Food and Drug Law: An Electronic Book of Student Papers

Final Assigned Student Presentations

(One to three minutes per student)

II. Jurisdiction and Enforcement

January 4:

1. The FD&C Act should apply to intrastate as well as interstate commerce.
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

January 5:

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.

January 6:

1. The best food nutrition label on page 198 of Hutt & Merrill is:

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 food.
For: Lin; Against: Bolce.

January 7:

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

January 10:

1. FDA should require patient package inserts for all human prescription drugs.
For: Nuzzo; Against: Emery.

2. Prescription drug advertising to consumers should be prohibited.
For: Pompeo; Against: Rowe.

January 11:

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.

January 12:

1. All unapproved uses of approved human new drugs should be prohibited by FDA.
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

January 13:

1. Animal feed should be subject to less stringent regulation than human food.
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 by FDA.
For: Gardner; Against: McGraw.

VI. Regulation of Human Biological Drugs and Biotechnology

January 14:

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

January 18:

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 III.
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.

January 19:

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 the costs.
For: Kaufman; Against: Lin.

VIII. Regulation of Human Cosmetics and Color Additives

January 20:

1. The FD&C Act should be amended to impose more stringent regulatory requirements for cosmetics.
For: Carlin; Against: Aaronson.

IX. Regulation of Carcinogens

January 21:

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 carcinogens.
For: Hunn; Against: Fuller.

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