1. Dr. BAIDYANATH MISHRA
CHIEF SCIENTIFIC OFFICER
PRODUCT DEVELOPMENT, REGULATORY AND MEDICAL AFFAIRS
OLIVE LIFE SCIENCES PVT LTD, BANGALORE

4. To discuss in brief the guidelines and points related in
major four :
 Regulation on Nutrition and Health Claims in Canada
 Regulation on Nutrition and Health Claims in US
 Regulation on Nutrition and Health Claims in EU
 Regulation on Nutrition and Health Claims in UK
 Regulation on Nutrition and Health Claims Japan
 Regulation on Nutrition and Health Claims SEA
countries

5.  There is no global uniformity for regulating
nutraceuticals.
 Approaches vary by country and
 Canada, the U.S. and Europe do not have regulations that
specifically refer to “nutraceuticals” or “functional
foods”.
 Instead regulations refer to such categories as “natural
health products”, “dietary/food supplements” or “novel
foods”.
 Definitions vary and deciding where a product fits is
often difficult and dependent on national perceptions.

6.  Nutraceuticals sits at the boundary between drugs and food and
depending on the claims made the “nutraceutical” may fall within
either drug or food regulations
Firms working in these industries will need to ensure that they
understand how each country views their product and which
regulations apply. Since working with regulations can be
complex, expert advise may be required to fully understand the
impact the regulatory environment will have on any given company
or product.

7. Dietary Supplements 0,0001%
Honey Bee Stings 0,0008%
Insect Stings (All) 0,0020%
Sports injuries 0,0020%
Lightning 0,0041%
Animal Bites (dogs,etc) 0,0048%
Horse/animal riding 0,0052%
Penicillin Allergy 0,0144%
Slips/Falls Whilst Walking 0,019%
Electrical Accidents 0,038%
Freezing 0,048%
Firearms Accidents 0,079%
Poisonings 0,17%
Asthma 0,19%
Home Fires 0,19%
Drowning 0,21%
Food 0,24%
Pedestrians-vehicle 0,37%
Radon Gas 0,62%
Murder 0,94%
Suicide 1,41%
Motor Vehicle Accidents 2,20%
Preventable Medical Misadventure 2,40%
Alcohol 4,49%
Properly Prescribed & Used Drugs 5,18%
Smoking 7,19%
Cancer 22,11%
Statistical comparison of
frequent causes of death in
USA (Law 2004)

8. Source : Nutrition Business Journal estimates (consumer sales)
$108 Billion U.S. Nutrition Industry Consumer Sales-Latest Trend

9. Source : Nutrition Business Journal estimates (consumer sales)
$108 Billion U.S. Nutrition Industry Consumer Sales-Channels

11. Source : Nutrition Business Journal estimates (consumer sales)
$4.9 Billion U.S. Speciality Supplement Product

12. All Segments Research International: Market
quantification September 2010

13.  Products for health food claims for functional foods
are managed under the authority of the Food and
Drugs Act, well defined under Natural Health
Products (NHP), considered as sub-category of drug
(2004), set requirements for efficacy, safety and
quality reviews , with NHPD being the responsible
authority for license, registration and regulation of
like products.

14.  Food claims:
Expressing the composition, quality, quantity or origin of a
food product.
 Nutrition claims:
Characterizing the amount of nutrient in a food, or its energy
value.
 Health claims:
Suggesting a relationship between an ingredient and health
or disease risk reduction.
Depending on the nature of the claim, there are different
regulatory requirements. Disease risk reduction claims have
a higher evidentiary requirement and more stringent than
USA, and currently only five such claims are allowed in
Canada

15.  Under current U.S. regulations, functional foods
can be classified as conventional foods, food
additives, dietary supplements, medical foods, or
foods for special dietary use.
 They are the Federal Food Drug and Cosmetic Act,
which regulates all foods and food additives, and
 Dietary Supplement Health and Education Act of
1994 (DSHEA), which covers supplements and their
ingredients.

16.  Under DSHEA, the manufacturing firm is responsible to
ensure that the supplements it makes or distributes are
safe, and that no false or misleading claims are being
made pursuant to their use.
 Only in the case of a new ingredient is pre-market
approval required.
 Good manufacturing practices for supplements are also
regulated: in 2007, the FDA published rules to control
manufacturing, quality
control, facility, packing, labelling, and holding practices
for dietary supplements, with staggered compliance
dates, depending on the size of the firm.

17. Nutrient content claims: for example, the product contains
fats, sodium, sugar, etc.
Structure/function claims: for example, calcium is good for bones, fibre
for digestive health, vitamins A/C/E for natural defenses, vitamin A for
eyes, etc.
Health claims describe the relationship between a food and a disease or
condition. Unlike structure/function claims, these must be pre-
approved by the FDA, approved based on publicly available scientific
evidence, authoritative statement, or qualified (emerging) health
claims. (Approval required from authorities-3rd Category)
The FDA also allows Dietary Guidance statements to promote better
nutrition, for example, fruits and vegetables are good for one’s health.
Manufacturers who wish to make “significant scientific agreement”
(SSA) or qualified health claims for a new product, however, must
petition the FDA and provide documentary evidence in support of their
claim

18. The European approach to regulation of
nutraceuticals is quite complex.
The General Food Law Regulation, EC
178/2002, applies to all foods, and there is no
separate category for functional foods.
Numerous rules may also apply, depending on the
nature of the food/ingredient: for instance, there is a
separate regulatory stream for dietetic foods, food
supplements, novel foods, herbal medicines, and so on

19.  General Food Regulation (EC) No 178/2002
 Novel Food Regulation (EC) No 258/97
 Food supplements Directive 2002/46/EC
 Fortification of Food Regulation 1925/2006
 Directives on Food Labelling
 Regulation on Nutrition and Health Claims (EC) No
1924/2006

20. Food supplements: Directive 2002/46/EC of the
European Parliament and of the Council of 10 June 2002
on the approximation of the laws of the Member States
relating to food supplements.
 Medicinal products: Directive 2004/27/EC applies to
all medicinal products and defines criteria based for
“medicinal” as being based on the claims made for the
product, the pharmacological properties of the
ingredients, a comparison with potentially similar
licensed products in the market, and the presentation to
the public made through
labeling, packaging, promotional literature and
advertisements.

21.  Directive 2001/83/EC determined that if a food could
satisfy the definition of either a medicinal or a food
product, medicinal regulations should apply, and the
product must obtain a marketing authorization.
 Novel Foods and Novel Food Ingredients: Novel Food
Regulation EC 258/97: Under the regulation, novel foods
are classified as: Class 1: pure chemicals or simple
mixtures with/without a history of food use in the EU;
Class 2: complex novel foods with/without a history of
food use in the EU; or Class 6: foods produced using a
novel process resulting in a changed chemical composition
or structure affecting purity, nutritional value or
metabolism.

22.  Foods for Particular Nutritional Purposes (PARNUTS):
framework directive is Directive 89/398/EEC, which sets up 9
sub-categories. Several of these categories have led to separate
and specific Directives:
 Infant formulas and follow-on formulas, Directive 91/321/EEC;
 Processed cereal-based foods for infants and young
children, Directive 96/5/EC, amended by Directive
2003/13/EC;
 Food used for energy-restricted, weight reduction
diets, Directive 96/8/EC, as amended by Directive
2007/29/EC; and
 Foods for special medical purposes, Directive 1999/21/EC.
These directives are considered especially valuable for the
functional food industry inasmuch as they relate functional
properties to risk, consumer protection, manufacturer
responsibility, and other issues in this area of growing
commercial value.

23. Botanicals present special challenges because of their complex
nature and composition, especially as these affect quality and
safety. Applicable directives have been interpreted to include:
 Directive 2004/27/EC (definitions),
 the General Food Law Regulation 178/2002, article 2 (food vs.
medicine), the Novel Food Regulation EC 258/97,
 Directive 89/398/EEC
 Directive 2002/46/EC (food supplements),
 Regulation EC 1925/2006 (foods for particular nutritional
Purposes),
 Directive 89/107/EEC (food additives), (addition of
vitamins, minerals and certain other substances to food), and
 Directive 76/768/EEC (cosmetic agents including some herbal
products)

24.  In order not to jeopardise free movement of food, a Community
 rule on the use of nutrition and health claims was needed
 • December 2006, council and parliament adopted a Regulation,
 i.e., Regulation (EC) No 1924/2006 on the use of nutrition
 and health claims for foods
 • The Reg y ulation lays down harmonised rules for the use of
 health on nutritional claims (e.g. ”low fat”, “high fibre”) on
 foodstuffs based on nutrient files
 • The health claim Regulation will ensure that any claim made on
 food in the EU is substantiated
 • Health claims will only be authorised after a scientific
 assessment. This assessment is performed by European Food
 Safety Authority (Parma)

25.  Entered into force 19th January 2007
 Applied from 01 July 2007
 Covers labelling, presentation and advertising of a
food
 Only allows products with genuine health or
nutritional benefits to refer to them on their labels

26.  Health claims referring to the reduction of
 disease risk and to children's development and
 health must be authorised and included into the
 Community list
 • Statement (labelling, p , resentation, advertising),
 that the disease to which the claim refers to has
 multiple risk factors. Reduction of one of the risk
 f tacors may or may not have b fi i l beneficial eff tec

27.  All Health Claims other than those referring to the
reduction of disease risk and to children's
development and health
 Claims can be used without an authorisation, if
therapy are provided in the Community list
 The Community list will be prepared by 31 January
2010
 New additions of claims can be requested and
protected (Art. 18)

28.  Food Supplements Directive which was passed into EU
law in 2002 and has now been integrated into the
national laws of the member states (in the UK as the
Food Supplements (England) Regulations 2003). These
regulations are into force on 1 August 2005.
 Any substance not present in these positive lists cannot
be used in food supplements
 A food supplement as any food the purpose of which is
to supplement the normal diet and which:
(1) is a concentrated source of a vitamin or mineral or
other substance with a nutritional or physiological
effect, alone or in combination
(2) is sold in dose form.

29.  Anything which is taken orally and not classified as a medicine
is, by default classified as food.
Not acceptable
 ‘contains calcium which helps to prevent osteoporosis’; ‘prevents
heart disease’
 ‘helps to prevent cancer’; ‘helps to prevent or treat arthritis’
 ‘prevents colds and flu’; ‘treats eczema’
Acceptable
 ‘contains calcium which is important for strong bones’
 ‘helps to maintain a healthy heart’
 ‘helps to mop up excess cell-damaging free radicals (these may
contribute to many of the diseases of old age)’
 ‘helps to maintain healthy joints’; ‘helps to maintain a healthy skin’
 ‘helps to maintain an effective immune system’
 ‘helps to maintain normal blood cholesterol levels

30.  Concept of functional food has a long culture
 Legislation dated 1991
 Unregulated food: No health Claim
 Regulated food: Health Claim
 FOSHU, Food for Specified Health Use government
approved at product specific level
 ƒ FNFC, Food with Nutrient Function Claims, pre-
approved content levels and pre-approved health
claims

31.  In 1993, the Ministry of Health and Welfare in Japan
established a policy of “Foods for Specified Health Uses”
(FOSHU) by which health claims of some selected
functional foods are legally permitted.
 In 2001, a new regulatory system, foods with health
claims (FHC) with a ‘foods with nutrient function claims’
(FNFC) system and newly established FOSHU was
introduced.
 In addition, the Govt. changed the existing FOSHU, FNFC
and other systems in 2005.
 Such changes include the new Sub-systems of FOSHU
such as, Standardized FOSHU, Qualified FOSHU, Disease
risk reduction claims for FOSHU.

32.  No official definition of functional foods in SEA countries
except Indonesia.
 No harmonized regulations on nutrition labeling and
claims in the SEA countries.
– No mandatory labeling for general foods in selected SEA
countries except Malaysia as per current national
regulations
– Only mandatory labeling for foods for special dietary
use, foods that are enriched or fortified and foods
making nutrient claims
• Thailand: Also mandatory for some snacks foods such as
potato chips, popcorn, extruded snack, biscuit/cracker
and filled wafer

33. Brunei Indonesia Malaysia Philippines Singapore Thailand Vietnam
-Yes
-Energy
value
- The
amounts
of protein,
carbohydr
ate, fat
and the
amount of
any other
nutrients
for which
a nutrition
claim is
made in
respect of
the food
-Yes
• Nutrient
Content
Claims
• Nutrient
Comparative
Claims
- Using NRV
Indonesia.
-Yes
2 types:
1) Nutrient content
claim
-Format and criteria
similar to Codex
except:
i) claims on
cholesterol: do not
link to Sat FA &
Trans
FA
ii) Low sugar claim
iii) Content claim
for
sodium in liquid
form
2) Nutrient
comparative claim
- Format and
criteria
similar to Codex
In addition, Claims
for
enrichment are also
permitted
-Yes. Same as
Codex
- Nutrient
Content Claim
- Nutrient
Comparative
Claim
-But the dietary
standard used
is not the
Codex NRV
but the
Philippine
RENI
Yes
2 types:
1) Nutrient content
claim
- as given in Codex,
use RDA in place of
NRV
- Requirements for
protein and energy,
and RDAs for
vitamins & minerals
are given in
Regulations. To
follow guidelines
established by Health
Promotion Board for
other nutrients
2) Nutrient
comparative claim
- To follow guidelines
established by Health
Promotion Board
Yes,
2 types:
1)Nutrient
content
claim
-Format and
criteria
similar to
Codex but
using Thai
RDI in place
of NRV
2) Nutrient
comparative
claim
-Format and
criteria
similar to
Codex
-Yes, claims
as to the
presence of
vitamins and
minerals
2 Types
1) Nutrient
qualitatively
content claim
2) Nutrient
qualitatively
comparative
claim

34.  Allows greater legal security and more predicable
Allows greater legal security and more predicable
environment
 Supports innovation (food and drink products)
 Prevents unfair competition from manufactures
using false or misleading claims
 If positive claims cannot be made, the regulation
does not oblige anyone to make negative claims
about the product oblige anyone to make negative

35. I am may be contacted for further references at:
Dr. Baidyanath Mishra,
Chief Scientific Officer
Olive Life Sciences Pvt Ltd
#2203, Pragathi, 16th Cross, 8th Main, D-Block, Sahakar Nagar,
Bangalore- 560 092
Ph: +91-8792845101
Mail: baidyanathmishra@hotmail.com/mishra@olivelifesciences.com