Dr. Bubalo lecture #3....herbal safety issues

[Guest guest]

Dr. Bubalo lecture, #3....herbal safety issues

Herbals and supplements are regulated as food under the Dietary

Supplement Health and Safety Act (DSHEA). This act:

*stopped FDA from regulating supplements

*established new Supplement category

*made FDA responsible for proving a supplement unsafe

*increased consumer access to supplements

*required specific labels

*did not require companies marketing supplements to forward

complaints to the FDA

*restricted claims that a supplement could be for curative purpose

*did not require GMP (Good Manufacturing Practices)

Good Manufacturing Practices (GMP):

*current food and supplement manufacturers do not have to follow

medication production standards

*no standard " quality " to compare to

*United States Pharmacopoeia (USP) is setting standards for strength,

quality and purity

*also standards for disintegration, dissolution, packaging, labeling,

etc.

*the preparation method is reproducible to insure the potency or

safety of the product

*National Nutritional Foods Association (NNFA)

When you purchase a supplement..........

*who ensures the bottle contents, checks for impurities and

contaminants

*check for a seal of approval

*there are 2 large oversight groups for Certified Brands........USP

and NSF

*also Consumer Lab and NNFA (National Nutritional Foods Association)

Ephedra ban.....took effect 4/2004

>17,000 reports of adverse events, primarily cardiac events, however

strokes and other side effects seen

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Safety and Efficacy

*does it cause harm at any dose? are there increased effects or side

effects that will cause problems? is the manufacturer using GMP? in

what part of the plant is the active ingredient found? what is the

contamination risk? will it affect other therapies I am using?

*has the agent been used in the condition you are interested in? has

the agent ben used in people like you? how much (what dose) is used

to treat the condition? how strong is the evidence?

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Reading the Label

*name, including plant part

*structure/function claim

*directions for use

*supplement facts panel with other ingredients in descending order of

content by common name or proprietary blend

*name and place of business of manufacturer or distributor

*address to write for more product information

*NSF, CL or USP label

Dr. Bubalo..... " don't take things from animal source, ie bovine

(beef) " ......because of issues such as mad cow disease.