Judge Rebuffs FDA on Effort to Ban Diet
Supplement
Submit written comments to:
Dockets Management Branch (HFA-305) FDA
200 C. St. SW
Washington, DC 20204
Re: [Docket No. 98 N-044] RIN 0910-AA59 Regulations on
Statements Made for Dietary Supplements Concerning the Effect
of the Product on the Structure or Function of the Body
To whom it may concern at FDA:
Your proposed rule will have an adverse effect on public
health by placing arbitrary and capricious limits on the
allowable health information to be presented to consumers at
the point of sale on dietary supplements, in complete
violation of the first amendment. Your definition of disease
is overly broad. You are clearly over reaching here. Under
proposed § 101.93(g)(1) a disease is any deviation from,
impairment of, or interruption of the normal structure or
function of any part,organ, or system (or combination therof)
of the body that is manifested by a characteristic set of one
or more signs or symptoms.)
Thus, in your zeal to "insure that dietary supplements
don't act as a disincentive to new drug development" (the
"immortal" words of Gary Dykstra), you would even disallow
structure/function claims relative to aging: ie, "hot
flashes". (Since when are "aging" or the menopause "disease
states"?)
Judge Dale Kimball just issued an injunction against you
forcing you to lift your ban on cholestin, which he declared
was a dietary supplement under the terms of DSHEA. You tried
to ban this safe Chinese red rice yeast extract which helps
lower cholesterol, because its sale angers Merck. We remind
you that dietary supplements were specifically exempted from
the harmonization language in the FDA Reform Bill, and that
Congress was flooded with faxes, email and outraged calls on
this issue as recently as October, 1997. Prior to that, in
1994 Congress received more mail on this issue than on
anything since the Vietnam war. For the sake of the public
health, we strongly urge you to stop blurring the distinction
between a disease, and a health condition. Stop trying to
harmonize our laws to EEC 65/65 in the EU, where dietary
supplements are regulated as "drugs."
Signed:__________________________________________________
Address:_________________________________________________
City:___________________________________________State:__________
Zip:___________
(Info provided by International Advocates for Health
Freedom)
Return to the previous
page
|