NSF International is an independent organization that develops standards and certification programs to protect public health. They provide third-party certification to verify that products meet technical standards. NSF has developed Standard 173 for dietary supplements, which includes testing for contaminants and verifying label claims. The standard outlines requirements for raw materials, finished products, and labeling of dietary supplements. Manufacturers must submit information about product composition and testing methods to verify label claims under the standard.
NSF certification, Standard for dietary supplement
1. Atul S. Bhombe
M. Pharmacy ( DRA)
Savitribai Phule Pune University,Pune,Maharsatra
2. NSF International, an independent, not-for-profit, non-
governmental organization, is dedicated to being the
leading global provider of public health and safety risk
management solutions while serving the interests of
all stakeholders.
NSF accredited third-party certification provides all
stakeholders – industry, regulators, users and the
general public – assurance that a certified product,
material, component or service complies with the
technical requirements of the referenced standard.
3. Manufacturers, regulators and consumers look to NSF
International for the development of public health
standards and certification programs that help protect
the world’s food, water, consumer products and
environment.
NSF International was founded in 1944 as the National
Sanitation Foundation.
4. To develop uniform, consensus-based national
standards, NSF bring together regulators, industry,
consumers and public health experts. Their scientists,
engineers and public health professionals test to these
standards or protocols.
5. A dietary supplement is a manufactured product
intended to supplement one's diet by taking a pill,
capsule, tablet, powder or liquid. A supplement can
provide nutrients either extracted from food sources or
that are synthetic in order to increase the quantity of
their consumption.
The class of nutrient compounds
includes vitamins, minerals, fiber, fatty
acids and amino acids.
6. 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.
7.
8. 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.
9. The purpose of NSF/ ANSI Standard 173 is to serve as
an evaluation tool for analyzing dietary supplements
(DS) and dietary ingredients.
Provides test methods and evaluation criteria to allow
for the determination that DS contain the ingredients
claimed on the label or product specifications, either
qualitatively or quantitatively and that they do not
contain specific undeclared contaminants.
The standard includes provisions for single ingredient
products, multiple ingredient products, raw materials
and/or finished products
10.
11. The manufacturer shall submit, at a minimum, the following
information for each product;
1. The composition of the formulation (in percent or parts
by weight for each ingredient in the formulation including
excipients)
2. The reaction process, if applicable;
3. the raw material ID number (if applicable),
chemical/material name, trade name and supplier(s) for
each chemical present in the formulation;
4. a list of known or suspected impurities associated with
the finished product
5. an analytical method used to verify the claims listed on
the label or certificate of analysis.
12. Product labels shall declare the identity of dietary
ingredient and/or marker constituent included in the
product.
Labels of products other than proprietary blends shall
declare the quantity of each dietary ingredient and/or
marker constituent.
which shall be labeled by common name according to
the Merck Index or in accordance with the appropriate
regulatory agency guidance when available.
13. Labels of products containing botanicals shall include the
part of the plant from which the ingredients are derived.
Common names of botanicals shall be in accordance with
Herbs of Commerce or the International Code of Botanical
Nomenclature.
The amount of active or desired ingredient shall be listed in
addition to the total amount of the ingredient. Product
literature may also include this information
This implies that the label meets all FTC and FDA
requirements but, if a product is certified by NSF that may
not meet the interpretations of the FDA
14. Earlier that is generally verified by testing
laboratories
Now, verified by testing laboratories was
removed because there are aspects of the
product requirements that are verified by
auditing and/or the testing that is performed
by the client.
15. 1. Raw materials: The identity of the raw material shall
be verified using the test method appropriate for
establishing identity based on the manufacturer’s
claims.
2. Finished product: Manufacturers are responsible for
ensuring finished products shall contain each of the
dietary ingredients and/or marker constituents
declared on the label when tested in accordance with
The source of each ingredient shall be verified as
listed on the label.
16. This change is being made because of the requirements
that manufacturers of Dietary Supplements meet GMP
requirements.
When the Standard was originally written, these
requirements were not in place.
This is accomplished through compliance with GMP.
identity testing is a GMP requirement for each lot of
raw material prior to incorporation into a finished
product.
17. Raw materials: The quantity of marker constituents
shall be verified when declared on the certificate of
analysis. Other declarations made in the certificate of
analysis and/or the Raw Material Specification shall be
verified
Finished products: Finished product claims will be
reviewed to determine a set of verification tests to
confirm quantity of dietary ingredients, marker
constituents and/or nutritional declarations as declared
on the label.
18. Raw materials:
◦ Raw materials shall not contain undeclared metals in amounts
greater than the following:
◦ arsenic content shall not exceed 5 parts per million;
◦ cadmium content shall not exceed 0.3 ppm;
◦ chromium content shall not exceed 2 ppm;
◦ Lead content shall not exceed 10 ppm;
Finished products
◦ Finished products shall not contain undeclared metals at rates of
intake greater than the following:
◦ inorganic arsenic content shall not exceed 0.01 milligrams per daily
dose (mg/d);
◦ cadmium content shall not exceed 0.006 mg/d;
◦ Chromium content shall not exceed 0.02 mg/d;
◦ lead content shall not exceed 0.02 mg/d;
◦ mercury content shall not exceed 0.02 mg/d.
19. Unless a manufacturer has controls in place to screen
for pesticides or use certified organic ingredients as
demonstrated in the GMP audit.
Broad pesticide screen shall be performed to confirm
compliance with USFDA regulated limits and the
absence of banned pesticides in botanical products.
The purpose of this deviation is to assure all botanical
products are tested for banned pesticides
20. Raw materials shall not contain aflatoxins at levels
greater than 20 ppb.
Finished products shall not contain aflatoxins greater
than 20 ppb.
Finished products in a liquid form with an alcohol
content less than or equal to 50% shall not contain
Pseudomonas aeruginosa.
Finished products with an alcohol content greater than
or equal to 50%
21. Health Claims
Disease or health claims show a link between a food or
substance and a disease or health-related condition.
An example of this type of claim would be, "calcium and a
lower risk of osteoporosis" if a supplement contains
sufficient amounts of calcium.
Structure/Function Claims
Structure/function claims refer to the supplement's effect on
the body's structure or function.
Examples of structure/function claims include "Calcium
builds strong bones" and "Antioxidants maintain cell
integrity".
22. Nutrient Content Claims
Nutrient content claims describe the level of a nutrient in a food
or dietary supplement.
For example, a supplement containing at least 200 milligrams
(mg) of calcium per serving could carry the claim "high in
calcium." A supplement with at least 12 mg per serving of
vitamin C could state on its label, "excellent source of vitamin
Other Types of Claims
Outrageous claims.
Most of us have seen supplements that promise to help make us
thinner, smarter, stronger or faster or to improve our sex life
without making any other changes in lifestyle. Just as with other
products, if it sounds too good to be true, it probably is
23. So much information is displayed on the labels of
dietary supplements,
Serving size. The manufacturer's suggested serving
size is normally stated per tablet, per capsule, per
packet or per teaspoonful.
Since consuming excessive levels of dietary
supplements may have adverse health effects, be sure
to follow the serving size instructions indicated on the
label.
