Unregulated Herbal Supplements: Facing the Menace

Unregulated Herbal Supplements:
Facing the Menace
“Ito Ay Hindi Gamot”
Esperanza I. Cabral, MD.
Unregulated Herbal Supplements:
Facing the Menace
46th PCP Annual Convention, May 2, 2016
• Describe law regarding food supplements.
• Discuss commonly used food supplements, i.e.,
herbal medicines.
• Review the reasons why people are using herbal
medicines.
• Describe risks from the consumption of herbal
medicines.
• What we can do to keep patients safe.
TERMS
Varying terms used
EXAMPLE: GINKGO IS VARIOUSLY CLASSIFIED AS:
•Natural product [Canada]
•Food supplement [Phil; EU]
•Dietary supplement [US]
•Food w/ specific health use [Japan]
•Health function food [Korea]
•Functional food [China]
•Complementary medicine [Australia]
•Traditional medicine [Malaysia]
•Nutritional supplement, nutraceutical, herbal
supplement, health supplement, etc.
Health Supplement ASEAN definition
• Any product that is used to supplement a diet
to maintain, enhance and improve the healthy
function of human body,
• contains one or more of the ff:
(a) Vitamins, minerals, amino acids, fatty acids,
enzymes, probiotics, other bioactive substances.
(b) Substances derived from natural sources,
including animal, mineral and botanical materials.
(c) Synthetic forms of (a) and (b).
• presented in small oral doses and excludes
parenterals (e.g., injectables, eyedrops).
Regulatory Issues
“Dietary Supplement” officially defined in
the US in 1994 by the Dietary Supplement
Health and Education Act (DSHEA) as “a
product taken by mouth that contains
a ‘dietary ingredient’ intended to
supplement the diet.
Dietary Ingredient - one or any combination of
the following: Vitamin, Mineral, Herb or
Botanical, Amino Acid, Enzymes, Tissues,
Metabolite, Concentrate, Constituent, or
Extract.
• Herbs classified as dietary supplements
• Dietary supplements NOT regulated like drugs
because they are legally, not drugs
• Manufacturers can market supplements w/o
proof of safety or efficacy. Manufacturers
responsible for product safety
• No FDA approval needed to sell and FDA must
prove the product unsafe to remove it from the
market
• No established dosage guidelines
• No purity restrictions
US: Structure/Function Statement
• “This product is not intended
to diagnose, treat, cure or
prevent a disease.”
Herbalgram 2000;48:32-8
RA 9711 “Food and Drugs Administration
(FDA) Act of 2009”
 renames the Bureau of Food and Drugs
(BFAD) as Food and Drug
Administration (FDA)
 strengthens its regulatory powers,
resources and capabilities to efficiently
and expeditiously perform its mandate
Definition of a DRUG
RA 9711
1. article intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in
man or other animals;
2. article (other than food) intended to affect the
structure of any function of the body of humans or
animals; or
3. article intended for use as a component of any
article specified in clauses (1) or (2) but does not
include devices or their components/ accessories.
Vitamins & minerals classified as drug:
• a therapeutic claim made for the preparation
for a specific deficiency, state or disease
• strength per dosage form is >105% RDA for fat
soluble & >150% RDA for water soluble vitamins;
• any pharmaceutical form
• highly purified
Vitamins & minerals classified as food supplement:
• no therapeutic claim made for the preparation
• strength per dosage form is <105% RDA for fat
soluble & <150% RDA for water soluble vitamins
• oral preparation only
• no additional pharmacologically active ingredients
Definition of Herbal Medicines
(A.O. 172 s.2004 Re: Guidelines on the Registration of Herbal Medicines)
Finished medicinal products that contain as
active ingredient(s), aerial or underground
part(s) of plants or any plant material, or
combination thereof, whether in the crude
state or as processed forms
Definition of Herbal Medicines cont’d.
Not intended for use in the diagnosis,
alleviation, cure or treatment of disease,
promotion of health or intended to affect or
modify the structure or any function of the
body of humans or animals
Preparations containing plant material(s)
combined with chemically defined
therapeutically active substances, are NOT
considered to be herbal medicines.
TRADITIONALLY-USED HERBAL PRODUCTS
(A.O. 184 s.2004: Guidelines on the Registration of Traditionally-Used
Herbal Products)
Definition: preparations from plant materials
whose application is based on traditional
experience of long usage of at least five (5)
decades as documented in medical, historical
and ethnological literature
• do not contain chemically defined
therapeutically active substance(s),
• classified as food supplements/herbal
medicines
Ten “Approved” Traditionally Used Herbal Products
Yerba buena
Clinopodium douglasii
Tsaang gubat Ulasimang bato
Ehretia microphylla
Peperomia pellucida
Niyog niyogan
Sambong
Quisqualis indica
Blumea balsamifera
Ten “Approved” Traditionally Used Herbal Products
Ampalaya
Guava
Momordica charantia
Psydium guajava
Lagundi
Vitex negundo
Garlic
Akapulko
Allium sativum
Cassia alata
REGULATION OF HERBAL PRODUCTS
AO 184 S 2004: Guidelines on the
registration of traditionally-used herbal
products
Guidelines on the registration of herbal food
products based on ASEAN harmonization of
evaluation of health supplements and
traditional medicines
Herbal Medicines Registration
Requirements cont’d.
• No product shall be registered as Herbal
Medicine if:
• There is a valid report of adverse drug reaction
on the use of the plant material
• There is a valid report of abuse or dependence
potential on the use of the plant material.
•
It contains chemically defined therapeutically
active substance(s) used in conventional/
western medicine.
Food Supplements
CA upholds DOH rule on 'no approved
therapeutic claim' tag on supplements
By: Brian Maglungsod, Interaksyon.com
December 21, 2014 11:21 PM
…all food & dietary supplement
products sold in the market
should strictly carry on their
labels the phrase
“Mahalagang paalala:
Ang (name of product) ay
hindi gamot at hindi dapat
gamiting panggamot sa
anumang uri ng sakit”
Department of Health: a legal victory for truth in advertising.
Sehat Badan is being sold
illegally – particularly in
Mindanao – for P180 per box.
Sehat Badan's Facebook page:
claims it can "treat various
diseases" such as asthma,
allergy, and hypertension… This
claim is not approved by the
Philippine FDA.
In 2014, the FDA ordered its food
and drug regulation officers to
confiscate the unregistered food
supplement which contains
sugar (sucrose and fructose),
Diclofenac sodium, Paracetamol
and Ibuprofen.
FDAs have fought
for decades to
regulate supplements,
but
have been defeated
politically, and
economically, by
the supplement
industry
History of Herbal Remedies
The Egyptians first codified
herbal remedies.
Shennong, a mythical person,
tested hundreds of herbs,
passed knowledge about plants
and poisons over 2,000 years ago
to others.
Herbal guide De Materia Medica
was written by a 1st century
Greek physician, Dioscorides.
In the Americas, herbalism,
deeply tied to spiritualism among
Native American tribes.
Useful Supplements
Not all natural products are safe
Drug – Food Supplement Interactions
• St. John’s Wort:
•
•
•
•
•
•
Amitryptiline, Anticonvulsants,
Antihistamines, Benzodiazepines, CCBs,
Chemotherapeutics, OCPs, Digoxin,
Simvastatin, SSRIs, Warfarin
Milk Thistle: Metronidazole
Black Cohosh: Iron, Hormones, Warfarin,
Salicylates
Echinacea: Immuno-suppressants
Saw Palmetto: Hormones (e.g., OCPs)
Gingko biloba: Acetaminophen, Anticonvulsants,
Antidepressants, Aspirin, Thiazides
Garlic: Aspirin, HIV medications, Warfarin
Safety Considerations
• 40 to 70% of patients do not inform
physicians about use of alternative
therapies
• Adverse reactions not known to patients
• One or more chemical component of the
plant
• Incorrect manufacturing process
• FDA does not require reporting of adverse
reactions from alternative therapies
Safety Considerations
• No Standardization
• Nomenclature and chemical constituents
vary
• Mixtures are NOT standardized
•
•
Lack of Good Manufacturing Practices
Examples: ginseng, ephedra
• Difficult to identify ingredients
• Lack of active ingredient
• Contamination
Herbal Remedies – NCAHF* warning
“ Herbal remedies not only waste funds, but on
occasion poison and kill, and they do even
greater harm to the fools who take them because
they often at the same time are not treating a
serious medical condition scientifically…”
“ Books could be filled with the controlled
studies that have failed to find significant value
to herbal remedies.”
*National Council Against Health Fraud, Inc.
In the Philippines: “Ito ay hindi gamot”
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•
•
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Memory Plus Gold
Optein
Liveraide
Lungcare
Kidneycare
Kolestrim
Diabetrol
Robust, Fitrum
MX3
Sehat Bedan
In the Philippines: “Ito ay hindi gamot”
•
•
•
•
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CNS: ginkgo, St Johns wort, melatonin
Eye: lutein
CVS: policosanol, garlic, omega-3, resveratrol
Skin: glutathione
Liver: silymarin
Kidney: balbas pusa
Men’s RH: tongkat ali, saw palmetto, lycopene
Women’s RH: black cohosh, oil of evening primrose
Diabetes: ampalaya, banaba, turmeric, chromium
Joint: glucosamine, chondroitin
Tonic/immune: ginseng, echinacea
In the Philippines: “Ito ay hindi gamot”
• Comfrey
• Kargasok tea
• Apple cider
• Aloe
• Noni
• Barley
• Wheat grass
• Ashitaba
In the Philippines: “Ito ay hindi gamot”
• Narra
• Mahogany
• Pitupito
• Virgin coconut oil
• Malunggay
• Guyabano
• Mangosteen
If herbals have
not been proven
to be effective
for preventing,
diagnosing or
treating any
disease and
may be harmful,
Why do people keep taking them?
Major trends in the Philippines:
• ↑ concern about drug safety issues
• ↑ concern about quality & cost of health
care
• ↑ health consciousness and ↑ awareness
of lifestyle related diseases
• ↑ demand for disease prevention
products and services
• ↑ in self medication with herbal
medicines
• ↑ demand for health and wellness
products
Herbal versus
Conventional Medication
• Disappointment with current conventional
therapies
• Fear of safety and long-term effects of drugs
• Lack of effective treatments/cures
• Belief that herbal products are safe because
derived from nature
• Peer influence
• Desire to have control of one’s own health
• False claims from manufacturers
Herbal versus
Conventional Medication
Demand stimulated by
aggressive marketing
campaigns, including
television & radio
commercials, usually
involving Filipino celebrities
(even doctors).
Many people will keep
taking food supplements
What can we do to make it
less risky for them?
Clinicians
1. Resist the temptation to make money
from gullible patients
2. Routinely ask patients about their use
of herbal products/food
supplements. Give them advice.
3. Report adverse effects to the FDA
4. Write up and submit for publication
case reports in which patients have
experienced adverse effects from
herbal product use.
Give Advice to Consumers
1. Do not assume that herbal remedies are
safe just because they are natural.
2. Do not take herbal remedies if you are
pregnant or attempting to become
pregnant or breastfeeding. Don’t give
to children.
3. Do not take large quantities of herbal
products or for prolonged periods.
4. Buy only products that identify active
ingredients and state contraindications
for use.
Advice to Consumers cont’d.
5. There are dangerous herbs and advice not
to take them.
6. Do not use herbal remedies without
checking with your doctor.
7. Do not trust your health to “practitioners”
who use unregulated titles such as
“herbalist,” “herb doctor,” “herbologist,”
“Master Herbalist,” “Natural Health
Counselor,” etc.
8. Beware of exaggerated claims about the
benefits of herbal remedies.
Advice to Consumers cont’d.
9. Herbal-pharmaceutical interactions do
occur
10. Lack of standardization (variability in
content and efficacy among brands)
11. Lack of quality control and regulation
(contamination and misidentification)
12. Tell health service provider about herbal
use
Thank
You!