In this slide contains introduction, amendments of FD&C act, HACCP system and different department of USFDA. Presented by: R.Bhanu Teja (Department of pharmaceutical analysis), RIPER,anantapur.

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1
Presented by
R. BHANUTEJA
(Reg. No: 20L81S0707)
Under the guidance of
Dr. P. Vinod Kumar, M. Pharm., PhD
Professor of Pharmaceutical Analysis ,
Head of department –pharmaceutical analysis.
LEGISLATION REGULATIONS OF FOOD
PRODUCTS AS PER FDA
A seminar as a part of curricular requirement for 1st year
M. Pharm 1st semester

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2
1. Introduction of food legislation.
2. USFDA.
3. Amendments & addition to FD&C act.
4. Regulations.
5. HACCP system.
6. Different departments under USFDA.
7. References.
Contents

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3
• Food legislation developed in many countries around the world requires
that microbiologically safe food shall be produced.
• By means of process, equipment that minimizes the risk of
contamination and that is easily cleanable.
• Good hygienic engineering and design practices have become the tools
to reduce or exclude microbial, Chemical & Physical Contamination Of
Food.
• cross-contamination of one batch by a previous batch can be avoided
by means of good hygienic design practices.
Introduction of Food legislation

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4
United States Food and Drug
Administration (FDA)
• The FDA is a US government agency within the Department of Health
and Human Services (DHHS).
• The FDA is responsible for regulating, the safety of foods, cosmetics,
drugs, medical devices, biological and radiological products.
• It acts under laws passed by the United States congress to monitor the
affected industries and ensure the consumer of the safety of such
products.

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
5
• Knowledge of government regulations relevant to the chemical
analysis of foods is extremely important to persons working in the
food industry.
• Federal laws and regulations reinforce the efforts of the food industry
to provide wholesome foods, to inform consumers about the
nutritional composition of foods and to eliminate economic frauds.
• They dictate what ingredients a food must contain, what must be
tested, and the procedures used to analyze foods for safety factors and
quality attributes.

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6
Federal Food, Drug and Cosmetic Act of 1938:
• It was intended to assure consumers that foods are safe, wholesome,
produced under sanitary conditions, packaged and labeled truthfully.
• FDA was given power to seize illegal products and imprison and fine
violators.
• The federal food and drug, and cosmetic act and subsequent amending
status are codified into title 21chapter 9 of united states code
Legislative History

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Miller Pesticide Amendment – 1954
• It specifies the acceptable amount of pesticide residues on fresh
fruits, vegetables and other raw agricultural products when they enter
the market place.
• This amendment then under the authority of FDA, is now
administered by the Environmental Protection Agency (EPA).
Amendments and additions to 1938
FD&C Act
7

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
• To protect the health of consumers by requiring a food additive to be
proven safe before addition to a food.
• To permit the food industry to use food additives that are safe at the
intended level of use.
Food Additives Amendment – 1958
8

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
It defines color additives, sets rules for both certified and uncertified
colors and to limit the levels of colors. It also contains a Delaney Clause.
Nutrition Labeling and Education Act 1990
Made nutrition labeling mandatory on most of food products
Emphasized the relationship between diet and health and provided
consumers a means to choose foods based on complete and truthful label
information.
Color Additives Amendment 1960
9

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
• The FDA has developed many administrative rules, guidelines and
action levels in addition to the above regulations.
They include-
• GMP regulations (21 CFR 110)
• Food labeling regulations (21 CFR 101)
• Recall guidelines (21 CFR 7.40)
• Nutritional quality guidelines (21 CFR 104)
• FDA has placed considerable emphasis on GMP regulations and on
Hazard Analysis Critical Control Point (HACCP) systems to reduce
the incidence of food borne illness and include the FDA, USDA,
EPA and the centers for Disease Control (CDC).
Other regulations
10

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11
These are designed to prevent adulterated food in the marketplace.
It defines requirements for acceptable sanitary operation in food, plants
and includes the following relevant to food processing:
• General provisions that define and interpret the detailed regulations.
• Requirements & expectations for maintaining grounds, buildings and
facilities.
• Requirements & expectations for design, construction and maintenance
of equipment.
• Requirements for production and process controls.
• Defect action levels (DALs) for natural and unavoidable defects .
GMP Regulations

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
It was developed and implemented by a food processor, originally
designed to produce zero defect (no hazard). It has the following
components:
• Determine potential hazards in each process.
• Identify critical control points.
• Establish control limits for each critical control point.
• Establish procedures to monitor control points.
• Establish corrective actions when limits of control point are exceeded.
• Establish appropriate system of record keeping.
• Establish program to verify efficacy of program.
HACCP system
12

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
13
• When violations of the FD&C act through periodic inspections of
facilities and products and through analysis of samples,
• The FDA can use warning letters, seizures, injunctions or recalls
depending on circumstances.
• FDA cannot file criminal charges, but rather recommends to the
Justice Department that court action be taken that might result in
fines or imprisonment of offenders.

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14
United States Department of Agriculture
• It administers several federal statutes relevant to food standards,
composition and analysis. These include standards of identity for meat
products, grade standards, and inspection programs.
United States Department of Commerce
• Seafood Inspection Service.
• National Oceanic and Atmosphere Administration (NOAA).
• National Marine Fisheries Service (NMFS).
• Interaction and FDA and EPA (Environment protection agency).
• Work with NMFS for assurance of seafood safety.
Different departments under USFDA are

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
• Regulatory responsibilities for alcoholic beverages.
• Specified by Federal Alcohol Administration Act.
• Standards and composition of beer, wine & distilled beverage spirits.
United States Customs Services (USCS)
• Ensures products are taxed properly, safe for human consumption.
United States Bureau of Alcohol, Tobacco, Firearms
and Explosives

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
Harmonized tariff schedule of the United States (TSUSA)
• Goods imported into US are subject to duty or duty-free as per
TSUSA
• Has official tariff schedules for over 400 edible items exported into
US
Food consumption and the TSUSA
• The rate of duty of food products is determined by their chemical
composition

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
It covers various aspects of advertising and sales promotion practice for
food.
They keep business and trading competition free and fair.
Includes-
• Enforcement AuthorityProtect both consumer and business person
from anticompetitive behavior and unfair business and trade practices
• Food labels, Food composition and Deceptive Advertising
FTC has primary authority over advertising of foods
FDA has primary authority over labeling of foods
United States Federal Trade Commission
17

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
• S.Suzanne nielsen, Food analysis 5th edition, pg no . 19-31.
• Adams DG, cooper Rm, kahan JS, Food and drug law regulation,3rd
edition (2014).
• Pina w, pines k ,A practical guide to FDA’s food and drug law and
regulation, 5th edition (2014).
• Curtis PA, Guide to food laws and regulations (2005).
References

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
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