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