• does not require a physicians order
• generally regardedas safe touse without direct doctor supervision
• requires to submit clinical data tomfda for approval prior to marketing

• use of plantsfor pharmacological purpose
• a.k.a. botanicals, phytotherapy
• does not requie a physicians order
• folks medicine tradition

• organic substances found in food
• minute quantity necessary
• essential for normal growth and metabolism
• not synthesized by the body
• 2 types 

1. fat-soluble
2. water-soluble

• ordinary/conventionalmedications
• use of medications & surgeryto fight disease
• received by most americans

homeopathic

• health is more than the absence of disease
• sees symptoms as signs that the body is attempting to help its self
• uses herbs, diet, &vitamins to improve health
• based on law of similars

• live micro-organisms(mostly bacteria) that help improve the intestinal tract environment
• humans are 90% bacteria cells and only 10% animals cells

• product (other than than tabacco) intended to supplement the diet and contains one or more of the following:

1. vitamin
2. mineral
3. herb
4. amino acid

• increases daily intake of the constituent

• 1800s-1900s

• pharmaciessold a # of leaves, roots, teas, powders, and herbal extracts
• scirntific botanicalstudiesbasedon folkloric herbal use conducted

• 1st united states pharmacopeia- naional formulary included an axcess of 400 botanical monographs

• isolation and production of pure chemical compounds increased
• chemical synthesis of structural analogs also increased
• FDAs greatest contribution= demand of manufacturer to prove safety and efficacy of products

• USP convention adopted a resolution to explore setting standard and developing information for botanical used as dietary supplements

unique challenge to develop clinical criteria

• botanical substances accounts for less than 0.003% of the USP - NF entries

• USP Dietary Supplement Compendium(DSC)
• 500 + dietary supplements and ingredients
• contains quality specification for dietary supplement:

1. identity
2. strenght
3. purity
4. performance characteristics

• herbs and vitamins classified as dietary supplements

• studies indicate 24-60 million americans use herbs annually

• world health administration

• german federal health adency forms committee to study safety and efficacy of herbs

• physicians
• pharmacists
• scientists (toxicologists &biostatisticians)
• laypersons

• published monographs for191 approved and  108 unapproved herbs

• federal food, drug, &cosmetic act
• replaced the F&D Act of 1906
• required label of processed or packaged food, net weight, & name, address of manufacturer

• nutrition labeling  & education act
• added herbs or similiar nutritional substances  to definition of dietary supplements

• dietary supplement health and education act
• dietary supplement were nop longer subjected to pre-market safety evaluations
• expanded meaning to include ginseng, fish oils, psyllium, enzymes, glandurals, and various mixtures of these substances

• labels may not include claims about use in DX, prevention, alleviations, TX, or cure of a specific disease

• this statement has not been evaluated by the food and drug administration. this product is not intended to dx, treat, cure, or prevent any disease

• consist ent level of active ingredients from dose to dose proven by the manufacturer

• indicates product potency and ensures consistent effictiveness

• product is assayed and contains (within a range of + or -10%) a certain level must of constituents thought to provide some health benefit

• "standardized" product should be able to provide a general "fingerprint analysis" to ensure batch to batch reproducibility

• voluntarily participation by  manufacturers to verify:
• fine chemicals, vitamins
• minerals, amino acids
• botanical extracts, non-botanicals

• common use:
• prevention and TX of colds