NSF certification, Standard for dietary supplement

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 is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services

1. NSF Certification, NSF Standard for Food Dietary Supplement 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. NSF

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 . About NSF

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 . NSF Standard for Food Dietary Supplements

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. Certification

7. Process of certification

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. NSF standards for food dietary supplements

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 NSF/ANSI Standard 173

10. Standard for dietary supplement

11. The manufacturer shall submit, at a minimum, the following information for each product; T he composition of the formulation (in percent or parts by weight for each ingredient in the formulation including excipients ) T he reaction process, if applicable ;  the raw material ID number (if applicable), chemical/material name, trade name and supplier(s) for each chemical present in the formulation; a list of known or suspected impurities associated with the finished product an analytical method used to verify the claims listed on the label or certificate of analysis. Formulation submission

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. Labeling and requirements

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 N ow , 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. Product requirements

15. 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. 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. Identify

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. Quantity

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. Contaminants: Metals  

19. Unless a manufacturer has controls in place to screen for pesticides or use certified organic ingredients as demonstrated in the GMP audit. B road 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 Contaminants: 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% Contaminants: Microbiological

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". Dietary Supplements Claims

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. Labeling

24. https:// www.slideshare.net/RxvidhiRamani/nsf-standard-123382008 https://www.nsfinternational.eu/food/dietary-supplements / References