Introduction to Dietary Supplements:

Efficacy, Safety and Regulations

Ali Alhammad PhD Student

President, VCU-ISPOR Chapter

Department of Pharmacotherapy and Outcome Sciences

School of Pharmacy, VCU

Saudi Student Organization (SSO)April 8, 2011

Overview

Overview of Dietary Supplements (DSs)

Overview of DS Efficacy

Overview of DS Safety

Overview of DS Regulations

Dietary Supplement Health and Education Act (DSHEA)

How to get the high quality DS

Conclusions

Introduction

How many of you are currently taking a dietary supplement?

What is A Dietary Supplement (DS)

Before 1994, no official definition of DS

Dietary Supplement Health and Education Act (DSHEA) definition of a dietary supplement: “a product take by mouth that contains a ‘dietary ingredient’ intended to supplement the diet…[may include]…vitamins, minerals, herbs, botanicals, amino acids, enzymes, extracts…”

Types of DS

Vitamins Minerals Botanicals (herbal) Sports nutrition supplements Weight management products Specialty supplements

Forms of DS

Capsules Softgels Tablets Liquids/tinctures Powders Bars Beverages

What is DS

Distinguished from Drugs: Drug = article intended to diagnose, cure, treat,

or prevent disease Both intended to affect structure and function of

body Drug must undergo FDA approval

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What is DS

Distinguished from Foods: Foods not intended to affect structure and

function

DS intended only to supplement diet Not for use as conventional food (a meal or the

diet) No premarket approval No premarket testing

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Growth in DSs Use

Increased cost and consumer dissatisfaction with conventional health care

More people have turned to herbal medicine and ‘natural’ treatment options than to traditional medical treatment

½ of US population use DS

Herbal use increased by 380% from 1990-1997.

1. Eisenberg DM et al. Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey. JAMA 1998;280:1569-75.

In 2007, the global sales approximately $53.4 billion In 2006, $51 billion (4.7%) In 1997, $38.5 billion (38.7%)

Asia Pacific region, $22.6 billion (44.2% market share)

North American , $16.4 billion (32.2% market share)

http://www.marketresearch.com/browse.asp?sortby=p&categoryid=189&g=1 Hartmon Group Phase III National Study

Growth in DSs Use

Effectiveness

Commonly used DS

St. John’s Wort Echinacea Ginseng Garlic Ginkgo

St. John’s Wort Most scientifically studied herbal supplement on the

market over the last 20 years

Uses: Anxiety Bed-wetting, Bronchial inflammation, Burns, Cancer, Depression,

Hemorrhoids, Insect bites, Insomnia, Kidney disease, Scabies, Digestive issues, Wound healing

Interactions: Allergy medications, alcohol, amphetamines, antidepressants called

MAOIs and tricyclics,Desyrel®, and oral contraceptives/pregnancy

Side Effects: Allergic reactions, constipation, dizziness, dry mouth , restlessness,

sensitivity to sunlight, stomach upset, sleep disturbances

Echinacea Also among the most-studied herbs with St. John’s

Wart Said to stimulate the body’s immune system

Uses: Antibacterial, Antiviral, Blood Cleanser, Skin wounds

Interactions: Allergic Reaction to any of its parts

Side Effects: Fairly well-tolerated

Ginseng Ancient Chinese herb used for over 2000 years and known as the ‘ultimate

herb’ among most herbalists Used by about 6 million Americans regularly

Uses: sleep aid, depression, diabetes liver problems, energizer, healing, enhancer of physical and mental performance,

resists stress, improves mental concentration

Interactions: anti-hyperglycemia drugs (Insulin, Amaryl®),MAOIs, and stimulants like coffee and

teal

Side Effects: chest/breast pain, diarrhea, headache, hypertension(high blood pressure), insomnia,

impotence, itching, nausea, nervousness

Ginkgo Very old botanical [200 million years ago] May be the most popular herbal in the world as it comes specifically as

a standardized extract world-wide Uses:

Asthma, blood vessel disease, poor memory dementia, inner-ear disorders, improving brain function, impotence treatment,

premenstrual syndrome, macular degeneration, Alzheimer's (via increased mental alertness)

Interactions: Coumadin and Aspirin

Side Effects: Digestive upset (diarrhea, gas, nausea), headache, seizures, skin irritation, unusual bleeding or bruising

Ginkgo

Performance Enhancing Supplements

Amino Acid powders/Protein drinks Creatine Anabolic Steriods

Amino Acids

Amino Acids are building blocks

of proteins Powder form for sport performance/body

building 20 different amino acids Get varying amounts from protein containing

foods Animal products, grains, legumes

Amino Acids

Increases muscle size Weight gain Must have training along with

supplement Will not make you look like a body builder

unless you have type of body to do so.

Side Effects: Well-tolerated Stomach cramping, diarrhea, weight gain

Creatine

Phosphocreatine for energy ATP -> Phosphocreatine -> Glucose -> Fat Best used in sports/events needing short bursts of

energy Sprinting Wrestling Shot put

Side Effects Nausea Cramping Diarrhea Stomach pain

Anabolic Steroids

Synthetic form of testosterone Gels Tablets Injections Patches

Build muscle 3 million people use steroids, 1 in 4 started as teens Side Effects

Slow bone growth Permanently short stature Heart damage Liver damage

Safety of DS

Safety of DS

Around 60% of people do not disclose their use of DS

DS-Drug Internactions

DS Purity

Arpund 25% of DS are contaminated with heavy metals, steroids and/or medications

FDA imposed new regulations in June 2007 that DS must be: Produced in a quality manner Free of contaminants or impurities Accurately labeled

Manufacturers are required to test all ingredients to ensure quality

Combining Supplements

Additive or 1+1=2 When two supplements are combined so the effect = DS1 +

DS2 (Calcium and Vitamin D)

Antagonize or 1+1=0 When one supplement negates the effects so DS1 + DS2 = 0

(Creatine and Caffeine)

Synergize or 1+1=3 When two supplements are combined so the effect > DS1 +

DS2 (Coenzyme Q10 and fat)

Potentiate or 1+1 = 10 Similar to synergism, but to a greater degree

Choosing Supplements

Supplements should be clearly labeled with “Seals of Approval”

It should be stamped

Supplements to Avoid Steroids and Steroid-Enhancers

Linked to liver toxicity, testicular shrinkage, and increased risk of heart attack and stroke

Valerian Sold as a sleep aid Can be dangerous when mixed with alcohol

Ephedra Kava Kava

Linked to liver damage and liver failure! Banned in European countries and Canada

St Johns Wort Interferes with a huge number of medications Safety warnings posted in other countries

Some Products without Legitimate Evidence to Support Claims

Boron

Garcinia

Cambogia

Nitric Oxide

Carnitine

Ginkgo Biloba

Pycnogenol

Ginseng

Glutamine

Yohimbe

Whey Protein

Potentially Useful Supplements

Omega-3 Fatty Acids

Quercetin dihydrate

CoEnzyme Q10

Glucosamine/

Chondroitin Sulfate

Adaptogens

HMB

Creatine

Pre-Probiotics

Zinc

Regulation of DS

History of Dietary Supplements

1994 President Clinton signed Dietary Supplement, Health and Education Act (DSHEA) into law

Regulation of DS Unlike drugs

DS do not have to be proved safe before going on the market

federal authorities can act to take them off the shelves if they are shown to be unsafe

Before drugs or food additives go on the market hundreds of research studies must be submitted to

the FDA for review of the product’s efficacy.

FDA Enforcement Authority

FDA bas the “Burden of Proof” Must prove that product is “unsafe”

After DSHEA, no FDA enforcement unless can prove supplement is “unsafe” (significant or unreasonable risk of injury)

FDA must provide 10 days notice before initiating civil proceeding Whose idea was this!!!!!!!!!!!

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Congress passed DSHEA in 1994 on the basis of two quite questionable assumptions: that supplements are basically harmless, and that supplement makers are honest.

-Marion Nestle, RDProfessor of Nutrition, Food Studies, and

Public Health at New York University

DSHEA authorized to provide accurate information to consumers

Label must include: Name of each ingredient Quantity of each ingredient Total weight of all ingredient if a blend Identity of part of plant derived from Term “Dietary Supplement”

Must contain nutritional labeling information also Calories, fat, sodium

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Labeling of Dietary Supplements

Labeling of Dietary Supplements

DSHEA authorized use of FDA approved “Health claims” on label

Describe the connection between a nutrient or food substance and a disease or health-related condition (diet/disease relationship)

Statements may be included on the label that give the manufacturers description of the role of the D/S Not authorized by FDA Manufacturer resp. for accuracy and truth of statement

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Health Clams

FDA Approved Health Claims

Folic acid and neural tube pregnancies Calcium and osteoporosis Sodium and hypertension Fruits and vegetables and cancer Dietary lipids and cancer Saturated fat and cholesterol and coronary

artery disease

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Structure and Function Claims

Manufacturers may use S/F claims Not authorized by FDA

Must be true and not misleading Must be accompanied by disclaimer

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease”

Examples: “Calcium builds strong bones” “Antioxidants maintain cell integrity”

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Other Claims:

Health-maintenance claims: “Maintains healthy circular system”

Non-disease claims: “helps you relax” “for muscle enhancement”

Cannot make maintenance claims about osteoporosis and other “serious diseases”

Can make health claim about relationship between a product or substance and the disease if approved

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How To Choose…

How To Choose…

How To Choose…

Look for standardized supplements (USP)

How To Choose…

Consult doctor and your pharmacist

Single name supplements

Buy only single-name supplements

Too Good to be True

Be aware of claims that sound too good to be true

Question????

How many of you are currently taking a supplement?

Summary

Not food, not drug Supplements not meant to replace foods, but

to supplement diet Broadly definition under DSHEA (1994) No premarket approval Must be labeled as “Dietary Supplements”

“If it doesn’t have a side effect, it probably doesn’t work.”

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