Weight Loss supplements as drugs?

[Guest guest]

See below...feel free to pass on as this clearly is an attempt to further

regulate the supplement industry before allowing GMPs and the other programs to

fully take effect. It is interesting to note that GSK (Glaxo) filed a similar

petition with the FSA about two years ago asking fo weight loss productsto be

considered more of a drug and obesity as a disease by BMI criteria, thus GSK

with ALLI in their pocket make seek to use influence with association and the

Regulatory authorities to grab the weight loss market for themselves.

Action time?

I hope that all interested send letters to the FDA (www.fda.gov) about the issue

below and the attached.

It has been learned that the American Dietetic Association (ADA), along with

The Obesity Society (formerly 'NAASO " ), Shaping America's Health and

GlaxoKline

Consumer Healthcare, LP, has filed a joint citizen's petition with the

Food and Drug Administration (FDA), asking the Agency to treat weight

loss claims for dietary supplements as disease claims. The petition

requests FDA to require manufacturers of weight loss supplements to

obtain FDA review of their claims before the products can be sold. We

are curious whether the petition confuses " disease claims " (which are

not permitted for dietary supplements at all) and " health claims " (which

are permitted for supplements but must be reviewed and approved by FDA)

since it refers to " disease claims " yet clearly contemplates FDA review

and approval of certain claims for weight loss and weight maintenance.

Attached, please find the letter and petition that those groups

submitted to the Agency.

S. Kalman PhD, RD, CCRC, FACN

Director, Nutrition & Applied Clinical Research

Miami Research Associates

6141 Sunset Drive #301

Miami, FL. 33143

or x3309

Fax

ADA petitions FDA to crack down on natural weight-loss claims

By sen

CHICAGO (Apr. 22) The American Dietetic Association last week filed a

joint citizen's petition to the Food and Drug Administration regarding

the weight-loss claims made by marketers of

dietary-supplement-containing diet aids.

" The American Dietetic Association this week is joining with three other

groups in asking the U.S. Food and Drug Administration to raise the

scientific standard bar for weight-loss supplement health claims, " the

ADA noted in its weekly online newsletter published Friday.

The groups, which filed the petition April 17, are asking the FDA for

changes in the regulation of weight-loss supplements so that

manufacturers would be required, on the basis of credible scientific

evidence, to obtain prior FDA approval of weight-loss claims.

Traditionally, regulating weight-loss claims made in advertising has

fallen under the purview of the Federal Trade Commission. That would

change, however, if the FDA were to rule that weight-loss claims are a

disease state claim, as the citizen's petition argues.

The ruling could weaken the ability of makers of natural diet aids to

market their products to consumers, stacking the deck in favor of

GlaxoKline's over-the-counter medicine weight-loss drug Alli, the

one brand that would still be able to make weight-loss claims under

those restrictions.

The move would potentially drive more of the $180.3 million in diet aid

tablet sales that Alli doesn't already control into GSK's bucket.

According to Information Resources Inc., Alli alone generated sales of

$118.9 million for the 52 weeks ended Jan. 27, across food, drug and

mass channels (excluding Wal-Mart), accounting for 32.2 percent of all

dollars spent in the category and 13 percent of all units purchased.

GSK, according to the ADA report, is one of the companies that has

signed the petition. The other petitioners are Shaping America's Health

and the Obesity Society.

The general public already assumes the FDA is governing dietary

supplement diet aid claims, the ADA claims. According to ADA statistics,

some 34 percent of consumers have used weight-loss products, and 46

percent believe that the FDA regulates natural diet aids for efficacy,

which it does not.