DSHEA and Regulation of Natural Products

Issues with DSHEA

- DSHEA allows the FDA to regulate dietary supplements - Excludes dietary supplements from strict purity and potency standards applied to prescription and nonprescription drugs - Clinical trials not required to prove safety and efficacy of dietary supplements - The manufacturer is responsible for product's safety and efficacy -DSHEA requires that the FDA must prove that a dietary supplement is unsafe in order to be taken off the market - Enforcement must be based on court- presented evidence

this is considered misbranding

- Manufacturers fails to follow labeling requirements - Manufactures claims that product will diagnose, cure, mitigate, treat, or prevent disease - Manufacturer fails to include name or place of manufacturer, packer, or distributer on label - Manufacturer fails to include accurate statements regarding quantity of the contents

new ingredient dietary supplements manufacturers must

- Notify FDA 75 days in advance of its intent to market the new product - Provide FDA with evidence the dietary supplement is safe in humans

US Pharmacopeia

- Voluntary verification program - Products with USP certification have a seal of

Federal Trade Commission (FTC) is responsible for advertising claims on ______

- print - advertisements - infomercials - catalogs - direct marketing materials

labeling requirements for supplements

- product name - net quantity of contents - serving size (dose) - ingredients list (supplements fact box) - directions - name and address of manufacturer - allows structure and function claims - plant name and part use

lack of standardization in manufacturing leads to

-Plant misidentification -Drug adulteration -Substitution of cheaper herbals -Adding fillers

three types of dietary supplement claims

-health claims -nutrient content claims -structure function claims

top then herbal supplement sales by US natural health and food outlets

1. Cannabidiol 2. Turmeric 3. Elderberry/Barley grass 4. Wheatgrass 5. Ashwagandha 6. Aloe vera 7. Flax seed/Flax oil 8. Mushrooms 9. Echinacea 10. Milk thistle

top ten herbal supplements sales by US Mainstream Multi Outlet Market

1. Horehound 2. Echinacea 3. Elderberry 4. Turmeric 5. Cranberry 6. Ivy leaf 7. Ginger 8. Garlic 9. Cannabidiol (CBD) 10. Green tea

publication of first USP

1830

renewed interest in herbals

1960s

FDA OTC Drug Review Panel

1972, scientific review of OTC product ingredients in use for safety, effectiveness, and labeling standards

____% of the world population is dependent on traditional medicine for their primary health care

80%

what happened in 1993 with health food supplement products

A campaign to save the health food supplement industry spearheaded by health food stores

Nutritional Labeling and Education Act (NLEA) of 1990

Allowed for limited health label claims for food and health food supplement for seven categories (no other food or food supplements were allowed to include any disease label)

Dietary Supplement Health and Education Act of 1994

Defined "dietary supplements" as vitamins, minerals, herbs, botanicals, fatty acids, and amino acids as long as they are prescribed in dosage forms, such as capsules, tablets, liquids, gels or powders, used orally

any health claim on a supplement requires __________

FDA approval, it needs to describe relationship between a food, food component, or dietary supplement ingredient and resulting reduction in risk of a disease or health-related condition

Category I ingredient

GRAS- generally recognized as safe and effective for the claimed therapeutic indication

problems with labeling on herbal products

If information (indication) appeared on the label, product was confiscated by the FDA as an unapproved drug

drug

Products labeled to diagnose, treat, prevent or mitigate a disease

Kefauver-Harris Amendment of 1962

Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval .

Good Manufacturing Final Rule (2007)

Requires manufacturers of dietary supplements to assume responsibility for premarket product safety - Dietary supplements must be manufactured without adulterants or impurities - Must be labeled accurately- Raw materials must be evaluated by the manufacturer

what disclaimer do dietary claims need to have

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

dietary fat

cancer

fiber-containing grain products

cancer

fruits, vegetables

cancer

Federal Food, Drug, and Cosmetic Act of 1938

drugs must be proven safe before marketing

Food and Drug Act of 1906

drugs must meet standards of strength and purity

true or false: Some products are standardized to only one active constituent

false, it can be one or more

problems with herbal products

found undeclared contaminant, substitute, and filler species, or none of the labelled species in more than a 27% of products

fiber containing grain products, fruits, vegetables

heart disease

saturated fat and cholesterol

heart disease

some harmful things that can be found in herbal supplements

heavy metals, pesticides, arsenic

sodium

hypertension

consumerlab.com

independent company that tests products for identity, purity, and consistency of label ingredients

NSF International

independent, nonprofit that provides certification of dietary supplements

Category III ingredient

insufficient data available to permit final classification

Category II ingredient

not generally recognized as safe and effective or having unacceptable indications

calcium

osteoporosis

pharmacognosy

study of medicinal drugs obtained form plants or other natural sources

Phytotherapy

study of the use of extracts of natural origin as medicines or health-promoting agents

true or false: FTC requires dietary supplement claims of safety and efficacy to be supported by "competent and reliable scientific evidence"

true

true or false: some companies have made "standardized extracts" by adding expected active chemical to plant material to obtain the appropriate spike on high performance liquid chromatography (HPLC)

true

herbal medicine

use of roots, stems, leaves, flowers, or seeds of plants to improve health, prevent disease, and treat illness

characteristics of herbal medicine

• Constituents- Very complex • Plant constituents vary- Soil, weather, storage, manufacturing process • Active ingredient often unknown• Several constituents may be responsible for effects