Deadline
to Register: Monday, May 19, 2014
If
you were to ask anyone in the regulated community whether FDA has been flexing
its muscles in the last few years, you would get a resounding “yes” (or a “you
betcha” in Minnesota). If you were
a fly on the wall at FDA, you might hear employees say something like: “This is
how we roll now!” That brings
us to a key question: is FDA right to push/exceed the limits of the law in order
to achieve objectives they believe advance important health objectives? On that question, where you stand
depends on where you sit.
In
the case of trans fat, FDA has taken their approach to an entirely new level and
the effect has been polarizing—people either love it or curse it. In doing so, FDA has raised a whole host
of issues, including:
Does FDA have the statutory authority to ban trans
fat?
Is banning a nutrient contrary to decades of nutrition
policy?
Should FDA evaluate the safety of nutrients in the diet
(i.e. fat, carbohydrate, protein) the same way they review additives?
Are epidemiological studies, which show a correlation (but
not causation) between a substance and a disease, relevant to GRAS
determinations?
Do statements of nutrition policy panels (e.g., Institute of
Medicine) operate to overturn GRAS determinations, including those made by
FDA?
Do the data actually show that trans fat is harmful to
health?
We
will cover these and other implications of FDA’s actions.
Lunch
and registration will start at 11:45 a.m.
The section’s annual meeting will start at Noon, followed by the CLE
program from 12:15-1:15 p.m. As part
of the annual meeting, the section will elect new officers and council members
for the 2014-2015
term.
Lunch
will be provided. Special meal
requests need to be received no later than Monday, May 19.
Presenter:
Greg
Thompson, Chief Food Law Counsel, General Mills
CLE
Credits:
1.0
Standard CLE credit will be applied for | Event Code: 189759
Remote
Participation:
Teleconferencing and webcasting is available. Please indicate that you will attend
remotely when registering.
Instructions will be sent via e-mail on
Wednesday, May 21.
Cost:
Food
Drug & Device Law Section Member:
$20.00
MSBA Member But Not A Food Drug & Device Law Section
Member: $25.00
Non-MSBA
Members: $30.00
Law
Students:
Free
Join
the Food Drug & Device Law Section: $28.00 MSBA members who are not members of the
Food Drug & Device Law Section can join the section & attend this event
for FREE. Pay the 12-month section
dues and your section membership will expire on June 30, 2015. Click
here to add the Food Drug & Device Law Section to
your membership and then contact Sue Bores to register for this meeting at no
charge.
Non-attorneys
who are not eligible for membership in the MSBA can join the Food Drug &
Device Law Section. Details are available here.
Credit
card payments should be made online:
http://msba.mnbar.org/Meetings/Meeting?ID=333
To
pay by check, use the registration form located here.
Need
to cancel? Please see our
cancellation policy.
Questions? Contact:
Sue Bores l sbores@mnbar.org l
612-278-6325