration is being
faced with its own set of regulatory challenges.

Regulation
When the regulation of herbal supplements is discussed, many turn to the Food and Drug
Administration for answers but what they find may surprise them.

The FDA does not actually have full regulatory power of supplements sold in the U.S.

Congress limited the FDA’s regulation of dietary supplements, which includes herbal
supplements. Under the Dietary Supplement Health Education Act of 1994, the safety of
these supplements is the sole responsibility of the manufacturer before it hits market. The
FDA only had a say in whether or not the supplement was safe if someone got sick from
or complained about the product. Manufacturers, generally not required to register their
products with the FDA, also did not have to have their products approved by the FDA
before they are produced or sold.

This lax oversight led to increased consumer danger. In one striking example of the
effects of lenient oversight Ephedra, a Chinese herb believed to be in use for 5,000 years
17

as a treatment for asthma, became a major ingredient in many weight loss pills. After
over 800 reported injuries and approximately 50 deaths, the deputy commissioner of the
FDA at the time, Dr. Michael Friedman, released a statement saying, "Consumers should
be aware that just because a product is labeled 'natural' or from an herbal source it is not
guaranteed to be safe. The effects of ephedrine alkaloids are potentially powerful ones.
We urge people to talk to their doctors before using dietary supplements containing
ephedrine alkaloids, and to always use them with caution."

Because the herb Ephedra was being used in a dietary supplement, the FDA was, by law,
unable to regulate the product. They were limited to recommending a voluntary recall but
remained unable to mandate a recall.

“Congress has really tied [the FDA’s] hands. They have basically said that while the
FDA has authority [to regulate drugs] they can’t really control their authority [when it
comes to herbal supplements used as drugs],” he said.

Under current laws, the FDA has to clinically prove that an herbal product is unsafe in
order to take action against it and in order to do that, it must run costly studies with
resources and funding it doesn’t have, Clemens said.

“So it’s a matter of law that the FDA authority [on regulating herbal supplements] has be
usurped,” he said.

18

The formulation of the act began in the 1990s as an effort to battle health fraud. Congress
was considering two bills, one that they hoped would strengthen the FDA’s enforcement
power and another that would make illegal the advertising of unproven nutritional and
therapeutic claims on supplement labels.

However, the health-food industry and its allies, feeling threatened by these discussions
in Congress worked diligently to convince Congress to “preserve the consumer’s freedom
to choose dietary supplements.” They warned retailers that, if these bills passed, they
would soon find themselves out of business. Consumers, they said, would have their
rights to purchase the vitamins taken away by Congress.

Complaints and outcries from lobbyists pressured Congress to reevaluate the bills and
subsequently created the Dietary Supplement Health Education Act, which placed dietary
supplements in a completely different regulatory category. It also gave retailers more
freedom to advertise their products the way they wanted.

Still, Congress had left some restrictions in place. Herbal supplement vendors are limited
by law and cannot claim to cure, treat, mitigate or prevent any disease. Pharmaceuticals
can, and have been proven in clinical trials to do so.

Despite the legal limitations that the FDA faces, other non-governmental organizations
such as the American Herbal Products Association based in Washington, DC have taken
19

the initiative to ensure the safety of herbal products being sold in the U.S. through
encouraging responsible manufacturer and retail practices.

The AHPA is the only national trade association completely focused on better consumer
practices for herbal products. Mostly privately funded, AHPA does what the FDA doesn’t
have resources to do. Part of its mission is scientifically researching various herbs and
herbal products in the market to determine their efficacy.

Herbologists sometimes cringe at the idea of studying medicinal herbs through western
clinical trials. Abel worries that the standards of regulation in the U.S. will ultimately sell
herbal treatments short, labeling only the most potent of their effects and essentially
disregarding their holistic benefits.

“[Western medical physicians] take a look at a very western approach [to treatment] and
so they’ll say, ‘This herb is good for digestion,’ and get stuck on that,” said Abel. Though
the herb may be good for digestion, it might also have a number of other benefits that act
simultaneously. Western medicine may not accept the less potent benefits of the herb
because of the way it defines treatment. Treatment in western medicine is focused on
isolating the most effectual part of an herb and localizing its impact, as opposed to
treating the body as a whole.

When you remove the element of holistic benefits, you take away an important principle
of alternative medicine: the whole is greater than the sum of its parts.
20

“The herb has an efficacy in it but a lot of it is that a holistic effect,” Abel explained.

Abel fears herbal supplements will follow the trend of other products that have been
forced to label each ingredient and advertise the ingredients’ benefits. Companies trying
to keep up with the market value of advertising particularly popular ingredients such as
protein, or calcium have been known to find shortcuts in producing their products.

“They’re creating products for labels,” he said. An ingredient is often advertised because
of its consumer popularity, even though it’s not necessarily in the most effective form
(for the body to digest) in the product or the safest amount.

Abel says that synthetic substitutes are beginning to take the place of real herbs. A
supplement label might read “100% gingko” when there’s really only 60 percent pure
gingko and 40 percent of a similar synthetic product mixed in. Consumers think they’re
getting what they want while retailers decrease their spending by purchasing cheaper
synthetic ingredients and increase profit by loosely advertising their products as
something they are not, so to appeal more to their growing consumer base.

It’s a trap that Abel feels will consume the herbal industry if supplement labels are
required to define each ingredient.

21

Manufacturer Responsibility
Recent efforts are being made to ensure that manufacturers of herbal supplements are
held accountable for the quality and safety of their products. Good Manufacturing
Practices or GMP requires manufacturers to "to evaluate the identity, purity, quality,
strength, and composition of their dietary ingredients and dietary supplements,"
according to the Food and Drug Administration.
The rule was announced in June of 2007 and mandated that by the end of that year the
dietary supplement industry must report all serious adverse effects of supplements to the
FDA.

The FDA began formulating GMP when Congress passed the Dietary Supplement Health
Education Act in 1997. Because there was an obvious hole in the regulatory process after
the passage of the act, the FDA put forth the concept of having a rule of Good
Manufacturing Practices for the dietary supplement industry. It took six years before the
FDA formally proposed the rule and another four years before the rule was finalized and
enacted.

According to the FDA, the aim of GMP is to ensure that supplements do not contain the
wrong ingredients or have too much or too little of a dietary ingredient. But the FDA is
not stopping there, they are also going after improper packaging and labeling. They are
also fighting a larger battle, and one that is far more complex in its number of factors.
GMP seeks to guarantee that supplements are not contaminated by natural toxins,
bacteria, pesticides, glass, lead or any other substances.
22

With supplements imported to America from all over the world, where agricultural
standards are different than in the U.S., many in the herbal supplement industry face new
obstacles in getting their products on the shelves. If manufacturers are delinquent in
following GMP the FDA now has the power to determine the product adulterated and
misbranded as well as penalize the manufacturer. Still, many products on the shelf today
do not follow GMP as they were produced before the passing of the rule. Those that do
are marked as such for consumer knowledge.

GMP was a major move toward safer practices in the herbal supplement industry that
strengthened the credibility of some manufacturers but put many other small herbal
supplements out of business. Some were shut down because their standards of practice
did not meet the new rule while others simply did not have the resources or infrastructure
to test on all their products in the manner which was now required.

Though GMP focuses on larger players in the dietary supplement industry, the FDA is
considering measures to ensure that individual practitioners are following similar safety
standards in their practices. In a Federal Register report on the new rule to the FDA said
it would use, “enforcement discretion in deciding whether to apply the requirements of
this final rule to certain health care practitioners, such as herbalists, acupuncturists,
naturopaths, and other related health care providers.”

23

It has yet to be seen how this new rule will impact the herbal supplement industry as a
whole. Still, this step is an indication of a changing tide in how supplements will be
made, sold and seen.

Conclusion
The understanding and regulation of herbal supplements is at a crossroads. Though herbal
treatments date back thousands of years, their contemporary uses struggle to squeeze into
the already complex western biomedical system. If the trend toward the use of herbal
medicine continues to rise, biomedicine is going to have to make greater efforts to
understand its impact. To the same degree, the herbal supplement industry will likely face
a new system of regulation to ensure supplement safety.

Our pill-popping nation is due for a check-up and the prognosis seems to suggest a major
overhaul in what we understand medicine as today. The hard-science world may need to
take a lesson from the social sciences and find a perfect blend of east and west if it wants
to continue to heal its patients and truly eliminate risk of harm. Enter; a new era where
rapidly changing technologies and medical advancement converge with healing traditions
dated thousands of years in the past.

Abstract (if available)

Abstract Herbal supplement use is a growing trend in the United States. As more and more people turn to supplements there is increased concern over the safety of herbal products. However, regulation of herbal supplements is challenging to enforce because of the diversity of supplements and the various forms in which they are taken. Many supplements come from international sources making their ingredients and production standards difficult to track. Used as a primary source of treatment for a large population, herbal supplements are being dissected by the western medical world as it searches for proofs of its efficacy as well as its interaction with pharmaceuticals.

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Asset Metadata

Creator Unus, Wafa Iqbal (author)

Core Title Regulation of herbal supplements

School Annenberg School for Communication

Degree Master of Arts

Degree Program Journalism (Print Journalism)

Degree Conferral Date 2009-05

Publication Date 11/11/2009

Defense Date 05/01/2009

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag alternative medicine,herbal supplements,herbs,OAI-PMH Harvest,supplements

Language English

Contributor Electronically uploaded by the author (provenance)

Advisor Cole, K. C. (committee chair), Birman, Daniel H. (committee member), Richmond, Frances J. (committee member)

Creator Email unus@usc.edu,wafaunus@gmail.com

Permanent Link (DOI) https://doi.org/10.25549/usctheses-m2236

Unique identifier UC1280035

Identifier etd-Unus-2864 (filename),usctheses-m40 (legacy collection record id),usctheses-c127-235597 (legacy record id),usctheses-m2236 (legacy record id)

Legacy Identifier etd-Unus-2864.pdf

Dmrecord 235597

Document Type Project

Rights Unus, Wafa Iqbal

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Repository Name Libraries, University of Southern California

Repository Location Los Angeles, California

Repository Email cisadmin@lib.usc.edu