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Derek Hall New Haven Regional Power Point

Hippocrates
460 BC – 370 BC

The father of western medicine
Believed that diseases were caused
naturally and not as a result of superstition, or
by the gods
Believed that disease was a product of
environmental factors, diet, and living habits
Hippocratic therapy focused on simply easing
this natural process

Hippocrates
460 BC – 370 BC

Hippocrates believed "rest and
immobilization were of capital importance.”
The Hippocratic medicine was very kind to the
patient; treatment was gentle, and it emphasized
keeping the patient clean and sterile.

One hundred years ago the six leading
causes of death were:
1. Pneumonia
2. Influenza
3. Tuberculosis
4. Diarrhea
5. Heart disease
6. Stroke

Marijuana, heroin, and
morphine were all available
over-the-counter at the
corner drugstore

One hundred years ago it was
believed that heroin cleared the
complexion, gave buoyancy to
the mind, regulated the stomach
and bowels, and was, in fact, a
perfect guardian of health!

Pharmaceutical Beginnings
The 1920s and 30s ushered in the important discoveries
of insulin and penicillin and the development of the modern
pharmaceutical industry really began
FDR signed into affect the Food, Drug and Cosmetic Act
on June 24, 1938, allowing the FDA new authority over
drugs by mandating premarket review and banning false
claims
In the 1960s and 1970s, increased regulation on the
pharmaceutical companies led to the beginning of required
clinical trials

Pharmaceutical Beginnings
By the 1970s, most governments began to put in place
strong patent systems, designed to give pharmaceutical
firms incentives to innovate and develop new and effective
medicines
By the 1980s, pharmaceutical firms had become well-
established, but small pharmaceuticals were struggling for
survival due to the rising costs of research and
development required to patent a new drug for market
During the 1980s pharmaceutical manufacturing became
more and more consolidated due to merger and takeover
activity, leading to the domination of the pharmaceutical
industry only by large firms.

Where did all this lead us?
Domination by a few huge pharma companies
Tens of thousands of detail reps calling on doctors
Medical schools moving from natural healing to
pharmaceutical dosing
Pharmacy schools stopped teaching pharmacognosy
We are bombarded from every direction by drug
advertising and marketing
Insurers rarely provide coverage for alternative care

Common Drug Side Effects
CIALIS: headache, indigestion, back pain, muscle
aches, flushing, and stuffy or runny nose.

PLAVIX: unexpected bleeding or bleeding that
lasts a long time, blood in your urine, red or black
stools, bruising, cough up blood or blood clots, or
vomit blood

Common Drug Side Effects
LIPITOR: Severe allergic reactions (rash; hives; itching;
difficulty breathing or swallowing; tightness in the chest;
swelling of the mouth, face, lips, throat, or tongue); change
in the amount of urine produced; dark urine; muscle pain,
tenderness, or weakness; painful, difficult, or frequent
urination; pale stools; persistent loss of appetite; persistent
pain, soreness, redness, or swelling of a tendon or joint;
red, swollen, blistered, or peeling skin; severe or persistent
nausea, vomiting, or stomach pain; unusual tiredness;
yellowing of the eyes or skin.

The Good, Bad and the Ugly of
Natural Products:
The Good:
They are Generally Recognized As Safe (GRAS)
Used safely for millennia
Found in nature
Available without a prescription
Limited side effects

Natural Products:
The Bad:
Often inadequate current science
Dosage not consistent and can vary by patient
Lack of information in the public domain
Not covered by health insurance
Doctors are generally uneducated in the area
natural products

Natural Products:
The Ugly:
Pre-market approval not required
Unsafe products can be introduced to
the market
Irresponsible companies make illegal
claims
Responsible companies are judged
along with the bad players

Dietary Supplement Claims

How do I explain the benefits of
Qivana products legally?

DSHEA
Dietary Supplement Health and
Education Act of 1994
Created a new category of consumables
under the Food Drug and Cosmetic Act

Created a unique claims and labeling
structure (supplement facts and
structure/function)

What is a Dietary Supplement?
Taken by mouth and contains a "dietary
ingredient" intended to supplement the diet.

Dietary ingredients include: vitamins, minerals,
herbs or other botanicals, amino acids, and
substances such as enzymes, organ tissues,
glandulars, and metabolites.

What is a Dietary Supplement?
Can be extracts or concentrates, tablets,
capsules, softgels, gelcaps, liquids, or powders.
Cosmetics, creams and patches are not
considered dietary supplements.

Can also be in other forms, such as a bar, but if
they are, the product must not be represented as
a conventional food or a sole item of a meal or
diet.

What are the Labeling Requirements?
Labeling refers to the label as well as any
accompanying material that is used to promote
and market a specific product.
Allowable claims must also be, under Federal
Trade Commission (FTC) rules, “truthful and not
misleading”.
Must include a disclaimer: “This statement has
not been evaluated by the FDA. This product is
not intended to diagnose, treat, cure, or prevent
any disease.”

What Kind of Claims are Allowed?
General wellness claims such as:
“Take vitamin C and feel good…”

Structure and function claims that
characterize the relationship
between a nutrient and the normal
structure and function of the body

What Kind of Claims are Allowed?

Health Claims that characterize the
relationship between a nutrient and a
health condition, i.e., folic acid for birth
defects or calcium for osteoporosis
require prior FDA approval

Specifically Allowed Terms
Stimulate Adaptogen
Support Tonic
Regulate Calmative
Maintain Digestive aid
Energizer Helps maintain
Rejuvenative intestinal flora
Revitalizer Boosts stamina

Specifically Disallowed Terms
Restore Antiseptic, kills
Correct germs
Relieves chest pain Hormone
Prevents irregular Sunscreen
heart beat Antibiotic
Antibacterial Laxative

 Cannot treat, cure, prevent, mitigate or diagnose

Specifically Disallowed Terms

Antimicrobial Diuretic
Analgesic Antidepressant
Antiviral Vaccine

 Cannot treat, cure, prevent, mitigate or diagnose

Limited Allowed Terms

Promote Inhibit
Augment Protect
Strengthen Defend
Reduce Supports the
Improve immune system
Modify Relief (depending
on what is relieved)

Limited Allowed Terms

Allowed Disallowed

Promotes normal Promotes joint
joint function healing
Supports the Supports immune
immune system defense against
germs

Healthcare Related Terms
Allowed Disallowed
 Hyper Reactivity  Allergies
 Spiritual Relaxation  Spiritual Healing
 Feedback / Training  Treatment
 Muscle Re-education  Sport Therapy
 Therapy that may Benefit  Treatment
 Discomfort, soreness  Pain
 Cravings  Addictions

Testimonials
“Results not typical” disclaimer is no
longer a safe haven
New rule requires all testimonials to
be examples of typical results, or the
typical results must be declared
equally

Testimonials

Interim disclaimer that can be used,
pending further regulatory
developments:
"Testimonials represent a cross section
of the range of results that appear to be
typical with these products. Results may
vary depending upon use and
commitment."

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Derek Hall New Haven Regional Power Point

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