Final Assigned Student Presentations
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(One to three minutes per student)
II. Jurisdiction and Enforcement
1. The FD&C Act should apply to intrastate as well as interstate
For: Hutt; Against: Nuzzo.
2. FDA should be given increased enforcement authority (e.g., detention,
recall, and subpoena power).
For: Roskes; Against: Silliman.
III. Regulation of Human Food
1. FDA should be required to approve all food labeling prior to use.
For: J. Johnson; Against: Dichter.
2. The function and quantitative amount of every food ingredient
should be required to be declared on the food label.
For: Williams; Against: Server.
3. Food standards should be abolished.
For: Dunkum; Against: Liang.
1. The best food nutrition label on page 198 of Hutt &
Current label: Topol
Improved label I: Liao
Improved label II: Kaufman
The final FDA label now appearing in grocery stores: Carlin
None of the above: Sheft
2. FDA should strictly control the fortification of food with nutrients.
For: Solt; Against: Urso.
3. FDA should reduce the restrictions on disease prevention claims
For: Lin; Against: Bolce.
1. All food should be labeled with the filth content.
For: H. Johnson; Against: Fuller.
2. The Hotlix product is and should be unlawful.
For: Flaherty; Against: MacRae.
3. The FD&C Act should be amended to delete the GRAS exclusion
from premarket approval of food additives.
For: Hutt; Against: Yahr.
IV. Regulation of Human Drugs
1. FDA should require patient package inserts for all human prescription
For: Nuzzo; Against: Emery.
2. Prescription drug advertising to consumers should be prohibited.
For: Pompeo; Against: Rowe.
1. The IND phase of human drug development should be deregulated.
For: Williams; Against: Shelton.
2. FDA should greatly loosen the NDA approval requirements for all
human new drugs.
For: Duhl; Against: Oliver.
1. All unapproved uses of approved human new drugs should be prohibited
For: Jackson; Against: Gevertz.
2. The FD&C Act should be amended to permit FDA to restrict the
distribution of approved human new drugs.
For: Dargan; Against: Baar.
3. The OTC Drug Review is unlawful.
For: Hunn; Against: Giezentanner.
V. Regulation of Animal Feed and Drugs
1. Animal feed should be subject to less stringent regulation than
For: Topol; Against: Elton.
2. As long as there is any uncertainty about human safety, antibiotics
should be banned from animal feed.
For: Miller; Against: Rabinowitz.
3. All unapproved uses of approved animal new drugs should be prohibited
For: Gardner; Against: McGraw.
VI. Regulation of Human Biological Drugs and Biotechnology
1. The 1902 Biologics Act should be repealed.
For: Cohen; Against: Hutt.
2. FDA should exercise regulatory control over all organs and tissues
used for human replantation or transplantation.
For: Sherman; Against: Witherspoon.
3. FDA approval of a human vaccine should preclude tort liability
for the manufacturer for all injury to consumers.
For: Ramirez; Against: Kim.
4. Special regulatory requirements should be imposed by FDA for any
new product made by biotechnology.
For: Davis; Against: Hutt.
VII. Regulation of Human Medical Devices
1. Tapes and computer programs that do no more than provide advice
should not be regulated as medical devices.
For: Stranne; Against: Bucholtz.
2. The FD&C Act should be amended to delete the "substantial
equivalence" exception to the requirement of premarket approval
of medical devices.
For: Bolland; Against: Bucholtz.
3. The FD&C Act should be amended to delete Class II and to
require reclassification of all medical devices as Class I or Class
For: Kaiser; Against: Hutt; Comment: Curi.
4. FDA should not prohibit breast implants for cosmetic purposes
and should let women make their own choices.
For: Lefko; Against: Silverman; Comment: Curi.
1. The premarket approval requirements for medical devices should
be applied by FDA as stringently as the premarket approval requirements
are applied for new drugs.
For: Silber; Against: Jackson.
2. FDA should exert no authority over the emergency use by physicians
of an unapproved medical device.
For: Hom; Against: Dunkum.
3. Technology assessment should be undertaken by FDA for every new
medical device to determine whether the societal benefits outweigh
For: Kaufman; Against: Lin.
VIII. Regulation of Human Cosmetics and Color Additives
1. The FD&C Act should be amended to impose more stringent regulatory
requirements for cosmetics.
For: Carlin; Against: Aaronson.
IX. Regulation of Carcinogens
1. The FD&C Act should be amended to permit carcinogenic food
additives and color additives that present only a de minimis risk.
For: Law; Against: Dargan.
2. Risk assessment is so uncertain that it should not be the basis
for evaluating the safety of carcinogens.
For: Yahr; Against: Kaiser.
3. The Delaney Clause should be interpreted to ban all secondary
For: Hunn; Against: Fuller.
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