| Comment Record |
|
Commentor |
Ms. Debra Markel |
Date/Time |
2003-03-19 19:27:10 |
|
Organization |
Apothecarian Herbals, LLC |
|
Category |
Health Professional |
| Comments for FDA General |
| Questions |
|
1. General Comments
|
March 5, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Dear Sir/Madam,
I own/work for a health food store/dietary supplement company in Anytown, U
SA, and have been in the
natural products industry for several years. Both my customers and I apprec
iate the significance of
the Dietary Supplement Health and Education Act of 1994 with regard to prot
ecting our right to
choose how we care for ourselves.
I am concerned that FDA has only just begun to implement key sections of DS
HEA. For instance, the
agency recently released its proposed good manufacturing practices for the
industry, and yet is
immediately calling for suggestions for increased legislative authority in
order to better regulate
the supplement industry. Shouldn't you first give DSHEA a chance to work as
it was intended to
before calling for new laws?
Please also don’t overlook that DSHEA actually increased FDA's enforcement
powers. FDA can seize a
dietary supplement if it presents an unreasonable or significant risk of il
lness or injury. In
addition, the government can stop the sale of an entire class of dietary su
pplements if they pose an
imminent public health hazard. In sum, I agree with the former FDA commissi
oner, Dr. Jane Henney,
that DSHEA provides FDA with the necessary legal authority to protect publi
c health.
DSHEA improved consumer access to dietary supplements and information about
them, while increasing
consumer protection against unsafe products and false and misleading claims
. I strongly support
DSHEA and do not think any additional legislative authority is necessary fo
r FDA to regulate ephedra
or any other dietary supplement.
Sincerely,
Debra M. Markel
Powhatan, VA 23139
|
|