SAC360

1. Copyright © 2021 by Jones & Bartlett Learning, LLC an Ascend Learning Company. www.jblearning.com.
CHAPTER 24
Safe Food and
Drugs: An
Ongoing
Regulatory Battle

2. Copyright
©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Causes of Foodborne Illness
 Bacteria
– Salmonella: eggs, poultry, meat
– E. coli 0157:H7: ground beef, alfalfa sprouts, unpasteurized apple juice,
raw milk, lettuce
 Viruses
– Hepatitis A: green onions from Mexico, shellfish
– Norwalk virus: shellfish
 Parasites
– Cyclospora
– Parasites in sushi, sashimi, ceviche

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Government Food Safety Activities
 Major inconsistencies exist in the way safety is regulated for different types of
food.
 Responsibility is divided among many agencies.
– Department of Agriculture (USDA): meat, poultry, processed eggs
– Food and Drug Administration (FDA): all other foods
– States: shellfish
– State and local governments: stores, restaurants, institutions (schools, nursing
homes)

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Irrationality of System
 USDA has bigger budget and more authority.
– Regulates 20% of food
– Has detailed laws on regulation of meat
 FDA has smaller budget and less authority.
– Regulates 80% of food
– Regulates imported food
• More than 80% of seafood is imported.
• About 50% of fresh fruits are imported.
• 20% of fresh vegetables are imported.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Safety Measures
 Hazard Analysis Critical Control Point (HACCP)
– Focuses on procedures
– Reduces need for inspections
 Irradiation
– Kills bacteria, parasites, pests
 Refrigeration
– At 40 degrees Fahrenheit or below
 Heating
– Internal temperatures above 140 degrees Fahrenheit
 CDC surveillance for foodborne disease
– FoodNet
– PulseNet: DNA fingerprinting of bacteria

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Additives and Contaminants
 EPA sets tolerance levels for pesticide residues.
– Hormones
• Estrogen is banned in chickens.
• Bovine growth hormone is allowed for cows.
o BGH does not get into milk.
– Antibiotics
• They cause antibiotic resistance.
– Organic foods
• USDA set standards in 2004.
• A 2014 law expanded federal support for organic farming.
– Additives
• They are used to prevent deficiency diseases.
• Preservatives are to improve color, flavor, or texture.
• FDA or GRAS must approve them.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Drugs
 FDA must approve after studies by the pharmaceutical company.
– Company files a new drug application (NDA).
– If NDA is approved, there are three phases of trial:
I. Use a small number of subjects; measure absorption, distribution, metabolism, and
excretion; look for side effects and toxicities.
II. Test a larger number of patients for signs that the new drug is effective.
III. Conduct a full-scale controlled trial.
 FDA can revoke approval through postmarketing surveillance.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Cosmetics
 Cosmetics are loosely regulated by the FDA.
 No requirements exist for safety testing of cosmetics, but a warning label must
be attached to any product not tested.
 Several ingredients that were used in the past have been shown to be harmful
to health, and their use is prohibited by law.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Food and Drug Labeling and Advertising
 FDA regulates labeling of foods with information on nutrients and
recommended daily intakes.
 FDA regulates labeling of prescription drugs.
– Labeling of over-the-counter drugs is by Federal Trade Commission.
 Labeling was one of the important provisions of the original Pure Food and
Drugs Act in 1906.
– Recommended daily allowances for nutrients became required on labels in 1994.
 In 2015, FDA banned adding trans fats to food.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Dietary Supplement Health and Education Act
 Passed in 1994
 Forbids FDA from regulating herbs and food supplements
– FDA can remove a substance from the market only if proven harmful.
• Ephedra was removed only after many deaths.
– A law passed in 2007 requiring supplement manufacturers to report serious adverse
effects to the FDA.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Politics of the FDA
 FDA is subject to intense political pressures.
 Complaints are that the FDA is too slow in approving drugs.
 Drug companies pay a fee to speed up the review process.
 Now complaints are that the FDA is too cozy with the industry.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Politics of the FDA (cont.)
 Too many drugs are found to be unsafe only after approved for marketing.
– Fen-phen, Vioxx, antidepressants for children
 Problems exist with the way clinical trials are reported.
 There are calls for a database of all clinical trials, with the substance registered
at the beginning of the trial, and with all trial results reported.
 Safety concerns with drugs not manufactured in the U.S.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Discussion Question 1
 Identify three or more types of food contaminants.
 How has government regulation reduced the hazards of these contaminants?
 What measures can consumers take to further reduce the risk from each
contaminant?

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Discussion Question 2
 Choose a packaged food that you eat frequently and read the label on the
package.
 How healthy is this food, given the dietary recommendations from
ChooseMyPlate.gov (Figure 16-3)?

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2021
by
Jones
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Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Discussion Question 3
 Discuss the pros and cons of the Dietary Supplement Health and Education
Act.

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Discussion Question 4
 Do you think that all clinical trials should be required by law to be registered at
the start and that all results should be made public?
 Discuss the reasons for your answer.

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2021
by
Jones
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Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Discussion Question 5
 Visit the FDA website, www.fda.gov.
 What are the hot topics that the FDA is dealing with?
 How many warnings has the FDA issued, and how many recalls has it
recommended over the past month?

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©
2021
by
Jones
&
Bartlett
Learning,
LLC
an
Ascend
Learning
Company.
www.jblearning.com
Discussion Question 6
 Visit the USDA website, www.usda.gov.
 Look for information on food safety.
 What can you find out about HACCP?