Dietary Supplements

True or false, quality assurance programs ensure safety and efficacy.

False

DS Hazards:

False advertising/ quackery Consumer induced - over supplementation (intentional and accidental) - adverse effects - medication interactions - disease interactions

Patient Counseling (1):

- DS can interact w/ several medications. always inform your HCP of all DS you are taking - purchase products w/ QA Seal or from large, reputable manufacturers - stay on the same brand and formulation. those who don't have results w/ first brand may consider another - know which DS you are taking and report to HCP - report and ADRs - read labels carefully - never share DS w/ others - do not use products w/o lot number and expiration date; discard after 1 year if not present

Patient Counseling (2):

- do NOT use products w/o dosing recommendations or manufacturer info. - seek advice from pediatrician before giving to your child - do NOT use DS when PG, trying to become PG, or breast feeding - consult you PCP if considering DS for life-threatening conditions - natural does not mean safe; report any ADRs to PCP immediately - do NOT take a DS for a condition already being treated w/ medication - do NOT take these products w/ alcohol

Contents of DS Label:

1. name of product PLUS the word "supplement" 2. manufacturer, packer's, or distributors name & place of business 3. directions for use 4. supplement facts listing dietary ingredients, amount per service size and % daily value 5. total weight of blend and components of blend 6. fillers, artificial colors, sweeteners, flavors, or binders

FDA tip-offs:

1. personal testimonials 2. quick fixes 3. "all natural" 4. "miracle cure" 5. conspiracy theories 6. "one product does it all"

Evidence Table:

ARR= absolute risk reduction NNT= number of patients needed to treat for the study period to prevent 1 event

True or false, health and nutrient claims do not require FDA approval.

False

"Pharmaceutical grade" is a term that is standardized by the FDA and is approved in FDA laboratories. True or False.

False

True or False, use of alcohol does NOT cause sedation and disulfiram reactions in special populations.

False

True or false, disease treatment claims are allowed in supplements.

False

What are the 3 types of claims?

Health claims Nutrient claims Structural claims

True or False, 1994 Dietary Supplement Health and Education Act (DSHEA) allows FDA to regulate Dietary Supplements (DS) under the standards that apply to food preparation (Center for Food Safety and Applied Nutrition). Required establishment of Good manufacturing practices (GMP).

True

True or False, DS cannot claim to diagnose, cure, treat, or prevent disease; only FDA approved medications can make these claims.

True

True or False, Dietary supplements are classified as foods, NOT drugs unless it is a "new dietary ingredient" or the manufacturer is making a claim about a product, there is no mandate to register a product with the FDA or obtain FDA approval before selling supplements.

True

True or False, FTC is responsible for advertising claims and requires that claims of safety and efficacy be supported by "competent and reliable scientific evidence (e.g. tests, analysis, research studies)."

True

True or False, Manufacturer is responsible for product's safety and efficacy with FDA providing post-marketing surveillance.

True

True or False, adding prescription drugs to dietary supplements is not allowed and it is considered adulteration.

True

True or False, premarket notification (75 days in advance) is required for "new dietary ingredients" which have not been previously marketed.

True

True or False, proof of safety, effectiveness, and post-marketing surveillance are not required for supplements.

True

True or False, there are 2 regulating bodies that have authority over dietary supplement claims. The FDA regulates the labeling And packaging associated with the product. The FTC or Federal Trade Commission is responsible for regulating advertising claims.

True

True or false, "one product does it all" is an FDA tip off.

True (A New York firm claimed its products marketed as dietary supplements could treat or cure senile dementia, brain atrophy, atherosclerosis, kidney dysfunction, gangrene, depression, osteoarthritis, dysuria, and lung, cervical and prostate cancer. In October 2012, at FDA's request, U.S. marshals seized these products)

DSHEA Definition of DS:

a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid (enzymes, organ tissue, or glandular extract), a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients

A medication is being picked up by a patient. Out of the following, which is NOT considered special populations? a. older adult b. teenage adult c. liver disease adult d. surgery patient e. pregnant patient

b. teenage adult

Extracts=

concentrates from soaking in alcohol, water, and/or oil

Adulteration=

containing impurities, metals, enhancing substances (simvastatin), hazardous substances (i.e. poisons), poor quality (i.e. inferior ingredients), unsafe, represents significant and unreasonable risk of illness or injury when used in accordance with suggested labeling.

Health Claims:

describe the relationship between a food, food component or dietary supplement and the reduction in risk of a disease or condition

Nutrient Claims:

describe the relative amount o fa nutrient or dietary substance in a product.

Structure Claims:

describes how the supplement maintains normal healthy structure of function of the body. Ex: calcium builds strong bones... or fish oil supports healthy cholesterol levels...the manufacturer cannot legally claim that fish oil reduces high cholesterol levels.

Tinctures=

fluid extracts of chopped herbs with alcohol

Freshly pressed juice=

may use an alcohol extract (Echinacea purpurea ) alcohol increases the shelf-life

A rating:

means the supplement has a similar level of evidence as would be required to pass the FDA approval process. Effective supplements are generally considered appropriate to recommend. Likely effective products have a high level of reliable evidence and are also generally considered appropriate to recommend

What does special populations consist of?

older adults children pregnancy and lactation kidney disease liver disease surgery

Extraction ratio=

parts of herb used to make 1 part of extract [that it takes X part of the product to make one part of the extract. For example of five to one ratio would mean that it would take five parts of the product to one part of extract. Ginko is often prepared in a 50 to 1 ratio. Meaning 50 parts of the ginkgo leaf were used to make one part extract]

Teas=

root, bark, leaf, fruit

Misbranding=

to brand or label incorrectly, falsely, or in a misleading way. (e.g. making false claims, omitting required information, inaccurate information on the label) Note: package inserts and medication information sheets are considered part of the label

Categories of Supplements that FDA cites as "Clearly Problematic"

•Treatments of potentially life-threatening diseases (e.g., HIV, cancer) or serious medical conditions such as Alzheimer disease • Weight-loss products • Chelation products • Treatments for behavioral disorders such as attention-deficit/hyperactivity disorder or autism • Treatments for intellectual disability or Down syndrome • Colloidal minerals and silver products • Supplements for addiction (e.g., smoking, drinking, opiate use) • Supplements for body building or athletic performance enhancement • Supplements for sexual enhancement (e.g., impotence)