Food Law and Regulations in the USA Flashcards

Question

What is the Standard of Identity for Peanut butter?

Answer 1

* Must contain at least 90% peanuts (21 CFR 164.150) ## Footnote This does not mean all peanut butter is the same!

Answer 2

* Must contain 45% juice or fruits. ## Footnote Imitations are less expensive to produce which provides economical gain as incentive for non-compliance with standards of identity.

Answer 3

* Margarine (or oleomargarine) is food in plastic form or liquid emulsion, containing **not less than 80 percent vegetable fat** determined by the method prescribed in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980) * Fat phase and water phase ingredients are specified * Vitamin D is an optional ingredient * The finished oleomargarine contains **not less than 1,500 IU of vitamin D per pound**.

Answer 4

* 1993 - Amendment to FDCA (21 CFR Sec. 130) allows modifying of nutrients in standardized foods.

Answer 5

Only if: * Food complies with NLEA rules * Food maintains its performance properties * Food must not be nutritionally inferior * Safe and suitable ingredients must be used for modification * If an ingredient is a key ingredient of standard food, it shall not be replaced * Fat may be reduced in peanut butter, but it still must have at least 90% of peanuts * Water and fat analogs may be added to replace fat and calories * The name of the modified food is the appropriate nutrient content descriptor followed by the name provided by the Standard of Identity * e.g., reduced fat ice-cream

Answer 6

* Prior-sanctioned ingredients * Food additives * As classified by the 1958 Food Additive Amendment to FDCA * Colour additives * As classified by the 1960 – Color Additive Amendment to FDCA * Substances that are Generally Recognized As Safe (GRAS) (effective since 1961) * Pesticide residues * Salt is an additive

Answer 7

True. ## Footnote Not in Canada!

Answer 8

False. Salt is an additive. ## Footnote It is not an additive in Canada.

Answer 9

* Any substance that was in common use in food before January 1, 1958 * Shown no evidence of safety problems from that use * They were approved by FDA or USDA before September 6, 1958 * There is no official list of all “prior sanction ingredients; however, some of them are listed in 21CFR, part 181 | https://www.law.cornell.edu/cfr/text/21/part-181

Answer 10

* Prior sanctioned material * Food colorant * GRAS * Pesticide chemical | 21 CFR Part 170 - 172

Answer 11

* Additives permitted for direct addition to food for human consumption

Answer 12

* Direct food additive

Answer 13

Substances that may become part of food as: – component of packaging material – adhesives – food processing equipment – surfaces and containers used for food handling, including during distribution – production aids and sanitizers ## Footnote 21 CFR Part 174 - 178

Answer 14

* Substances for food uses that are determined as safe by “experts qualified by scientific training and experience” * Classification of GRAS substances (21CFR part 182) – Multiple purposes – Anticaking agents – Chemical preservatives – Dietary supplements - some vitamins that are not listed as nutrients (niacin, riboflavin, thiamin, etc.) – Sequestrants – Stabilizers – Nutrients

Answer 15

* When the status of a substance has been reevaluated, it will be deleted from this part (182) and will be issued as a new regulation under the appropriate part, e.g., “affirmed as GRAS” under part 184 (Direct GRAS) or 186 (Indirect GRAS)” or “prohibited from use in food” under part 189 of this chapter * “Any ingredient affirmed as GRAS shall be used under current good manufacturing practice”

Answer 16

* A dye, pigment, or other substance made by process of synthesis or extracted, isolated from vegetable, animal, mineral, or other sources * Nine certified colours (purity determined by the FDA laboratories) (21 CFR Part 74, subpart A) – FD&C Blue No. 1, and No.2 – FD&C Green No. 3 – FD&C Orange B – FD&C Citrus Red No. 2 – FD&C Red No.3 and No. 40 – FD&C Yellow No. 5 and 6

Answer 17

* Derived from spices (paprika; saffron; turmeric) * Caramel * Fruit and veg-based (beet powder; grape colour extract; juice; carrot oil) * Mineral based products (synthetic iron oxide; titanium dioxide)

Answer 18

* Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest. * These include insecticides, herbicides, fungicides, and various other substances used to control pests

Answer 19

* The EPA sets tolerances to ensure the food safety of foods based on: * the toxicity of the pesticide and its break-down products * amount and frequency of applications * the residual amount remains in or on foods * Maximum residue limits apply to domestic and imported foods

Answer 20

* 1862 - 1906 * Dr. Harvey Wiley - chief chemist - focused attention on misbranding and adulteration * "Poison squad" - 12 employees of the USDA; **self-testing** of preservatives

Answer 21

* 12 employees of the USDA who self-tested preservatives

Answer 22

* In 1980 the FDA was moved under the Department of Health and Human Services (HHS)

Answer 23

* Inspired by 'The Jungle' by Upton Sinclair - signed the 1906 Pure Food and Drugs Act (A big success of Dr. Wiley and the Bureau of Chemistry) * The Meat Inspection Act was passed on the same day

Answer 24

* Bureau of Chemistry * Also controlled the interstate transportation of food (penalties for selling unlawful foods)

Answer 25

* Name of food * Net quantity of contents * Ingredient statement if it is made from two or more ingredients * Name and address of manufacturer, packers, or distributor * Requirement for additional information on dietary foods

Answer 26

* The act prohibited the use of ingredients that may harm or present a health hazard to consumers * The act requires a label that is not misleading or false. * There are no requirements for an affirmative label

Answer 27

* Declaration of contents * Required declaration by (1) weight, (2) measure, or (3) numerical count

Answer 28

* Lack of proper regulatory control * Jamaican ginger incident: 35,000 – 50,000 victims (1930) * Elixir Sulfanilamide: wonder drug for children – 100 people died (1937)

Answer 29

* Signed by President F.D. Roosevelt (25 June 1938) * Food, drugs, cosmetics and medical devices controlled under the same act * Prohibition against economic adulteration * Prohibition of false or misleading statements on labels * Imitation of foods must be labelled as such ## Footnote The 'proper beginning' of what exists today.

Answer 30

* To ensure access to wholesome and safe foods and fair competition * There is no single agency that controls all aspects of the production and marketing of foods. * Agencies: FDA, USDA, Environmental Protection Agency, Federal Trade Commission ## Footnote Other agencies: US Department of Commerce; Bureau of Alcohol, Tobacco, and Firearms; US Department of Labor, and Public Health Service

Answer 31

Once the law is allowed, regulations are promulgated in “**the Federal Register**” * *The Proposed Rule* - A minimum of 30 days allowed for comments before a proposed rule became a final rule * *An Advanced Notice of Proposed Rulemaking* - Intent to a proposed rule that needs more comments from the industry and the general public * *Final Rule* - Time varied. Most of the time, within months after the deadline for filing comments * Promulgated regulations have the full force of laws passed by Congress * Regulations may be issued as “guidelines” ## Footnote Promulgate - put into effect by official proclamation

Answer 32

* The **Federal Register** is published **daily**, except Saturdays, Sundays and federal holidays. It includes presidential documents, notices of agency meetings, proposed rules, final rules, affected CFR parts, and Reader Aids. * Federal regulations are first published in the Federal Register and later codified by subject matter in the Code of Federal Regulations * **The Code of Federal Regulations** (CFR) provides subject regulation access. It contains fifty titles. The Code of Federal Regulations is republished every year, every quarter.

Answer 33

* Title 21 of the Code of Federal Regulations (21 CFR), the first three volumes – foods (FDA) * Title 9 CFR – meat, meat products, poultry and poultry products, and eggs (USDA) * Title 7 CFR – National Organic Program (USDA)

Answer 34

It includes (1) presidential documents, (2) notices of agency meetings, (3) proposed rules, (4) final rules, (5) affected CFR parts, and (6) Reader Aids.

Answer 35

Food and Drug Administration (Department of Health and Human Services) | All foods but meat (if >3%), poultry (if >2%), egg products. ## Footnote The FDA is the primary agency responsible for regulating most foods in interstate commerce. The USDA regulates meat products with more than 3% meat and poultry products with more than 2% poultry, as well as egg products. If a food contains less than those percentages of meat or poultry, the FDA is responsible. For eggs: -processed egg (dried, liquid, frozen; don’t count pasteurization on shell egg) + products with >2% egg ingredients =USDA - shell egg (whole, unprocessed, can be pasteurized ) + products with <2% egg ingredients = FDA

Answer 36

* Safety of food supply and food ingredients * Food processing; GMP; HACCP * Food labelling * Cooperation with other agencies * Implementation of laws

Answer 37

* Jurisdiction over various aspects of the food supply * Meat, poultry, eggs – raw and processed * Domestic and import * Pre-approval of labelling

Answer 38

* Food Safety and Inspection Service of the USDA * Created in 1981, currently 9,000 employees * Overlooking the safety of meat, poultry and egg products * Oversees the domestic inspection of animals and processing of meat, poultry and eggs * Administration of the quality grading for agricultural products

Answer 39

* Federal Meat Inspection Act (1906) * Poultry Product Inspection Act (1957) * Eggs Products Inspection Act (1970)

Answer 40

* Labelling of foods and approval of labels – Nutrition Labeling of Meat and Poultry Products (1993) – Voluntary nutrition labelling on single-ingredient, raw meat and poultry products – Mandatory nutrition labelling requirements for all other meat and poultry products * Import and export of USDA food products * Implementation of laws: – Federal Meat Inspection Act (1906) – Poultry Product Inspection Act (1957) – Eggs Products Inspection Act (1970) * HACCP

Answer 41

* Introduced in 1996 * Focuses on the prevention and reduction of illness- causing pathogens on raw products (PR – pathogen reduction) * Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures are required in all FSIS-inspected establishments * Implementation of HACCP/PR began in January 1997 and was completed in more than 6,000 federally inspected and 2,100 state-inspected meat and poultry plants in January 2000.

Answer 42

* Extend its zero-tolerence policy for six serogroups of pathogenic *E. coli* in addition to O157:H7 * Serogroups O26, O103, O45, O111, O121 and O145 (Non-O157:H7 Shiga-toxin producing *E.coli*, or non-O157 STEC ## Footnote If found in raw beef, they will be declared adulterants.

Answer 43

* **Agricultural Research Services** * Research on the breeding of plants and animals, utilization of agricultural products for foods and non-foods * Nutrition research - USDA nutrient database * **Federal Grain Inspection Services** * Sets standards, and provides inspection and grading services for all types of grains * **Agricultural Marketing Services** * Develops grade standards based on quality for meat, poultry, eggs, dairy, fruits and vegetables

Answer 44

* **Advertising** * May take action against any producers if FTC considers advertising of a product false or misleading * A potential for overlap in the responsibility of FTC and FDA (advertising versus labelling)

Answer 45

* Controls the safety of drinking water * FDA overlooking water used for food processing and bottled water since water is food (FDCA) * Overlooking environmental programs; residue limits for chemicals and pesticides in food production * Research on health-relating problems

Answer 46

* Export trade assistance * Technical assistance for the seafood industry * Gathering and disseminating statistical data on the food industry * Information on research projects * Methods and procedures for weights and measures compliance checks

Answer 47

USDA - FSIS

Answer 48

Misbranding/misleading The label shows strawberries, but in tiny print it says 'contains no fruit'.

Answer 49

* Specified foods and functions * Specified maximum amount or use under GMP * 43 established food categories and 32 physical or technical functions ## Footnote ~3000 food additives in the USA.

Answer 50

* Reinforced the need to enhance the security of the US food supply. * **The Public Health Security and Bioterrorism Preparedness and Response Act** was passed by Congress and signed by President Bush on June 12, 2002

Answer 51

* Protecting Safety and Security of Food and Drug Supply

Answer 52

* **More inspections** of imported foods * **Faster detection** of intentional adulteration * Focus on rapid detection methods (R&D) * **Closer collaborations** between all agencies (coordinate research between CDC, NIH, EPA, and USDA) * Communicating to Congress the progress made in research

Answer 53

* FDA is authorized to detent any foods which may present a threat of severe adverse health * FDA must have **credible evidence or information**

Answer 54

* Requires the owner, operator, or agent in charge of a **domestic or foreign facility** to submit a registration to the Secretary * For a foreign facility, registration must include the **name of the U.S. agent for the facility.** * Registration shall contain the **name and address** of each facility (manufacturing, storage, etc.) * FDA to assign a registration number to each facility * Starting on October 2012 - registration must be updated every two years (FSMA)

Answer 55

* Every two years (FSMA) * Starting October 2012 ## Footnote This makes sense because a lot can change in two years (new process methods; new recipes; new products; etc.)

Answer 56

* FDA is authorized to have **access to certain records** (e.g., manufacture, processing, packing, distribution, or importation) when there is a **reasonable belief** that an article of food is adulterated and presents a threat of severe adverse health consequences or death to humans or animals * Limits **record-keeping requirements to two years** (practically many companies keep records for much longer, just in case) * All gathered information is kept confidential by the FDA

Answer 57

* An importer must notify the FDA about a food shipment in advance! * FDA provides a compliance policy guide * Summary information about submission of prior notice, including data on the types of errors * Required information to acheive compliance with imported foods

Answer 58

The exact requirements of the FDCA, label and labelling and other applicable laws as foods that are produced in the US.

Answer 59

* The Secretary of the Treasury (through U.S. customs) * The Secretary of Health and Human Services (through the FDA)

Answer 60

* It requires prior notice of imported food shipments. * The notice must provide the article, the manufacturer and shipper, the grower (if known), the country of origin, the country from which the article is shipped, and the anticipated port of entry. * The prior notice to the FDA must be submitted at least 2 hours (for food arriving by road), 4 hours (for food arriving by rail), 8 hours (for food arriving by sea) and **not before five calendar days before** the anticipated date of arrival of the food * States that the article shall be refused admission if notice is not provided. | Then: ## Footnote Entry filed with US Customs – An importer must notify USC (filing and submitting entry papers, names, and registration numbers) and arrange for sampling, examination, release, or other specific action appropriate for the food shipment

Answer 61

* Only a small % of shipments is sampled and examined for compliance by the FDA (they need to pay for sampling if the product is found to be non-compliant) * If not sampled - FDA issues 'may proceed notice' to importer * If sampled: * FDA must notify the importer * If samples comply, FDA pays for analyses and issues 'a release notice' to the importer * If samples are not in compliance, a 'notice of detention and hearing' is issued to the importer * Shipment may be allowed to the USA after re-conditioning and re-labelling and further re-examination on the cost of the importer * Shipment may be denied entry and return to the country of origin or destroy

Answer 62

* To reduce the 'risk of tampering or other malicious, criminal, or **terrorist** actions on the food supply' (FDA)

Answer 63

* **2002** - WHO declared that malicious contamination of food is a real threat and can be used by terrorists * **2003** FDA declassified a document in which they concluded that **food terrorism is real**, and a significant number of people will be affected

Answer 64

* **Large batches** - a large number of consumers * **Uniform mixing** - contaminate all servings in a batch * **Short shelf life** - minimal time to identify a problem and intervene * **Ease access** - accessible targets are more attractive ## Footnote Rajaratnam (2008)

Answer 65

**1989)** - **USA** - grapes shipped to the US from Chile were contaminated with cyanide – testing revealed two grapes were tinted with a small (non-lethal) level of cyanide – *no casualties* **1990)** - **Japan** – curry contaminated with arsenic during the summer festival – *4 dead, 63 hospitalized* **2002)** - **China** – noodles in restaurants tainted with rat poison – *38 dead, 300 injured* **2018)** – **Australia** - sewing needles in strawberries - *186 reports, one person injured*

Answer 66

* reducing “the risk of tampering or other malicious, criminal, or **terrorist actions on the food supply**” (FDA) * reducing the risk of food contamination **resulting from natural disasters and accidents** * **Implementing a plan** for preparedness, response and recovery activities * **To detect, confirm and investigate any abnormalities** in the food supply * To ensure the **availability of safe foods** * To maintain **communication** between government and the private sector

Answer 67

* Bioterrorism Act * Food Safety and Modernization Act (FSMA)

Answer 68

* FDA regulates: – $417 billion worth of domestic food and $49 billion in imported food * FDA has oversight of more than 420,000 registered domestic and foreign food facilities (BT Act) * Approximately 189,000 registered foreign food facilities account for 15% of the US food supply * The US trades with over 150 countries/territories ## Footnote 70% of frozen apple juice in American markets is from China. Over half of world apple supply is from China. Unfortunately this has lead to the disappearance of orchards in other countries because they cannot compete.

Answer 69

* An increasing number of food-borne diseases (US CDCP, 2010) * About 76 million each year * 300,000 hospitalizations, 5,000 deaths, cost $152 billion annually * Inspection of imported products and facilities is limited (<2% in 2010) due to understaffing and funding * An increasing number of adulterated imported foods * Rising number of food-borne illnesses associated with import – 2011 (Henan Province) – pork tainted with clenbuterol, the banned additive, which increases muscle mass; several outbreaks of acute illness in China and EU countries

Answer 70

* To improve: * Prevention of food safety problems * Detection and responding to food safety problems * The safety of imported food

Answer 71

* Preventive Controls * Inspection and Compliance * Imported Food Safety * Response * Enhanced Partnerships

Answer 72

* FDA is allowed to force companies to recall adulterated foods * Increasing the number of domestic and foreign facility inspections ## Footnote Note before the FSMA, recalls were fully voluntary!! But most companies were very proactive.

Answer 73

“Hazard Analysis and Risk-Based Preventive Controls.”

Answer 74

* Each food facility to **develop a written food safety plan and implement a food safety system**

Answer 75

* **Hazard analysis** * **Preventive controls** (PC) include process, food allergens, sanitation controls, supply-chain controls, and a recall plan * Management of PC, including **monitoring, corrective actions, and corrections, verification** * cGMP (employees must have the proper education, **training**, and experience) * Compliance Dates: Jan 1st, 2019 (Final Rule)

Answer 76

**HACCP** - Based on a guideline recommended by **CODEX** and National Advisory Committee on Microbiological Criteria for Foods **HARPC** - Based on the **FSMA** and principally, the final rule for Preventive Controls for human foods.

Answer 77

**HACCP** - Conventional (biological; chemical; physical) **HARPC** - Beyond the conventional risks for actual and potential food safety hazards

Answer 78

**HACCP** - Primarily, a competent HACCP coordinator with assistance from multidisciplinary team **HARPC** - Trained preventive controls qualified individual as described in FSMA

Answer 79

**HACCP** - at least once a year, or when required **HARPC** - at least every 3 years, or when required

Answer 80

**HACCP** - For the FDA and the USDA mandated establishments, or when required for certification purposes **HARPC** - For all establishments along the food supply chain that serve U.S. consumers, unless exempted

Answer 81

**HACCP** - Unless mandated/required for certification, HACCP is voluntary, and GMPs are mandatory **HARPC** - Exemption list provided by FDA, but this does not exempt facilities from following at least current GMPs

Answer 82

**HACCP** - Stakeholders: auditors, inspectors, and customers **HARPC** - FDA

Answer 83

**HACCP** - 12 steps of HACCP (includes 7 Principles) **HARPC** - 7 steps of developing a HARPC plan

Answer 84

* Establishing **additional traceability recordkeeping for foods that are more prone** to being associated with food-borne diseases. * It is part of preventive control. * It will help quickly identify consumers who purchased the foods in question and mitigate outbreaks faster. ## Footnote https://www.fda.gov/food/food-safety-modernization-actfsma/ food-traceability-list

Answer 85

* Importers must verify that their foreign suppliers have **adequate preventive controls** in place to ensure safety * Review a **compliance status** with the FDA regulations * Food-safety performance history (any violations?) * **On-site auditing** (annual or less frequent – *still under discussion*)

Answer 86

Fees related to: * food facility re-inspection * food recalls * the voluntary qualified importer program * to establish and administer the third-party accreditation program

Answer 87

In a **risk-based manner** (high-risk facilities first), while also adopting **innovative** inspection approaches ## Footnote High risk facilities = previously poor performance/compliance

Answer 88

False. The Law does.

Answer 89

* GFSI benchmarked program: **Foreign Suppliers' Verification Program** (FSVP) ## Footnote Part of the FSMA

Answer 90

* FDA is authorized to accredit qualified third-party auditors to certify that foreign food facilities comply with U.S. food safety standards. * Foreign government agencies or private companies * Once the FDA accredits third-party auditors, they can extend accreditation to other auditors that may audit and issue certifications for foreign food facilities. * Inspections are designed to pinpoint safety problems before foods arrive in the US. * User fee program | Imported Food Safety - FSVP

Answer 91

* For the first time, the FDA will have **mandatory recall authority** for all food products (so far the industry has honoured requests for voluntary recalls) * **Enhanced partnerships** - the legislation also recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals.

Answer 92

****Food Safety Modernization Act**** * Cost: $1.4 Billion (2011 -2015) – 2,000 new inspectors – Inspection of 50,000 foreign and domestic food production facilities * As of May 2013, FDA **established foreign offices** with American and local employees – Examples: Beijing, Shanghai, Guangzhou (China); New Delhi, Mumbai (India); Mexico City (Mexico), Santiago (Chile), Brussels (Belgium), Parma (Italy), Pretoria (S. Africa), London (UK), San Jose (Costa Rica)

Answer 93

* **Relationships** with national agencies * **Engagement** with the food industry in support of safe and quality foods * Conducting **inspections** * US$ 10 million to add 7 food and 9 drug inspectors in China * President Obama – FY2013 Budget * **Training and information exchange** * Collaboration with academia (e.g., Ocean University Safety training) * **Monitoring and reporting** on conditions and events that may impact food safety * Based on the detection of unapproved antibiotics in Chinese aquaculture, FDA put 5 seafood species (aqua farm) on import alert * FDA inspection found that the low-acid canned food industry lacks understanding of FDA requirements

Answer 94

* AQSIQ developed a training program based on FDA requirements * FDA monitors progress

Answer 95

* To provide **informed choice** to the consumer * Accurate information as to the quantity of the contents * Non-misleading information * Facilitate value comparisons * To ensure **fair trade** between manufacturers

Answer 96

* To lose weight * For nutritious diet * To manage medical condition

Answer 97

* Food Drug & Cosmetics Act * Nutrition Labelling and Education Act (NLEA) * The Food Allergen Labelling and Consumer Protection Act (FALCPA)

Answer 98

“means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale”

Answer 99

“means that part of the label immediately contiguous and to the right of the PDP as observed by an individual facing the PDP”

Answer 100

* Depends on the shape of the container * Size of PDP = 40% height x circumference with height measured by excluding 'heel' at the bottom and 'shoulder' at the top IP to the right of PDP

Answer 101

* Statement of identify (product name) * Ingredient statement * Amount of food in package (net quantity of contents) * Name and place of business (manufacturer, packer, or distributer) * Nutrition information

Answer 102

* Common or usual name of food product (e.g., cookies) * Standard of identify name (e.g., cheddar cheese) * Descriptive name, not misleading * Placed on label parallel to the base of the package * Should stand out * Bold type * At least 1/2 the size of the large print on the label

Answer 103

* Resembles food and is a substitute * Contains less protein, a lesser amount of vitamin/mineral * Imitation is part of name * e.g., imitation crab

Answer 104

* 'Drink'; 'beverage' or 'cocktail' is part of the name * Special statement on information panel (10% juice)

Answer 105

* Name is commonly understood by the public (e.g., JELL-O)

Answer 106

* **Blueberry Muffins** - Flavored with blueberry fruits * **Blueberry Flavored Muffins** (or Natural Flavor Blueberry Muffins) - Fruits and natural flavour * **Artificially Flavored Blueberry Muffins** - Contains artificial flavour

Answer 107

* Lists each food ingredient in descending order of predominance * Exemption: if ingredients are used at a level of 2% or less without regard to the order of predominance if preceded by a statement: 'Contains 2% or less of' * Must be placed on the information panel (or the same panel as the manufacturer's name and address); may also be placed on the principle display panel * Uses the common name of ingredients * Minimimum type size * Not less than 1/16th inch

Answer 108

* milk, salt, sugar * starch (means corn starch) but potato starch, rice starch, etc. * Other types of starch will need to be specified, since starch always refers to starch from corn * flour (means white wheat flour) but rye flour, corn flour, etc. * Same thing here, other types of flour need to be specified * eggs (means dried whole eggs, frozen whole eggs, and liquid whole eggs) * Refers to chicken eggs; egg whites must be specified

Answer 109

* A complex ingredient (two or more ingredients) can be declared in the statements of ingredients by: * its established common name (e.g., enriched bleached flour) followed by a list of all ingredients in descending order of predominance * listing ingredients in descending order of predominance in the finished food without listing the ingredient itself | Examples ## Footnote Enriched bleached flour (bleached wheat flour, niacin, malted barley flour, reduced iron, thiamine mononitrate, riboflavin, folic acid) or Bleached wheat flour, niacin, malted barley flour, reduced iron, thiamine mononitrate, riboflavin, folic acid

Answer 110

**Single fat or oil** * Listed by common or usual name (e.g., lard, corn oil, etc.) **Blended Fats or Oils** * Each oil (fat) may be listed separately * Name of blend followed by a parenthetical listing of the individual products * Vegetable shortening (hydrogenated soybean oil and palm oil) **Use of an optional source of fats or oils** * Vegetable oil (cottonseed oil, palm oil, and/or soybean oil) * Vegetable oil (contains one or more of cottonseed oil, palm oil, and/or soybean oil)

Answer 111

* Must be listed by their common names * Certified colours must be listed by their specific names * e.g., FD&C Yellow #5 (tetrazine) * If an ingredient is synthetic, it must be declared as “artificial” * Spices may be listed by their common names (e.g., garlic, onion, etc.)

Answer 112

Must be declared unless dissipated in processing

Answer 113

* Must be declared by name followed by function in parentheses [e.g., soya lecithin (emulsifier)]

Answer 114

* Must be declared by their specific names followed by their functions in parentheses [e.g., calcium propionate (anti-fungal)]

Answer 115

* Amount of food in a package * Placed on PDP, lower 30%, parallel to the base of the package, conspicuous * State in U.S. customary **and** metric

Answer 116

* The area of PDP determines the minimum type size * PDP 5 sq in or less - type size: 1/16 in * PDP more than 400 sq in - type size: 1/2 in

Answer 117

The information panel

Answer 118

* Placed on the information panel * Unless actual manufacturer – “distributed by”, “packed for” * Address (city, state, country) * Country of origin required by U.S. Customs (Made in Italy)

Answer 119

* Name and address of manufacturer or distributor * Ingredient list * Nutrition Facts panel

Answer 120

* All packaged foods regulated under the FDCA that are labelled on or after January 1, 2006, must comply with FALCPA's food allergen labeling requirements * The labels of packaged foods containing major food allergens is required to be following FALCPA * FALCPA requires that in the case of tree nuts, the specific type of nut must be declared (e.g., almonds, pecans, or walnuts). * The species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp). ## Footnote 2004 – Food Allergen Labeling and Consumer Protection Act (FALCPA)

Answer 121

* Milk * Egg * Fish (specify species) * Crustacean shellfish (specify crab, lobster etc.) * Tree nuts (specify almonds, pecans, etc.) * Wheat * Peanuts * Sesame * Soybeans ## Footnote Sesame added as 9th major additive effective January 1, 2023.

Answer 122

* Organic is a labelling term and refers to products produced following the Organic Act and Regulations * **Title 7** CFR 205 (National Organic Program) * Organic foods (products) are prepared using “approved methods that integrate cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity”. * USDA National Organic Program

Answer 123

Product must contain (by weight or fluid volume, excluding water and salt) 100 percent organically produced ingredients

Answer 124

Product must contain (by weight or fluid volume, excluding water and salt) 95 percent organically produced ingredients

Answer 125

Product must contain (by weight or fluid volume, excluding water and salt) at least 70 percent organically produced ingredients

Answer 126

100% organic

Answer 127

Made with organic ingredients

Answer 128

* Foods or products made from foods listed by Agricultural Marketing services (AMS) * e.g., soybean, sugar beet, non-browning apple, sweet corn * Threshold (alternative) food, in which an ingredient contains a BE substance that is inadvertantly or technically unavoidable, and accounts for no more than: * 1-A: 'Five-percent (5%) of the specific ingredient by weight, would not be subject to disclosure' (e.g., grain) * 1-B: 'Nine-tenths (0.9%) of the specific ingredient by weight, would not be subject to disclosure' * Highly refined foods (e.g., oils, candies) are exempted from labelling * The mandatory compliance date is January 1, 2022

Answer 129

It requires mandatory labelling of BE food and ingredients using the following options: * A label statement using plain language * A QR code (can be scanned by smartphones) * A 1-800 to call for information * A symbol

Answer 130

True. ## Footnote It means that “the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and the product and its ingredients are not more than minimally processed” * smoking, roasting, freezing, drying and fermenting * grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices

Answer 131

False. 'Natural' is a regulatory descriptive term defined by USDA but not FDA. ## Footnote It means that “the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and the product and its ingredients are not more than minimally processed” * smoking, roasting, freezing, drying and fermenting * grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices

Answer 132

* This term is defined by the USDA but not FDA * It means that “the product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR 101.22), or any other artificial or synthetic ingredient; and the product and its ingredients are not more than **minimally processed**” * smoking, roasting, freezing, drying and fermenting * grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices

Answer 133

False. This term is defined by USDA and FDA ## Footnote – a food that is raw, has never been frozen or heated and contains no preservatives” (**FDA**) – a food product has not been frozen, processed, or preserved; however, poultry may be stored at 24°F (-4.4°C) and retain 'fresh' term (**USDA**)

Answer 134

True. ## Footnote It means “a food that is raw, has never been frozen or heated and contains no preservatives” (FDA) – a food product has not been frozen, processed, or preserved but allows to be stored (poultry) at 24oF (-4.4oC) (USDA)

Answer 135

* It means “a food that is raw, has never been frozen or heated and contains no preservatives” (FDA) * A food product has not been frozen, processed, or preserved but allows to be stored (poultry) at 24oF (-4.4oC) (USDA) ## Footnote Note the exception of poultry where being frozen is allowed and still retain the 'fresh' label.

Answer 136

* FDA-regulated foods * For raw produce (fruits and vegetables) and fish * All meat and meat products, poultry and poultry products intended for human consumption and offered for sale * Nutrition labelling for single-ingredient and raw products is voluntary

Answer 137

* Serving size appears larger, and in bold * Calories are now displayed in larger, bolder font * Daily values updated * Added sugars, vitamin D, and potassium are now listed.

Answer 138

* On February 24, 2014, HHS announced changes related to a nutritional label and Reference Amounts Customarily Consumed Per Eating Occasion (RACC) for food products * Changes to the Nutrition Facts panel: * (1) Different design of Nutrition Facts (graphics, fonts) * (2) Displaying of “Added Sugars” under Total Carbs * (3) Removing the “calories from fat” * (4) Removing Vitamins, A and C and % DV from the panel * (5) Adding Vitamin D and Potassium with % DV to the panel

Answer 139

* Removing Vitamins A and C and % DV from the panel

Answer 140

* Adding Vitamin D and Potassium with % DV to the panel | 'Added Sugars 'are also required under Total Carbs. ## Footnote Effective on January 1, 2021

Answer 141

* Note: *trans* fat content is declared zero for products that contain **< 0.5 gram of total *trans* fat in a serving**

Answer 142

* Polyunsaturated Fat * Monounsaturated fat * Soluble fibre * Insoluble fibre * Most of the vitamins and minerals

Answer 143

Vitamin D Calcium Iron Potassium

Answer 144

* Two forms of the same food * Per serving and per unit

Answer 145

May be used if the package has less than **40 sq inches of available space** for labelling

Answer 146

For small or intermediate-sized packages. May be used if the package has **less than 12 sq inches of available space** for labelling

Answer 147

“Not a significant source of eight or more of the following:” total fat; saturated fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, protein, vitamin D, potassium, calcium, iron

Answer 148

* A serving size is **(1) the amount of food upon which the nutrient content is based.** * To ensure consistent serving sizes between similar products, NLEA defines serving size as **(2) the amount of food customarily eaten at one time**. * The serving size included on the Nutrition Facts panel may vary slightly between similar products. Still, it is **(3) based on the Reference Amounts Customarily Consumed Per Eating Occasion (RACC) established by the FDA.** * The serving size is **(4) the household measure** (e.g., cups, tablespoons, pieces, slices, fractions, or containers) closest to the RACC, **(5) followed by the metric equivalent**. * For a package of crackers where each cracker weighs 7 grams, and the RACC is 15 grams, the serving size would read "2 crackers (14g)."

Answer 149

* % of Reference Amount * ≥ 67% and < 200% = 1 unit * > 50% and < 67% = 1 or 2 units * ≤ 50% = R.A./unit weight = whole number ## Footnote Note: “If a unit weighs ≥ 200% of the reference amount, the manufacturer may declare one unit as the serving size if the whole unit can reasonably be consumed at a single-eating occasion.”

Answer 150

* More realistically reflect what the typical American consumes in one serving * Reflect impact of packaging on serving

Answer 151

The higher RACC values for total fat, saturated fat, cholesterol, and sodium have an impact on foods that qualify for health claims and nutrient content claims E.g., Food that contains 3 g of total fat per serving size of ½ cup (120 g) is qualified for the “low fat” claim. For the RACC that increased to 1 cup (240 g), food would contain 6 g of total fat and would not be eligible for the claim.

Answer 152

Any direct statement about the level (or range) of a nutrient in the food (e.g., 'low sodium' or 'contains 100 calories') ## Footnote **Direct Claims** state the nutrient level explicitly, while **Implied Claims** suggest a nutrient content (e.g., "healthy," "no butter") without directly stating it.

Answer 153

* Any claim that: * Describes the food or an ingredient suggesting the nutrient is absent or present in a certain amount (e.g., 'no cholesterol', 'high oat bran'); or * Suggests that the food links its nutrient content with maintaining healthy dietary practices (e.g., 'healthy, contains only 2 grams (g) of fat') ## Footnote Examples: "Healthy" (implies the food is low in fat and meets other nutrient requirements) "Made with whole grains" (implies the product is a good source of fiber or nutrients associated with whole grains) "No butter" (implies low or no fat content)

Answer 154

Nutrient content claims are often referred to as **descriptors**.

Answer 155

* “healthy” or related terms (such as “health,” “healthful,” "healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) - 21 CFR 101.65(d) * Foods must meet specific criteria for nutrients to be limited in the diet: * Low total fat, low saturated fat, cholesterol, and sodium. * Contains at least 10% of RDI/RA of one or more vitamins, minerals, protein, or fiber (depends on the type of foods) * NEW: Redefining use of the term “Healthy” (Sept 28/2016) * Food doesn't meet “low total fat” but contains predominantly mono and polyunsaturated fat or contains at least 10% of the daily value per RACC of potassium or vitamin D

Answer 156

* Claim can be used if approved by NLEA regulations * Nutrition labeling required * Claim cannot be larger than two times the statement of identity * A referral statement is required for all claims * Directing consumers to the panel where “Nutrition Facts” are located. “See side panel for nutrition information.”

Answer 157

* Identifies nutrients present at levels that may "increased risk of disease or health-related condition” based on consideration of the total diet * Required if a food contains more than the following per reference amount, per labelled serving, and if serving size is small (30g or less), per 50g | If any specified nutrient exceeds the threshold - disclosure required.

Answer 158

* Brand names used before 10/25/89 that use undefined terms * “Diet” in brand names of soft drinks used before 10/25/89 * Medical foods and infant formulas * Claims on restaurant foods must meet definitions, but disclosure and referral statements are not required, and compliance is determined using a reasonable basis for claims * “Fluoridated” on bottled water

Answer 159

It may be used with: Sodium, sugars, calories, fat, cholesterol

Answer 160

It may be used with: Sodium

Answer 161

It may be used with: Sodium, calories, fat, saturated fat, cholesterol

Answer 162

It may be used with: Any nutrient with an RDA or DRV ## Footnote RDA: Recommended dietary allowance DRV: Dietary reference value

Answer 163

It may be used with: vitamins, minerals that are at ≥ 100% of RDI

Answer 164

It may be used with: Sodium, calories, fat, saturated fat, cholesterol

Answer 165

It may be used with: Fiber, protein, vitamins, minerals

Answer 166

It may be used with: Sodium, calories, fat, saturated fat, cholesterol

Answer 167

It may be used with: Limited to calories and/or fat

Answer 168

* “Good Source”, “High”, “Enriched”, “Excellent source” * Food that contains a high nutrient content * **High:** - 20% or higher of the RDI or DRV (NLEA regulations) – example: Broccoli and vitamin C * **Good Source:** - 10-19% of the RDI or DRV – example: the serving of sweet potatoes is a good source of fiber * Enriched: - example: enriched bread * “Antioxidant” * High in antioxidant vitamin C (vitamins C and E) * Good source of antioxidant vitamin A (or β-carotene)

Answer 169

* “Calorie Free”, “Low Calorie”, “Reduced Calorie” **Calorie Free** – less than 5 calories/serving **Low Calorie** – 40 calories or less/serving **Reduced Calorie** – less than 25% calories per 100 g than a reference food

Answer 170

* “Sugar Free”, “No Added Sugar”, “Reduced Sugar” **Sugar free** – less than 0.5 g of sugar/serving **Reduced Sugar** – 25% or less sugar than reference food/100g

Answer 171

* “High Fiber”, “Good Source of Fiber" **High fiber** – 5 g or more of fiber per serving size **Good source of fiber** – 2.5 to 4.9 g of fiber per serving

Answer 172

* "Sodium Free”, “Low Sodium”, “Reduced Sodium”, “No Added Sodium”, “Very Low Sodium” **Sodium Free** – less than 5 mg/serving size **Low Sodium** – 140 mg or less/serving size of 30g or larger (two tablespoons); 140 mg or less/serving size and per 50 g of food if serving size is smaller than 30 g * “salt free”, “unsalted”, etc. ## Footnote Molecular mass of sodium chloride ~ 58.44 g/mol, so if you have 5 mg of sodium from sodium chloride that is ~12.5 mg of salt.

Answer 173

* “Fat Free”, “Low Fat”, “Reduced Fat”, **Fat free** – less than 0.5 g/serving **Low fat** – 3 g or less/serving size of 30g (two tablespoons) or larger; 3 g or less/serving size and per 50 g of food if serving size is smaller than 30 g * “Saturated Fat Free”, “Low in Saturated Fat”, “Reduced Saturated Fat”, “Trans Fatty Acid Free” **Saturated fat free** – less than 0.5 g/serving **Trans free** – less than 0.5 g of trans fat/serving and less than 0.5 g of saturated fat/serving ## Footnote Remember the 30g/50g rule - for sure will be quiz question on this.

Answer 174

* “Cholesterol Free”, “Low Cholesterol”, “Reduced Cholesterol” May only be used on foods containing not more than 2 g of saturated fat per reference amount **Cholesterol free** – less than 2 mg/serving and 13 g or less of total fat/serving of **30g** (two tablespoons) or larger; 13 g or less per serving size and **50 g** of food if serving size is smaller than 30 g ## Footnote Note the 30g/50g rule again.

Answer 175

Relates to how certain product attributes are perceived or understood by consumers. **Credence** (invisible) attributes are qualities that consumers cannot verify even after purchase or consumption. For example, things like nutrient content, organic status, or whether a product is non-GMO are aspects consumers must trust based on labels or certifications, as they cannot directly experience or verify them themselves. These are often regulated by standards that require producers to disclose this information, such as "organic" or "non-GMO" labels. **Experience** (visible) attributes, on the other hand, are qualities that consumers can judge through personal experience, such as flavor and texture. Regulations also play a role here by ensuring that product labels and claims, such as flavor descriptions or freshness, are truthful and not misleading. In both cases, **regulations help address the asymmetric information problem**, where producers and marketers know more about a product than consumers. By enforcing standardized labels (e.g., nutritional information, serving sizes), regulations ensure consumers are better informed about both visible and invisible product qualities.

Answer 176

* **HACCP** - to prevent (or) reduce hazards to a safe level (in that priority) * **HARCP** - preventive controls that prevent or minimize 'known or reasonably foreseeable' risks

Answer 177

* Any representation in labelling and advertising that states, suggests, or implies that a **relationship exists between a food or a component of that food and health** ## Footnote Two main categories: Structure/function claims and disease risk reduction claims

Answer 178

* The link between a nutrient or dietary ingredient and the structure or function of the human body (Canada, US, EU) or psychological and behavioural function (EU). | Examples ## Footnote * Calcium aids in the development of strong bones and teeth. (structure) * High fibre helps maintain regularity. (function) * This food helps in the management of weight (EU ONLY! NO CLAIMS RELATED TO WEIGHT ARE ALLOWED IN CANADA OR US)

Answer 179

* The link between a food ingredient and the reduced risk of a particular chronic disease * Risk reduction means **significantly altering a significant risk factor** for a disease or health-related condition (e.g., cholesterol in CHD) | Examples: ## Footnote * Plant sterols lower cholesterol. * This food may reduce risk of CHD.

Answer 180

* Authorized by the FDA under the Nutrition Labelling and Education Act (NLEA) (12 claims) * No objection based on authoritative statements under the USFDA Modernization Act (5 claims) * FDA, NIH, CDC, National Academy of Sciences * Letter of enforcement discretion when the strength of evidence falls below the FDA requirements (39 claims) * Authorization under 'Qualified Health Claims'

Answer 181

* It is supported by significant scientific agreement. * If there is: * Publicy available supporting scientific evidence from well-designed studies * An agreement among qualified scientific experts that the substance/disease relationship is **supported by the *totality* of the publicly available scientific evidence**

Answer 182

* About the link between diet and certain serious chronic disease conditions. * Based on scientific evidence that is reviewed and accepted by the FDA

Answer 183

* Specific in describing the health benefit of the compound that, upon ingestion, has on the risk reduction of a particular chronic disease condition * Made in the context of the total diet

Answer 184

* Disqualifying nutrient levels

Answer 185

* Food must contain 1 gram or less of saturated fatty acids per reference serving and not more than 15% of calories from saturated fatty acids.

Answer 186

* Food must contain 20 mg or less of cholesterol per reference serving size if serving size is greater than 30 g * And per 50 grams if serving size is 30 g or less ## Footnote This two-part rule ensures that products with very small serving sizes aren't misleadingly labeled as low cholesterol if they have a high cholesterol concentration when the serving size is scaled up.

Answer 187

1. Calcium and osteoporisis 2. Dietary fat and cancer 3. Sodium and hypertension 4. Dietary saturated fat and cholesterol and risk of CHD 5. Fiber-containing grain products, fruits and vegetables, and cancer 6. Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of CHD 7. Fruits and vegetables and cancer 8. Folate and neural tube defects 9. Dietary sugar alcohol and dental caries 10. Soluble fiber from certain foods and risk of CHD 11. Soy protein and CHD 12. Plant sterols/stanols and CHD (pending)

Answer 188

* FDA proposed a model statement for each claim * Wording such as 'may' and 'risk reduction of' are used * For example * Adequate **calcium and vitamin D** throughtout life, as part of a well-balanced diet, may reduce the risk of **osteoporosis**.'

Answer 189

* Amount of 2 g of phytosterols (free bases) is the daily dietary intake required to justify the CHD reduction claim * The minimum amount of 0.5g/RACC phytosterols (free bases) in food is required to make a claim * Sterols-containing foods must be eaten with meals or snacks up to four servings per day * Sterols, stanols, and their esters are qualified for the same claim | Must be free bases because plant sterols may be esterified.

Answer 190

* Broad - fibre and risk of CHD * Specific - Quaker Oats petition (beta-glucan soluble fiber/total and LDL lowering effect) ## Footnote Soluble fiber from foods such as oat bran (oatmeal), as part of a diet low in saturated fat and cholesterol, may reduce risk of heart disease.

Answer 191

* Soluble fiber from foods such as [name of soluble fiber source, and, if desired, name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease * One or more eligible sources of the whole oat (or barley or a combination), containing at least 0.75 g soluble fiber per RA; or psyllium seed husk containing at least 1.7 g of psyllium husk soluble fiber per RA

Answer 192

* A new class of health and nutrient content claims * Based on the authoritative statement from FDA, NIH, CDC, and National Academy of Sciences * Requires 120-day pre-submission of: * Claim wording * Reference Authoritative statement * Balanced literature review

Answer 193

* Potassium and the Risk of High Blood Pressure and Stroke * "Diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke."

Answer 194

* 15 days of receipt, FDA will acknowledge petition * 45 days of receipt, FDA will file petition and issue a docket number * Petition is posted for 60 days for public comments * On or before 270 days, a final decision (letter of enforcement discretion) is sent to the petitioner ## Footnote The letter of enforcement discretion means the FDA will allow the use of the health claim, even if the scientific evidence does not fully meet the "significant scientific agreement" standard, as long as the claim is qualified with appropriate disclaimers.

Answer 195

* **Proposed claim**: Selenium may reduce the risk of prostate cancer. Scientific evidence supporting this claim is convincing but not yet conclusive. * **FDA modified claim**: Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer. * The court action was lodged by five companies against the FDA in July 2009 over selenium claims, seeking ”declaratory and injunctive relief”

Answer 196

CVD - 14 Diabetes - 4 Hypertension - 4 Cancer - 10 Cognitive Function - 3 Neural tube defects - 2 Atopic dermititis risk - 1 Peanut allerge - 1 Urinary tract infection - 1

Answer 197

* Supportive but not conclusive research shows that consumption of Omega-3 fatty acids may reduce the risk of CHD * The FDA did not establish a minimum amount of DHA plus EPA to qualify for this claim * Daily consumption of DHA and EPA should not exceed 3 g/p/d from food and 2 g/p/d from dietary supplements * FDA evaluated the data and determined that, although there is scientific evidence supporting the claim, the evidence is not conclusive ## Footnote Applies to marine sources only. (i.e., others souces like walnuts are not included)

Answer 198

* No requirement for approval by FDA * 75 days from the time of FDA notification to marketing * Structure-function claims allowed * No claim to mitigate, treat, prevent, or cure a disease is permitted * FDA must be informed within 30 days to use a claim * Safety and efficacy data must be available * Medicinal format, food format without intention to use as a food * FDA disclaimer ## Footnote Primarily medicinal format (e.g., pills etc.) - some food products are approved under this though - like snack bars! 75 days: Required for notifying the FDA about a new dietary ingredient before the product can be sold. 30 days: Required for notifying the FDA about the use of structure/function claims after the product is marketed.

Answer 199

**For larger serving sizes** (30 g or more): * Low Sodium means the product must contain 140 mg or less of sodium per serving. **For smaller serving sizes** (less than 30 g): * The product must meet two conditions: * 140 mg or less of sodium per serving. * 140 mg or less per 50 g of the food. * This ensures that even if the serving size is very small (like 10 or 20 grams), the sodium content stays low when adjusted to a standard amount (50 g). ## Footnote This two-part rule ensures that products with very small serving sizes aren't misleadingly labeled as low sodium if they have a high sodium concentration when the serving size is scaled up.

Answer 200

* **Authorized Health Claims**: Based on significant scientific agreement (SSA) and require pre-approval by the FDA. * **Qualified Health Claims**: Supported by scientific evidence but not meeting the SSA standard. These claims must be accompanied by a disclaimer explaining the level of scientific evidence. * **Structure/Function Claims**: These describe the role of a nutrient or ingredient in maintaining normal structure or function in the body (e.g., "calcium builds strong bones"). These claims don’t need pre-approval by the FDA but must be truthful and not misleading. ## Footnote Health claims must be supported by scientific evidence and go through FDA authorization. Claims are either fully authorized (based on strong scientific consensus) or allowed as qualified claims with disclaimers. Structure/function claims do not need FDA approval but must be truthful.

Answer 201

"Claim is supported by SSA... evidence is derived from well-designed studies" ## Footnote NLEA claim

Answer 202

"Although there is scientific evidence supporting the claim, the evidence is not conclusive."

Answer 203

"Some scientific evidence suggests... however, FDA has determined that this evidence is limited and not conclusive."

Answer 204

"Very limited and preliminary scientific research suggests... FDA concludes that there is little scientific evidence supporting this claim."

Answer 205

# FDA Category A First level

Answer 206

# FDA Category B Second level

Answer 207

# FDA Category C Third level

Answer 208

# FDA Category D Fourth level

Answer 209

* **FPLA (1966)**: Focuses on clear, consistent packaging and labeling for all consumer products, requiring essential information like *product identity and net content*. * **NLEA (1990)**: Focuses on *nutritional information* for food products, mandating Nutrition Facts labels and *regulating health and nutrient content claims* on food packaging. * **DSHEA (1994)**: Specifically addresses *dietary supplements, allowing structure/function claims but requiring disclaimers*, and distinguishing dietary supplements from conventional foods and drugs. * **FALCPA (2004)**: Focuses on *allergen labeling*, requiring that the nine major food allergens are clearly identified on food packaging to protect consumers with allergies.

Answer 210

Threshold (alternative) food, in which an ingredient contains a biologically engineered substance that is **inadvertantly or technically unavoidable**, and accounts for no more than: * 1-A: ‘Five-percent (5%) of the specific ingredient by weight, would not be subject to disclosure’ (e.g., grain) * 1-B: ‘Nine-tenths (0.9%) of the specific ingredient by weight, would not be subject to disclosure’

Answer 211

Highly refined foods (e.g., oils, candies)

Answer 212

BE component accounts for no more than: * **1-A**: ‘Five-percent (5%) of the specific ingredient by weight, would not be subject to disclosure’ (e.g., grain) * **1-B**: ‘Nine-tenths (0.9%) of the specific ingredient by weight, would not be subject to disclosure’ ## Footnote Threshold (alternative) food, in which an ingredient contains a biologically engineered substance that is **inadvertantly or technically unavoidable**.

Food Law and Regulations in the USA Flashcards

(250 cards)