FDA ban on ephedra & pinellia/dietary supplement definition

[Guest guest]

Below you will find a summary of the definition of " dietary

supplement " taken from the FDA Center for Food Safety and Applied

Nutrition (http://vm.cfsan.fda.gov/~dms/dietsupp.html). Clearly, any

prepared herbal product (tablets, capsules, tinctures, granules) are

considered " dietary supplements " . It has absolutely nothing to do

with the product being used for weight loss or other " dieting "

application. We should be VERY concerned about the FDA regulations.

 

DEFINITION OF DIETARY SUPPLEMENT

FDA traditionally considered dietary supplements to be composed only

of essential nutrients, such as vitamins, minerals, and proteins. The

Nutrition Labeling and Education Act of 1990 added " herbs, or similar

nutritional substances, " to the term " dietary supplement. " Through

the DSHEA, Congress expanded the meaning of the term " dietary

supplements " beyond essential nutrients to include such substances as

ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and

mixtures of these.

 

The DSHEA established a formal definition of " dietary supplement "

using several criteria. A dietary supplement:

 

is 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, 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.

 

is intended for ingestion in pill, capsule, tablet, or liquid form.

 

is not represented for use as a conventional food or as the sole item

of a meal or diet.

 

is labeled as a " dietary supplement. "

 

includes products such as an approved new drug, certified antibiotic,

or licensed biologic that was marketed as a dietary supplement or

food before approval, certification, or license (unless the Secretary

of Health and Human Services waives this provision).

 

Hope this helps clarify the need to take action to stay/revise the

FDA ban proposal.

 

Jason Wright, MS, LAc