FDSC 3010 Exam 2 Information
_________ agents cause more outbreaks; depending on the hazard, these bacteria will either be killed, controlled, or prevented.
biological
Currently, GMPs were written __________ to be applicable to ALL human food. - However, there are unique safety issues that must be covered for specific types of food product.s
broadly
In terms for something to be labeled "100% organic" or "organic" , the processor must also be a _________________ handler for the finished product to be labeled as one.
certified organic handler
Many Kosher certifying bodies and many different symbols exist (U) and (K). - Responsibility to oversee the kosher status of the food rests largely with the ____________ organization.
certifying
In the United States, the only poultry accepted by mainstream kashrut organizations as kosher are...
chicken, turkey, duck, and goose.
Are nutrition facts exempt if the food product makes a health claim or nutrient content claim?
no - they must be labeled!
______% of calories are consumed outside of the home.
33%
Are dietary guidance statements claims?
no - often thought of as such by consumers.
"For joint function" vs. "for joint pain" - Which is the correct way to word this structure and function claim?
"for joint function"
term the FDA feels best describes the biotechnology used in genetic modification; however, you will start to see the term _________ on food labeling as well.
"genetic engineering" and "bioengineered"
What two things do Kosher rules cover?
(1) types of foods that may be consumed (2) methods of handling
Means that the literacy or artistic work of the label is protected under US copyright laws.
(C) - C with a circle around it
What symbol means that a trademark used on the label is registered with the US Patent and Trademark Office (USPTO)?
(R) - R with a circle around it
What happened to cause dietary supplements to become regulated as drugs?
- 1989 to 1990 - 37 deaths and 1500 cases of permanent disability from the ingestion of L-Trp (amino acid).
Acidified foods: - finished equilibrium pH of _________ or below. - Water activity = ________.
- 4.6 or below - 0.85
Dietary supplements: - ____ billion dollar revenue/year. - How many different supplements are on the market today? - _____ primary herbs with 1800 different names.
- 40 billion - 85,000 supplements - 550 primary herbs
What is the purpose of the Aquabounty Salmon?
- Genetically engineered to allow the salmon to grow FASTER! - Not larger, just grow faster.
What is the compliance date for vending machines provision of final rule? What are the exceptions?
- December 1, 2016 EXCEPTIONS: 1.) front of pack calorie declarations on food products sold in glass-front vending machines 2.) calorie declarations for gums, mints, and roll candy products sold in glass front vending machines in packages that are too small to bear front-of-packaging labeling.
Dietary supplements HACP: - Current _______ to help maintain quality and overall safety. - Unique since they typically come in a capsule, gel cap, powder tablet, etc. - 2007: established GMPs for manufacturing, labeling, packaging, and ______ of DS.
- GMPs - holding
What are the two new requirements for the Health Care Reform Bill "Creating Healthier Communities" Sect 4205?
- Menu and Menu Board Nutrition Labeling - Vending Machine Content Nutrition Labeling
Health Care Reform Bill: - implemented on March 23, 2010 - ____________________ Act: Divided into 9 titles
- Patient Protection and Affordable Care Act
Restaurant Provision of Law: - Who was included? __________ - 298,600 establishments and 2,130 chains - Cost of initial compliance estimated __________ million with recurring costs. - Approximately $_________ per establishment.
- Restaurant chains, retail food establishments - $315.1 million - $1,100 per establishment
What is the difference between authorized health claims and qualified health claims?
- The strength and totality of scientific evidence may be lacking. That is fewer quality studies in general and smaller sample sizes prohibit the claim from meeting the standard SSA.
What classifies as a low-acid canned food? - cannot be _________. - finished equilibrium pH greater than ______. - water activity greater than ____________ - Excludes __________.
- alcohol - 4.6 - 0.85 - tomatoes
Why was the passage of the Dietary Supplement Health and Education Act (DSHEA) unique?
- because it was the first time that an act or amendment DID NOT expand FDA authority and rather de-regulated it.
Why do we genetically engineer foods?
- better flavor - higher crop yield - insect resistance - immunity to plant diseases
Identifying the hazard under FSMA: - What are the three kinds of hazard analyses? - These may occur...
- biological, chemical (includes radiological), and physical - These may occur: naturally, unintentionally introduced, or introduced for economic gain.
Pareve: - Eggs must be checked for.... - Produce must be checked for _______. - Can't be processed on ______ or ________ equipment. - Can this have additives?
- blood spots - insects/larvae - meat or dairy - no
National Bioengineered Food Disclosure Standard (2016) requires that...
- by 2022, food makers, importers, and certain retailers label foods that are bioengineered or have bioengineered ingredients - must have approved methods, including text on the package that states "bioengineered food", the bioengineered food symbol, or directions for using your phone to find the disclosure.
Foundation of FSMA: - ________ were revised under FSMA and certain language changed ("must" instead of "shall") - revised to consider the threat of food-allergen ____________. - Emphasis on __________ employees.
- cGMPs - cross contact - educating
What are exclusions to dietary supplements?
- cannot be a new drug unless sold as a dietary supplement before 1994 - cannot be tobacco
Meat: - The Torah states that kosher mammals are those that do what two things? - Animals that chew cud = __________. - Examples?
- chew their cud and are cloven hoofed (split hooves) - ruminant - cows, deer, goats, antelope, and giraffes
Goal of FSMA is to have a food safety system that is built upon a ________ food safety culture, a sound foundation of _______ prerequisite programs, and incorporates risk-based ________ controls directed to controlling hazards.
- corporate - GMPs - preventative
What is daily reference value established for? - How is this broken down? - Based on ________ calories.
- established for fat, saturated fat, total carbohydrate, protein, cholesterol, sodium, and potassium. - broken down by age and gender - 2000 calories
Over the next 20 years, how much is the new nutritional panel expected to cost when switching from the 2016 format?
- estimated to cost food processors between $1.4 billion and $2.3 billion dollars.
Egg Safety Rules: - Production Storage and Transportation of Shell Eggs. 2009: Final regulation - Prevent egg contamination on a ______ level (farm biosecurity practices, rodent/fly pest prevention program) - If possibly present will prevent further growth in _______ and ________. (washing and refrigeration are important) - shell egg producers must register with _______.
- farm level - storage and transportation - FDA
Exclusions of the restaurant provision (4):
- food trucks - school menus if school participates with USDA nutrition program - airplanes - trains
Physical hazards include...
- foreign objects (glass and brittle plastic which can result in cuts and choking) - Metal (cuts, broken teeth, choking) - wood and stones
RDI: Reference Daily Intake - This is how much... - What is this based on?
- how much you need - Based on the recommended dietary allowances (RDA's) determined by the National Academy of Sciences.
Dairy in Kosher: - Produced by ________ animals. - Ingredients must be _______ and free of ________ derivatives. - Produced, processed, and packaged on _________ equipment.
- kosher - kosher and free of meat derivatives - kosher
In 1973, the FDA issued the final rule for bottled water. This established quality standard regulations for allowable levels of ___________, _______________, __________, and ______________ contaminants.
- microbiological - physical - chemical - radiological
What is classified as a small package and therefore be exempt from nutrition facts?
- must be less than 12 square inches for labeling - a number must be listed to call and obtain the information.
What are the two criteria for Kosher fish?
- must have fins and scales.
Nutrition support statements: - Role of the ______ or ____. - Mechanism by which it _________. - Nutrition deficiency disease - but must disclose its ___________. - general well-being - No disease claims UNLESS... ________.
- nutrient or DI - acts - prevalence - UNLESS "the claim is an authorized health claim for which the product qualifies"
How did engineers ensure that Aquabounty Salmon were safe and would not be released into the wild?
- only used sterile females, so if they were accidentally released into the wild, they would not be able to reproduce.
Daily Value (DV) FDA terminology: - In _____________ total recommended on a daily basis. - Combination of ___________ and ________. - How much you are getting from the food you are eating.
- percentages - DRV and RDI
What foods cannot be consumed with Halal?
- pork - alcohol - no birds of prey - vanilla extract
What is APHIS's (Animal and Plant Health Inspection Services) job in GMOS?
- responsible for the environmental safety of the genetically modified crop (making sure it is not a harm to surrounding habitats or other agriculture)
When is the EPA responsible for a GMO?
- responsible when the genetic modification relates to infects, bacteria, and viruses.
HACCP: - Science based _____ control plan. - stands for... _____________ - ____________ based food safety system - Risks from ingredients, process, and final food are analyzed. Steps to control identified risks and monitor controls.
- risk - Hazard analysis and critical control point - Prevention
Chemical controls: - Thorough and comprehensive allergen-management program (storage, cross contact, cleaning, and labeling) - only approved chemicals - __________ sheets - chemical safety training for __________ - monitor ingredients from suppliers for potential ___________.
- safety - employees - allergens
In 2018... - GMO _________ made up 94% of all the ones planted. - GMO ________ made up 94% of all the ones planted. - GMO ______ made up 92% of all the ones planted.
- soybean (94%) - cotton (94%) - corn (92%)
How do we control biological hazards?
- time/temperature controls (thawing/tempering, cooking, freezing, storing, etc.) - GMPS: employee hygiene, sanitation programs - packaging integrity - preservation factors (pH, water activity) - consumer directions for use (prevent abuse)
What is the FDA's role in GMOs?
- to make sure all food products are safe. - Must ensure that all genetically engineered foods meet the same legal requirements.
What is the FDA's responsibility in terms of dietary supplements?
- to take action against any unsafe dietary supplement after it reaches the market. - monitoring safety - production information (labeling, claims, packaging inserts, and accompanying literature).
Chemicals unintentionally or accidentally present can include:
- undeclared allergens - cleaning compounds - lead in candy
Manufacturers must be prepared to supply the FDA with showing what three things for DS implemented before 1994?
- use as a dietary supplement - in the US - Before October 15, 1994
How do you know if an ingredient was grandfathered in for NDIs (new dietary ingredient)?
- you don't: no master list of ingredients that were on the market prior to 1994.
What is considered no nutritional significance?
0 or less than 1 gram of each nutrient on facts panel
What are foods that are exempt from labeling?
1.) custom orders 2.) daily special 3.) temporary menu item (less than a total of 60 calendar days a year) 4.) general use condiments 5.) foods that are not on a menu/menu board and are not on display or self serve. 6.) foods that are part of a customary market test (less than 90 consecutive days).
Vending Machine Provision of Law: 1.) How many companies operate vending machines in the US? 2.) ________ million machines in 1.5 million locations. 3.) Initial cost of _______ million with recurring costs. 4.) cost per operator = __________. 5.) Operators who own _____ or more.
1.) 12,000 companies 2.) 5-6 million machines 3.) $25.8 million with recurring costs 4.) $2,400 5.) 20 or more
What is required of vending machines now? 1.) Disclosing calorie information of foods sold in vending machines operated by a person owning or operating )_____ or more machines, subject to certain exceptions. 2.) Where can calorie information be placed? 3.) Posting of calorie information for foods sold from _______ vending machines (ex: gumball machines, mixed nut machines). 4.) Disclosing __________ of covered operators on the machines or otherwise with the required calorie declaration to enable FDA to contact operators for enforcement purposes.
1.) 20 2.) on a sign (small placard, sticker, poster), near the article of food or selected button, or electronic/digital displays may also be used. 3.) bulk vending machines 4.) contact information
To be considered a dietary supplement, a product MUST CONTAIN ALL of the following: 1.) Intended use? 2.) Ingredients (contains one or more of)?
1.) Be intended to supplement the diet (that is, not intended to be a drug or conventional food). 2.) must contain a vitamin, mineral, an herb or other botanical, an amino acid, or a dietary substance for use by humans to supplement the diet b increasing the total dietary intake.
Due to the Dietary Supplement Health and Education Act, there are 3 hurdles that the FDA has to do before they can take enforcement action. - What are these 3 things?
1.) Burden of proof of adulteration 2.) Advanced notice of prosecution - FDA must provide the manufacturer with the opportunity to present its side to the FDA BEFORE FDA proceeds with case. 3.) De Novo Review - eliminates deference to the viewpoint of the FDA when an adulteration case is brought to court.
What are the benefits of HACCP?
1.) Creates a complete system to ensure safety. - Corrective actions, verifications, record keeping, potential risks. 2.) Clearly recognizes that the responsibility of ensuring safe food rests on the food industry. - problem solving and prevention are at facility level 3.) Allows traditional inspections to be more productive. - record keeping
What are the 3 components of a nutrient content claim?
1.) Direct statement about the level or range of a nutrient in the food. Ex: "low sodium" or "contains 100 calories" 2.) Implied claim describes a food or an ingredient in a manner that suggest that a nutrient is absent or present in a certain amount. Ex: "high in oat bran" 3.) A claim that suggest that a food because of its nutrient content may be useful in maintaining health dietary practices when the claim is made with an explicit claim or statement about a nutrient. Ex: "healthy, contains 3 grams of fat"
7 Principles to HACCP: 1.) ___________ and risk assessment. 2.) Determine the _____________ to control the identified hazard. 3.) Establish critical _________ for the preventative measures. 4.) Establish ___________ to monitor the critical control points. 5.) Establish corrective ___________ to be taken when monitoring shows that critical limit has been exceeded (or other deviation occurs in CCP monitoring). 6.) Establish effective ______________ systems that documents the HACCP system is working correctly. 7.) Establish procedures for _________ that the HACCP system is working correctly.
1.) Hazard 2.) critical control point 3.) limits 4.) procedures 5.) actions 6.) record keeping 7.) verification
What are different certifying organizations of Halal?
1.) Islamic Society of Washington Area 2.) Islamic Food and Nutrition Council of America 3.) Islamic Society of North America's Halal Certification Agency 4.) Halal Food Council International
Potential concerns of dietary supplements:
1.) Kratom 2.) Delta-8 3.) Cannibas derived 4.) Tianeptine 5.) Nitrite "poppers'
What are examples of third party certifications?
1.) NSF International NSF/ANSI (The American National Standards Institute) 2.) USP 3.) Consumerlab.com
Country of Origin Labeling (COOL): 1.) Enforced by __________________. 2.) _____ and _______ must also be labeled "farm raised" or "wild." 3.) Implemented over concern of _______ of imported foods. 4.) What are exempt from these labeling requirements? 5.) Follows the ______________ clause.
1.) USDA Agricultural Marketing Service (AMS) 2.) fish and shellfish 3.) safety 4.) food service establishments 5.) substantial transformation clause
Who are the main three agencies involved with GMOs?
1.) USDA and APHIS (Animal and Plant Health Inspection Services) 2.) EPA (Environmental Protection Agency) 3.) FDA
Example of a model health claim that can be used in food labeling to describe the relationship between calcium and osteoporosis:
1.) adequate calcium throughout life, as part of a well-balanced diet, MAY reduce the risk of osteoporosis. 2.) Adequate calcium as part of a healthful diet, along with physical activity, MAY reduce the risk of osteoporosis in later life.
GMO crops grown and sold in the US include...
1.) alfalfa 2.) apples 3.) canola 4.) corn 5.) cotton 6.) papaya 7.) potatoes 8.) soybeans 9.) summer squash 10.) sugar beets
List pre-approved authorized health claims:
1.) calcium and osteoporosis 2.) dietary fat and cancer 3.) dietary saturated fat and cholesterol and risk of coronary heart disease. 4.) sodium and hypertension 5.) fiber-containing grain products, fruits, vegetables, and cancer. 6.) Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. 7.) fruits and vegetables and cancer 8.) folic acid and neural tube defects 9.) Dietary carcinogenic carbohydrate sweeteners and dental caries 10.) Dietary soluble fiber, from certain food and risk of coronary heart disease. 11.) stanols/sterols and risk of coronary heart disease
(RESTAURANTS): On menus, menu boards (including drive through menus) or on signs for food on display must include... 1.) Number of ________ listed 2.) What are the two ways calories can be written? 3.) ________ to the name on the menu or to self-service food and foods on display. 4.) Clearly __________ with the item. 5.) Can be a ___________ for variable menu items.
1.) calories 2.) cal or calories 3.) adjacent 4.) associated 5.) range (200-280cal)
What are different available forms of dietary supplements?
1.) capsule 2.) tablet 3.) liquid 4.) powder 5.) softgel 6.) gelcap OR into products that... - are in conventional food form and must not be represented as conventional form NOR as a sole item of a meal or diet.
What does the menu labeling law require?
1.) disclose calorie information on menus and menu boards for standard menu items. 2.) disclose calorie information on signs adjacent to foods on display and self-service foods that are standard menu items. 3.) post a succinct statement concerning suggested daily caloric intake. 4.) provide written nutrition information for standard menu items upon consumer request. 5.) post on menus and menu boards statement that written nutrition information is available upon request.
Structure and function claims: 1.) Does not reference a _______ or _______. 2.) ________ does not pre-review these claims. 3.) While mainly used in ___________, it's growing in the food industry due to the less regulations based on trying to get a new health claim approved or incorrect wording on label. 4.) Consumers are still drawn to these claims as much as others and many do not understand the differences.
1.) disease or illness 2.) FDA 3.) dietary supplements
Rationale for Health Care Reform Bill (Vending Machines + Menu Labeling) to be added to Patient Protection and Affordable Care Act 1.) Portion sizes have _________ in the last 20 years. 2.) 5% of money spent on food away from home goes in ____________. 3.) 1 vending machine for every ______ adults.
1.) doubled 2.) vending machines 3.) 40 adults
What are two important aspects of Dietary Supplement Health and Education Act?
1.) excludes dietary supplement ingredients from the legal definition of "food additive" 2.) categorizes all DS as "food" and excludes supplements that make general non-specific health claims from drug definition.
Succinct statements: 1.) When are these optional? 2.) Type size no ________ than the smallest calorie declaration appearing on the same menu or menu board, with certain color and contrast requirements. 3.) Must appear on the _______ of each page of a multi-page menu and the bottom of a menu board, above, below or beside the statement of availability.
1.) for use on children's menus and menu boards. 2.) smaller 3.) bottom (each page)
What are examples of core nutrient level descriptions?
1.) free 2.) good source 3.) healthy 4.) high 5.) lean and extra lean 6.) less and fewer 7.) light 8.) low 9.) more 10.) reduced
Written food safety plan requirements under FSMA must include what 8 things...
1.) hazard analysis 2.) preventative controls 3.) supply-chain programs 4.) recall plan 5.) procedures for monitoring the implementation of the preventative controls. 6.) corrective action procedures 7.) verification procedures 8.) records
Nutrition Labeling and Education Act Exemptions include...
1.) if served in restaurants or other establishments in which food is served for immediate consumption. 2.) sold for sale or for use in such establishments.
Contamination of food products typically comes from one of the following 3:
1.) ingredients 2.) processing environment (including equipment). 3.) people
What are some food safety rules designed under HACCP?
1.) low acid canned foods 2.) acidified foods 3.) bottled drinking water 4.) instant formula 5.) fish and fishery products 6.) juice 7.) dietary supplements 8.) refrigeration of shell eggs held for retail distribution
How do calories have to be written for a menu item that comes in different flavors or varieties but are listed as only a single item?
1.) must be presented with a slash between the 2 calorie declarations (150/250 cal) 2.) or as a range (150-300 cal) if there are three or more options.
What are other nutrition fact exemptions?
1.) no nutritional significance - 0 or less than 1 gram of each nutrient on facts panel. 2.) Dietary supplements - own labeling laws. 3.) Medical foods - own requirements. 4.) Bulk shipments - intended for further processing and labeling 5.) Raw Fruits/Vegetables and Fish 6.) Small packages - less than 12 square inches for labeling however a # must be listed to call and obtain information 7.) Bulk containers - must be available somewhere at point of purchase.
What are the 4 types of labeling claims?
1.) nutrient content claims 2.) authorized health claims 3.) qualified health claims 4.) structure/function claims
List the three different ways that calorie information can be labeled on a vending machine:
1.) on a sign (small placard, sticker, poster) 2.) near the article of food or selected button. 3.) Electronic or digital displays may also be used.
What are some examples of additional labeling claims?
1.) organic 2.) country of origin 3.) Non-GMO 4.) Free range chicken 5.) Local 6.) Fair trade 7.) Animal welfare 8.) Grass fed
QUALIFIED HEALTH CLAIMS: 1.) Claims are reviewed and must have _________ on the label. 2.) Posts of claims that have been _______ to help aid industry in approaching a new claim. 3.) FDA has _______ days to review and rule on a proposed new claim.
1.) pre-approval 2.) denied 3.) 540 days
7 Final Rules of FSMA:
1.) preventative controls for human foods 2.) preventative controls for animal foods 3.) produce safety 4.) foreign supplier verification program 5.) third party certification 6.) sanitary transportation 7.) intentional adulteration
What are dietary supplements according to the expanded definition from DSHEA?
1.) products that are taken by mouth and contain dietary ingredients (except tobacco). 2.) categorized as foods; not drugs or food additives (intended to be ingested). 3.) may not be represented as a conventional food or meal (not consumed primarily for taste or aroma). 4.) must be labeled as a "dietary supplement"
Examples of substantial transformations:
1.) raw fish imported 2.) breaded, fried, and frozen
Why FSMA?
1.) response from a series of illness outbreaks and contamination incidents. 2.) addresses food safety on a global scale. 3.) scientific assessment of risk and implementation of controls. 4.) focus is on being proactive instead of reactive. 5.) amends the FD&C which now requires food facilities implement a written hazard analysis and risk based preventative control plan.
What must dietary labels include?
1.) statement of identity (supplement) 2.) net quantity of contents 3.) direction for use 4.) other ingredients in descending order of predominance 5.) supplemental facts (nutrition label) 6.) name and address of manufacturer or distributor 7.) If a S/F statement is used, FDA disclaimer must appear.
What are consumers fears with GMOs and genetic engineering?
1.) super weeds 2.) introduction of a new food allergen or toxin 3.) pests develop resistance to what they were created to combat.
Who does the restaurant provision generally include?
1.) table-service establishments 2.) quick-service establishments 3.) cafeterias 4.) pastry and retail confectionary stores 5.) coffee shops/ice cream shops 6.) salad/hot food bars 7.) multi-purpose establishments that have presented themselves publicly as restaurants. 8.) establishments within lager establishments that are part of a chain (ex: Starbucks in barnes and noble) 9.) grocery stores 10.) convenience stores
What are examples of physical controls?
1.) thorough inspection of raw materials upon receipt 2.) equipment maintenance 3.) employees complying with cGMPs (jewlery) 4.) improper storage 5.) metal detectors
The nutrition information for standard menu items that must be available in written form on the premises of the covered establishments and provided to the consumers upon requests include...
1.) total calories 2.) calories from fat 3.) total fat 4.) trans fat 5.) saturated fat 6.) cholesterol 7.) sodium 8.) total CHO 9.) sugars 10.) dietary fibers
What is required on a nutrients fact label?
1.) total calories 2.) total fat 3.) saturated fat 4.) trans fat 5.) cholesterol 6.) sodium 7.) total carbohydrate 8.) dietary fiber 9.) sugars 10.) protein
What ingredients must a dietary supplement contain?
1.) vitamin 2.) mineral 3.) herb or other botanical 4.) amino acid 5.) a dietary substance for use by humans to supplement the diet by increasing the total dietary intake.
Dietary supplements History: - When did supplements begin to change and find a larger consumer market?
1970
What gave enhanced authority over labeling of foods and dietary supplements?
1990 - Nutrition Labeling and Education Act
When were genetically engineered plants first introduced into our food supply?
1990s
When and what was the first FDA approved genetically engineered animal intended for food?
2015 - Aquabounty Salmon
Format for nutrition facts panel: Reference ____ CFR.
21
The FDA issued a final rule which included updated RACCs based on data from NHANES. The final rule specifically targets consumption data which has increased/decreased by at least _______% since the 1993 RACCs.
25%
For a food to be considered part of a customary market test, these food must appear on the menu for less than _____ consecutive days.
90
"organic"
95% or more ingredients in processed foods are certified organic.
_____% of annual food dollars are for food prepared outside of home.
50%
Why was menu/menu board nutrition labeling and vending machine content nutrition labeling added in a law?
68% of adults and 32% of children/adolescents are overweight or obese. - Obesity-related medical cost $147 billion. - Over consumption of calories and minimal physical activity. - increased risk of health problems: type 2 diabetes, stroke, heart disease, hypertension, arthritis, certain cancers). - 33% of calories consumed outside of the home. - 50% of annual food dollars for food prepared outside of home.
"made with organic ingredients"
70% of more ingredients certified organic.
What percent of US adults take dietary supplements?
71%
Manufacturers must report NDIs (new dietary ingredient) to the FDA at least ______ days prior to market. - What must they include?
75 days - must include supporting information of it being reasonably safe.
What can the FDA do in terms of actions against dietary supplements?
Actions against... - misbranding: must contain what label says - adulteration (GMPS)
Who was affected by the restaurant provision of the menu labeling law?
All restaurants and "similar retail establishments" that: - operate 20+ locations - use the same name (franchises) - sell same menu items
Who is covered under the menu labeling requirements?
Applies to restaurants and similar retail food establishments that are... - part of a chain of 20+ locations - doing business under the same name - offering for sale substantially the same menu items - offering for sale "restaurant type foods." - voluntarily register with FDA to be covered.
Three grams of soluble fiber from oatmeal daily in a diet low in saturated fat and cholesterol may reduce the risk of heart disease. This cereal has 2 grams per serving. What kind of health claim is this?
Authorized health claim
What are serving sizes based on in a nutrition facts panel?
Based on RACC -> Reference Amount Customarily Consumed
Why do we have additional labeling claims?
Because consumers often pay more money for a food product that bears a credence claim.
In 1973, the FDA issued a rule designed to control the primary factors that determine the formation and growth of _____________ in canned food.
C. botulinum
What was the FIRST RETAIL food crop sold in the US that was genetically engineered? - Longer _________. - ___________ labeled their product as GE "trans genetic plants" - Was this successful?
Calgene's Flavr Savr Tomato - Longer shelf life - Voluntarily - No, it ultimately failed. People were scared of GE foods.
COOL
Country of Origin Labeling
What was passed in 1994 as a result of the L-Trp Investigation and lobbying war?
Dietary Supplement Health and Education Act
A low-fat diet, with plenty of fruits and vegetables will promote healthy living. What kind of claim is this?
Dietary guidance
T/F: Pork is considered a a kosher mammal.
FALSE - NOT PORK! - These only have split hooves and do NOT chew their own cud.
The Nutrition Labeling and Education Act was further amended by the _______________ Act of 1997. - Were health claims permitted?
FDA Modernization Act - yes!
T/F: The Dietary Supplement Health and Education Act expanded FDA authority.
False - IT DE-REGULATED FDA AUTHORITY. - This was the first time this had ever happened.
T/F: There is only one format for a nutritional facts panel, and it is not specific.
False - many possible formats. - Each format has very detailed specifics.
T/F: People do not choose Kosher foods unless it is for a religious reason.
False - others may choose this as well.
Who is exempt from certification in terms of organic certification?
Farms that sell less than $5000 are exempt from certification. - must have direct sales.
Food for specified health use
FoSHU
FSMA - When was this signed into law?
Food Safety Modernization Act - signed into law by Barack Obama on Jan 4, 2011
What is the difference between FSMA and HACCP?
HACCP: focuses on processing controls (CCPs) - no recall plan - process control with CCPs FSMA: expands to include allergen preventative controls, sanitation preventative controls, and supplier controls. - includes a recall plan -preventative controls
foods permitted under Islamic law (Qur'an)
Halal
HACCP
Hazard Analysis Critical Control Point
Can "made with organic ingredients" use USDA's organic seal?
No!
Why was the nutrition labeling and education act passed in 1990?
In response to consumers and their demand for more nutritional information as well as ingredient declaration for food additives and allergens.
improved protection of infants by establishing greater regulatory control over formulation and production of infant formula - amended FD&C Act
Infant Formula Act of 1960
FDA proposed to amend the front-of-pac calorie labeling requirements for food sold in glass front vending machines and proposed a compliance date of ___________.
Jan 1, 2020
What foods were the three main crops first used for genetic engineering? What are other examples?
Main crops: cotton, corn, and soybeans Others: sugar beets, potatoes, squash, apples, and papayas.
When was the health care reform bill signed into law?
March 23, 2010
In Kosher foods, what two things should NOT be consumed together?
Meat and dairy (no cheeseburgers, pepperoni pizzas, etc.)
Establish uniform standards for production and handling foods as "organic."
OFPA (Organic Foods Production Act)
a dietary ingredient that was not on the market in the United States before October 15, 1994.
NDI (new dietary ingredient)
What did the Organic Foods Production Act authorize? ______ Farm Bill
NOP - National Organics Program 1990
If something is "organic" but contains non-organic, they must still be allowed per the...
National List.
NDIs
New dietary ingredient
Can dietary supplements make claims such as "reduces pain" or "treats heart disease"?
No - claims like these can only be made for drugs, not dietary supplements.
Is there a federal law that specifically applies to Kosher or Halal? - What happens if this is mis-used?
No - misuse of the term would fall under general prohibition against false or misleading labeling of the FD&C Act.
Is Pareve a meat or dairy food in Kosher?
No - not meat or dairy food.
How has labeling change with bioengineered foods? - What are allowed vs. not allowed statements
Not allowed statements; - "GMO free" or "Non-GMO" Allowed statements: - Label only those that are bioengineered - Symbol states bioengineered
What is the important date associated with NDIs (new dietary ingredients)?
October 15, 1994
OFPA
Organic Foods Production Act
Foods that were not supplied prior to 1994 are subject to additional review requirements and must be reported to the FDA ___________ to marketing.
PRIOR
PCQI
Preventive Controls Qualified Individual
disease, diarrhea, fever, vomiting, headache, cramps, some it gets into bloodstream, most recover while some fall severely ill and can be fatal. - among the leading bacterial causes of foodborne illness - shell eggs are a predominant source of SE in the United states.
Salmonellosis
Describe the two nutrition facts exemptions for small businesses:
Small Businesses (Two exemptions exist) 1.) Direct sales to consumers total annual sales of $500,000 or less. 2.) Low Volume: number of employees and number of units sold.
Calcium builds strong bones. Fiber helps maintain digestive regularity. What kind of claim is this?
Structure/function
Means that a trademark right is claimed, but the mark is not registered with USPTO.
TM
How are authorized health claims established?
The FDA uses a significant scientific agreement standard to complete extensive review and determine if the relationship described by the health claim is well established.
All foreign articles imported into the US must be marked with the country of origin for the ultimate purchaser.
The Tariff Act of 1930
In terms of organic certification, who is in charge of overseeing this?
The USDA
In Kosher, wine must be made by...
Torant-observant Jews
Who is the last person to receive the article in the same condition it was imported? - This could be a consumer or a manufacturer that further processes.
Ultimate purchaser
What must structure and function claims be accompanied by>
a disclaimer that states that the FDA has not officially authorized or scientifically evaluated the claim.
Authorized health claim: - Labeling statement that describes...
a relationship between a food or food component and its relationship to a disease or health-related problem.
low-acid food to which acids or acid foods are added and which has a finished equilibrium pH of 4.6 or below and water activity greater than 0.85.
acidified foods
Why did juice HACCP form?
after a series of food borne illness outbreaks associated with juice products in 1996. High profile outbreaks of E. coli 0157:H7 infections associated with drinking unpasteurized apple juice. - 66 cases of illness - 14 cases of HUS - 1 death (child) Final rule 2002 (very small businesses had until 2004 to be in compliance).
Blended items composed entirely of the same commodity (think bagged lettuce) must bear ____ countries of origin.
all
"100 percent organic"
all ingredients in the product are certified as organic.
Chemicals that naturally occur...
allergens and mycotoxins
How does the Dietary Supplement Health and Education Act (DSHEA) define dietary supplements?
as non-food additives and as non-pharmaceutical drugs.
What is the real option for the Rationale for Health Care Reform Bill (Vending Machines + Menu Labeling)?
consumer education - informed decision making - transparency to increase consumers in lower calorie options.
Task force of qualified health claims:
consumer health information for better nutrition
Most important limitation of dietary supplements: When sold in conventional form, a dietary supplement must NOT be represented as a....
conventional food
What did the Farm Bill Country of Origin Labeling (COOL) require retailers to notify customers of?
country of origin of... - beef - pork - lamb - chicken - goat meat - wild and farm raised fish and shellfish - perishable agricultural commodities - peanuts - pecans - ginseng - macadamia nuts
Strawberries that we buy today are genetically modified and are an example of _______ breeding.
cross breeding (two different varieties are cross bred).
cGMPS
current good manufacturing practices
DRV
daily reference value
What do structure and function claims do?
describe the way a nutrient affects normal structure or function in humans.
Structure and function claims can be used for food labels but were originally developed for use in...
dietary supplements
Why do we need specific GMPs and rules for different types of food products?
different pathogens can survive and fluorish in different environments, so the rules must be different to kill these pathogens.
Examples of Pareve:
eggs, fish, fruit, vegetables, grains, unprocessed juices, pasta, soft drinks, coffee, tea, and candy
Many people argue that there is too little oversight from the FDA with new dietary ingredients, and others argue with self regulation. - What was the solution to this?
enter third party certification by organizations (optional)
Brought requirements like standard of identity listed, net quantity, and manufacture location/addresses.
fair packaging and labeling (1966)
T/F: Dietary supplements can be represented as a conventional food and be sold a sole item of a meal or diet.
false - Products must be in conventional food forms and MUST NOT be represented as a conventional food form or a sole item of a meal or diet.
T/F: GE Aquabounty salmon are ideal because it allows for the salmon to grow BOTH larger and at faster rates.
false - salmon only grown at faster rates. - NOT larger!
Organic agriculture: - Combination of _________ practices and ___________ for production of methods and materials.
farming practices and standards for production
In short, dietary supplements are a subcategory of _________ but are not regulated in the same way.
food
Chemicals used in formulation include...
food additives, color additives, and preservatives
FSMA regulations recognize the role of the ____________ in food safety and gives the regulatory authority to the _______.
food industry; FDA
Kosher - What is their biblical origin?
food that conforms to Jewish dietary law - biblical origin: The Torah
In 2000, the FDA issued the final rule on shell egg refrigeration regulation. What was this designed to prevent?
foodborne illnesses and deaths resulting from the contamination of shell eggs with salmonella enteridis (SE).
What are dietary supplements categorized as?
foods - not drugs or food additive.s
How long have food crops been genetically modified by humans? - What are two common ways this is done?
for thousands of years - selective and cross breeding
conventional food product enhanced to provide specific health benefits. Examples: Ca +2 rich Orange juice, Ca2+ rich yogurt
functional foods
S/F means
general non-specific health claim
What does GMO stand for?
genetically modified organism
any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury.
hazard
Is helps "maintain cardiovascular function" or "protects against heart disease" an acceptable S/F example?
helps maintain cardiovascular function
What is the only way that the FDA can remove a dietary supplement from the market?
if FDA determines that the DS contains a poisonous or deleterious substance.
Prior to 1990, all health claims were considered...
illegal drug claims.
When was HACCP developed? Who developed it?
in 1950s by the Pillsbury Company alongside NASA. - presented to conference for food protection in 1971 - started with low-acid canned foods in 1974 - huge success
How are ingredients listed on a dietary supplement?
in descending order of predominance
Religious Symbols/Certifications: Symbols and certification partly regard process but also ___________ requirements.
ingredient
- Halal focuses on both the _________ in a food and the way the food is _________. - ________ must meet the Muslim slaughter ritual for animals. One slit of the throat, and then allowing the animal to bleed out.
ingredients and how it is processed. Meats
any biological, chemical (including radiological), or physical hazard that is known to be, or has the potential to be, associated with the facility or the food.
known or reasonably forseeable hazard
For a menu item to be considered temporary and exempt from labeling, how long can this item be on the menu?
less than a total of 60 calendar days
any food (other than alcoholic beverages) with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products having a finished equilibrium pH less than 4.7
low-acid canned food (LACF)
If is acceptable to say "affect" or "maintains" for S/F examples?
maintains
HACCP implementation for ________ and _________. - final rule was in 1996 - In 1993, 700 people were sick from E.coli O157:H7 - Hamburgers from Jack in the Box
meat and poultry
USDA Food Grades include what 5 foods? - Carries a label that denotes their quality. - Generally letters ____, ____, and ___ (for eggs). - Prime, Choice, Select for Meats - Most established by ________; participants pay for this extra grading.
milk, butter, orange juice, meat, and eggs. - AA, A, and B - USDA
A product lacking a correct nutrition label is deemed ___________ by the FDA (with minor exceptions).
misbranded
Can gelatin be considered Kosher dairy?
no - gelatin is normally of animal origin. It cannot be used.
Are meal replacements apart of the dietary supplement category?
no - meal replacements are excluded.
Are dietary supplement manufacturers required to register dietary supplements with the FDA or to report adverse events?
no
Prior to 1996, were previous claims allowed to be made connecting diet and overall health?
no
Does the Torah enumerate specific characteristics to distinguish permitted and forbidden birds/poultry?
no!
Is the country of origin required for a substantial transformation?
no, no country of origin is required here.
Do dietary supplements require premarket approval?
no-- FDA must prove unsafe before removing from the market. - Presumption of safety
supplement or enhancement to provide a specific health benefit. - Nutrition + pharmaceutical - ranges from isolated nutrients, DS and specific diets to genetically engineered designer foods, herbal products, and processed foods such as cereals, soups and beverages. Ex: energy booster of herbs, vit in capsule
nutraceutical
Health claims make a connection between __________ and ____________. - Do dietary guidance statement contain both of these as well?
nutrient and a health-related condition. - No, do not contain both.
Low fat Cholesterol free High in oat bran What kind of claim is this?
nutrient content
Advances in science has proved the link between __________ and __________. - What act did this ultimately result in the passage of?
nutrition; disease - Nutrition Labeling and Education Act (1990)
For menus, where is the written nutrition information statement of availability placed?
on the first page of the menu and menu items listed either above, below, or beside the succinct statement.
If there is "substantial transformation", then what needs to be labeled?
only the country of manufacture needs to be labeled.
an ecological production management system that promotes and enhances biodiversity, biological cycles, and soil biological activity. - It is based on management practices that restore, maintain, and enhance ecological harmony.
organic agriculture
Biological hazards include...
pathogens, bacteria, viruses, and parasites
non-digestible carbohydrates broken down by colon bacteria. - breakdown products foster good bacteria.
prebiotics
Kosher: - Food is processed on SEPARATE equipment and facilities. Kosher restaurants will often have 2 kitchens to separate _______ and _______. - Animal slaughter is carried out by a ______ cut to the throat then allowing the animal to bleed out. - Must be performed by a ________, who is an authorized individual satisfying qualifications.
preparation and utensils - single cut - Shohet
live, beneficial bacteria found in fermented foods.
probiotics
What did the Proxmire Vitamin and Mineral Amendment to the FD&C act do?
prohibited the FDA from establishing max limits on the potency of any vitamin or mineral.
Scientific evidence suggest but does not prove that eating 1.5 oz per day of most nuts as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. What kind of health claim is this?
qualified claim
"Scientific evidence suggests, but does not prove, that whole grains are part of a low saturated fat, low cholesterol diet, and may reduce the risk of diabetes mellitus type 2." This is an example of what kind of health claim?
qualified health claim
"supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts as a part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease." Must also be followed by: "see nutrition information for fat content." This is an example of what kind of health claim?
qualified health claim
RDI
reference daily intake
Bottled drinking water HACCP: - Resulted from field inspections and surveys of bottling plants not meeting ___________ criteria of chemical analyses and bottling under sanitary conditions.
regulatory
statement that compares the level of a nutrient in the food with the level of a nutrient in a reference food.
relative claim (example: reduced sodium)
Self-service food includes...
restaurant type food that is available at a salad bar, buffet line, cafeteria line, or similar self-service facility, including self-serve beverages and that are served by customers themselves.
In 1995, the FDA established HACCP requirements for the _______ industry. - Nature of the product presents wide range of possible hazards.
seafood
What section does the new health care reform bill (Menu labeling + vending Machines) amend in the Food, Drug, and Cosmetic Act?
section 403(g)
Clostridium botulinum can form...
spores capable of surviving under adverse conditions and can produce botulinum toxin, which can cause botulism. - This is a paralytic illness that can be fatal.
________________ laws require calorie declaration, but laws vary. - One standard for the industry.
state/local laws
Qualified health claims: - Approved certain qualified claims describing food substances/disease relationship but manufactures must use a disclaimer about the ___________ of the scientific evidence supporting the claim.
strength
"Calcium builds strong bones." What kind of health claim is this?
structure and function claims
"Fiber maintains bowel regularity." What kind of health claim is this?
structure and function claims
Nutriton support statements aka...
structure/function statements on dietary supplements
"2000 calories a day is used for general nutrition advice, but calorie needs vary." This is a...
succinct statement
Health claims are not the "fad-of-the week." Instead, for health claims to be used, there needs to be...
sufficient scientific agreement among qualified expert that the claims are factual and truthful.
Unlike drugs, ___________ are not intended to treat, diagnose, prevent, or cure diseases.
supplements
What kind of dietary supplements are exempt from any requirement for FDA approval?
supplements in use prior to 1994
What did the FDA's final rule for bottled water require?
that bottled water be safe and that it is to be processed, bottled, held, and transported under sanitary conditions. - also required analytical testing
Who is the Tariff Act of 1930 enforced by?
the US Customs and Border Protection
What are dietary guidance statements based on?
the dietary guidelines for Americans (reviewed every 5 years). - statements can be made without pre-review
Structure and function claims: Although the FDA does not pre-review these claims, what happens if these products are revealed to be misleading or not truthful?
the product would be misbranded.
What is the purpose of a succinct statement?
to enable consumers to understand, in the context of a total daily diet, the significance of the calorie information provided on menu and menu boards.
Dietary supplements CAN NOT BE A NEW DRUG (unless sold as a dietary supplement prior to 1994) and CAN NOT be tobacco.
true
T/F: All agricultural products labeled organic must originate from farms or handling operations certified by a state or private agency accredited by the USDA.
true
T/F: Dietary supplements must be labeled as a dietary supplement.
true
T/F: Dietary supplements were a booming industry with minimal FDA oversight.
true
T/F: Food facilities are required to develop and implement a written plan for preventative controls and written recall plans. - This is the facilities Food Safety plan, often written by PCQI.
true
T/F: Kosher food is a multi billion-dollar industry.
true
T/F: Many food crops today would be unrecognizable when compared to the wild ancestor.
true
T/F: Restaurants with less than 20 locations can register to be "voluntarily" included in the program (menu labeling law).
true
T/F: Some products sold as supplements have drug-like effects.
true
T/F: The FDA must provide an advanced notice of prosecution BEFORE taking enforcement action on a dietary supplement.
true
T/F: The food product bearing the authorized health claim must meet other requirements and NOT just contain the nutrient.
true
T/F: There is no clearance or FDA approval associated with NDIs. The FDA has 75 days to question the safety of the new dietary ingredient, and if they do not, it can be put on the market after 75 days.
true
How do we track FSMA's success? - For each rule, the FDA has identified measures that will help evaluate how well the rules are being implemented and where there could be room for improvement. - metrics for evaluating the improvement areas as well as success areas.
via FDA-track
Written nutrition information must include the nutrients that are currently required in the nutrition facts label on packaged foods, except _______ and ______.
vitamins and minerals
Blended items that contain different commodities would be labeled...
where it was packaged
Is the statement "additional nutrition information available upon request" required on menu and menu boards?
yes
Are allergens considered a chemical hazard?
yes!
Can farms that are exempt from organic certification use the label "organic"?
yes, can say organic as long as it is accurate that they are in fact organic. - Cannot say "certified organic"
