Extra Credit Assignment #2

From the FDA website (http://www.cfsan.fda.gov/~dms/labstruc.html)ää..

"Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. However, the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory procedures for such claims for dietary supplement labels. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

Assignment:

Find one advertisement (from the internet, newspapers, magazines, etc.) that displays a product label and makes a "structure/function" claim. In two full typewritten pages, respond to the following:

1. What is the "structure/function" claim that is made in the advertisement?

2. Did the manufacturer follow the recommendations put forth by the FDA for supplement labeling? (see class notes or http://www.cfsan.fda.gov/~dms/dslg-1.html (response to question #2), as a reminder of the recommendations.) If so, describe how this was accomplished.

3. If the manufacturer were to decide to market this product as a drug (instead of a supplement), briefly describe the steps that the company would need to follow.

4. Describe one experiment to test the safety of the drug in humans. What permissions would you need to have prior to beginning this study? Include in your description the independent and dependent variables in the study. How many subjects would be in the study, and how would this be decided? Finally, discuss whether or not the study would be placebo-controlled, and how you would come to that decision.

5. Make certain to include the advertisement (or a photocopy of it) with your paper.