Welcome to USC Master's of Regulatory Science

MPTX 514: Regulation of Foods and Dietary Supplements

Instructors: Roger A. Clemens, Dr.P.H., CNS, FACN, FIFT, School of Pharmacy, USC
Frances Richmond, PhD, School of Pharmacy, USC
Course weight: 3 units
Placement: UPCOMING COURSE SCHEDULE

Latest agenda (may be from previous class)

Introduction and Purposes:

The growing importance of “healthy foods” in today’s society has resulted in a growth of regulations governing foods, functional foods and dietary supplements. These rules vary substantially amongst different countries of the world. Students will examine the differing rules governing traditional foods, functional foods and dietary supplements in the US. They will consider the impact of recent scientific advances, social pressures and new communication channels, such as the internet, on the development of regulatory policy. The regulation of foods and botanicals in other countries will be examined and the relative merits of different systems will be analyzed and debated.

By the end of the course, students will be expected to demonstrate the following knowledge and skills:

Explain the features that differentiate dietary supplements from foods and food additives
Formulate appropriate claims for dietary supplements and functional foods, recognizing the limits to which claims language must adhere
Write a draft test plan to evaluate the safety of a new food additive and explain how this would differ if the substance were to be considered as a new dietary supplement
Describe what is commonly considered a functional food and the controls placed on claims made by functional foods
Design a label for a food and for a dietary supplement
Describe a testing approach to characterize a botanical product and explain how to find and negotiate with a third-party testing laboratory
Describe the roles of the FDA and FTC in enforcement actions against companies that violate labeling and advertising rules
Identify how the process of marketing a dietary supplement in another country might be approached
Identify three key pressures on the policy arena that will probably change the laws governing foods and dietary supplements over the next two years.
Students will work in teams to develop appropriate testing plans, documentation and advertising for a range of food-related products. Some parts of the course will be taught through case studies presented by the students. An emphasis will be placed on relatively informal lecture formats in which students are encouraged to ask and answer questions throughout the didactic session.

This syllabus may not reflect recent changes or additions.

Course Requirements and Grades:

At the end of the course students should be able to demonstrate a competent knowledge of the subject matter as appraised by amid-term and end-of-term examination. However, students also will work in a group to present a short case-study illustrating the application of a particular regulatory requirement, or to define a testing and marketing strategy for an assigned food or dietary supplement.

Examination: 50%
Case study (class presentation): 30%
Mid-term test: 20%

Case study presentations will be evaluated on both the presentation to the class (40%) and the written submission to the instructors (60%). The presentation in class will be marked by both the class members and the instructors using the appended evaluation sheet. The written submission will be evaluated on the basis of:

Clarity of presentation
Appropriate identification and description of problem to be solved
Correct identification of regulatory issues
Appropriateness of solutions to the problem
Appropriate use of source materials collected as a reference list

Class Sessions

Topics below are grouped into 3-hour blocks

1. Differentiation of Foods and Dietary supplements; Regulations governing approval of new foods and dietary supplements

History of food safety legislation
Impact of DSHEA on regulation of dietary supplements
Boundaries between foods functional foods, food additives and dietary supplements
Where to find regulations and what to look for

2. Testing of food and food additives

Analytic testing for content and contaminants
Microbiological concerns
Nutritional content of foods and their implications for labeling

3. Regulation of food additives; dealing with adulterated foods

Interpretations of current guidelines
Case study presentation 1
Identification of adulterated products; Management of recalls

4. Functional foods; claims and substantiation

What is a functional food? Guest speaker from industry
Regulation of foods with recognized health benefits
Safety and public attitudes to functional foods
How do you prove the claims made about functional foods?

5. Genetically engineered foods: current regulations and emerging trends

The FDA view on genetically engineered foods
Conflicts with European views, regulations and trade practices
Identifying and testing genetically engineered foods
The labeling debate
Implications of genetically engineered foods on economics of food production

6. Overview of common dietary supplements and their applications;

Types of products considered dietary supplements
Overview of commonly used botanicals
Interactions between botanicals and drugs
Case study 2

7. History and current status of dietary supplement regulations in the US

current rules governing dietary supplements
emerging policies regarding Good Manufacturing Practices
adverse events reporting
pressures affecting the political climate surrounding dietary supplements

8. Characterization of botanicals containing active ingredients:

thin layer chromatography; high performance liquid chromatography
fourier transform infrared spectroscopy, organoleptic testing
macro-and microscopic taxonomy visit to Analytic Testing Facility on campus

9. Claims and advertising for dietary supplements: FDA and FTC actions

Role of FTC in policing advertisements
Case study 3
Internet advertising and sale of food products
FDA enforcement actions

10. Using foods and dietary supplements as drugs

Patenting foods and food constituents
Should foods sometimes be marketed as drugs?
The European experience with pharmaceutical uses of food products
Case study 4

11. Field trip to industrial setting that grows and manufactures botanical products

12. Management and oversight of dietary supplements in Europe and Asia

Guest speaker: Rules in Canada and Europe
Guest speaker: History and current climate for dietary supplements in Asia
Procedures required to market a dietary supplement or functional food abroad
Rules for importing dietary supplements

13. Regulations governing unsafe foods and dietary supplements

review of key concepts
Case study 5

Attendance and Conduct:

The Student Handbook, SCampus and University Catalogue provide guidance regarding academic policies and procedures. Students should regard the program as a part of their professional development in which courtesy and responsibility are significant factors in success. Thus, students are expected to communicate absences from class and are expected to attend all examinations and class presentations by themselves and their colleagues. Under normal circumstances, papers and exams must be completed on the day that they are scheduled for submission. Failure to make appropriate arrangements in case of justifiable delay will result in a penalty of 10% in the assigned mark.

Textbooks and Reference Materials:

No one book covers the topics important to understanding this newly emerging specialty. A textbook is however, in progress that will be available for inspection and possible adoption later in 2000. The instructors will make every effort to construct an electronic textbook” from appropriate source materials and references on web-sites easily accessed from the computer labs on the 3rd floor, Pharmaceutical Sciences building, or from home computers with web access. References not available on the web will be collected into a reader available at the bookstore. Useful reference texts are also identified below.

N.B. Reference texts and links are not updated regularly.

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TOPIC READING
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1. Differentiation of Foods and Dietary supplements; Regulations governing approval of new foods and dietary supplements Burdock, GA (2000) Dietary supplements and lessons to be learned from GRAS. Reg Tox Pharm 31:68-76
Institute of Medicine, National Research Council (1998) The current food safety system In: Ensuring Safe Food from Production to Consumption. National Academy Press, Washington DC

Kurtzweil P (1999) An FDA guide to dietary supplements FDA Consumer. http://vm.cfsan.fda.gov/~dms/fdsupp.htm

Reference: Bass, IS and Young AL (1996) Dietary Supplement Health and Education Act: A Legislative History and Analysis. The Food and Drug Law Institute, Washington DC

2. Testing of food and food additives National Advisory Committee on Microbiological Criteria For Food Hazard Analysis and Critical Control Point Principles and Application Guidelines (Aug 14, 1997) http://vm.cfsan.fda.gov/~comm/nacmcfp.html
Institute of Medicine, National Research Council (1998) Where current food safety activities fall short In: Ensuring Safe Food from Production to Consumption National Academy Press, Washington DC

Somoji A (2000) Food Regulation: Use of science-based decisions to determine appropriate levels of protection. Reg Tox Pharm. 31:106-111

3. Regulation of food additives; dealing with adulterated foods Degnan, FH (1991) Rethinking the applicability and usefulness of the GRAS concept. Food Drug Cosmet. Law J 46:553-582
Hallagan JB and Hall, RL (1995) FEMA GRAS- A GRAS assessment program for flavor ingredients. Regul Toxicol Pharmacol 21:442-430

Taylor, MR (1984) Food and Drug Administration regulation of color additives- Overview of statutory framework. Food, Drug Cosmetic Law Journal 39: 273-280

Rumore, MM. Strauss, S. Kothari, AB. ( 1992)Regulatory aspects of color additives. Pharmaceutical Technology. 16: 68-82

4. Functional foods; claims and substantiation Napier, C (1999) Fat Replacers: The Cutting Edge of Cutting Calories http://www.acsh.org/publications/booklets/fats.html
Adam J. Lieberman and Simona C. Kwon (2000) Facts Versus Fears, A Review of the Greatest Unfounded Health Scares of Recent Times Third Edition

http://www.acsh.org/publications/reports/factsfears.html

5. Genetically engineered foods: current regulations and emerging trends US FDA CFSAN (1996) Safety Assurance of Foods Derived by Modern Biotechnology http://vm.cfsan.fda.gov/~lrd/biojap96.html
Thompson, L (2000) Are bioengineered products safe? http://vm.cfsan.fda.gov/~dms/fdbioeng.html

Millstone E, Brunner E, and Mayer s (1999) Beyond ‘Substantial equivalence” Nature, 401:525-526

Reference: Grace, ES (1997) Biotechnology Unzipped: Promises and Realities. Joseph Henry Press

6. Overview of common dietary supplements American Botanical Council. ABC Botanical Series. http://www3.allherb.com/consumer/default.asp
Herbal E: Expanded European Commission E Monographs http://www.herbalgram.org/

7. History and current status of dietary supplement regulations in the US Martinez, AC (1999) The Nutraceutical Research and Education Act: A Proposal for the 106th Congress. RAPS 4:23-25
Steele, EA and Campbell, EJ (2000) FDA attempts to clarify allowable statements of nutritional support for dietary supplements. Regulatory Affairs Focus Feb:26-29