Food Law and Regulations in the USA Flashcards
- 1906 - Meat Inspection Act
- 1938 – Food, Drug and Cosmetic Acts (FDCA)
- 1957 – Poultry Products Inspection Act
- 1958 – Food Additive Amendment to FDCA
- Delaney Clause
- 1960 – Color Additive Amendment to FDCA
- 1970 - Poultry Products Inspection Act
- 1977 - Egg Product Inspection Act
- 1966 - The Fair Packaging and Labeling Act (FPLA)
- 1990 - Nutrition Labeling and Education Act
- 1994 - Dietary Supplement, Health and Education Act
- 2002 - The Public Health Security and Bioterrorism Preparedness and Response Act (The Bioterrorism Act)
- 2011 – Food Safety Modernization Act
Describe the White House Conference relating to food regulations in 1969.
- White House Conference on Food, Nutrition, and Health, main topics:
- Nutritional needs of Amercians
- Malnutrition and hunger
- The link between diet and health
- Food safety
This is when GRAS was introduced as well.
Describe the White House Conference relating to food regulations in 1977.
- Dietary Goals for the US Report by Senate’s Select Committee on Nutrition and Human Needs.
Describe the White House Conference relating to food regulations in 2022.
- White House Announces Conference on Hunger,
Nutrition and Health in September. Goals:- “Ending hunger and increasing healthy eating and physical activity in the U.S. by 2030 so that fewer Americans experience diet-related diseases, such as diabetes, obesity, and hypertension.
What is the Federal Food, Drug, and Cosmetic Act and Relating Acts?
- The major law in the USA to ensure safe food supplies (86 years)
- It has been amended several times
- It contains general and specific requirements for foods
Applies to all states, district of Columbia, as well as Puerto Rico.
Where does the FDCA apply?
- All states, District of Columbia, Puerto Rico, and territory or possession, imports but not exports.
Where are terminologies of the FDCA defined?
- Section 201 of the FDCA
https://www.law.cornell.edu/cfr/text/21/170.3
Without defined terminologies it’s very difficult to execute laws and regulations.
Define: food as per the FDCA
- Articles used for food or drink for man or other animals, chewing gum, and articles used for components of foods
- “Food” also includes pet foods and animal feeds
- Any food additives are considered foods
Note the Canadian and European definition of food is different than this! The American definition includes consideration of animals, and includes additives and chewing gum.
What is a label per the FDCA?
- Written, printed, or graphic material on the immediate package of food. It could be on the outside wrapper or container of the food.
Define: labelling per the FDCA.
- Includes the definition of “label” and any written, printed, or graphic material accompanying the food.
- It could cover tear-off pads of promotional material, in-store posters, books, and to some extent, advertising.
Be sure you know the difference between labels and labelling.
Label: Written, printed, or graphic material on the immediate package of food. It could be on the outside wrapper or container of the food.
Define: safe per the FDCA.
- This term refers to the health of man or animal.
- Therefore, a substance found to be unsafe in laboratory animal tests may be banned from use in foods.
What is the Delaney Clause?
- prohibits from use in foods any substance found to cause cancer in man or animal
- If the material has been shown to cause cancer at any level
The Delaney Clause is part of the Food Additive Amendment to the FDCA (1958).
Describe an example of the Delaney Clause in action.
- FDA remove the following synthetic flavouring substances in food: benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine.
- Although the FDA determined that these substances do not pose a risk to public health under the conditions of their intended use, these substances are being removed under the Delaney Clause.
- The agency acted upon data provided by petitioners that these additives induce cancer in laboratory animals, resulting in this finding in animals.
What is section 301 of the FDCA?
Prohibited Acts
Per the FDCA, food is considered adulterated if: [3]
- it contains a poisonous or deleterious substance which may render it injurious to health or,
- it is adulterated for economic reasons
- food may be declared adulterated if processed, packed, or stored under unsanitary conditions
https://www.law.cornell.edu/uscode/text/21/342
It is illegal (Sec. 301) to adulterate or misbrand food. What are the exemptions to this? [2]
(1) Naturally occurring adulterants in un-harmful levels (e.g., mycotoxins like aflatoxin in peanuts) and (2) unavoidable substances at permissible levels (e.g., pesticides)
If found in levels above the allowable level then the food will be deemed adulterated.
When is food considered misbranded? [6]
- If the label or labelling failed to reveal complete and accurate information concerning a product or if the presented information is false or misleading (21 U.S. Code 343)
- If a name is inaccurate or another food name is used
- If food is imitation, and it is not declared on the label
- All information should be conspicuous
- Nutrition information should be accurate and presented in the proper format
- Nutrient content and health claims should meet the requirements of the NLEA
https://www.law.cornell.edu/uscode/text/21/343
e.g., selling ‘Rits’ crackers would be prohibited
Describe 4 actions the FDA can take.
- Injunction - the FDA can obtain a court order in a short period to stop anyone from committing a violation
- Penalties - imprisonment and fine
- Seizure - if adulterated or misbranded, products may be seized and destroyed by the FDA
- Criminal investigations
List 3 important USDA Food Acts.
- Meat Inspection Act
- Poultry Inspection Act
- Egg Product Inspection Act
What does the Meat Inspection Act mandate the inspection of? [2]
- live animals, carcasses, and processed products, as well as improved sanitary conditions for slaughter and processing
- pre-market approval of labelling for processed meat products
What does the Poultry Inspection Act mandate the inspection of? [2]
- poultry processing plant and products in any area designated by USDA as a major consuming area, such as metropolitan localities
- pre-market approval of labelling for processed poultry products
What does the Egg Inspection Act mandate the inspection of?
- the processing of liquid, frozen, and dried egg products
What do Standards of identity define? [6]
Standard of Identity for Food Products (21 CFR Part 130)
- what a given food product is
- its name
- the ingredients that must be used, or may be used (optional) in manufacturing said food
- prescribed minimums of certain ingredients
- maximum fat and water content
- methods of processing and preparation
Why do foods have Standards of Identity? [2]
- To ensure that consumers get what they expect
- To provide fair competition among manufacturers
What is the Standard of Identity for Peanut butter?
- Must contain at least 90% peanuts (21 CFR 164.150)
This does not mean all peanut butter is the same!
What is the standard of identity for jams and fruit jelly?
- Must contain 45% juice or fruits.
Imitations are less expensive to produce which provides economical gain as incentive for non-compliance with standards of identity.
What is the standard of identity for margarine?
- 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.
In 1990 the NLEA prescribed nutrient content claims - ‘free’; ‘low’ ‘light’ ‘reduced’. How was this made to work with standardized foods which have fixed levels of nutrients?
- 1993 - Amendment to FDCA (21 CFR Sec. 130) allows modifying of nutrients in standardized foods.
When does the Amendment to FDCA (21 CFR Sec. 130) allow modifying of nutrients in standardized foods? [7]
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
List substances and additives used in foods. [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
Salt is an additive.
True or False?
True.
Not in Canada!
Salt is an ingredient.
True or False?
False.
Salt is an additive.
It is not an additive in Canada.
What are prior-sanctioned ingredients?
- 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
A substance is a food additive if it is not [4]:
- Prior sanctioned material
- Food colorant
- GRAS
- Pesticide chemical
21 CFR Part 170 - 172
What are direct food additives?
- Additives permitted for direct addition to food for human consumption
What is BHA?
- Direct food additive
What are indirect food additives?
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
21 CFR Part 174 - 178
What are substances that are GRAS?
- 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
What is affirmed GRAS?
- 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”
What are colour additives?
- 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
Which colours are exempt from certification (21 CFR Part 73, subpart A)?
- 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)
What is a pesticide per the Environmental Protection Agency?
- 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
What is a maximum residue limit?
- 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
What is the Division (Bureau) of Chemistry?
- 1862 - 1906
- Dr. Harvey Wiley - chief chemist - focused attention on misbranding and adulteration
- “Poison squad” - 12 employees of the USDA; self-testing of preservatives
What is the poison squad?
- 12 employees of the USDA who self-tested preservatives
What is the HHS?
- In 1980 the FDA was moved under the Department of Health and Human Services (HHS)
What did President T. Roosevelt sign in 1906?
- 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
Who had enforcement power of the 1906 Pure Food and Drugs Act?
- Bureau of Chemistry
- Also controlled the interstate transportation of food (penalties for selling unlawful foods)
Describe the 1938 Food, Drug, and Cosmetics Acts requirement for affirmative labelling. [5]
- 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
What did the 1906 Pure Food and Drugs Act do?
- 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
Describe the 1913 amendment to the 1906 Pure Food and Drugs Act.
- Declaration of contents
- Required declaration by (1) weight, (2) measure, or (3) numerical count
Describe problems associated with the 1906 Act.
- Lack of proper regulatory control
- Jamaican ginger incident: 35,000 – 50,000 victims (1930)
- Elixir Sulfanilamide: wonder drug for children – 100 people died (1937)
Describe the 1938 Food, Drug and Cosmetic Acts.
- 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
The ‘proper beginning’ of what exists today.
What is the role of the US Federal Government in food law and regulation?
- 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
Other agencies: US Department of Commerce; Bureau of Alcohol, Tobacco, and Firearms; US Department of Labor, and Public Health Service
Describe the US Legislation Process.
Describe the Rule Making Process in the US.
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”
Promulgate - put into effect by official proclamation
Describe publication of the Federal Register and the Code of Federal Regulations.
- 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.
Which parts of the Code of Federal Regulations are relevant to Food law? And which agencies are responsible?
- 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)
What does the Federal Register include? [6]
It includes (1) presidential documents, (2) notices of agency meetings, (3) proposed rules, (4) final rules, (5) affected CFR parts, and (6) Reader Aids.
How many titles are there in the Code of Federal Regulations?
50
What is the primary agency with the responsibility for food being moved in interstate commerce?
Food and Drug Administration (Department of Health and Human Services)
All foods but meat (if >3%), poultry (if >2%), egg products.
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
What is the scope of authorities of the FDA?
- Safety of food supply and food ingredients
- Food processing; GMP; HACCP
- Food labelling
- Cooperation with other agencies
- Implementation of laws
What are the responsibilities of the U.S. Department of Agriculture? [4]
- Jurisdiction over various aspects of the food supply
- Meat, poultry, eggs – raw and processed
- Domestic and import
- Pre-approval of labelling
What is the FSIS?
- 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
- Federal Meat Inspection Act (1906)
- Poultry Product Inspection Act (1957)
- Eggs Products Inspection Act (1970)
What are the responsibilities of the FSIS?
- 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
What is HACCP?
- 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.
In September of 2011, what did the USDA do?
- 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
If found in raw beef, they will be declared adulterants.
In addition to the Food Safety and Inspection Service, what other services are provided by the USDA? [3]
-
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
What does the Federal Trade Commission have jurisdiction over?
- 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)
What is the role of the Environmental Protection Agency?
- 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
Describe the role of the Department of Commerce (USDC). [5]
- 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
Who tests for the presence of E. coli O157:H7 at ground beef establishments and retail?
USDA - FSIS
What is this an example of?
Misbranding/misleading
The label shows strawberries, but in tiny print it says ‘contains no fruit’.
Describe the restriction on use of Food Additives. [3]
- Specified foods and functions
- Specified maximum amount or use under GMP
- 43 established food categories and 32 physical or technical functions
~3000 food additives in the USA.
What act was passed after the events of September 11, 2001?
- 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
What is Title III of the Bioterrorism Act of 2002?
- Protecting Safety and Security of Food and Drug Supply
How does the Bioterrorism Act (2002) protect against adulteration of food? [3]
- 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
What Administrative detention does the bioterrorism Act (2002) allow?
- FDA is authorized to detent any foods which may present a threat of severe adverse health
- FDA must have credible evidence or information
Describe the Registration of Food Facilities mandated by the Bioterrorism Act (2002).
- 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)
How often does registration of food factilities need to be updated per the Bioterrorism Act (2002)?
- Every two years (FSMA)
- Starting October 2012
This makes sense because a lot can change in two years (new process methods; new recipes; new products; etc.)
Describe the maintenance and inspection of records required by the Bioterrorism Act (2002).
- 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
Describe the prior notice of food shipments required by the Bioterrorism Act (2002).
- 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
Imported foods must comply with […]
The exact requirements of the FDCA, label and labelling and other applicable laws as foods that are produced in the US.
Imports are the responsibilities of: [2]
- The Secretary of the Treasury (through U.S. customs)
- The Secretary of Health and Human Services (through the FDA)
Describe the prior notice required by the Bioterrorism Act (2002) during the importation process.
- 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:
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
Describe the FDA import process flowchart.
Describe the sampling that occurs as a part of the importation process.
- 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
What is the food protection Venn diagram?
What is the purpose of food defense? [3]
- To reduce the ‘risk of tampering or other malicious, criminal, or terrorist actions on the food supply’ (FDA)
Why is food defense necessary?
- 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
List 4 vulnerabilities in food supplies.
- 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
Rajaratnam (2008)
Give 4 examples of Selected Defence Incidents.
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
What is the purpose of food defense? [6]
- 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
Which acts and regulations address food defense? [2]
- Bioterrorism Act
- Food Safety and Modernization Act (FSMA)
Describe the modern food landscape regulated by the FDA. [4]
- 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
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.
What are the reasons for the Food Safety Modernization Act?
- 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
FSMA amends the FDCA.
What was the main goal? [3]
- To improve:
- Prevention of food safety problems
- Detection and responding to food safety problems
- The safety of imported food
What are the 5 major elements of the FSMA.
- Preventive Controls
- Inspection and Compliance
- Imported Food Safety
- Response
- Enhanced Partnerships
What are the outcomes of the FSMA? [2]
- FDA is allowed to force companies to recall adulterated foods
- Increasing the number of domestic and foreign facility inspections
Note before the FSMA, recalls were fully voluntary!! But most companies were very proactive.
What do preventive controls for human foods require?
- Each food facility to develop a written food safety plan and implement a food safety system
FDA requirements for food traceability are final rules as part of FSMA. What does this regulation require?
- 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.
https://www.fda.gov/food/food-safety-modernization-actfsma/
food-traceability-list
What responsibilities do importers have regarding the safety and compliance of foreign suppliers? [3]
Foreign suppliers’ verification program
- 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)
What fees is the FDA authorized to collect? [4]
Fees related to:
- food facility re-inspection
- food recalls
- the voluntary qualified importer program
- to establish and administer the third-party accreditation program
What was the response of the GFSI benchmarked program: “Foreign Suppliers’ Verification Program (FSVP)”
- 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.
What are the FDAs functions in China? [6]
- 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
What occurred as a result of the following:
- 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
- AQSIQ developed a training program based on FDA requirements
- FDA monitors progress
Why do people read food labels? [3]
- To lose weight
- For nutritious diet
- To manage medical condition
What laws govern food labelling?
- Food Drug & Cosmetics Act
- Nutrition Labelling and Education Act (NLEA)
- The Food Allergen Labelling and Consumer Protection Act (FALCPA)
What is the principle display panel?
“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”
What is the information panel?
“means that part of the label immediately contiguous and to the right of the PDP as observed by an individual facing the PDP”
What is the size of the principle display panel?
- 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
What must a principle display panel contain?
What is the ingredients list? [4]
- 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
Describe the declaration of fats and oils required on labels.
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)
Describe net quantity of contents statements. [3]
- 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
Where is the name and address of the manufacturer or distributor placed on a label?
The information panel
Describe allergen information required on labels.
- 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).
2004 – Food Allergen Labeling and Consumer Protection Act (FALCPA)
Describe the location of label declarations.
What are BE foods?
- 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
How are BE foods declared on labels?
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
Nutrition labelling is required (NLEA).
When is nutrition labelling voluntary?
- 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
Describe the standard format of labels. [4]
- 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.
Describe a nutritions facts label with specific declarations.
- Note: trans fat content is declared zero for products that contain < 0.5 gram of total trans fat in a serving
What are the voluntary nutrients on a nutrition facts label? [5]
- Polyunsaturated Fat
- Monounsaturated fat
- Soluble fibre
- Insoluble fibre
- Most of the vitamins and minerals
What is an aggregated format label?
What is dual listing format?
- Two forms of the same food
- Per serving and per unit
What is tabular format?
May be used if the package has less than 40 sq inches of available space for labelling
What is linear format?
For small or intermediate-sized packages. May be used if the package has less than 12 sq inches of available space for labelling
What is simplified format?
“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
What is a serving size? [5]
- 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).”
Describe rounding of common household units on nutrition facts labels.
How are serving sizes determined?
- % of Reference Amount
- ≥ 67% and < 200% = 1 unit
- > 50% and < 67% = 1 or 2 units
- ≤ 50% = R.A./unit weight = whole number
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.”
Use cheese to show how serving sizes are calculated.
Use bread to show how serving sizes are calculated.
Discuss how ‘serving sizes got a reality check’. [2]
- More realistically reflect what the typical American consumes in one serving
- Reflect impact of packaging on serving
Describe why it’s important that changes were made to RACC (serving sizes) to better reflect the eating habits of Americans.
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.
What are disclosure statements?
- 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.
Describe approved nutrient content claims.
Describe fibre claims allowed on labels.
- “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
Describe fat claims allowed on labels.
- “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
Remember the 30g/50g rule - for sure will be quiz question on this.
What is a health claim?
- 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
Two main categories: Structure/function claims and disease risk reduction claims
What is the Jellybean rule?
- Disqualifying nutrient levels
What is the proposed rule for phytosterol health claims?
- 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.
Compare the broad and product specific categories for fiber.
- Broad - fibre and risk of CHD
- Specific - Quaker Oats petition (beta-glucan soluble fiber/total and LDL lowering effect)
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.
Give an example of an approved claim per the USFDA Modernization Act.
- 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.”
Describe the FDA categories of qualified health claims.
Describe the ‘selenium case’ petition for a qualified health claim.
- 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”
What is the current status of qualifying claims?
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
