1. The Politics of Food Agenda for Thursday April 9
Carry-over: Simply Orange, Olestra, and transgenic fish
The FDA and the “Saccharin Revolt”
The FDA and GRAS
Reducing Trans fats in the American Diet
Final 500-word essay
[Note: these slides have been posted to Canvas]

4. Industrialized orange juice

5. Olestra and savory snacks

6. The AquaAdvantage Salmon

14. FDA and food additives

15. Food Additive or Adulterant?

16. Additive or Adulterant?

18. Standards of Proof
Food additive: petitioner has the burden to demonstrate “a reasonable certainty of no harm” from the intended use. (Unless GRAS)
Food adulterant: government has the burden to prove contamination.

20. Marion Nestle, chs. 7 & 8 FDA has allowed genetically-modified foods:
Without premarket notification*
With pre-market testing
Without labeling
FDA interpreted its mandates to mean that they could not consider dread-and-outrage factors
*Unless there are allergens, toxins, or
“substantial alternation of the nutritional content”

21. FDA 1992 Policy Statement
The importance of the “substantial similarity” to non-GM foods idea.
Implication: after-the-fact recall only, no pre-market approval (unless allergens, toxins, or “substantial alternation of nutritional content.”)

23. The Delaney Clause (1958 amendment to the Food, Drug and Cosmetic Act of 1938)
FDA “shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals.”

24. Exceptions: Pesticide residue* 2. Saccharin, 1977-1991
*Direct pesticides use was never covered by the FDA

27. Question
Should the FDA be able to determine that a cancer risk is small enough to be considered de minimis?

28. Food Coloring

29. Food Additives Amendments of 1958
No review of substances “generally recognized as safe” (GRAS)
Companies can make GRAS determinations without notifying FDA
Companies can also petition for voluntary GRAS review

30. What is GRAS?
“It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use.”
21 CFR 182.1(a)

31. What is GRAS?
Substances that are recognized as safe under conditions of their intended use…
“As shown through scientific procedures…”
“… or based on common usage in food prior to 1958.”

37. “Natural Flavorings”

38. Nanotechnology and food packaging: are these additives?
“Active packaging” that absorbs oxygen
“Electronic tongue” that detects substances
“Release on command” preservatives

39. Nanotechnology
How should FDA approach nanotechnology absent any specific command from Congress?
Are nanoparticles GRAS?

40. Transfats

41. Transfats

42. Transfats
How successful have efforts been to reduce consumption of trans fats?
How generalizable are those lessons?

43. Transfats

47. 500-word essay
Why was the effort to reduce the intake of trans fats largely successful and why might that success be difficult to achieve for many other important dietary goals? This will be posted to Canvas later today. Due next Wednesday by 9PM.