Food and Drugs as Public Health Issues

Flashcards covering food and drug safety regulations, key legislation, and drug approval processes.

List six ways that food affects health and disease.

Too little food, too much food, deficiencies of vitamins and minerals, contaminants, individual susceptibilities, and foodborne communicable diseases.

What U.S. government agencies play a role in food safety?

FDA, CDC, and U.S. Department of Agriculture

What are the phases of drug approval required by the FDA?

Preclinical research, Phase 1, Phase 2, Phase 3, and Phase 4 (post-approval monitoring)

What are food security programs?

SNAP and WIC

What is the purpose of SNAP?

Supplemental Nutrition Assistance Program, commonly called 'food stamps'

What is the purpose of WIC?

Supplemental Nutrition Program for Women, Infants, and Children, for healthcare and nutrition of low-income pregnant women, breastfeeding women, and children under the age of five

Which governmental agencies regulate food safety?

The FDA, USDA, and CDC

What is the Food and Drugs Act of 1906?

Law that created what is known today as the FDA; requires accurate labeling indicating ingredients.

What did the Federal Food, Drugs, and Cosmetic Act of 1938 require?

Required safety testing prior to making a new drug available to the market.

What was the impact of the Kefauver-Harris Drug Amendments of the 1960s?

Focused on efficacy, not safety, and mandated efficacy testing before a drug could be approved and marketed.

What did the Food Safety Modernization Act of 2010 do?

Gave the FDA and USDA increased authority and provided the ability to track foods to locate the source of a foodborne disease outbreak.

What is included in Phase 1 of drug testing?

The initial administration of a drug to human beings, focusing on pharmacology, dosage range, route of administration, safety, and side effects.

What are Phase 2 and 3 of drug testing designed to establish?

Efficacy of a drug for a particular use or indication.

What is the gold standard for establishing efficacy for one particular indication of medicine?

Phase 3 trials

How are adverse effects of a drug monitored in Phase 4 after FDA approval?

Spontaneous reporting system