____ ____: any substance added to food, either intentionally or unintentionally.
-Most are ____ added and must be approved by the (____).
food additive
intentionally
FDA
___ ___ – substances that accidentally get into a food product during processing or packaging.
Indirect Additives
_____– deliberate addition of ___ ingredients to a food to make it appear of higher quality.
adulteration
cheap
___ ____ are added accidentally, but are anticipated and addressed by the ___.
Unintentional additives
FDA
Food additives have been used for centuries in order to achieve some purpose in the ___ of ____ ___.
- ___, ___/___, ___, ___.
- ____?
production food products salt herbs/spices sugar vinegar Irradiation
Key Uses of Food Additives:
- Maintaining product consistency
- Improving/maintaining __ ____.
- Foods can either ___ nutrients or ___ them during ____.
- Examples: Fortified ____, milk and juice
product consistency nutritional value lack lose processing cereal
Key uses of food additives:
-Maintaining ___ and ____.
- Foods lose flavor and freshness due to ___ and ___ to ___, ____ and other ____.
- Examples: ____
palatability and wholesomeness aging exposure oxygen bacteria microorganisms preservatives
Key uses of food additives:
Providing ___ or control ___/____.
-____ agents allow baked goods to ___ during baking.
leavening
acidity/alkalinity
leavening
rise
Key use of food additives:
- Enhancing ____ or imparting __ ___.
- ___ and other flavors enhance ___, while ___ ___ improve appearance.
flavor desired color spices taste color additives
Safety of a food additive must never be in ____.
Additive must function in food systems in accordance with its ___ _____ under specific conditions of use.
doubt
intended purpose
The additive must not diminish the ___ ___ or be used to hide ___ ___ characteristics.
Should be detectable by a ____ and ___ method of analysis.
nutritional value
inferior product
specified
defined
Food additives have been classified by the FDA, primarily by ____.
function
Types of Food Additives:
____ ____: inhibit the growth of microorganisms in food products.
Examples: ___ ___, ___ ___, sodium chloride, sodium benzoate
Antimicrobial agents
Sodium nitrate
sorbic acid
Types of Food Additives:
_______: inhibit oxidation of fats or colorants that could cause a product to become rancid.
Examples: ___, ___, ascorbic acid, tocopherols
antioxidants
BHA
BHT
Types of Food Additives:
_____ – can be added to offset color losses during processing or to correct for natural color variations.
Example: ___ ___ ___ __ and __, FD&C Green No. 3, FD&C Yellow No. 5, etc.
colorants
FD&C Blue No’s 1 and 2
Types of Food Additives:
___ ___ – help to retain the pink color in cured meats.
Ex: ___ ___.
Curing Agents
sodium nitrate
Types of food additives:
______ – natural or synthetic additives that are used for flavor production or modification.
Ex: __ ___(artificial banana flavor), ___.
Flavorings
amyl acetate
MSG
Types of food additives:
____ _____ – compounds that provide much greater sweetness intensity per amount when compared to sucrose.
Examples: ___, ___-_, ____
Nonnutritive sweeteners
aspartame, acesulfame-K, saccharin.
Act– begins as a ___ before ___ and becomes ___ when ___ of US signs it.
bill
congress
law
president
Statue – not strictly ___, but a ____ or __ ___ issued by ____ ___ at all levels
law
rule
administrative code
government agencies
______ - collections of laws and statutes that are codified for ease of administration.
E. g. ___ of ___ ___ (__) codifies rules enacted by Congress.
Codes
Codes of federal regulations (CFR)
____ ____- a publication that details all new Federal laws and regulations.
Federal registration
Proposed rule:
- Written whenever a ___ is needed in an ___ ___.
- __ day comment period.
- The __ ___ reporting of proposed rules has a preamble and the regulatory text.
change
agency’s regulations
60
Federal Register
FINALIZED RULE__
This is the __ version of the rule that includes any ___ from the ___ ___ and indicates an ___ date and an ___ date.
final revisions proposed rule effective implementation
Codifying of final rule into the CFR:
- ___ a year; all changes to the rules are updated into the ___.
- The CFR is divided into ___ different ___ (different sections), which are then subdivided into __ ___.
- ____ TITLE ___
- ____ TITLE ___
once CFR 50 titles chapters sections FDA 21 USDA 7
1958 – FDA publishes first list of ___ (____ ____ as ____) substances
GRAS(Generally Recognized As Safe)
1995 – Seafood ___ (___ ___ ___ __ ___)
HACCP (Hazard Analysis Critical Control Points)
Early Events and Legislation:
The first significant legislation was the ___ ___of ___.
-Prohibited the ___ ___ in misbranded or adulterated food, beverage, or drugs.
-The ___ ___ Act was passed at about the same time.
Drug Act 1906
interstate commerce
Meat Inspection
The 1938 FFDCA and Amendments:
The ___ ___, ___ and ___ ___: the basis of modern food law.
- Gave the ___ authority.
- Included considerations for standards of ___, __ __, ____ ___ ___, etc.
- Requiring new ___ to be shown ___ before marketing.
- Provide safe tolerances be set for ___ ___ substances.
- Authorizing ___ inspections.
- Caused by ____ of ___ which contained solvent diethylene glycol.
Federal food, drug and cosmetic act FDA identity, minimum quality, container fill drugs safe unavoidable poisonous factory Elixer of sulfanilamide
___ ___ ____ OF 1958
-Required ___ ___ of food additives prior to inclusion into foods.
-___ groups of substances were exempted:
1. ___ ____ substances – those approved by USDA/FDA before 1958 amendment.
Ex: ___ used to preserve luncheon meats
- ___ substances - generally recognized as safe.
Ex: __, ___, ___.
food additives amendment FDA approval two Prior sanctioned nitrates GRAS salt, sugar, spices
The ___ ____ Amendments – required the demonstration of safety for all dyes used in food regardless of prior history of use.
Color additives
The ___ ____ – prohibited the approval of any food additive that was found to cause cancer. Led to the cancellation of ___ additives:
Delaney Clause
8
The delaney cause:
- Since 1996, this clause has no longer been used because of the adoption of the “__ ___” concept by the FDA.
- Additives are now deemed as safe if ___ use (___ years) presents no more than __ in a million risk of cancer in humans.
negligible risk
lifetime
70
1
____ __ ___ –laws were needed to protect the consumer from deceptive products.
-1966 ___ ___ and ____ ___ countered problems with underweight products or deceptive packaging practices.
Processed Foods Innovations
fair packaging and labeling act
___ and ____ – shifted the burden of proof that pesticides were not harmful to food products to the pesticide manufactures.
Pesticides and Toxicants
_______ – a previously GRAS alternative sweetener.
-Spurred the call for review of all ___ substances.
cyclamates
GRAS
______ – the only artificial sweetener left at the time that it was discovered to cause cancer.
- Congress had to pass a special law that imposed a moratorium on its ban, under the ___ ____.
- Required ____ label.
- In ___, label removed.
Saccharin
delaney cause
warning
2000
___ ____ – established a more consistent policy with regard to the safety of additives relative to the risk of being carcinogens.
Red Book
____ ____– addressed the need to better inform the public about the nutritional value of foods.
nutritional labels
________– The FDA focuses on the safety of the food.
-Unless the practice introduces new, __-___ substances (e.g. ___) that would not be otherwise in the food product.
biotechnology
new
non-GRAS
allergens
The two primary agencies that enforce food law in the U.S.
- ___ and ___ ___
- ___ ___ ___ of ___
Food and Drug Administration (FDA)
United States Department of Agriculture (USDA)
International Food Agencies:
- ___ ____ ____ (___)
- ___ and ____ ___ (___)
- The ___ ___ ____
World Health Organization (WHO)
Food and Agriculture Organization (FAO)
The Codex Alimentarius Commission
The USDA is responsible for the wholesomeness and safety of all __ __, ___, and ___ products.
-___ ___ and ___ ___ (__).
Animals are inspected before slaughter and carcasses after slaughter for any sign of disease.
red meat, poultry, dairy
Food Safety and Inspection Service (FSIS)
The FDA is part of the ___ ___ ___ of ___ and ___ ___.
- It is responsible for the ____ of all food products except __ ___, __, and ___ products.
- Had no authority to order a ___.
U.S. Department of Health and Human Services
safety
red meat, poultry and dairy
recall
FDA:
Three types of recalls
____ ____Dangerous or defective product that could cause serious health problems or death. Can go to jail if intentional.
Ex: Food containing ___ ___.
class I botulinum toxin
FDA:
___ ___– Products that might cause temporary health problem
Class II
FDA:
___ ____– Products unlikely to cause health problem, but violate regulations
Ex: Package that contain __ ___ amount stated on label
class III less than
FDA:
-Puts forth directives concerning ___ ___ ___ called __ __ __ (___).
proper food processing
Good manufacturing practices (GMPS)
FDA ____ and _____ Act of 1997.
-Requires highly specific scientific support of all health claims made about food products in company advertising.
Modernization
Accountability
___- __ and ___ ___ ___ ___
-Protect animals and plants from pests, part of ___
APHIS—Animal and Plant Health Inspection Service
USDA
___- ___ for __ __ and __ ___:
Protect consumers from fraud, misinformation and unsafe food products.
Promote ____, component of ___.
CFSAN Center for Food Safety and Applied Nutrition
innovation
FDA
___- ___ ____ ___:
-A distinct agency whose mission is to assure food safety, primarily through regulation of pesticides, water safety.
EPA—Environmental Protection Agency
____- ___ ___ ____ ___:
-Part of to National Academies of Sciences.
Sets standards for purity of food additives.
FCCC—Food Chemicals Codex Committee
___-____ ____ ___:
-Enforces consumer protection laws such as truth in advertising.
FTC- Federal Trade Commission
____- ____ ___ ___ ___
- Part of the Department of Commerce.
- Responsible for seafood quality with voluntary inspection program.
NMFS—National Marine Fisheries Service
The Approval Process for Food Additives:
All food additives must be proven to be __ and __.
The ____ verification.
_____ safety of any food component can not be guaranteed.
____ must decide if the intended use of a food additive possesses a significant risk to the population.
safe and effective
FDA
Absolute
FDA
Testing Additive Safety
______ – the potential of a chemical to cause harm.
-____ - short term effect; rapid toxic response.
-__-__ - less rapid but still short term effect.
-____ - occurs over longer period due to exposure to low levels.
toxicity
Acute
sub-acute
chronic
Chronic toxicity can be due to the following:
- _____ - changes/damages DNA
- _____ - causes birth defects
- ______ - causes cancer
Mutagenic
Teratogenic
Carcinogenic
The Ames Test:
- ___ test of ____ potential of chemicals.
- Mutagenic substances often turn out to be ____.
- Based on the ability of a potentially mutagenic substance to reverse the mutation in a strain of the bacteria ____ ______.
- ____ tool for mutagens with follow up animal studies.
Rapid mutagenic carcinogenic Salmonella typhimurium Screening
The Nutrition Labeling and Education Act of 1990:
- The new labeling requirements focused on ___ and ____.
- Became law in ___ to allow food companies to obtain the data necessary to meet new labeling requirements.
- The ___ has requirements complementary to ___ requirements for meat and poultry.
calories macronutrients 1994 USDA FDA
The Nutrition Facts Label:
Required information includes:
- ___ ____
- Amount per serving of __, ___ __, ___ ___, ___, ___, __ ___, and ___.
- ____ of each nutrient (except __ and ___) as a percent of the __ ___ for a ___ calorie diet
Side note: Any sort of processes done to product must be on labels except ____ )
Serving size Fat, Saturated Fat, Trans Fat, Cholesterol, Sodium, Total Carbohydrate, Protein Amount sugars and protein Daily Value 2000 Radiation
Daily Value: replaces the term ___ ___ __ (__).
- It takes into account the ___ __ __ (__) and the ___ ___ ___ (___).
- ___ ___ ___ is a relative term that is used on labels to eliminate the need to know the units for each of the nutrients.
recommended dietary allowance (RDA)
Reference Daily Intake (RDI)
Daily Reference Value (DRV)
Percent Daily Value
- _______
- Nutritionally altered product contains at least 25% less of a nutrient or of calories than the regular, or reference, product.
Reduced
“___ ___ ___”
- Must be low-fat or fat-free
- Must accurately reflect the amount of fat present in ___ g of food. (Ex. 2.5 g fat/ 50g food = 95% fat free)
“Percent Fat Free”
100
“____”
-FDA regulations state that it is used only on raw, never been frozen or heated, and contains no preservatives (___ at low levels is allowed)
“Fresh”
irradiation
“___ ___”
-This term means that one serving of a food contains 10-19% of the Daily Value for a particular nutrient
“Good source”
Baby Foods
-__ ____ ___ not allowed (___ and ___ are allowed). delicious
Broad health claims
unsweetened
unsalted
Health Claims:
Must be approved by ___ and must be clearly represented on label and all other forms of advertising.
- __ ___ from Whole Oats and Coronary Heart Disease
- Presence of high levels of __-___ that has been shown to reduce serum cholesterol.
FDA
Soluble Fiber
beta-glucan
A level of ___ grams of soy protein per day has been shown to lower serum cholesterol.
-Must contain at least ___ grams of soy protein per serving.
25
6.25
Health Claims:
- ___ ___ and ___ __ and Coronary Heart Disease
- Plant stanols and sterols have been shown to lower __ ___ (effective dose being ___grams for sterols and __ grams for stanols).
- Products so labeled must contain ___ the effective dose per serving.
Plant Sterol and Stanol Esters serum cholesterol 1.3 3.4 1/2
The ___ ___ ___ and ____ Act of 1994
Dietary Supplement Health and Education
Safety Testing of Dietary Supplements:
Dietary supplements are ____.
However, non-nutrients, and herbs remain largely _____.
They are not considered to be ____ and thus do not go through __ __ by FDA.
regulated
unregulated
drugs
safety testing
___ in ___people in the US suffer from foodborne illness each year (CDC).
1
6
Too many cases of preventable foodborne illness:
- ___deaths
- ____ hospitalizations
3000
128,000
Outbreaks:
- Cause ___ ____
- Disrupt ___ of food system
- Loss of __ ___
- ____ damage
foodborne illness
sectors
public confidence
economic
___ ___ is a widely shared goal and everyone’s responsibility.
Food safety
Why is law historic?
- It has been over __ years since the last major overhaul of food safety legislation.
- Focus is on ___ __, rather than ___ to problems.
- Gives FDA power to require ___.
- New requirements for ____ to ensure that food from abroad is just as safe as domestic foods.
70 preventative approach reaction recalls importers
FDA’s Key New Authorities and Mandates:
- ____
- ___ and ___
- ____
- ____
- ____ ____
- Prevention
- Inspection & Compliance
- Response
- Imports
- Enhanced Partnerships
Prevention:
- Mandatory ____ ___for food facilities.
- Mandatory produce ___ standards
- Authority to prevent ____ ___.
- FDA will issue regulations to protect against ___ ____ of food.
preventive controls
safety
intentional contamination
intentional adulteration
Inspection and Compliance:
- Mandated ____
- Records ____
- ____ by accredited laboratories
inspection
access
Testing
Response:
- Mandatory ___.
- ____ administrative detention
- Gives FDA more ____ to detain food that may be in violation of law.
- suspension of _____
- Enhanced product ___ abilities
- Additional ___ ___ for high risk foods
recalls Expanded flexibility registration tracing record keeping
Imports:
____ ____: Imports must verify that they had adequate preventative controls in place
- __ ___ certification
- Access to ____ ___
Import accountability
3rd party
deny
entry