Mandatory AERS for Dietary Supplements

[Guest guest]

CHA was asked to support the following amendment to DSHEA. My concerns

follow the press release

 

AHPA Update

April 1, 2004

IOM/NSR Calls for Mandatory AERs for Dietary Supplements

 

- Also recommends FDA 800-number on all dietary supplement labels -

 

A special committee of the National Research Council (NSR) and the

Institute of Medicine (IOM) of the National Academies held a press

conference this afternoon to announce the publication of a report

titled Dietary Supplements: A Framework for Evaluating Safety. Included

in this report was a specific recommendation to amend DSHEA “to require

that a manufacturer and distributor report to the FDA…any serious

adverse event associated with use of its marketed product….”

 

The Committee on the Framework for Evaluating the Safety of Dietary

Supplements was established at the request of the Food and Drug

Administration over 2 years ago and was charged with developing a

“framework” for categorizing and prioritizing dietary supplement

ingredients based on safety issues. The report issued today “outlines a

science-based process for assessing supplement ingredients, even when

data about a substance’s safety in humans is scarce.”

 

The Committee was chaired by Barbara Schneeman, Ph.D., University of

California, Davis. Dr. Schneeman stated in this afternoon’s press

conference, “Many of the supplements on the market are probably safe.”

She went on to say, “With the approach devised by the committee, it is

possible for the FDA to conduct effective safety evaluations within the

current regulatory framework established by DSHEA… [h]owever…the

committee noted that constraints imposed by aspects of DSHEA limit the

agency's ability to conduct these evaluations as effectively and

efficiently as possible [and have]… recommended some changes that could

mitigate these constraints and make the law more effective in meeting

the goal of protecting public health.”

 

“AHPA and its members have taken the lead in calling for mandatory

submission of serious adverse events,” commented Michael McGuffin,

AHPA’s President. “It is satisfying that an organization of this

stature has taken a position that incorporates our recommendation in

this matter, as identified in the Citizen Petition that AHPA filed over

a year ago.”

 

The Committee also recommended that the toll-free number for FDA’s

MedWatch should be printed on all supplement labels, an idea that

McGuffin called “inappropriate, so long as all other consumer goods –

from foods and drugs to household cleaners and pesticides – do not bear

such a labeling burden.”

 

The Committee’s press release and a link to the full report can be

found at

http://www4.nationalacademies.org/news.nsf/isbn/

0309091101?OpenDocument. The report can also be purchased from The

National Academies Press:

http://books.nap.edu/catalog/10882.html?onpi_newsdoc040104.

            's reply:

 

What concerns me about adverse event reporting as the main basis for

FDA regulating a dietary supplement is the lack of substantiation of

these adverse events in the recent ma huang debacle. Not to mention

the incredible hypocrisy of the FDA in this matter. Sudafed contains

far more pseudoephedrine than the now banned weight loss supplements,

yet this product remains legal. I can hardly imagine ma huang causes

more problems annually than sudafed, probably not even close. The FDA

could care less about safety. Ephedrine alkaloids in dietary

supplements caused 155 deaths in ten years, while tobacco has caused

4.3 million in the same time. Any mandatory AERS provision would

probably only be supported by CHA if DHSEA was also amended to specify

more precisely what constituted an adverse event and what magnitude of

adverse events justify controls as restrictive as a total ban.

 

This debate must necessarily consider the various hypocrisies inherent

in FDA regulation of far more dangerous rx and OTC drugs, not to

mention tobacco. It also must be clarified that the FDA cannot ban

dietary supplements by banning molecules but only by a true epidemic of

safety for a given product. The extension of the FDA ephedra ban to

ban xia shows they cannot be trusted to protect the public good as

there never has been and there never will be a single adverse event

related to the ephedrine content of ban xia. I will only support a

measure that would serve to extend FDA power if they are simultaneously

restrained in their misguided and probably illegal agenda of molecular

regulation. I believe this was neither the letter or spirit of DSHEA

and I do believe a lawsuit may ultimately be necessary to stop them

from utilizing this tactic in the future and reversing its use to this

date.

 

 

 

Chinese Herbs

 

 

FAX:

 

 

 

[Guest guest]

 

 

I support mandatory AER (adverse event report) submissions. In fact, Blue Poppy

Herbs is considering being the first Chinese herb

company to raise the consciousness about and promote the submission of AERs on

its website. Several years ago, the Registry of

Chinese Herbal Medicine (RCHM) in the U.K. promoted its own AER program for

Chinese herbal medicines as a way of getting out in

front of the bad press on Chinese herbs. I think we should do the same thing

here as an industry. Submitting AERs is a way of

showing the public that we are not the bad guys, that we are acting in good

faith, and that we are trying to be mature, responsible

medical professionals. Whether the FDA chooses to use AERs in its deliberations

or not (or genuinely or ingenously), I think we as a

profession only look good if we volutinarily popularize and promote the

submission of AERs. After all, if our products are as safe as we

think they are, what do we have to hide?

 

For those on this list that don't know what an FDA AER submission form looks

like, go to: www.fda.gov/medwatch/SAFETY/3500.pdf

 

Bob