UNIT 3

Codex Alimentarius is a group of international food standards, adopted by the Codex Alimentarius
Commission and uniformly presented. The very term Codex Alimentarius is taken from the Latin
term Codex Alimentarius, meaning Food Law or Legal Food Code. The Codex Alimentarius
standards cover all basic food types, raw, semi-processed and processed, that are intended for
distribution to the costumers. The regulations of the Codex refer to food hygiene and quality,
including microbiological standards, food additives, pesticides and residues from veterinary drugs,
contaminants, food labeling and marketing, methods for sampling and hazard analysis, food import
and export, certification system, etc.
• The Food and Agriculture Organization (FAO) and World Health Organization (WHO) -
took the responsibility of food and health related issues
• FAO in 1961 and WHO 1963 passed Resolution to establish the Codex Alimentarius
Commission
• Responsible for Joint FAO/WHO Food Standard Program
The FAO/WHO International Conference on Nutrition, 1992
• Recognized that:
• access to nutritionally adequate and safe food is a right of each individual
• Food regulations… should fully take international standards of the Codex
Alimentarius
Codex Objectives:
• To protect the health of consumers
• To ensure fair practices in the food trade
• To coordinate all work regarding food standards
• To determinate the priorities
• To initiate the preparation of standards
• To publish the standards
Codex Alimentarius Commission – structure and management
• The Executive Committee
• Chairperson
• 3 Vice-Chairpersons
• 7 Regional Representatives
• 6 Regional Coordinators
 • The Regional Coordinating Committees
• The Secretariat of the Commission
Regional Coordinating Committees
• 6 Regional Committees – for Africa, Asia, Europe, Latin America & Caribbean, North
America & Southwest Pacific, Near East
• The working tasks of the regional Coordinative Committees are identical and refer to:
• Defining the problems and needs of the region
• Promotion of cooperation and exchange of information
• Development of world-wide food quality and safety standards of regional interest
• Development of regional food safety and quality standards
• Coordination and promotion of the activities of the Codex Alimentarius
Commission
The Secretariat of the Commission
A high FAO body responsible for:
• Formulation and development of FAO/ WHO standards
• Administrative support to the Commission
• Relations with the National Codex Contact Point
• The Secretariat is composed of six representatives with full working time, situated in the
head office of FAO in Rome
Subsidiary bodies of the Codex Alimentarius Commission
• Codex Committees:
• Codex committees for general issues
• Committees for special types of foodstuff products
• Ad-hoc Intergovernmental Special Work Groups
Codex Committees on general issues (Horizontal committees)
1. Codex Committee on General Principles
2. Codex Committee on Food Labeling
3. Codex Committee on Methods of Analysis and Sampling
4. Codex Committee on Food Hygiene
 5. Codex Committee on Pesticide Residues
6. Codex Committee on Food Additives and Contaminants
7. Codex Committee on Import - Export Inspection and Certification systems
8. Codex Committee on Nutrition and Foods for Special Dietary Uses
9. Codex Committee on Residues of Veterinary Drugs in Foods
Product Committees (Vertical Committees)
1. Codex Committee on Cocoa Products and Chocolates,
2. Codex Committee on Sugars,
3. Codex Committee on Pocessed Fruit and Vegetables,
4. Codex Committee on Fats and Oils,
5. Codex Committee on Meat and Polutry Hygyene,
6. Codex Committee on Fish and Fishery products,
7. Codex Committee on Fresh Fruit and Vegetables,
8. Codex Committee on Milk and Milk Products,
9. Codex Committee on Natural Mineral Waters,
10. Codex Committee on Vegetable Proteins,
11. Codex Committee on Cereals, Pulses and Legumes.
Ad-hoc Intergovernmental Codex Task Force (established by the 23rd Session of the
CAC)
• Foods derived from Biotechnology (Japan, 14-17 March 2000)
• Animal Feeding
(Denmark, 13-15 June 2000)
• Fruit and Vegetable Juices
(Brazil, 18-22 September 2000)
Highest priority:
Formulation of commodity and general standards
The emphasis is put on the creation of market conditions where only the quality food will be
available, with minimum acceptable quality and without any hazards to the health of the population
 • There is a uniform (unified) procedure for acceptance of Codex standards, composed of 8
phases, but there is also an accelerated or shortened procedure, where the process of giving
proposals, comments, and the adoption of the standards is done in 5 phases.

Accelerated
• Scope of the standard
including its correct name i.e. the name of the relevant food
• Description of the standard
• definition of the product, the basic material from which it is produced, description
of the production process and packing
• Basic structure and quality factors
 • minimum standards for the relevant food
• Weights and measures
• Labeling
• according to the Codex general standards for labeling of packed food
• Contaminants
• Hygiene
• Food additives
• Methods for analysis

History
To meet a country’s sanitary and phytosanitary requirements, food must comply with the local laws
and regulations to gain market access. These laws ensure the safety and suitability of food for
consumers. Factors on which it depends, In some countries food laws also govern food quality and
composition standards.
Food laws and Regulations
The requirement of food regulation may be based on several factors such as whether a country
adopts international norms developed by the Codex Alimentarius Commission of the Food and
Agriculture Organization of the United Nations and the World Health Organization or a country
may also have its own suite of food regulations. Each country regulates food differently and
has its own food regulatory framework.
International and National Laws and Regulation
DESCRIPTION OF QUALITY SYSYEMS FOOD LAWS-
Food laws implemented for 2 reasons-
• Regulation of specification of food
• Regulation of hygienic conditions of processing/manufacturing.
Food laws are either mandatory or voluntary, they are set up to established by authorities to as a
rule to measure of quantity, weight, value or quality.
INTERNATIONAL ORGANIZATION GOVERNING FOOD SAFETY
1. WORLD HEALTH ORGANIZATION (WHO)
2. WORLD TRADE ORGANIZATION (WTO)
3. FOOD AND AGRICULTURE ORGANIZATION (FAO)
4. CODEX ALIMENTARUS COMMISSION (CAC) [UNDER FAO/WHO]
5. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
6. NATIONAL ADVISORY COMMITTEE FOR MICROBIOLOGICAL CRITERIA FOR
FOODS (NACMCF)
7. INTERNATIONAL COMMISSION FOR MICROBIOLOGICAL SPECIFICATION FOR
FOODS (ICMSF)
Legislation governing food industry in India
Different voluntary legislations are made for the purpose to guarantee stated quality and sales
promotion. Number of control orders have been formulated under the provisions of Essential
Commodities Act, which operate on the main objectives of regulating the manufacture, commerce
and distribution of essential commodities. There are various commodity boards such as Spices
board, Tea board, Coffee board, National Horticulture Board operating in India which undertake
research and development work for respective fields.
PREVENTION OF FOOD ADULTERATION (PFA) ACT, 1954
The Act was promulgated by Parliament in 1954 to make provision for the prevention of
adulteration of food. Broadly, the PFA Act covers food standards, general procedures for sampling,
analysis of food, powers of authorized officers, nature of penalties and other parameters related
to food.
• Makes provision for prevention of adulteration of food.
• Adulterated, misbranded, not in accordance with the conditions of license shall be
prohibited for selling.
• No such food shall be imported. Standards for commodities have been specified in the
rules. Proprietary foods shall specify the ingredients in the product in the descending order
of their composition of the label.
It deals with parameters relating to food additives, preservative, coloring matters, packing &
labelling of foods, prohibition & regulations of sales etc. The provisions of PFA Act and Rules
are implemented by State Government and local bodies as provided in the rules.

The salient features of the PFA Act includes objective, definition of food, meaning of adulterant,
concept of adulteration, misbranded items, sale of certain admixtures, relevant committees,
analysts, procedure for sampling & analysis,penalties and important miscellaneous provisions.
For the benefit of a learner like you, the small description of the major features of the Act are
given below ina simplified way so that it is easier for you to understand.
Objective
The main objectives of the act are:
1) to make provision for the prevention of adulteration of food;
2) to protect the public from poisonous and harmful foods;
3) to prevent the sale of substandard foods; and
4) to protect the interests of the consumers by eliminating fraudulent practices.
Definitions
Clear definitions are given for terms such as food, adulterant, misbranded items,manufacture, sale,
package etc. to describe the matters clear and simple. However,only some definitions which are
more relevant are given below for yourunderstanding of the Act clearly.

Definition of Food
a) Any article which ordinarily enters into or is used in the composition or
preparation of human food;
b) Any flavouring matter or condiments; and
c) Any other article which the Central Government may having regard to its use,
nature, substance or quality, declare, by notification in the official gazetteas food for
the purpose of this Act.

Meaning of Adulterant
Adulterant is defined as “any material which is or could be employed for the purposes of
adulteration”.

Concept of Adulteration
An article of food considered to be adulterated:
a) if the article sold by a vendor is not of the nature, substance or quality demanded
by the purchaser and is to his prejudice, or is not of the nature,substance or
quality which it purports or is represented to be;
b) if the article contains any other substance which affects, or if the article isso
processed as to affect, injuriously the nature, substance or quality thereof;
c) if any inferior or cheaper substance has been substituted wholly or in partfor the
article so as to affect injuriously the nature, substance or quality thereof;
d.) if any constituent of the article has been wholly or in part abstracted so as to affect
injuriously the nature, substance or quality thereof ;
e.) if the article had been prepared, packed or kept under unsanitary conditionswhereby it has
become contaminated or injurious to health.
 f.) if the article contains any poisonous or other ingredient which renders it injurious to
health;
g.) if the container of the article is composed, whether wholly or in part, of anypoisonous
or deleterious substance which renders its contents injurious tohealth;
h.) if any colouring matter other than that prescribed in respect thereof is present in the
article, or if the amounts of the prescribed colouring matter which ispresent in the
article are not within the prescribed limits of variability;
i.) if the article contains any prohibited preservative or permitted preservative in excess
of the prescribed limits;
j.) if the quality or purity of the article falls below the prescribed standard or its
constituents are present in quantities not within the prescribed limits ofvariability,
but which renders it injurious to health; and
k.) Provided that, where the quality or purity of the article, being primary food, hasfallen below
the prescribed standards or its constituents are present in quantitiesnot within the prescribed
limits of variability in either case, solely due to naturalcauses and beyond the control of
human agency, then, such article shall not bedeemed to be adulterated within the meaning
of this sub-clause.
If the quality or purity of the article falls below the prescribed standard orits constituents are
present in quantities not within the prescribed limits ofvariability but which does not render it
injurious to health:

Sale of Certain Admixtures Prohibited

To make things clear, admixtures of many items are clearly prohibited. For eg.Sale by
himself or by his servant or agent is prohibited in case of:-
a) Cream which has not been prepared exclusively from milk or which containsless than
25% of milk fat.
b) Milk which contains added water.
c) Ghee which contains any added matter not exclusively derived from milkfat.
d) Selling skimmed milk as whole milk.
e) Mixture of two or more edible oils as an edible oil.
f) Vanaspati to which ghee or any other substance has been added.
g) Any article of food which contains any artificial sweetener beyond theprescribed
limit.
h) Turmeric containing any foreign substance.
i) Mixture of coffee and other substance except chicory.
j) Dahi or curd not made out of milk.
k) Milk or milk products containing constituents other than of milk.
 l.) if the article consists wholly or in part of any filthy, putrid, rotten,decomposed or
diseased animal or vegetable substance or is insect-infestedor is otherwise unfit for human
consumption;
Misbranded
An article of food shall be deemed to be misbranded:
a) If it is an imitation of, or is a substitute for, or resembles in a manner likelyto
deceive, another article of food under the name of which it is sold, and is not
plainly and conspicuously labelled so as to indicate its true character;
b) If it is falsely stated to be the product of any place or country;
c) If it is sold by a name which belongs to another article of food;
d) If it is so coloured, flavoured or coated, powdered or polished; the fact thatthe
article is damaged, is concealed or if the article is made to appear better or of
greater value than it really is;
e) If false claims are made for it upon the label or otherwise;
f) If, when sold in packages which have been sealed or prepared by or at the
instance of the manufacturer or producer and which bear his name and address,
the contents of each package are not conspicuously and correctlystated on the
outside thereof within the limits of variability prescribed underthis Act;
g) If the package containing it, or the label on the package bears any statement,design
or device regarding the ingredients or the substances contained therein, which
is false or misleading in any material particular; or if the package is otherwise
deceptive with respect to its contents;
h) If the package containing it or the label on the package bears the name of a
fictitious individual or company as the manufacturer or producer of the article;
i) If it purports to be, or is represented as being, for special dietary uses, unless its
label bears such information as may be prescribed concerning its vitamin,
mineral, or other dietary properties in order sufficiently to informits purchaser
as to its value for such uses;
j) If it contains any artificial flavouring, artificial colouring or chemical
preservative, without a declaratory label stating that fact, or in contravention of the
requirements of this Act or rules made there under;
If it is not labelled in accordance with the requirements of this Act or rulesmade there under

Fruit Products Order (FPO), 1955

Mode of operation-
MOFPI CENTRAL FOOD PRODUCTS ADVISORY COMMITTEE
Special features-
Licensing authority ‘FPO’ standard mark shall be imprinted on the products.

It is mandatory for all manufacturers of fruit and vegetable products including some non fruit
products like non fruit vinegar, syrup and sweetened aerated water to obtain a license under this
Order.
REGULATIONS-
• Regulates manufacture and distribution of all fruit & vegetable products. Exempted from
the provisions of the order to products prepared by Drug control act and Educational
Institutions for training purposes. Quantity shall not exceed 10kg. License shall be issued
after the satisfaction of quality of product, sanitation, personnel, hygiene, machinery,
equipment and work area requirements as per the schedule specified.

Fruit product means any of the following articles,

• Non fruit beverages, syrups and sherbets
• Vinegar, whether brewed or non-fruit
• Pickles
• Dehydrated fruits and vegetables
• Squashes, crushes cordials, barley water, barreled juice, and ready to serve beverages, fruit
nectars or any other beverages containing fruit juices or fruit pulp
• Jams, jellies and marmalades
• Tomato products, ketchup and sauces
• Preserves, candied and crystallized fruit and peel
• Chutneys
 • Canned and bottled fruits, juices and pulps
• Canned and bottled vegetables
• Frozen fruits and vegetables
• Sweetened aerated water and without fruit juice pr fruit pulp
• Fruit cereal flakes
• All unspecified fruit and vegetable products which are considered microbiologically safe
and contains only permitted additives within permissible limits.

Meat Food Products Order (MFPO), 1973

• The main objective is to regulate production and sale of meat food products through
licensing of manufacturers, enforce sanitary and hygienic conditions prescribed for
production of wholesome meat food products, exercise strict quality control at all
stages of production of meat food products, fish products including chilled poultry
etc.
• Meat & Meat Products are highly perishable in nature and can transmit diseases from
animals to human-beings.
• Processing of meat products is licensed under Meat Food Products Order,(MFPO) 1973
which was hitherto being implemented by Ministry of food Processing industries.
• Under the provision of MFPO all manufacturers of meat food products engaged in the
business of manufacturing, packing, repacking, relabeling meat food products meant for
sale are licensed but excluding those manufacturers who manufactures such products for
consumption on the spot like a restaurant, hotel, boarding house, snack bar, eating house
or any other similar establishment.

• Meat is one of the oldest food items of human being.

• Initially, it was being taken raw but later it began to be processed to satisfy the palate and
to provide preservative action.
• But meat is a highly perishable commodity and sanitary conditions and utmost hygienic
measures are necessary to safeguard the quality of processed meat food products.
• With the advent of centralised meat processing units, the responsibility to maintain the
quality of meat food products became a central concern.
• In 1973, Government of India promulgated an Order to enforce strict quality control on the
productio0n and processing of meat food products under Essential Commodities Act 1955.
• The responsibility to enforce this order was entrusted to Directorate of Marketing and
Inspection, Ministry of Agriculture and Rural Reconstruction.
 • The Agricultural Marketing Advisor to the Government of India was made the ex-officio
Chairman of meat Food Products Advisory Committee with 10 members who aid and
advise ministry in any matter pertaining to this Order.
• The Order aims at maintenance of sanitary conditions in the slaughterhouses, ensuring
proper antemortem examination, postmortem inspection of carcasses, in-process inspection
and final product checking.
• No person could carry on business as a manufacturer except under and in accordance with
the terms and conditions of licence granted to him under this Order.
• Every application for grant of licence shall be made as per the proforma set out in the First
Schedule of this Order.
• All meat-processing units, which produce meat food products for, sale within the country
come under its preview.
• Restaurants and hotels that prepare meat food products for consumption within their
premises are exempted.
• Any food item which is made from flesh or any other edible part of the carcass through the
process of curing, smoking, cooking, drying or any other processing technique is referred
as meat food product.
• The Order does not apply on raw (chilled or frozen) meat.
• It may be noted that no dealer, agent, broker or vendor can sell or expose for sale or
despatch or deliver any meat food products unless the same arte manufactured by a MFPO
licencee.

Categories

• MFPO, 1973 initially categorises the meat food manufacturers into the following three
broad heads on the basis of source of raw meat:
o Category A : Includes those manufacturers or licencees of meat food products who
possess their own slaughterhouse.
o Category B : Includes those manufacturers of meat food products who purchase
meat from approved slaughterhouse.
o Category C : Includes those manufacturers of meat food products, who purchase
raw meat from any other source.
• The licence fee for each category differs and is collected every year at the time of renewal
of licence.

Schedules

Meat Food Products Order, 1973 contains four schedules:

• The First Schedule

o Deals with application for licence or renewal of licence under MFPO.
o The information related to applicant, address of factory, source of raw material,
description of meat food products which the applicants proposes to manufacture,
installed capacity, a plan of factory and a list of equipments has to be provided.
 o Application for renewal of licence should invariably contain the statements
pertaining to the quality and value of meat food products manufactured in the
previous year.
• The Second Schedule
o Deals with the minimum sanitary requirements to be complied with by a licencee.
o It contains detailed instructions regarding factory premises, construction, doors,
windows and ceiling, plumbing and drainage system, equipment and manufacturing
area, cold storage facilities, precautions against flies, rats and mice, water supply,
personnel hygiene and vaccination of factory workers, provision of proper aprons
and head gears, etc.
• The Third Schedule
o Deals with hygienic requirements to be complied with by a licencee who also
slaughters animals in his factory.
o It contains detailed instructions regarding separation between clean and dirty
sections within the slaughterhouse, provision of lairage, slaughter hall and
refrigeration facilities, antemortem examination, humane slaughter, postmortem
inspection and disposal of condemned carcasses or organs, etc.
• The Fourth Schedule
o Deals with the requirements to be complied with as regards to packaging, marking
and labeling the containers of meat food products.
o It contains detailed instruction with respect to proper packing and sealing of flexible
containers, use of internal lacquers and hermetic sealing in tin plate cans, use of
internal lacquers and hermetic sealing in tin plate cans, use of bottles and jars.
o As per MFPO standards, canned meat food products should not contain poisonous
elements viz. lead, copper, arsenic, tin, zinc in excess of 2.5, 20, 2, 250 and 50 ppm
respectively by weight.
• In the process MFPO officers conduct inspection of meat food product factories and
premises regularly.
• They conduct frequent surprise visits to licensed units so as to enforce the implementation
of MFPO regulations.
• Samples of meat food products are collected and sent to regional and central Agmark
laboratories for specified testing.
• At present there are more than 220 licensed meat food products units under MFPO, 1973
throughout India.
• These units manufacture as many as 185 different types of meat food products.
• Thus, MFPO is playing a major role in safeguarding the interest of meat food products
consumers.
 Milk and Milk Product order (MMPO), 1992
• The objective of the order is to maintain and increase the supply of liquid milk of desired quality
in the interest of the general public and also for regulating the production, processing and
distribution of milk and milk products.
• As per the provisions of this order, any person/dairy plant handling more than 10,000 liters per
day of milk or 500 MT of milk solids per annum needs to be registered with the Registering
Authority appointed by the Central Government.
• In every case where the milk or milk product is packed by the holder of a registration certificate
in a tin, barrel, carton or any other container, the registration number shall either be exhibited
prominently on the side label of such container or be embossed, punched or printed prominently
thereon
Vegetable Oil Products (regulation) Order ,1998
• [Ministry of Food Consumer Affairs]
Regulations-
• Regulates the production and distribution of all the edible oils. Specifications of the
• products provided.
Special features-
• Supersedes the vegetable oil products (control) order, 1947 and Vegetable Oil Products
(Standards of Quality) order, 1975. BIS Certification for the tin plates used for vanaspati
packaging is deleted.
Sugar (Control) Order, 1966
[Ministry of Agriculture and Irrigation and department of Sugar]

Regulations-
Regulates the manufacture, quality and sale of sugar
EXPORT (QUALITY CONTROL & INSPECTION) ACT, 1963
MODE OF OPERATION-
a) Ministry of Commerce
b.) Export inspection council, 5 regional export inspection agencies network of 50 offices
REGULATION-
• Regulates compulsory pre-shipment inspection
• Exportable commodities list has been notified for pre-shipment inspection
• Quality control of various export product is monitored
SPECIAL FEATURES-
• AGMARK has been recognized as an agent for inspection and quality control of certain items
STANDARDS ON WEIGHTS AND MEASURES ACT, 1976
MODE OF OPERATION-
a) Ministry of Food & Civil Supplies
b) Directorate of weights and measures
REGULATION-
• Prescribed conditions for packed products with respect to quantity declaration, manufacturing
date and sale price
SPECIAL FEATURES-
• Provides relief to the weaker sections of the society and protecting the consumer in general by
guaranteeing the quantity for the amount paid
THE CONSUMER PROTECTION ACT, 1986 [Ministry of Food & Civil Supplies]
REGULATION-
• Provision made for the establishment of consumer councils and other authorities for the
settlement of consumer disputes.
SPECIAL FEATURES-
• Protection of the interest of consumer

ENVIRONMENT PROTECTION ACT, 1986 [Ministry of Environment & Forestry]

REGULATIONS
THE INSECTICIDE ACT, 1968 [Directorate of Plant Protection, Quarantine and Storage,
Ministry of Agriculture]
REGULATIONS-
Describes the safe use of insecticides to ensure that residual level doesn’t pose any health
hazard
VOLUNTARY STANDARDS
1. AGRICULTURAL PRODUCE (GRADING & MARKETING) ACT,
1937 [Directorate of Marketing and Inspection]
REGULATION-
• Grade and Standards are prescribed for Agricultural & Allied Commodities
Grading, sorting as per quality attributes and inspection are included
SPECIAL FEATURES-
• Activity based on marketing and grading at producer’s level. AGMARK certification.
Standards are being harmonized with international standards keeping in view the WTO
requirements. Certification of agricultural commodities is carried out for the benefit of
producer/manufacturer and consumer.

National Food Safety System

The National Food Safety System provides a wide range of food safety functions includes
• Laboratory Operations – Developed eLEXNET
• Outbreak Coordination and Investigation – Developed guidelines, within which
federal, state and local agencies could more effectively respond to multi-state
foodborne outbreaks
• Roles and Responsibilities for Food Safety
• Uniform Standards – Developed uniform criteria for evaluating the capacity and
performance of local, state or federal regulatory programs for retail foods, meat and
poultry, seafood and manufactured foods regulatory programs.
• State Food Safety Task Force
• Examination of State Minimum Standards
State Roles and Responsibilities
State level agencies perform a wide range of food safety function is including:
• Outbreak Response and Recalls: States often have lead responsibility, in collaboration
with local health departments and sometimes CDC, on large-scale outbreak
 investigations. States also implement recalls, often in collaboration with federal and
local regulatory agencies.
• Surveillance: States have important responsibility for ongoing foodborne illness
surveillance, working both independently and in collaboration with CDC and localities
on FoodNet, PulseNet, OutbreakNet, and other surveillance initiatives.
• Laboratory Testing: State laboratories conduct the majority of all food-related
laboratory testing.
• Retail and Food Service Inspection: While retail and food service safety oversight is
largely conducted by local agencies, some state agencies are involved in standard
setting and inspection of retail and food service establishments.
• Processing Inspections: States conduct more than 80 percent of all non- retail food
establishment inspections, other than in meat and poultry establishments, including the
majority of “FDA inspections.” These inspections are conducted by state agencies
under contract with FDA.
• Farm Inspections: States conduct on-farm inspections for animal health and other
conditions related to food safety,
• Education
• Technical and Training Assistance
Local Roles and Responsibilities
• There are thousands of local health departments and food inspection agencies are
present across the country and they are best known for their primary role in preventing
foodborne illness through regulation and inspection, they perform a wide range of food
safety functions, including
• Outbreak Response and Recalls: Local agencies are the first responders and lead
investigators on local outbreaks and are actively involved with state and federal
agencies on larger, multijurisdictional outbreaks.
• Surveillance: Local agencies have frontline responsibility for reporting foodborne
diseases and other local activities essential to on-going foodborne illness.
• Laboratory Testing: Local agencies carry out food safety laboratory functions.
Foodborne Illness Surveillance
• Emerging Infections Program(EIP)
• FoodNet (Active Foodborne Disease Surveillance System): #FoodNet is a
collaborative effort among the CDC, FDA, USDA.
used to follow nine major food-borne diseases #Infection caused by nine pathogens
(Campylobacter, Cryptosporidium, Cyclospora, Listeria, Salmonella, Shiga toxin-producing
Escherichia coli O157, Shigella, Vibrio, and Yersinia).
• PulseNet (National Molecular Surveillance Network)
established by Center for Disease Control
eLEXNET
The Electronic Laboratory Exchange Network (eLEXNET) is a seamless, integrated, web-
based information network.
It is coordinated by FDA,
Epi-X: Run by the CDC, Epi-X is a web-based surveillance communications tool for public
health professionals.
Outbreak Response
• OutbreakNet: OutbreakNet is a national CDC-coordinated network of public health
who investigate outbreaks of enteric disease, including foodborne outbreaks.
• The Council to Improve Foodborne Outbreak Response
that to improve performance and coordination among local, state and federal agencies
The Council includes CDC, FDA, USDA, ASTHO, NACCHO, AFDO, APHl, CSTE and
NEHA.
Association of state and territorial officers
The National Aboriginal Community Controlled Health Organisation
Association of Food and Drug Officials
Association of public health laboratory
Council of State and Territorial Epidemiologists
National environment health association
Epi-Ready: Epi-Ready is a nationwide team-training initiative, led by the Center for Disease
Control and the National Environmental Health Association, which provides up-to-date
foodborne disease outbreak investigation and surveillance training to public and private sector.
• CAL-FERT: The California Food Emergency Response Team (CalFERT) is an
outbreak emergency response team of investigators and analysts that engage in
collaborative training and investigation of foodborne outbreaks.
Inspection and Regulatory Activities
• FDA’s Food Code: It is a model that provides state and local food safety agencies with
a sound technical and legal basis for regulating the retail and food service segment of
the industry (restaurants and grocery stores and institutions such as nursing homes).
• FDA Voluntary National Retail Food Regulatory Program
• FDA-State Cooperative Inspection Agreements:
State employees carry out inspections at food processing plants under federal-state cooperative
inspection Agreements.
These Inspections are performed under the States’ laws and authorities or the provisions of the
U.S. Food, Drug and Cosmetic Act (FDCA) or both.
• Manufactured Food Regulatory Program Standards:
FDA-sponsored program
It establishes a uniform foundation for the design and management of State programs for the
regulation of food processing plants.
AGMARK CERTIFICATION

AGMARK is a certification mark for agricultural produce, assuring that they conform to a
grade standard notified by Directorate of Marketing & Inspection (DMI), Department of
Agriculture, Cooperation and Farmers Welfare, Ministry of Agriculture & Farmers Welfare
under Agricultural Produce (Grading Marking) Act, 1937.These standards differentiate
between quality and 2-3 grades are prescribed for each commodity. Till date, grade standards
for 222 agricultural commodities have been notified. These include fruits, Vegetables, cereals,
pulses, oilseeds, vegetable oils, ghee, spices, honey, creamery butter, wheat, atta, besan, etc.

While framing the standards, the existing standards in The Food Safety and Standards Act,
2006, Codex Alimentarius Commission, International Organization for Standardization, etc.
are considered. Trade Associations, Research Institutions, etc. are also consulted.

While the certification scheme is essentially voluntary, Food Safety and Standards (Prohibition
and Restriction Sale) Regulations 2011 have prescribed mandatory certification under
AGMARK for certain products viz. Blended Edible Vegetable Oil, Fat Spread. In case of Til
Oil, Carbia Callosa, Honey dew, Tea and Ghee FSSAI has prescribed few conditional
restrictions.

The certification scheme is implemented through 11Regional Offices, 26 Sub Offices, 11

Regional Agmark Laboratories and Central Agmark Laboratory (Apex laboratory) of the
Directorate. Out of twelve laboratories, 09 laboratories are accredited with the National
Accreditation Board for testing and Calibration Laboratories (NABL) as per the International
Standard ISO17025. Persons desirous of grading and certifying a notified agricultural
commodity under Agmark can apply to the nearest field office of the DMI. The details are
available at www.dmi.gov.in portal under AGMARK icon.

USFDA
EU
CODEX Alimentarius
WTO
BIS
2. BUREAU OF INDIAN STANDARDS (BIS) [Indian Standards Institution]
REGULATION-
• Prescribing of grade standards, formulation of standards, specification of foods,
standards for limit of toxic compounds as applicable.
• Implementation of regulation by promotion through its voluntary and third party
certification system, specifying of packaging and labelling requirements.
SPECIAL FEATURES-
• General cover on hygienic conditions of manufacture, raw material quality & safety
are given. Quality and safety oriented standards
2.1 CERTIFICATION MARKS SCHEME, BIS ACT, 1986 (rules and regulations) [BIS]
REGULATIONS-
• Regulates the certifications scheme for various processed food products, ingredients
and packaging containers.
SPECIAL FEATURES-
Ensure the quality to the consumer by certification.
BIS

BIS certification scheme is voluntary and aims at providing quality, safety and dependability
to the ultimate consumer. Presence of certification mark known as Standard Mark on a product
is an assurance of conformity to specifications The activities of Bureau of Indian Standards
(BIS) are formation of Indian Standards in the processed food sector and the implementation
of standards through promotion, voluntary and third party certification systems.
Under BIS many of the standards are laid down based upon ISO (International
Organization for Standardization) standards which is a worldwide federation of National
Standard Bodies.
Establishment, Publication and Promotion of Indian Standards: For the purpose of
formulation of Indian Standards in respect of articles or processes, technical committees of
experts are constituted. Such committees may include Division Councils, Sectional
Committees, Sub-committees and Panels and each of these councils have specified functions .
Procedure for Establishment of Indian Standards: Any Ministry of Central or State
Government, consumer organizations, industrial units, industry-associations, professional
bodies, can submit proposals to the Bureau for establishing a standard or for revising,
amending, a standard by making a request in writing. Division Council concerned will assign
the task of formulating the standard to an appropriate Technical Committee. Later a draft
standard prepared and duly approved by a Committee shall be issued and widely circulated for
a period of not less than one month amongst the various interests concerned for critical review
and suggestions for improvement. The appropriate Technical Committee shall thereafter
finalize the draft standard giving due consideration to the comments that may be received. The
draft standard shall be submitted to the Chairman of the Division Council concerned for
adoption. All established standards shall be reviewed periodically, at least once in five years,
to determine the need for revision or withdrawal. Standards which there is need to revise or
amendment shall be reaffirmed.

Grant of License: Manufacturing units can apply for BIS license on a prescribed form along
with application fee and other documents such as location map of factory list of manufacturing
and testing equipments, flow charts of the process, details of the technical staff etc. BIS office
will do a preliminary inspection verify all documents and process. The product samples are
drawn and sent for analysis at BIS certified lab. After satisfactory inspection and sample report
of the product, license is granted 1 to 2 years which can renewed periodically.
Inspection: The certified units are inspected by inspecting officers. The may be done at
manufacturing place, dispatch place or at the place where it is used. At manufacturing place,
the inspection will also be for the QA systems, verification and validation. The Bureau shall
designate such of the officers of the Bureau as Inspecting Officers.
STOP Marking: If there is evidence that the product is not as per the conforming standards
and agreed clauses, the licensee will be directed to stop marking. The reasons can be Non-
conformance of products at manufacturing place or at market place, Non implementation of
Scheme of Testing of the products, Non availability of testing staff , Significant modification
of plant and machinery without informing BIS, Relocation of plant and machinery, Prolonged
closure of the unit, Marking non conformed product, Marking standard mark other than that
are included in the license. The licensee can resume only after re inspection and satisfactory
compliance.
Consumer Protection Act, 1986
Consumer: The term consumer refer to: any person who-
(i) (a) buys any goods for a consideration which has been paid or promised or partly paid and
partly promised, or under any system of deferred payment, and
(b) includes any user of such goods other than the person who buys such goods for
consideration paid or promised or partly paid or partly promised, or under any system of
deferred payment,
(c) when the said use is made with the approval of such person (original buyer),
(d) but does not include a person who obtains such goods for resale or for any commercial
purpose;
(ii) (a) hires or avails of any service for a consideration which has been paid or promised or
partly paid and partly promised, or under any system of deferred payment, and
(b) includes any beneficiary of such service other than the person who hires or avails of the
services for consideration paid or promised, or partly paid and partly promised, or under any
system of deferred payment,
(c) when such services are availed of with the approval of the first mentioned person,
(d) but does not include a person who avails of such service for any commercial purpose
Complaint: The term complaint means or refers to:
(i) any allegation in writing,
(ii) made by a complainant or
(iii) for obtaining any relief as provided by or under this Act
Defect: The term Defect refers to any (i) fault, (ii) imperfection or (iii) shortcoming in the (a)
quality, (b) quantity, (c) potency, (d) purity or (e) standard which is required to be maintained
by or under any law for the time being in force or under any contract, express or implied or (iv)
as is claimed by the trader in any manner whatsoever in relation to any goods or product and
the expression "defective" will be construed accordingly.
Consumer Dispute: The term ‘Consumer Dispute’ refers to a dispute where the person against
whom a complaint has been made, either denies or disputes the allegations contained in the
complaint.
The nature of complaints to be made may include.
(i) an unfair contract or unfair trade practice or a restrictive trade practice has been adopted by
any trader or service provider;
(ii) the goods bought by him or agreed to be bought by him suffer from one or more defects;
(iii) the services hired or availed of or agreed to be hired or availed of by him suffer from any
deficiency (The terms “in any respect” was deleted under the Act, 2019).
(iv) trader or a service provider, as the case may be, has charged for the goods or for the services
mentioned in the complaint, a price in excess of the price-
(a) fixed by or under any law for the time being in force; or
(b) displayed on the goods or any package containing such goods; or
(c) displayed on the price list exhibited by him by or under any law for the time being in force;
or
(d) agreed between the parties;
(v) The goods, which are hazardous to life and safety when used, are being offered for sale to
the public-
(a) in contravention of standards relating to safety of such goods as required to be complied
with, by or under any law for the time being in force;
(b) where the trader knows that the goods so offered are unsafe to the public;
(vi) the services which are hazardous or likely to be hazardous to life and safety of the public
when used, are being offered by a person who provides any service and who knows it to be
injurious to life and safety.
(vii) a claim for product liability action lies against the product manufacturer, product seller or
product service provider, as the case may be.
Consumer Rights: These Consumer Rights include:
(i) the right to be protected against the marketing of goods, products or services which are
hazardous to life and property;
(ii) the right to be informed about the quality, quantity, potency, purity, standard and price of
goods, products or services, as to protect the consumer against unfair trade practices;
(iii) the right to be assured, wherever possible, access to a variety of goods, products or services
at competitive prices;
(iv) the right to be heard and to be assured that consumer's interests will receive due
consideration at appropriate fora;
(v) the right to seek redressal against unfair trade practice or restrictive trade practices or
unscrupulous exploitation of consumers; and
(vi) the right to consumer awareness.
AGMARK, PFA, FPO, BIS, MMPO, FPO, FSSA 2006,
FSSA, 2006
An Act to consolidate the laws relating to food and to establish the Food Safety and Standards
Authority of India for laying down science based standards for articles of food and to regulate
their manufacture, storage, distribution, sale and import, to ensure availability of safe and
wholesome food for human consumption and for matters connected therewith or incidental
thereto.

 Food Safety and Standards Authority of India (FSSAI), established under the Food
Safety and Standards Act, 2006, is the regulating body related to food safety and laying
down of standards of food in India.
 Science based standards for articles of food and to regulate their manufacture, storage,
distribution, sale and import to ensure availability of safe and wholesome food for
human consumption.
 www.fssai.gov.in
 To ensure that all food meets consumers’ expectations in terms of nature, substance and
quality and is not misleadingly presents;
 To provide legal powers and specify offences in relation to public health and
consumers’ interest;
 To shift from regulatory regime to self compliance through Food Safety Management
system.
 Science based standards
 Proprietary food, novel food, GM food, dietary supplements, nutraceuticals etc brought
into the ambit of the new act.
 The Act covers activities throughout the food distribution chain, from primary
production through distribution to retail and catering.
 The Act gives the Government powers to make regulations on matters of food safety.
  The Food Safety & Standards Authority of India is the principal Government Authority
responsible for preparing specific regulations under the Act.
FUNCTIONS OF AUTHORITY
• To regulate, monitor the manufacture, processing, distribution, sale and import
of food to ensure its safety and wholesomeness.
• To specify standards, guidelines for food articles
• Limits for Food additives, contaminants, veterinary drugs, heavy metals,
mycotoxin, irradiation of food, processing aids.
• Mechanisms & guidelines for accreditation of certification bodies engaged in
FSMS certification
• Quality control of imported food.
• Specify food labelling standards including claims on health, nutrition, special
dietary uses & food category systems.

ROLES & RESPONSIBILITIES OF FOOD SAFETY COMMISSIONER

➢ Prohibit in the interest of public health, the manufacture, storage, distribution, or sale
of any article of food.
➢ Carry out survey/inspection of the food processing units in the state to find out
compliance of prescribed standards.
➢ Conduct training programmes for the personnel engaged in food safety.
➢ Ensure efficient and uniform implementation of the standards and other requirements
of food safety.
➢ Sanction prosecution for offences punishable with imprisonment under this Act.
ROLES & RESPONSIBILITIES OF DESIGNATED OFFICER
➢ Issue or cancel license of Food Business Operator.
➢ Prohibit sale in contravention of this Act.
➢ Receive report and samples of articles of food from Food Safety Officer and get them
analyzed.
➢ Make recommendation to the Commissioner of Food Safety for sanction to launch
prosecutions
➢ Sanction prosecution
➢ Maintain record of all inspections made by Food Safety Officers
➢ Get complaints investigated in respect of any contravention of the provision of this Act
or against FSO
LICENSING AND REGISTRATION OF FOOD BUSINESS
Registering Authority
State Licensing Authority
 Central Licensing Authority

Designated Officer
Food Safety Officer or any official in appointed by the Chief
Panchayat, Municipal Corporation or Designated Officers appointed
any other local body in an area, under Section 36(1) of the Act by Executive Officer of the
notified as such by the State Food the Food Safety Commissioner of a
Safety Commissioner for the purpose State or UT for the purpose of FSSAI
of registration licensing and monitoring.
in his capacity of Food

Safety Commissioner

Registration required for the Food Business Operator, who –

a. manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor
or temporary stall holder; or
b. such food business including small scale or cottage or tiny food businesses with an annual
turnover not exceeding Rs 12 lakhs and or whose-
i. production capacity of food (other than milk and milk products and meat and meat products)
does not exceed 100 kg/ltr per day or
ii. production or procurement or collection of milk is up to 100 litres of milk per day or
iii. slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or
less than that
Central License required for the Food Business Operator, who –
(i) Dairy units including milk chilling units process more than 50 thousand litres of liquid
milk/day or 2500 MT of milk solid per annum.
(ii) Vegetable oil processing units having installed capacity more than 2 MT per day.
(iii) All slaughter houses equipped to slaughter more than 50 large animals or 150 or more
small animals or 1000 or more poultry birds per day
(iv) Meat processing units equipped to handle or process more than 500 kg of meat per day or
150 MT per annum
(v) All food processing units other than mentioned above having installed capacity more than
2 MT/day.
Central License required for the Food Business Operator, who –
(vi) 100 % Export Oriented Units
(vii) All Importers importing food items for commercial use.
(viii) All Food Business Operators manufacturing any article of Food which does not fall under
any of the food categories prescribed under these regulations or deviates in any way from the
prescribed specification for additives therein.
(ix) Retail chains operating in three or more states.
(x) Food catering services in establishments and units under Central government Agencies like
Railways, Air and airport, Seaport, Defence etc.
Scientific advice and technical support to central / state governments
Standard of Identity, Standard of Fill, Standard of Quality
Standard of Identity

The FDA began establishing Standards of Identity (SOI) in 1939, and since then, the agency
has established more than 250 SOIs. Products like milk, milk chocolate, various breads, peanut
butter, and ketchup have a SOI. SOIs often describe in detail what a food must contain and
what is optional and sometimes describe the amount or proportion of ingredients or
components. Many SOIs also prescribe a method of production or formulation.

The FDA is updating its SOI program with the goal of maintaining the basic nature and
essential characteristics of standardized foods while permitting flexibility with respect to their
composition.

Background

SOIs were first established in 1939 to help address economic adulteration that was occurring
in the marketplace. For example, there were products that were represented as jams containing
fruit, but the products contained little fruit (e.g., the SOI for fruit preserves and jams requires
that products represented as jam contain a minimum amount of fruit).

SOIs were developed to help protect consumers and promote honesty and fair dealing. SOIs
have been established to ensure that the characteristics, ingredients and production processes
of specific foods are consistent with what consumers expect. Today, economic adulteration is
no longer such a prominent issue for most foods, and changes in food labeling requirements
give consumers more information about the foods they buy (e.g., nutrition information,
ingredient lists, and food allergens). However, the establishment of food standards may still
benefit consumers in some cases by ensuring honesty and fair dealing.

The FDA’s work to update SOIs falls into three categories:

• Establishing principles to communicate more transparently what the agency will

consider when determining whether to revise, eliminate, or establish a food standard;
• Updating individual SOIs to allow for continued innovation in the marketplace,
including updating SOIs to reflect modern technologies and processing methods; and
• Updating SOIs to ensure they are supporting the production and innovation of
healthier food.

Standard of Fill of the container

EU
The EU's members are Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, and Sweden.
The European Union (EU) has a comprehensive set of regulations governing food safety,
quality, and labelling to ensure the protection of public health and facilitate trade within the
single market. These regulations are designed to ensure that food is safe for consumers and that
they are provided with adequate information about the products they purchase. Here are key
aspects of the EU's food regulations:
General Food Law Regulation (Regulation (EC) No 178/2002)
Framework: Establishes the general principles and requirements of food law, food safety, and
food traceability.
European Food Safety Authority (EFSA): Created under this regulation to provide scientific
advice and support to EU legislation.
Precautionary Principle: Allows for preventive measures when there is a potential risk to human
health.
2. Food Hygiene Regulations (Regulations (EC) No 852/2004, 853/2004, 854/2004)
Regulation 852/2004: Sets out general hygiene requirements for all food business operators.
Regulation 853/2004: Specifies hygiene rules for products of animal origin.
Regulation 854/2004: Lays down specific rules for the organization of official controls on
products of animal origin intended for human consumption.
3. Food Information to Consumers (Regulation (EU) No 1169/2011)
Labelling: Standardizes food labelling to provide clear, comprehensive, and accurate
information.
Nutrition Information: Mandatory nutrition labelling for most pre-packed foods.
Allergen Information: Requirements for listing allergens present in food products.
4. Novel Foods Regulation (Regulation (EU) 2015/2283)
Definition: Covers foods and ingredients that were not significantly consumed in the EU before
May 15, 1997.
Authorization: Requires pre-market safety assessment and authorization by the European
Commission, based on EFSA's opinion.
5. Contaminants in Food (Regulation (EC) No 1881/2006)
Maximum Levels: Sets maximum levels for certain contaminants in foodstuffs to protect public
health.
Monitoring: Requires member states to monitor contaminants and report findings to the
European Commission.
6. Pesticide Residues (Regulation (EC) No 396/2005)
Maximum Residue Levels (MRLs): Establishes MRLs for pesticide residues in food and feed.
Evaluation and Monitoring: Regular evaluation and monitoring of pesticide residues.
7. Genetically Modified Organisms (GMOs) (Regulation (EC) No 1829/2003 and
1830/2003)
Authorization and Labelling: Requires thorough risk assessment and labelling of GMOs and
products derived from GMOs.
Traceability: Ensures traceability at all stages of the production and distribution chain.
8. Organic Food (Regulation (EU) 2018/848)
Standards and Certification: Sets rules for organic production, processing, labelling, and
certification.
Control System: Establishes a system of checks to maintain the integrity of organic food
products.
9. Additives, Enzymes, and Flavourings (Regulation (EC) No 1333/2008 and 1334/2008)
Safety Assessment: Additives, enzymes, and flavourings must undergo safety evaluations
before use.
Lists of Approved Substances: Maintains positive lists of substances approved for use in food.
10. Food Supplements (Directive 2002/46/EC)
Safety and Labelling: Regulates the composition and labeling of food supplements to ensure
they are safe for consumption.
11. Specific Food Categories
Infant Formula and Follow-on Formula (Regulation (EU) No 609/2013): Sets standards for
composition, safety, and labelling.
Foods for Special Medical Purposes (FSMP) (Regulation (EU) No 609/2013): Covers
composition, safety, and labelling for FSMP.
Implementation and Enforcement
Member States: Each member state is responsible for enforcing EU food regulations through
national laws and controls.
Rapid Alert System for Food and Feed (RASFF): Facilitates the exchange of information on
food safety issues between EU member states and the European Commission.
The EU's regulatory framework aims to ensure high standards of food safety, consumer
protection, and the free movement of food within the internal market. These regulations are
regularly updated to reflect new scientific knowledge and address emerging risks.
WTO
WTO’s main objectives relate to the following:
(i) achieving ‘sustainable development’ in relation to the optimal use of the world’s resources,
(ii) ensuring the need to protect and preserve the environment in a manner consistent with the
various levels of national economic development;
(iii) safeguarding the interest of developing countries to secure a better share of the growth in
international trade
The WTO is headed by the Ministerial Conference, while the daily operations are carried out
by three administrative bodies:
1. General Council: The General Council comprises the representatives of all member
countries. Its job is to carry out the implementation and monitoring function of the WTO. The
General Council is further divided into multiple councils and committees that focus on specific
topics. Examples of such bodies include the Council on Goods, the Councils on Services, the
Committee on Textiles under the Council on Goods, etc.
2. Dispute Settlement Body (DSB): The DSB is responsible for settling trade disputes between
member states. The purpose of DSB is to resolve such disputes by a rule-based system rather
than through unilateral retaliatory action by those complaining. There is now a time-table laid
down for dispute settlement. The amount of time each stage of the process should take has been
indicated, though there is some flexibility in the time-frames laid down. The DSB can reject
the findings of a panel or of an appeals report – only by consensus. The dispute settlement
system is undoubtedly the jewel in the WTO's crown. The consensus is certainly leaning in
favour of preserving and strengthening the dispute settlement function of the WTO. There is
also an Appellate Body, where member states can appeal any decisions made against them
during a dispute settlement.
3. Trade Policy Review Body: The Trade Policy Review Body is also a part of the General
Council and is responsible for ensuring the trade policies of member states are in line with the
goals of the WTO. Member countries are World Trade Organization required to inform the
WTO about changes in their laws and trade policies. The body undertakes regular reviews of
the policies to ensure they conform to the rules of the WTO. This is part of the monitoring
function of the WTO, and it helps the WTO to adapt to the changing economic landscape.
Overview
The Food and Drug Administration (FDA or USFDA) is a government agency of the United
States Department of Health and Human Services. The FDA is responsible for regulating and
supervising the safety of foods, tobacco products, dietary supplements, prescription and non-
prescription medication, vaccines, biopharmaceuticals, blood transfusions, medical devices,
electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
Establishment: The USFDA is a federal agency under the Department of Health and Human
Services.
Founding Year: 1906, following the passage of the Pure Food and Drugs Act.
Primary Role: Protecting public health by ensuring the safety, efficacy, and security of human
and veterinary drugs, biological products, and medical devices. Additionally, it oversees the
safety of the nation's food supply, cosmetics, and products that emit radiation.

Key Responsibilities
1. Regulation of Drugs and Biologics:
- Approves new drugs and biologics based on clinical trial data.
- Monitors post-market safety and effectiveness of drugs and vaccines.
- Issues drug recalls and safety alerts.
2. Medical Devices:
- Evaluates and approves new medical devices before they enter the market.
- Conducts post-market surveillance and issues recalls if necessary.
3. Food Safety:
- Sets standards for food safety and nutrition labelling.
- Conducts inspections and enforces regulations to prevent foodborne illnesses.
- Regulates food additives and dietary supplements.
4. Tobacco Products:
- Regulates the manufacturing, marketing, and distribution of tobacco products.
- Implements policies to reduce tobacco use and its associated health risks.
5. Cosmetics:
- Ensures that cosmetics are safe and properly labelled.
- Conducts research and takes action against harmful products.
6. Radiation-Emitting Products:
- Regulates devices like X-ray machines, microwave ovens, and other products emitting
electronic radiation.
- Ensures that these products meet safety standards to protect public health.
Organizational Structure
- Commissioner: Appointed by the President and confirmed by the Senate.
- Centers and Offices:
 - Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- Center for Food Safety and Applied Nutrition (CFSAN)
- Center for Tobacco Products (CTP)
- National Center for Toxicological Research (NCTR)
- Office of Regulatory Affairs (ORA)
Regulatory Framework
- Legislative Acts:
- Federal Food, Drug, and Cosmetic Act (FD&C Act)**: Foundation of FDA's authority to
regulate food, drugs, and cosmetics.
- Public Health Service Act: Provides authority to regulate biological products and control
communicable diseases.
- Tobacco Control Act: Grants FDA authority over tobacco products.

Processes and Procedures

- New Drug Application (NDA): Required for the approval of new drugs.
- Premarket Approval (PMA): Required for the approval of high-risk medical devices.
- Investigational New Drug (IND): Allows experimental drugs to be tested in humans.
- Good Manufacturing Practice (GMP): Regulations to ensure products are consistently
produced and controlled.

Public Health Initiatives

- Opioid Crisis: Implementing strategies to combat opioid abuse.
- Antimicrobial Resistance: Promoting the judicious use of antibiotics to curb resistance.
- Nutrition and Health: Initiatives to improve public dietary habits and reduce chronic disease.

Global Role
- Collaborates with international regulatory authorities.
- Works to harmonize regulatory standards globally.
- Engages in global health initiatives and emergency responses.
Challenges and Criticisms
- Balancing swift approval of new therapies with thorough safety evaluations.
- Managing resource constraints and increasing regulatory demands.
- Addressing public trust and transparency in decision-making processes.
Impact and Contributions
- Enhanced public health through rigorous scientific review and regulation.
- Pioneered advancements in drug safety and efficacy standards.
- Played a crucial role in managing public health emergencies and outbreaks.

By overseeing a broad spectrum of products and maintaining rigorous standards, the USFDA
continues to be a cornerstone of public health protection in the United States and an influential
entity in global health regulation.