Global Guidelines for nutraceuticals

1. Global Regulatory requirements
for Nutraceuticals
Prepared by,
Mythili Srinivasan,
Poona College of Pharmacy, BVDU.

2. What are Nutraceuticals?
 Any substance that may be considered a food or part of food and provides,
medical or health benefits, including the prevention and treatment of
disease.
 It includes Vitamins, minerals, herbs and other botanicals, amino acids, and
dietary substance for human use as a supplement diet.
 The Word Nutraceutical - Formed from ‘nutrition’ and ‘Pharmaceutical’
 Coined by Stephen Defelice, MD, founder and Chairman of the Foundation for
innovation in Medicine FIM, Cranford, NJ.
 Refers to a food or part of food that provides health and medical benefits.
2

3. Nutraceuticals - Definitions
USA:
 Defines Nutraceuticals as dietary supplement and “a product (other than tobacco) intended to
supplement the diet that bears or contains one or more of the following dietary ingredients:
vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent,
extract or combination of the ingredients listed above”. Furthermore, it must also conform to the
following criteria:
 Be intended for ingestion in pill, capsule, tablet, powder or liquid form.
 Not be represented for use as a conventional food or as sole item of a meal/diet.
 Be labelled as a “dietary supplement”
India:
 Food safety and standards authority (FSSAI) defines nutraceuticals as “Foods for special dietary
uses” in India.
Canada:
 In Canada Nutraceuticals are known as Natural health products under the natural health products
regulation.
3

4. Nutraceuticals - Definitions
Australia:
 In Australia, traditional, herbal, natural and alternative medicines and remedies are referred to
as complimentary medicines.
Japan:
 In Japan Nutraceuticals are functional foods comes under three functions numbingly,
 Nutrition
 Sensory satisfaction
 Physiological improvements
4

5. Scope of Nutraceuticals
5

6. Categories of Nutraceuticals
6

7. Types of Nutraceuticals
1. Based on Chemical Constituents
 Nutrients
 Herbals
 Dietary Supplements
2. Traditional and Non- Traditional nutraceuticals
3. Based on Diseases
 Cancer
 Obesity
 Allergy
 Classification Based on Chemical groups
7

8. Classification based on Chemical groups
8

9. Use of Nutraceuticals in Various Diseases
9

10. Major Nutraceuticals in Indian market
10

11. Global Nutraceutical Market
11

12. Nutraceuticals in Canada Market -Examples
12

13. Nutraceuticals in Australian Market- Examples
13

14. International Regulatory Scenario
14

15. Global Regulations in Nutraceuticals
In India
 The FSSAI has notified the food Safety and Standards ( Health Supplements, Nutraceuticals, Food for special
dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 in the
official Gazette on 23 December 2016. These regulations will come in to force on their publication in the
Gazette of India. However, the FSSAI has stipulated that food business operators will need to comply with these
regulations from 1 January 2018.
 According to FSSA, “foods for special dietary use” are specially processed or formulated to satisfy particular
dietary requirements, which exist because of a particular physical or physiological condition or specific diseases
and disorders. These foodstuffs are presented such that their composition must differ significantly from the
Indian Standard (IS) composition of ordinary foods of comparable nature, and may contain one or more of the
following ingredients:
 Plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or
hydroalcoholic extract, single or combination
 Minerals or vitamins or proteins or metals or their compounds or amino acids in amounts not exceeding the
Recommended Daily Allowance for Indians or enzymes (within permissible limits)
 Substances from animal origin
 Dietary substances for use by humans that supplement the diet by increasing total dietary intake
 Chapter 4, Article 22 of FSSAI addresses nutraceuticals: a nutraceutical doesn’t include any drug and it can only
be used for oral administration. They can be used as conventional foods, which cannot claim to cure any
specific disease, but can claim indirect health benefits such as “contains calcium.” The disease reduction claims
are not permitted in Asia, as Asian countries have not taken up the codes of practice defined by Codex
Alimentarius.
15

16. Global Regulations in Nutraceuticals
FSSAI Initiatives
1. FPAS system
FSSAI went for online registration process for product approval. FSSAI Product Approval System
(FPAS) was launched to make product approval & registration easier.
2. Establishing food parks
The Ministry of Food Processing Industries, Govt. of India has already taken up initiatives such as
approving a number of food parks and coming up with schemes for the development of food processing
to address the constraints in food processing sector. This initiative was taken in order to attract
investments.
3. Paradox
On one hand there have been some good initiatives from the FSSAI’s side but on the other hand we also
witnessed up rest regarding regulations was wherein the sudden implementation of reforms and
regulations had given food importers a real tough time.
Over 200 tonnes of foodstuff imported to India was stuck at the Indian seaports and airports due to Food
Safety & Standards Authority of India’s (FSSAI) zero-tolerance policy towards non-compliance of its
regulations. The imports mainly contain chocolates, nutritional supplements, snack items etc.
16

17. US Regulatory Agencies & Polices on Nutraceuticals
 Currently the FDA regulates dietary supplements under its own set of unique regulations,
summarized here, that differ from those covering “conventional” foods and drug products. Under
the Dietary Supplement Health and Education Act of 1994 (DSHEA)
 The manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that
the product is safe before it is marketed; and
 The FDA is responsible for taking action against any unsafe dietary supplement product after it
reaches the market.
 However, the absence of consistent enforcement by the Food and Drug Administration (FDA) and
globalization of supply sources has contributed to perceptions of significant safety loopholes.
Perhaps not surprisingly, it was the nutraceutical industry that pushed both the FDA and the
Department of Health and Human Services (HHS) to implement good manufacturing practices
(GMP). However, with the introduction of the federal Good Manufacturing Practice (GMP)
regulations (21 CFR, Part 111) in 2007, the FDA and HHS assumed oversight of GMP
enforcement. Under the rule, all domestic and foreign companies that manufacture, package, label
or hold nutraceuticals, including those involved with testing, quality control, and nutraceutical
distribution in the US, have safety-related responsibilities, including, but not limited, to the
following:
17

18. US Regulatory Agencies & Polices on Nutraceuticals
 Assuring the safety of the ingredients used in their products, both before and after
introduction to the market;
 Evaluating the identity, purity, quality, strength, and composition of dietary supplements;
 Preparing, packaging and holding products in compliance with FDA’s current good
manufacturing practice (cGMP) regulations; and
 Submitting reports to FDA of serious adverse events.
 From 2008 to 2011, the FDA received more than 6,300 nutraceutical-related “adverse event
reports” (AERs), according to a report from the Government Accountability Office (GAO).
 To help ensure companies are compliant with cGMP and adverse event reporting (AER)
requirements (e.g., submitting serious AERs, maintaining AER records, and including firms’
contact information on product labels), the FDA increased its inspections of nutraceutical
companies and took some actions against noncompliant manufacturers.
18

19. Regulations in Canada & Japan
Regulations in Canada
 In Canadian regulations, nutraceuticals come under the category known as “Natural Health Products,” as per “The
Natural Health Product Regulations” introduced in 2004 by Health Canada. The law is governed by the Food and Drugs
Authority of Canada. The definition covers the following products:
 vitamins and minerals
 herbal remedies
 homeopathic medicines
 traditional Chinese medicines
 probiotics
 other products, such as amino acids and fatty acids
Regulations in Japan
 Japan is the pioneer nation in the area of regulating functional foods/nutraceuticals. The concept of Foods for Specified
Health Use (FOSHU) was established in 1991. Foods identified as FOSHU must be approved by the Ministry of Health
and Welfare after the submission of comprehensive science-based evidence to support the claim for the foods when they
are consumed as part of an ordinary diet. As per the FOSHU Act, functional food can have three functions:
 nutrition
 sensory satisfaction
 physiological improvements
19

20. European Regulatory Agencies & Policies on
Nutraceuticals
In the European Union,
Food legislation is largely harmonized under the European Food and Safety Authority (EFSA). The
legislation focuses on “food supplements”, which the Europeans define as concentrated sources of
nutrients (e.g., proteins, vitamins and minerals) and other substances that have a beneficial
nutritional effect. The main EU legislation is Directive 2002/46/EC related to food supplements.
The EU maintains a list of permitted vitamin or mineral substances which may be added to food
supplements for specific nutritional purposes. Vitamin and mineral substances may be considered
for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the
safety and bioavailability of the individual substance by EFSA. Companies wishing to market a
substance not included in the permitted list need to submit an application to the European
Commission. New products originating from Europe are presumed to have passed these stricter
European development and quality requirements. As a result, European nutraceutical companies,
which are generally regarded as leaders in innovation, enjoy a perception of creating the highest
quality products. For the betterment of nutraceutical Industries, a coalition of Europe’s nutraceutical
companies, including CRN, Merck, DSM and BASF, created the Food Supplements Europe
(FSE) to work with regulators to ensure quality and “to shape a positive regulatory environment for
the future.” 20

21. Regulations in Australia & Russia on Nutraceuticals
In Australia,
Medicinal products/foods are referred to as ‘complementary medicines’ and are regulated as
medicines under the Therapeutics Goods Act, 1989, which was implemented in 1991.The law
is governed by the Department of Health and Ageing and the definition covers herbal
medicines, vitamins and minerals, nutritional supplements, homoeopathic medicines,
aromatherapy products and traditional medicines.
Regulations in Russia
According to the Russian Ministry of Healthcare and Social Development’s order number
1898, dated 15 April 1997 and titled “Concerning the Procedure for the Examination and
Health Certification of Active Dietary Supplements,” nutraceuticals are regulated under the
term Biologically Active Dietary Supplements (BADS). The definition covers nutraceuticals
(vitamins, minerals, amino acids, dietary fibres) and parapharmaceuticals (bioflavonoid,
alkaloids, essential oils, polysaccharides). As per the rule, BADS are “foodstuffs with
clinically proven effectiveness.” They are recommended prophylactic ally and for the
prevention of pharmaceutical therapy induced side-effects and the achievement of complete
remission. The focus in Russia is based more on preventive medicine for chronic disease
rather than as part of a person’s daily health food diet.
21

22. Regulations in China & Mexico on Nutraceuticals
China
 China Health Care Association (CHCA), a government-appointed association that oversees the
nutraceutical industry, estimates China’s domestic market at $15.8 billion based on 2011 sales.
However, this figure only accounts for those dietary supplement products that were officially
registered with China’s State Food and Drug Administration (SFDA). The US-China Health
Products Association (USCHPA) believes the number is actually closer to $20 billion with the
difference coming from the USCHPA’s better account of nutraceutical imports.
 There are three main entities involved in policing the industry. The first is the SFDA, which is
in charge of dietary supplements and issuing the “blue hat” registration. Next is the Ministry
of Health (MOH), which actually oversees SFDA, but its main influence in the dietary
supplement industry is overseeing the approval of new novel food ingredients; and finally, the
Administration of Quality Supervision Inspection and Quarantine (AQSIQ) controls all of the
imports and exports passing across China’s borders.
Mexico
 In Mexico, the National Association of Food Supplements Industry (ANAISA) was created in
September 2011 to bring together companies in the country dedicated solely to the
manufacture or marketing of food and dietary supplements. ANAISA cites
a Euromonitorreport that estimates the nutraceutical market in Mexico has grown by 25% in
the last five years with total sales in 2011 totalling $293 million.
22

23. Nutraceutical Regulation in Brazil and rest of Latin
America
Brazil
Representing the nutraceutical industry in Brazil is The Brazilian Association of Foods for Special
Purposes and Congeners (ABIAD). It works along with The Committee for Scientific and Technical
Assessment of Functional and New Foods (CTCAF) to advise and lobby the National Health Surveillance
Agency (ANVISA) regarding nutraceutical-related issues such as registration and regulation of new
products. ANVISA generally has a broad definition for nutraceuticals, for example by introducing low
recommended daily allowance requirements, and the regulatory process – whether for nutraceuticals or
pharmaceuticals – can be complex and time consuming. As a result, ANVISA has recently hired additional
staff and implemented electronic filing processes with the goal of reducing the time to evaluate new
products by 40%.
Rest of Latin America
The Latin American Responsible Nutrition Alliance (ALANUR) – together with the International Alliance
of Dietary/Food Supplement Associations (IADSA) – have held a number of workshops throughout Latin
America, most recently in Venezuela, to discuss trends in the regulation of food supplements in Latin
America and worldwide, including classification and definition; the use of nutrition and health claims; the
role of scientific risk assessment to establish maximum nutrient levels versus the use of Recommended
Daily Allowances (RDAs); and the characteristic features of the registration and notification systems and
monitoring of products once they are on the market across the globe. In Venezuela, the workshop was
attended by the National Institute of Hygiene “Rafael Rangel” (INHRR) and the Ministry of Health,
which are currently drafting regulations for nutraceuticals and other products bordering the supplement
category. 23

24. Regulations in Asian Countries
24

25. Conclusion
 Regulation presents significant challenges to the globalisation of nutraceuticals
in many ways. Mainly, the regulatory variation between countries hinders
global trade and marketing. For instance, most of the countries discussed take a
relaxed approach to regulation, yet China’s process for dietary supplement
approval involves a strict testing protocol, in line with the US process for
pharmaceutical approval. Unlike DSHEA, the regulations of some nations
don’t seem to provide adequate distinction between food, drug and
nutraceuticals.
 Also, unfortunately, nutraceuticals sometimes find themselves in the same
regulatory category as common foods: standardisation of dose and method of
delivery to improve efficacy and health benefits could overcome this. Thus,
there is an explicit need to study nutraceutical dose-related issues. It is essential
to test and regulate the use of nutraceuticals in a cost-effective and efficient
manner with regard to farm animals. This can offer a better health, not only to
those cultured animals, but to human beings who consume them.
25

26. References
1. Food Safety and Security Act of India:
www.drugscontrol.org/food%20safety%20and%20standards%20Act%2006.pdf (2006).
2. Health Canada – Natural Health Products Directorate website: www.hc-sc.gc.ca/dhp-
mps/prodnatur/about-apropos/index-eng.php#a2.
3. K. Yamada, et al., “Health Claim Evidence Requirements in Japan,” J. Nut. 138, 1192–1198
(2008).
4. Department of Health and Ageing, Therapeutic Goods Administration, Australia website:
www.tga.gov.au/industry/cm-basics.htm.
5. The Russian Federation Chamber of commerce and Industry website: http://old.tpprf.ru/en/
6. Bag chi D. Nutraceutical and Functional Food Regulations in the United States and Around the
World. Academic Press, 2008; pp. 115-364.
7. News-Medical net, Nutraceutical Regulation, Dr. Vojislav Mestrovic.
8. IJPBS |Volume 2| Issue 1 |JAN-MARCH |2012|177-187 International Journal of Pharmacy and
Biological Sciences (eosin: 2230-7605) Jagtar Singh*et al Int J Pharm Bio Sci www.ijpbs.com,
CLASSIFICATION, REGULATORYACTS AND APPLICATIONS OF NUTRACEUTICALS
FOR HEALTH - Jagtar Singh1* and Shweta Sinha1,Department of Biotechnology, Punjab
University, Chandigarh 160 014, India.
26

27. 27