1. You are an FDA inspector and on visiting a processing plant you notice the following label on a product
being manufactured in the facility. Old Fashioned Willows Wild Apple Jelly pectin-free. Would you take
regulatory action? Fully explain your answer.
1. What was the regulation called that prohibited the use of any substance which caused cancer in
humans or animals?
The Delaney proviso was in both the 1958 and 1960 legislation and banned the use in foods of
substances that cause cancer in animals.
1. What are the special provisions for listing ingredients used at 2% or less?
Ingredients present in amounts of 2% or less by weight do not have to be listed in descending
order or predominance. Instead, they may be listed at the end of the ingredient st
1. Who governs food sold in intrastate commerce?
Food sold in intrastate commerce is governed by the state. Establishments have the option to
apply for federal or state inspection. Under the agreement, a states program must enforce
requirements at least e
1. You are the plant manager for a seafood processing company and your boss wants you to produce the
following 2 products:
a. You receive 200 lb boxes of squid from China and repack in 2 lb packages and label Product of the
b. You receive 2
1. Listed below are three companies that were involved in recalls of food products within the last month.
What product(s) were recalled and what was the reason for the recall?
a. SunSprout Enterprises, Inc. Omaha, Nebraska
SunSprout voluntarily recalled a
1. Should the cGMPs for food be revised? Justify your answer.
Yes, the cGMPs for food are in need of modernization because there have been changes in both
the food industry and the science of food safety that indicate a need for modernization. cGPMPs shou
1. Codex has become the single most important international reference point for the developments
associated with food standards. Do you agree with this statement? Justify your answer?
2. Go to Codex Alimentarius and find the maximum residue limits for two
1. Why is there a need for special regulations for cured, smoked and salted fish products under Chapter
359 of the State of Maine Regulations?
2. Can states adopt the Federal Food Code? How would jurisdiction be determined?
3. What is one revision made to
1. The old regulation concerning imported foods stated that the importer or agent files entry documents
with U.S. Customs Service within 5 working days of arrival of shipment at port of entry. How has this
changed since 9/11 and under what law is it now c
1. Do you feel the U.S. has one of the safest food supplies?
2. What is the impact of imported food? How is food safety handled for imported foods? What products
would be of particular concern?
3. How has HACCP impacted food safety?
4. Food is generally a
1. What is a Trade Secret?
2. Inventors may be under contractual obligation to license or assign their patent to another. Can you
think of an example?
3. Perform a patent search for a patent dealing with blueberries (in the past 8 years) and briefly
1. What do you think is the largest category of dietary supplements?
Do you take a dietary supplement?
According to the FDA website, vitamins are the largest supplement category, with $4.9 billion in
sales in 1996 and 48% of the supplement market. Multivi
1. Go to the Federal website and provide one example of a MOU other than those covered in the video.
CPG 225-00-2000 MOU between FDA and FSIS/USDA policy responding to requests for
sanctioning the use of food ingredients and sources of radiation intended
1. What is the Islamic equivalent of kosher?
The Islamic equivalent of the kosher dietary laws is halal, which refers to food that is permissible
according to Islamic law. Examples of foods that are considered unclean and are not halal are pork and