Question 1. What is the correct citation (CFR Title Number; Part Number and Title; Section [] Number and Title) in the Code of Federal Regulations of the approved and authorized health claim that permits such claim on appropriate soy food articles? (Hint: See Attachment 2 page 57732.) (Point Value: 3 points)
Answer:
Question 2. What are the three (3) nutrient requirements that a soy food article must meet in order to legally make the health claim on the label? (Hint: See Attachment 2 page 57733.) (Point Value: 3 points
Answer:
Question 3. What is the exact citation of the 2017 Federal Register (Volume and Number, Day and Date, Initial Page Number, and Final Page Number) that presents the Proposed Rule by the FDA to consider revocation of the previously-authorized health claim on soy food articles? (Point Value: 3 points)
Answer:
Question 4. After eighteen (18) years of permitting the health claim on the label/labeling of soy food articles, what reason(s) did the FDA present to take the action of reviewing and potentially revoking the previously-approved (and regulated) health claim on soy food articles? (Point Value: 3 points)
Answer:
Question 5. In what way did the scientific community and principle of scientific agreement play a role in the FDAs decision to consider revocation of the previously-approved health claim on soy food articles? (Point Value: 5 points)
Answer:
Question 6. Under what specific codification of the Code of Federal Regulations (CFR Title Number; Part Number) permits the Commissioner (of the FDA) to …initiate a proceeding to revoke a regulation. (This codification is clearly indicated in the 2017 Federal Register Proposed Rule. It may take a bit of scanning the first few pages to find it!) (Point Value: 3 points)
Answer:
Question 7. As described in Chapter 1, the food supply and safety systems in the U.S. (production, transportation, processing, packaging, marketing, advertising) are scattered among numerous federal and state regulatory agencies. (Total Point Value: 10 points)
(A) Do you think the current system of food supply and safety regulation (across several agencies) is efficient and properly structured to assure the safety of the food supply? If “yes,” what makes the current system efficient and properly structured? If “no,” what are the deficiencies of the current system? (Point Value: 5 points)
Answer:
(B) Regardless of your answer in part (A) describe changes that could be made to the current system of food supply and safety regulation to have the greatest benefit to the food industry and to consumers. (Point Value: 5 points)
Answer:
Question 8. Defining an article as a food or a drug or a medical food can be problematic because very specific and detailed definitions are not written in either the FDCA or its regulations. (The USDA does not have this difficulty because the FMIA, PMIA, and EPIA more clearly define the products under the USDA authority.) (Total Point Value: 15 points)
(A) On what bases (plural) do you think an article that will be consumed by humans should be classified as a food in order to avoid the problem of its classification? (Point Value 5 points)
Answer:
(B) What definitions would you suggest so that a consumable article would clearly be considered a food and not a drug or a medical food? (Point Value 5 points)
Answer:
(C) What criteria (plural) could be used to assure that your suggested definition(s) of a food article would be understood by all parties (regulators, manufacturers, and consumers)? (Point Value 5 points)
