Assignment: Assignment 1

Congratulations! You have been offered a paralegal position with a firm in

Chicago, Illinois. A local pharmaceutical company that manufactures

homeopathic and herbal supplements has contacted your firm for legal

assistance. No one in the firm knows anything about this subject but would

like to expand into this area since the pharmaceutical industry is rapidly

growing in Illinois. Your supervising attorney has requested your help.

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. steps taken on Lexis to locate the relevant labeling code

information) and indicate the relevant title and sections of the CER

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 ER 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.