Question: Section B – Like Grandma Used To Make (5 Points) When I Teach This Course In The NJIT Classroom. I Tell The Class That I Always Ask At Least One Question On The Midterm That Comes Straight Out Of Recent History. This Is That Question. Nashoba Brook Bakery, LLC, In Concord, MA, Received An FDA Warning Letter On 22SEP2017 – It’s Available To Read Online. …

Section B – Like Grandma Used to Make (5 points) When I teach this course in the NJIT classroom. I tell the class that I always ask at least one question on the Midterm that comes straight out of recent history. This is that question. Nashoba Brook Bakery, LLC, in Concord, MA, received an FDA Warning Letter on 22SEP2017 – it’s available to read online. Among the numerous observations was this little gem, which regards the following label: “Your Nashoba Granola label lists ingredient “Love”. Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name (21 CFR 101.4(a)(1). “Love” is not a common or usual name of an ingredient, Oats,Whole Wheat Flour, Almonds, Honey, Brown and is considered to be intervening Sugar, Cinnamon Vanilla, Love. material because it is not part of the common or usual name of the ingredient.” Nashoba Granola Note: While this is not necessary for your answer. I want to define one of the FDA’s phrases for you. For food products, FDA defines “intervening material” as any non-FDA-approved text or graphics in a part of the label that has FDA-specified formatting or content (such as the ingredients list). By comparison, FDA considers drug/device labels to be more risky in terms of consumer communication, and approves essentially all contenu and formatting on those labels. 1) (4 points) Utilizing the definitions provided in class (which are pretty much the same for food as they are for drugs), please explain whether the FDA declared this food to be ADULTERATED, MISBRANDED, BOTH, or NEITHER, specifically as it pertains to this observation. As with the homework – you have to define both terms and explain fully why each does or does not apply to this situation. 2) (1 point) If instead this manufacturer had written “Made With Love” in an area without specified formatting, such as right below the product name, would your answer change? Why/how or why not? Page 2 of 11