To familiarize your understanding of the IRAC form as applied to a hypothetical legal situation. Below is the hypothetical situation and make and Follow the IRAC form until you reach a logical conclusion

--------------------------------------------------------------------- Listerine's new product "Listerine Pocket Packs Breath Strips" has been on the market for a number of years. The American Heartburn Association (AHA) believes this product to be within the Food, Drug & Cosmetic Act (FDCA) and would like the product defined as a food under 201(f) of the Act. The FDA has decided that Listerine Pocket Packs are not a food product and therefore will not be regulated as a food. AHA has decided to sue in order to have the court interpret whether or not "Listerine Pocket Packs" are a food product under 201(f) and therefore entitled to regulation under 401 of the FD&C Act. The pertinent sections of the Act are provided below: SEC. 201. [21 U.S.C. 321] For the purposes of this Act (f) 1 The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. SEC. 401. [21 U.S.C. 341] Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of

identity, a reasonable standard of quality, or reasonable standards of fill of container. Pocket Pack Ingredients Pullulan, Menthol, Flavors, Sucralose, Potassium Acesulfame, Copper Gluconate, Polysorbate 80, Carrageenan, Glyceryl Oleate, Thymol, Eucalyptol, Methyl Salicylate, Locust Bean Gum, Propylene Glycol, Xanthan Gum, FD&C Red No. 40. Use only the sections of the FD&C Act given (Drug sections do not apply), a dictionary, encyclopedia, law dictionary, Skidmore, Chevron, and Mead to interpret the courts decision. No outside websites. Your answer must be in the IRAC form.

Hints: Focus on 'chewing gum.' There is no right or wrong conclusion. Your IRAC may lead to the product being approved as a food and make logical argument that may lead to a good conclusion