This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.

1. REGULATORY ASPECTS OF FOOD &
NUTRACEUTICALS A GLOBAL PROSPECTIVE
PRESENTED BY :- KAPIL
M. PHARMACY 1ST YEAR (DRA)
ROLL NO. 180000802001

2. • Content
Introduction
WHO Guidelines On Nutrition:
NSF INTERNATIONAL
NSF INTERNATIONAL: Its Role In The Dietary Supplements And
Nutraceuticals Industries
NSF Certification
NSF Standards For Food And Dietary Supplements
Good Manufacturing Practices for Nutraceuticals

3. • World Health Organization (WHO) is a specialized agency
of the United Nations that is concerned with
international public health.
• It was established on 7 April 1948, and its headquartered
in Geneva; Switzerland.
• WHO is responsible for providing leadership on global
health matters, shaping the health research agenda, setting
norms and standards, providing technical support to
countries and monitoring and assessing health trends.

7. 1. DIETARY SUPPLEMENTS TRAINING: NSFsupport
the dietary supplement industry worldwide by providing
high-quality training on a variety of topics instrumental to
understanding regulations and critical to achieving or
maintaining regulatory compliance. Dietary supplements
training includes :
 PUBLIC TRAINING COURSES
 TRAINING AT YOUR SITE

8. • Training is essential for maintaining high
standards of quality assurance and compliance to
Good Manufacturing Practices (GMPs).
• GMP regulations clearly state that employees
involved in manufacturing, packaging, labeling or
holding of dietary supplements must be trained in
their respective role in maintaining compliance to
21 CFR 111.

9. 21 CFR 111 GMP Training
Batch Production Records
CAPA Management
Cleaning and Control of Cross Contamination
FDA Inspection Readiness
Process Definition
Risk Assessment
SOP and Record Keeping
Stability Program Development
Staff Recruitment
Testing Method Selection Training

10. • On-site training could offer a general overview of Good
Manufacturing Practices (GMPs) or specific, modular, task-
oriented training for individual departments.
• The process of bringing dietary supplement training to your
location involves these simple steps:
 NSF team discusses the course with you – your aims,
audience, location(s) and timing.
 NSF provide your company with a formal proposal of a
draft course program and outline all of the costs.
 NSF process all of your firm’s feedback and finalize the
details.

11.  NSF training experts then deliver your firm the
training, providing presentations, course booklets,
teamwork tasks and attendance certificates.
 To ensure NSF receive valuable feedback, our
professional trainer sits down with your firm to
discuss outcomes as well as follow-up training that
may be needed.

12. • NSF has worked for over a decade with sports
organizations, anti-doping agencies and supplement
manufacturers to help ensure supplement safety through
product testing and evaluation.
• NSF facilitated the development of the only American
National Standard for dietary supplements (NSF/ANSI 173)
and with NSF certification you can be sure that dietary
supplements do not contain unacceptable levels of
contaminants.

13. • The NSF Certification Mark indicates that the product
meets quality and safety standards. For instance, dietary
supplement products that have been authorized to bear the
NSF Mark must comply with numerous requirements
including label, testing, and auditing requirements.
• NSF Certification Requirements: NSF developed
NSF/ANSI Standard 173 to help protect consumers by
testing for contaminants and certifying that NSF Certified
supplements contain the ingredients listed on the label and
nothing else.

14. Label Claim Review
Toxicology Review
Contaminant Review
Facility Audits
Ongoing Monitoring

15. NSF follows the American National Standards Institute (ANSI) standards
development process.
Standards are developed by joint committees (balanced stakeholder groups
of public health, industry and user representatives).
NSF Council of Public Health Consultants (CPHC) members ensure that
NSF standards protect public health.
They provide guidance to NSF in the design and implementation of
conformity and assessment programs in health, technology and
environmental health safeguards.

16. • NSF has facilitated the development of more than 70
voluntary American National Standards including dietary
supplements to promote public health and safety.
• NSF/ANSI standards are developed through involvement of
stakeholders affected by the standard.
• The process ensures balanced input from industry
representatives, public health/regulatory officials,
users/consumer representatives
• For standard development or revision status, visit the NSF
Online Workspace.

17. • There are some basic manufacturing regulations or
guidelines that are available to the nutraceutical industry for
producing quality products.
• Nutraceutical industries are equally responsible for ensuring
the safety of their consumable products.
• For example, the combination of nutraceutical and
prescription drugs can be crucial or often may lead to
adverse reactions if not controlled properly.

18. Premises
• Personnel & material flow
• Walls & Celling
• Heating, Ventilation & air conditioning system
• Water Systems
Equipment
• Equipment ID
• Log books
• Qualifications of major equipment
• Calibration Program of instruments

19. Personnel
• Qualifications
• Job Responsibilities
• Trainings
• Health hygiene
Quality Assurance
Sanitation Program
Operations

20. Specifications
Stability
Samples
Records
Recalls

21. References:
1. William C. Shiel Jr., F. (2019). Definition of Nutrition. [online] MedicineNet. Available at:
https://www.medicinenet.com/script/main/art.asp?articlekey=4602 [Accessed 1 May
2019].
2. ToBeRe. (2019). What Does Good Nutrition Mean? - ToBeRe. [online] Available at:
https://tobere.com/what-does-good-nutrition-mean/ [Accessed 1 May 2019].
3. World Health Organization. (2019). WHO guidelines on nutrition. [online] Available at:
https://www.who.int/publications/guidelines/nutrition/en/ [Accessed 1 May 2019].
4. Bagchi, D. (2014). [online] Available at:
https://www.researchgate.net/profile/Debasis_Bagchi2/publication/296377503_Nutraceuti
cal_and_Functional_Food_Regulations_in_the_United_States_and_Around_the_World_S
econd_Edition/links/57262a9e08aef9c00b88f568/Nutraceutical-and-Functional-Food-
Regulations-in-the-United-States-and-Around-the-World-Second-Edition.pdf [Accessed 1
May 2019].

22. Continued…
5. Nsf.org. (2019). Dietary Supplements Training - NSF International. [online] Available at:
http://www.nsf.org/training-education/training-dietary-supplements [Accessed 1 May
2019].
6. Nsf.org. (2019). NSF Certification - NSF International. [online] Available at:
http://www.nsf.org/regulatory/regulator-nsf-certification [Accessed 1 May 2019].
7. Nsf.org. (2019). NSF Standards - NSF International. [online] Available at:
http://www.nsf.org/regulatory/regulator-nsf-standards [Accessed 1 May 2019].