Re: Digest Number 108

[Guest guest]

In a message dated 12/29/02 7:14:15, lipodystrophy writes:

the FDA is about to allow unverified health claims on food labels.

They already do this, essentially, on food supplements. The result will be an increase in fraud.

JB

[Guest guest]

In a message dated 12/29/02 7:14:15, lipodystrophy writes:

What additive(s) is(are) being used to disperse lipids?

I couldn't tell you. Each medication contains a host of stabilizers, surfactants, pH adjusters, whatever, depending on the manufacturer and the specific medication.

JB

[Guest guest]

At 09:28 AM 12/29/2002 -0500, you wrote:

>In a message dated 12/29/02 7:14:15, lipodystrophy writes:

>

>>the FDA is about to allow unverified health claims on food labels.

>

>They already do this, essentially, on food supplements. The result will

>be an increase in fraud.

Not entirely. The only claims that can be made for food or dietary

supplements are related to their effects on structure and function. These

must also be based on some degree of scientific agreement. The argument

formerly made by industry was that the phrase " significant scientific

agreement " set a bar as high or higher than over-priced drugs. Without

patents, industry claimed, there was no rationale to do the degree of

studies required. Over the past few years, the industry has seen

substantial increases in sales, thus the industry is richer than it once was.

By contrast, they are NOT permitted to make claims about medical

indications without data that rises to a reasonable, scientific level.

Thus, a food product or supplement can claim that calcium and vitamin D3

are good for your bones. They cannot say that they will treat osteopenia.

Can fraud happen? Are false claims made within these parameters? Are false

claims made *outside* these parameters? Of course. That happens with

pharmaceutical drugs too--witness the hit-and-run advertising that they put

on the air, get people freaked about a " new " disease and increase

prescription rates. Sleaze tends to happen with big business. There needs

to be oversight, regulation and cost controls for both the pharmaceutical

and nutriceutical industries.

ly, this does not help those of us who choose to eat or use

supplements for medical reasons. We need a practical and sensible

regulatory system to

1) evaluate potency and purity of foods and supplements;

2) evaluate medical value through good clinical trials.

Funding for the latter can come from industry and the NIH.

By contrast, FIAR hopes to develop novel sources of funding to undertake

studies (e.g., foundation grants, certain corporate contributions) to

evaluate medical efficacy--or lack thereof.

M.