Food Safety, Labeling,

and Supplements
Kirstin Vollrath MS, RD, LD
Food borne Illness
 Microorganisms that under specific conditions can cause illness in humans
 Virus
 Parasite
 Bacteria
 CDC Annual Estimates of Food borne Illness in U.S.
 48 million sick
 128,000 hospitalized
 3,000 die
 Foodborne Illness caused by
 Known pathogens
 Unspecified agents -> 38.4 million episodes of foodborne illness
Pope J., Nizielski S., McCook A. Nutrition for a Changing World, 2016
History of Food Safety Regulations
 1862: President Lincoln founded USDA
 1883: Harvey Wiley appointed chief chemist at USDA
 Wiley Act -> Pure Food and Drugs Act 1906
 Late 19th century: Railroad expansion
 Livestock
 Refrigerated rail cars
 Animal Disease in the Food Supply
 1865: Legislation to quarantine imported animals
 1884: Act signed creating USDA Bureau of Animal Industry
History of Food Safety Regulations
 1886: Wabash Case → Interstate Commerce Act 1887
 1890: First law requiring inspection of meat products
 1905: The Jungle by Upton Sinclair
 https://www.youtube.com/watch?v=Xxe9nosWawM
History of Food Safety Regulations
 1906:
 Pure Food and Drug Act
 Prevented manufacture, sale, or transportation of adulterated
or misbranded foods, drugs, medicines, or liquors
 USDA Bureau of Chemistry
 Federal Meat Inspection Act (FMIA)
 Prohibited sale of adulterated or misbranded meat and meat
products for food, and ensured meat and meat products were
slaughtered and processed under sanitary conditions
 USDA Bureau of Animal Industry
 1910: BAI established research center in Maryland
History of Food Safety Regulations
 1931: Bureau of Chemistry reorganized and renamed Food
and Drug Administration (FDA)
 1938: Federal Food, Drug, and Cosmetics Act
 Gave FDA authority to issue food safety standards and other
authorities
 1940: FDA moved from USDA to what is now Department of Health
and Human Services (DHHS)
 Post WWII: Federal highway system and refrigerated trucks
History of Food Safety Regulations
 1946: Agricultural Marketing Act
 Gave USDA authority to inspect, certify, and grade agricultural
products
 1953: Agricultural Research Service (ARS) formed
 Absorbed BAI and Bureau of Dairy Industry
 1957: Poultry Products Inspection Act
 1958:
 Food Additives Amendment
 GRAS List
 Delaney Clause
 Humane Methods of Slaughter Act
History of Food Safety Regulations
 1970: Egg Products Inspection Act
 Mandatory and continuous inspection of liquid, frozen, and dried
egg products
 1981: Creation of Food Safety and Inspection Service (FSIS)
 Perform all meat and poultry grading and inspection activities
 1993: E. coli O157:H7 outbreak at Jack in the Box
 400 illnesses and 4 deaths
 Led to the adoption of Hazard Analysis and Critical Control Points
(HAACP) for meat processing in 1996.
 E. coli O157:H7 named as food adulterant
Major Outbreaks
 2006: E. coli O157:H7 outbreak → spinach
 2007-2008: FSIS recalled millions of pounds of beef from
Kroger and Nebraska Beef for E. coli outbreak
 2008: Salmonella outbreak in DC linked to imported
peppers from Mexico
 2008-2009: Salmonella typhimurium outbreak traced to
peanut products from Peanut Corporation of America
 2010: Salmonella outbreak linked to two large Iowa egg
producers led to voluntary recall of over more than 300
million eggs
 Top ten pathogen/food combinations based on annual burden of
economic costs, illnesses, and deaths
Pathogen/Food Combination Cost of illness Illnesses Deaths
($ millions)
Campylobacter - Poultry 1257 608,231 55
Toxoplasma - Pork 1219 35,537 134
Listeria – Deli Meats 1086 651 104
Salmonella - Poultry 712 221,045 81
Listeria – Dairy Products 724 434 70
Salmonella – Complex Foods 630 195,655 72
Norovirus – Complex Foods 914 2,494,222 68
Salmonella – Produce 548 170,264 63
Toxoplasma - Beef 689 20,086 76
Salmonella - Eggs 370 115,003 42
Total 8151 3,861,128 765

Source: Batz et al. (2011)

Food Safety Modernization Act (FSMA) 2011
1. Preventive Controls for Human Foods
 Requires food facilities to have plans to id and control foods
safety hazards
2. Preventive Controls for Food for Animals
 Establishes Current Good Practices
3. Standards for Produce Safety
 Science-based standards for growing, packing, harvesting,
holding produce; domestic and foreign
Food Safety Modernization Act (FSMA) 2011
4. Foreign Supplier Verification Programs
 Importers verify imported food produced at domestic level
of protection
5. Mitigation Strategies to Protect Food Against Intentional
Adulteration
 Food Defense Principal
6. Sanitary Transport of Human and Animal Food
7. Accredited Third Party Certification
 Program of accreditation for 3rd party food safety auditors;
includes foreign facilities
FSMA (Cont.)
 Expands FDAs authority to inspect food manufacturing
facilities
 Provides power of mandatory recalls for unsafe foods
 Strengthens oversight for imported foods
 Expands HACCPs reach in food manufacturing
 New regulations for safe production and harvesting of f/v
Support and Opposition of FSMA
 For:
 Consumer groups
 Food Safety Advocates
 Industry
 Against
 Sustainable Agriculture Advocates
 Small producers
 Tester-Hagan Amendment
Food Safety Cost Benefit

Six Food Safety Technologies

1. Water rinse (149 F) &
sanitizing spray
2. Water rinse (149 F) alone
1
2 3. Water rinse (131 F) and
sanitizing spray
3
4. Water rinse (131 F) alone
4
5. Water rinse (77 F) and
5 sanitizing spray
6 6. Water rinse (77 F) alone

Source: Wilde, P. Food Policy in the United States

Policies and Information Gaps

 Policies and regulations are a response to imperfect

information in a free market economy
 Both consumer and producer have imperfect info
 Only producer has info
 Policy fights often involve who gets access to which
information
 Ex. NYC Health Inspection System
Types of Food Safety Policy Remedies
1. Process Rules
2. Performance Standards
3. Liability Enforcement
4. Food Labeling
5. Government Research
6. Consumer Education
 Where does your food
dollar go?
• In 2017, US consumers spent $1.7 T on
US produced food.
• Retailers account for approx. $0.13
for every dollar spent on food in US.
• In 2009, top 4 firms got 37% US retail
food sales (17.5% in 1996).
Food Retailers
 Supermarkets
 First opened in 1930’s
 Profit margins today only 1-2%
 Supercenters and warehouse stores
 Costco, Wal-Mart, Sam’s Club, Target
 1995: 3.2% market share food-at-home sales
 2010: 15.8% market share food-at-home sales
 Small outlets and other retailers
 20% US consumer food at home spending → Dollar stores
Food Deserts and Health Outcomes
 Neighborhood or district with inadequate access to
healthy food retail options
 Healthier diet and lower obesity rates associated with
 Greater access to supermarkets
 Less exposure to fast food restaurants
 Examples
 US HUD study
 WalMart Superstores
Identifying Food Deserts
 https://utxsph.maps.arcgis.com/apps/webappviewer/index.html?id=a2ad56a
8981347c489993140040effd6
 What type of retailer counts as providing adequate food access?
 What distance is considered adequately close?
 What account should be taken of household income?
 What account should be taken of access to a vehicle or public
transportation?

 Government Approaches
 Healthy Food Financing Initiative (HFFI) – census tract data
 2009 report to Congress – based on residential location and access to
vehicle
Food Deserts
 HFFI
 > 1 mile from supermarket in urban setting
 > 10 miles from supermarket in rural setting
 > 1/3 or 500 people in census tract have low access AND
 Tract has high poverty (> 20%)
 Does not account for smaller retailers or food retail adequacy at
household level
 2nd approach
 Lack of access to supermarket based on
 Residential location

 Lack of access to vehicle

The Restaurant Industry
 Full-service restaurants
 Fast-food restaurants
 Institutional foodservice & Other
Meals In Restaurants
 More kcals, fewer fruits and whole grains, more solid fats
and added sugars than equivalent meals prepped at home
 Pricing/Marketing Strategies can affect consumption
 value meals, meal deals, happy meals)

 Policies
 2008 LA City Council 2 yr freeze on new fast food restaurants
in South LA
 2010 San Fran banned free toys in children’s meals with high
levels kcals, fat, and sugar
Menu Labeling
 2010: Patient Protection Provision of ACA
 federal law for restaurants with 20+ locations clearly
disclose kcal info
 Includes grocers, convenience stores, movie theaters, pizza
delivery, & vending machines
 Final rule went into effect 1/1/20 after many extensions
 Must display kcal info & 2 messages
 Additional nutrition info available on request
 2000 kcal per day energy needs for average adult
 1990 Nutrition Labeling &
Education Act
 May 2016 FDA updated rule on
Nutrition Facts label
 Compliance with new label
effective 1/1/2020 with few
exceptions
 1999-2002 are included for biochemical indicators measured during that time period.

New information on nutrition de ciencies

Supplements
The Second Nutrition Report found less than 10% of the U.S. population had nutrition de ciencies for
selected indicators. However, for most nutrition indicators, de ciencies varied by age, gender, or race/
ethnicity and could be as high as nearly one third of certain population groups. For example, non-Hispanic
 53% of US population used at least one dietary supp (NHANES 2003-2006)
black (31%) and Mexican-American (12%) people were more likely to be vitamin D de cient compared to non-
Hispanic white people (3%).

Nutrition de ciencies in the U.S. population

10.5
9.5 The graph shows prevalence
8.1 estimates of nutrition
6.7
de ciencies among people
who live in the U.S. (NHANES
6 Nutrition indicators were
2003-2006). Of all the
2
groups (e.g.,1 year and nutrients listed, the most
<1 older) and population people had vitamin B6, iron,
groups (e.g., women 12-49
<1 years of age). and vitamin D de ciencies,
<1 and the fewest people had
vitamin A, vitamin E, and
0 2 4 6 8 10 12 14
folate de ciencies.
Percent of people with nutrition deficiencies (%)

National Center for Environmental Health

Division of Laboratory Sciences
CS229899-A
Supplement Regulations
 FDA does not approve dietary supps for efficacy of safety
 No testing for effectiveness, interaction, or safety requirements
like Rx and OTC drugs have
 Manufacturer is responsible for ensuring product is safe,
unadulterated, properly and truthfully labeled.
 Ingredients may be regulated
 GRAS (before 1958 foods; 10/15/1994 supps)
 New Dietary Ingredients (NDI)
Supplement Regulations
 1938: Federal Food, Drug, & Cosmetic Act (FFDCA)
 1994: Dietary Supplement Health & Education Act (DSHEA)
 Defined dietary supplement
 A product (other than tobacco) intended to supplement the diet;
contains one or more of vitamin, mineral, herb/botanical, amino
acid
 Health Claims
 This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.
 Labeling
 Good Manufacturing Practices (GMP)
 New Dietary Ingredients
Supplement Regulations
 Public Health Security & Bioterrorism Preparedness & Response
Act
 Required registration of food manufacturers, processors, and
packers with FDA
 Dietary Supplement and Non-Prescription Drug Consumer
Protection Act
 Mandatory reporting for adverse events for dietary supps
 2011: FSMA
 FDA has mandatory recall authority for adulterated food and food
without adequate allergen labeling
 Office of Foods, Center for Food Safety and Applied Nutrition
(CFSAN) – FDA department overseeing supplements
Energy Drinks
 Some marketed as dietary supps; some as beverages
 Dietary supps treated differently for adverse event reporting,
labeling, NDI, and GMP
 Conventional foods follow FDA regs on food additives and GRAS
 If marketed as a beverage, can avoid adverse event
reporting and be purchased with food stamps
 If marketed as a dietary supp, can avoid food additive and
GRAS restrictions
Other Future Policy Considerations
 Role of supplements in health care
 Safety of dietary supplements