A GLIMPSE OF GLOBAL REGULATORY OF

NUTRACEUTICALS Dr. BAIDYANATH MISHRA

CHIEF SCIENTIFIC OFFICERPRODUCT DEVELOPMENT, REGULATORY AND MEDICAL AFFAIRS

OLIVE LIFE SCIENCES PVT LTD, BANGALORE

Various nomenclatures for Nutra:

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

Round Up for today:

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.

Global Regulatory-Nutraceuticals

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

General course

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.

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%

Cardiovascular Disease    47%

Statistical comparison of frequent causes of death in USA (Law 2004)

Source : Nutrition Business Journal estimates (consumer sales)

$108 Billion U.S. Nutrition Industry Consumer Sales-Latest Trend

Source : Nutrition Business Journal estimates (consumer sales)

$108 Billion U.S. Nutrition Industry Consumer Sales-Channels

Source : Nutrition Business Journal estimates (consumer sales)

$4.9 Billion U.S. Speciality Supplement Product

All Segments Research International: Market quantification September 2010

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.

Nutra Regulation-Canada

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

Health Claims for Food in Canada

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.

Nutra Regulation-United States

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.

Other precautions-DSHEA

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

Health Claims for Food in United States

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

Nutra Regulations-EU

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

Main Regulations to be considered Nutrition Products in the EU

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.

Some of the key reference documents include

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.

Some of the key reference documents also include-EU

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.

Foods for Particular Nutritional Purposes (PARNUTS):EU

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)

Botanicals and Nutracueticals: EU

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)

Nutraceuticals – Near Future

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

Regulation (EC) No 1924/2006 onNutrition and Health Claims for Food

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

Reduction of disease risk claims & claims referring to children's development andhealth

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)

General Health Claims

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.

Nutra Regulations: UK

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

Nutra Regulations-Claims: UK

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 FNFC, Food with Nutrient Function Claims, pre-�

approved content levels and pre-approved health claims

Nutrition in Japan

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.

Regulations in Japan: A growth

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

Nutra Regulations: SEA

Brunei Indonesia Malaysia Philippines Singapore Thailand Vietnam-Yes-Energy value- The amounts of protein, carbohydrate, 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.

-Yes2 types:1) Nutrient content claim-Format and criteria similar to Codex except:i) claims on cholesterol: do not link to Sat FA & Trans FAii) Low sugar claimiii) Content claim for sodium in liquid form2) Nutrient comparative claim- Format and criteria similar to CodexIn 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

Yes2 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 nutrients2) 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 NRV2) Nutrient comparative claim-Format and criteria similar to Codex

-Yes, claims as to the presence of vitamins and minerals2 Types1) Nutrient qualitatively content claim 2) Nutrient qualitatively comparative claim

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

Benefits of the Regulation

I am may be contacted for further references at:

Dr. Baidyanath Mishra, Chief Scientific OfficerOlive Life Sciences Pvt Ltd#2203, Pragathi, 16th Cross, 8th Main, D-Block, Sahakar Nagar,Bangalore- 560 092Ph: +91-8792845101Mail: baidyanathmishra@hotmail.com/mishra@olivelifesciences.com