Law
The facts are as follows: The client is developing a turmeric supplement and medication. Your client is in the process of creating labels for the supplements and knows that the law dictates what can appear on a supplement and medication label. She seeks your assistance in working out the details.
She also knows that the government is talking about giving approval to a turmeric supplement as a cure for osteoarthritis. She wants to be able to put a drug label on the turmeric supplement, since everyone thinks highly of and is willing to pay extra for FDA approved medications, as opposed to homeopathic supplements.
Please respond to the following:
1. Let’s begin with the question about the label generally. This area of law is a good candidate for administrative regulations. Devise a strategy for locating relevant regulations on Lexis. Describe and explain your strategy below (e.g., steps taken on Lexis to locate the relevant labeling code information) and indicate the relevant title and sections of the C.F.R.
2. When working with regulations, always note how current they are and if they are still in effect or have been appealed. How current are the relevant regulations? How did you make this determination?
3. Have any amendments to the regulations been issued since the latest update to the C.F.R. database on Lexis/Westlaw? How did you make this determination?
4. How would you determine if the agency that issued the relevant regulations has proposed or is thinking of proposing any changes to the existing rules?
5. If you were asked by the firm not to incur Lexis/Westlaw charges for this client, what option(s) would you have for conducting the research required to answer Questions 1 through 3 above?
6. Turn your attention now to the issue of whether your client can use a “drug facts” label as opposed to a “supplement facts” label. Can the labels be used interchangeably? If not, how can the company appropriately claim that the turmeric supplement cures osteoarthritis? At what point can the supplement be sold as a medication? Please describe in detail the information you used to formulate your answer.
You do not need to “IRAC” or cite case law for each answer here. Just explain your answer as clearly as possible and give the reason. Cite applicable law and sources where necessary and appropriate.
