DIETARY HEALTH SUPPLEMENT

What is a Dietary Supplement?

• The Dietary Supplement Health and Education Act, approved by
Congress in 1994, defines a dietary supplement as a product that:
• Is intended to supplement the diet
• Contains one or more ingredients (like vitamins, minerals, herbs, amino acids
or their constituents)
• Is intended to be taken by mouth
• Is labeled as a dietary supplement
Who Regulates Dietary Supplements?
• The Food and Drug Administration (FDA) regulates dietary
supplements
• Dietary supplements are regulated differently than prescription and
over-the-counter (OTC) medicines
• Dietary supplements are regulated as foods because they are
intended to supplement the diet
 Differences in Regulation
Regulated As Requirements
Prescription Medicines Medicine • FDA considers new drugs to be unsafe until they are proven
safe through clinical trials
• Intended to diagnose, treat, cure or prevent disease
Over-the-counter medicines Medicine • FDA considers new drugs to be unsafe until they are proven
safe through clinical trials
• Intended to diagnose, treat, cure or prevent disease
• You must be able to:
o Self-diagnose
o Self-treat
o Self-manage
Dietary Supplements Food • FDA considers dietary supplements safe until they are proven
unsafe
• Not required to test new ingredients or supplements in clinical
trials
• Intended to supplement the diet
Dietary Supplement Uses
• Dietary supplement manufacturers are not able to claim that the
product can diagnose, treat, cure or prevent disease
• However, dietary supplements have been evaluated in clinical studies
and therefore are commonly used to support many bodily functions
and specific health needs
 Who Uses Dietary Supplements
Pregnant women Nursing mothers

Strict vegetarians

Senior 2013: estimated dietary

citizens supplement use 68% of
people
People with food
allergies or intolerances
What are Dietary Supplements Used For?

Desire to Desire to Promote Bone

Improve Health Maintain Health Health
(45%) (33%) (25%)
What Should I Look For On the Label?
• The term “dietary supplement”
should be listed on the label
• Contain a dietary supplement
facts panel that includes amounts
of all dietary ingredients Look for the
• Quality Indicators – Independent
USP mark
verification
What Should I Look For On the Label?
• What dietary supplements cannot do:
• Make claims to “diagnose, mitigate, treat, cure, or prevent
disease”
• Make false and misleading claims
How to Read
the Label
Dietary Supplement Label

Suggested Use:
How to use the product safely and correctly
Dietary Supplement Label
Serving Size:
How many tablets or capsules you
should take

%DV:
Indicates the amount that the
serving size represents
Dietary Supplement Label
Lot Number:
• Series of letters and numbers that help
track a product

Expiration Date:
• How long the ingredients will be effective
Dietary Supplement Label
Ingredients:
• Vitamin or mineral ingredients in each
tablet or capsule
• List of potential allergens, fillers,
binders, flavorings also included

Manufacturer Contact Information:

• Address and telephone number should
be provided
• Contact with questions or concerns
Dietary Supplement Safety
Tips for Using Dietary Supplements Safely
• Always talk with pharmacist and doctor before starting or stopping a
dietary supplement
• This is especially important when:
• A supplement contains an ingredient that is used for the same reason as
another medicine you are taking
• A supplement contains multiple ingredients
• You are combining dietary supplements with prescription or over-the-counter
(OTC) medicines
• Report side effects to MedWatch: FDA Safety Information and
Adverse Event Reporting Program
• Toll Free 1-888-SAFEFOOD, 1-888-723-3366
Are Dietary Supplements Safe?
• Yes, when used responsibly in moderation and with careful monitoring
• Despite good manufacturing practice rules, supplements may be found to
contain contaminants, impurities and harmful ingredients
• Both intentional and unintentional contamination can occur
• 20% of all cases of liver damage in the US are from dietary supplements; this is up from
7% from 2004
• Can interact with prescription medicines
Look-Alike, Sound-Alike Dietary Supplements
• Dietary supplements that start with the same letters
• For example: “gin”
• Ginkgo and Ginseng
• Dietary supplements with very similar names/spellings
• For example: DHEA and DHA
Common Interactions with
Dietary Supplements
Medicines that Interact with
Dietary Supplements
• Birth Control Pills/Morning After Pill
• Some dietary supplements may speed up how quickly birth control pills are
removed from the body
• This increases the chance of pregnancy
• St. John’s wort
• St. John’s wort supplements that contain the ingredient hyperforin interfere with birth
control pills
• Do not combine birth control pills with St. John’s wort
Medicines that Interact with
Dietary Supplements
• Warfarin (Coumadin®)
• The INR is a test that measures how quickly your blood clots
• The INR is used to help determine the dose of warfarin
• Many medicines interact and can increase or decrease your INR test
• Coenzyme Q10, Cranberry, Vitamins E & K, Garlic (raw garlic and garlic
extracts, Fish Oil
Medicines that Interact with
Dietary Supplements
• Some dietary supplements may block how platelets work
• Ineffective platelets can’t stop bleeding once it begins
• Vitamin E (800 Units or more per day)
• Vitamin K
• Garlic (raw garlic and garlic extracts)
• Very high doses of fish oil (although evidence of this interaction is not that
strong)
Commonly Used Dietary
Supplements
Multivitamins
• Vitamins are nutrients that our body does not make on its own; we must
obtain them from the foods we eat, or through supplements
• They are essential for providing good health and are necessary for many life
functions
• Not everyone needs a multivitamin
• Supplements are best when accompanied by a well
balanced diet
• Supplements should not replace a healthy diet
• Food provides calories and energy that are required
for daily activities, vitamin
• Supplements do not provide energy or calories
• Some people do need a multivitamin
Garlic
• How it works: used for heart health area to support normal
cholesterol levels
• Effects: May have garlic breath and body odor even with tablets;
rarely nausea, low blood pressure
• Safety: Generally safe, but can interact with many medicines
• Warfarin, blood thinners, some HIV medicines
Melatonin
• How it works: natural substance made in the brain’s pineal gland
• Works quickly (within 30 – 60 minutes); take once nightly 30 minutes
before desired bedtime
• Helps people fall asleep faster, better sleep and helps with daytime
alertness
• Well tolerated; rarely headache, nausea, some drowsiness and dizziness
• May worsen mood in people who suffer from dementia (a decline in
memory and thinking)
Glucosamine Sulfate
• How it works: amino-sugar naturally produced by cartilage cells serves
as cartilage nutrient
• Glucosamine sulfate is the most well studied form
• May lead to less pain and stiffness; can take 1 to 2 months to see a
difference
• Well tolerated; rarely upset stomach, headache, constipation/diarrhea
• Keep a diary of mobility, stiffness, pain
Dietary Supplements To Avoid
• Products claiming to be alternatives to FDA-approved drugs or to have effects similar
to prescription drugs
• Products claiming to be a legal alternative to anabolic steroids
• Products that are marketed primarily in a foreign language or those that are marketed
through mass e-mails
• Sexual enhancement products promising rapid effects, such as working in minutes to
hours, or long-lasting effects, such as working for 24 to 72 hours
• Product labels warning that you may test positive in performance enhancement drug
tests
• Weight loss supplements as they have not been proven more effective than diet and
exercise
Summary
• Scientists are just now beginning to study dietary supplements
• There is much that we don’t know:
• What is the exact active ingredient in a plant with thousands of chemicals?
• What dose of this active ingredient is best in order to see an effect?
• What dose is unsafe?
• How do these active ingredients affect pregnancy?
• Can supplement ingredients be transferred through a mother’s milk to the
infant?
• Do these active ingredients help some cells and harm other cells in the body?
Summary
• Dietary supplements contain active ingredients just like prescription
medicines and may lead to side effects and possible interactions with
other medicines
• Unlike prescription medicines, dietary supplements are not required
to undergo testing for safety or effectiveness in clinical studies before
being marketed
• Always read and follow the instructions on the label
• If you take supplements tell your doctor before undergoing surgery
• Always talk to your pharmacist and doctor before selecting or using
dietary supplements
Questions?
• Your Name and Credentials
• Your Practice Site [optional]
• Your Contact Information [suggested]

Always talk to your pharmacist!