Scientific & Regulatory Aspects of Nutraceuticals

“Scientific and Regulatory Aspects of

Nutraceuticals”

Manish Sharma

1. Introduction

2. India's dietary patterns

3. Market of nutraceuticals

4. Classification of nutraceuticals

5. Scientific aspects of nutraceuticals

6. Regulatory aspects of nutraceuticals in India

7. Improvements provided for FSSA

Contents

Quality healthcare is the foundation of any

prosperous nation. Today, food alone is unable

to fully service the nutrition needs of the body.

Nutrition is a fundamental need. It contribute

to more than 40% of deaths and 30% of the

overall disease burden in developing countries.

Hence, the requirement of external

intervention, that can supplement diet to help

prevent nutrition-related disorders and

promote wellness over treatment of illness, has

become critical. Such products are collectively

called as “nutraceuticals”.

Introduction

The term "nutraceutical" was coined from "nutrition" and "pharmaceutical" in 1989 by Stephen De Felice, MD, founder and chairman of the Foundation for Inno-vation in Medicine (FIM), Cranford, NJ. According to De Felice, nutraceutical can be defined as, "a food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease."

Nutrition required for

health

Pharmaceutical remedy for sickness or

injury

Nutraceuticals preventive

Medical Approach

Concept of Nutraceuticals

Nutraceuticals

Scientific Evidence

Nutritional Supplements

Pharmaceuticals

Nutraceuticals

Calorie sufficient, nutrient deficient

population- 570 million

Over nourished 80 million

Un

der n

ou

ris

hed

3

80

mil

lio

n

ICMR norm for fruits

and vegetables

Su

ffic

ien

t excess

Defi

cie

nt

80% of norm level as defined

by NSSO

Deficient

Adequate/excess

Mic

ron

utr

ien

t in

take

Calorie consumption

India’s dietary pattern

Traditional Medicines

Pharmaceuticals

food Nutraceuticals

Cu

rati

ve

Preven

tive

Natural Nature-

like Man

made

Usag

e

Sources

Position of nutraceuticals

Market of nuatraceuticals

In 2008, the Nutraceuticals market in

India was Rs 18.75 billion.

It is growing at the CAGR of 21.23%.

India’s nutritional supplement market is

expected to more than double to Rs 9,500

crore by 2013.

Affluence

Affordability

Awareness

Accessibility

21.23%

Affluence of working population with changing lifestyles

Reducing affordability of sick care, driving consumers towards wellness

Increasing physician awareness and media penetration

Increased accessibility due to emergence of newer channels

Drivers for growth of nutraceuticals

Critical impediments for growth of nutraceuticals market

Regulatory framework

Resources for enforcement

Lack of credibility

Prices of nutraceuticals

Prices of nutraceuticals

Product Quantity Price of conventional food/ pharmaceutical

Percentage increase in price for functional food functional beverages/ dietary supplement

Conventional and functional foods

Salt 1 Kg INR 11 73% for low sodium variant

Conventional and functional beverages

Chilled beverages 330 ml INR 20 350% for energy drink

Pharmaceuticals and dietary supplements

Multivitamin tablets

10 tablets INR 15 233 % for vitamins in the form of dietary supplements

Classification of nutraceuticals (As par US-FDA)

1) Dietary supplements

“A dietary supplement is a product taken by

mouth that contains a "dietary ingredient"

intended to supplement the diet. The "dietary

ingredients" in these products may

include: vitamins, minerals, herbs or other

botanicals, amino acids, and substances such

as enzymes, organ tissues, glandular,

and metabolites, extracts or concentrates,

and may be found in many forms such

as tablets, capsules, soft gels, gel

caps, liquids, or powders. E.g. iron

supplement capsules.

2) Functional foods:

Functional foods are designed foods which provide enriched foods close to their natural state to consumer, rather than manufactured dietary supplements in liquid or capsule form.

e.g. table salt fortified with iodine.

3) Medical foods:

In order to be considered a medical food the product must, at a minimum:

• be a food for oral ingestion or tube feeding (nasogastric tube)

• be labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements, and

• be intended to be used under medical supervision

e.g. Medical foods for management of diabetes mellitus generally contain slowly digested carbohydrates, which helps minimize peaks in blood sugar. Consistent maintenance of optimal blood sugar levels (avoiding highs and lows) over time can help reduce the complications of diabetes.

Scientific aspects of nutraceuticals

1. HIV/ AIDS:

United States Patent Application 20120195988; 2012, granted to inventors Rezai-Fard and Ali describes a saponin or sapogenin from the capsicum genus may be used

• in the treatment of HIV infection, or AIDS,

• to alleviate the symptoms of HIV or AIDS,

• to delay the onset of HIV infection, or

• to stop an HIV infection developing into AIDS.

2. Cancer:

United States Patent Application 20120195988, 2012; granted to Rezai-Fard and Ali mention a saponin or sapogenin as described herein can be used directly as a chemotherapeutic agent

• in the treatment of tumors and cancer in the human or animal body.

• to shrink tumors and kill cancer cells as part of chemotherapy.

• to decrease the swelling caused by cancers.

• to alleviate many of the side effects and symptoms caused by cancer and by various cancer treatments such as chemotherapy and radiation therapy.

Saponin and sapogenin from the capsicum genus, along with their derivatives, may be used to treat any form of cancer including but not limited to breast, liver, lung, prostate, testicular, ovarian, cervical, uterus, brain, skin, colon, throat, mouth, bone, pancreas, stomach and lymph node cancer.

Regulation of nutraceuticals

Issues with regulatory regime before FSSA-

Nine different laws and eight different ministries was governing the food sector

Laws framed by different Ministries/Depts. With different perspective and enforcement approach

Overlapping laws with different quality standards & labelling requirements

Need for new law (FSSA)-

Removal of multiple regulations

Harmonizing with international law

Framing regulatory requirements based on science and risk analysis

Facilitating trade without compromising consumer safety and bringing in innovation in foods

Food Safety and Standard Act

Manufacture, storage, distribution, sale and import of

Nutraceuticals in India are regulated under the Food

Safety and Standards Act, 2006. This Act consolidated the

laws relating to food and established the Food Safety and

Standards Authority of India for laying down science

based standards for articles of food.

• The Prevention of Food Adulteration Act, 1954

• The Fruit Products Order, 1955

• The Meat Products Order, 1973

• The Vegetable Oil Products (Control) Order, 1947

• The Edible Oils Packaging Order, 1998

• The Solvent Extracted Oil, De oiled Meal, and Edible Flour

(Control) Order, 1967.

• The Milk and Milk Products Order, 1992

FSSA & Nutraceuticals

Chapter IV section 22 of the Act addresses

nutraceuticals, functional food, dietary supplements.

• According to it “foods for special dietary uses or functional foods or nutraceuticals or health supplements” means:

foods which are specially processed or formulated to satisfy particular dietary requirements and the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:-

plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;

minerals or vitamins or proteins or metals or their compounds or amino acids or enzymes;

substances from animal origin;

a product that is labelled as a “Food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods” may be formulated in the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and are meant for oral administration;

such product does not include a drug as defined in clause (b) and ayurvedic, sidha and unani drugs;

does not claim to cure or mitigate any specific disease, disorder or condition (except for certain health benefit or such promotion claims) as may be permitted by the regulations made under this Act;

does not include a narcotic drug or a psychotropic substance.

Salient feature of the act

• Movement from multi-level and multi-department control to a single line of command.

• FSSAI as a single reference point for all matters relating to Food Safety and Standards, Regulations and Enforcement.

• Integrated response to strategic issues like Novel foods, Health Foods, Nutraceuticals, GM foods, international trade etc.

• Decentralization of licensing for manufacture of food

products.

• Achieve high degree of consumer confidence in quality

& safety of food.

• Investor’s friendly regulatory mechanism with

emphasis on self regulations and capacity building.

• Enforcement of the legislation by the State

Governments/UTs through the State Commissioner for

Food Safety, his officers and Panchayati Raj/Municipal

bodies.

• Emphasis on gradual shift from regulatory regime to self compliance through food safety management system.

• Consistency between domestic and international food policy measures without reducing safeguards to public health and consumer protection

• Adequate information dissemination on food to enable consumer to make informed choices.

• Compounding and Adjudication of cases – to reduce Court’s workload and expedite the disposal of cases

• Graded penalty depending upon the gravity of offences.

New provisions under the act • Regulation of food imported in the country

• Provision for food recall

• Surveillance

• New enforcement structure

• Envisages large network of food labs

• New justice dispensation system for fast track disposal of cases

• Harmonization of domestic standards with international food standards

• Covering Health Foods, supplements, Nutraceuticals

• Issuing Licenses within a time frame of 2 months

• Provision of Improvement Notice by Designated Officers

• Compensation to Victims (for any case of Injury/Grievous injury/ Death):

not less than five lakh rupees in case of death;

not exceeding three lakh rupees in case of grievous injury; and

not exceeding one lakh rupees, in all other cases of injury

• Reward to informer (informing about the violators – adulteration etc.) by State Govt.

• No License for small food business operators; only registration is mandatory: with an annual turnover not exceeding 12 lakh.

• Central licensing from Authority

Food safety commissioner

Designated officer

Food safety officer

Adjudicating officer

Appellate tribunal

Special court

Referral lab

Accredited lab

Food analyst

New enforcement structure

Designated Officer

Improvement Notice

State the grounds

Specify the matters

Specify measures

which require the food

business operator to take

Suspension

Cancellation

Appeal to commissioner

Notice of improvement

Registration of food business

Registration is required only for “Petty Food Manufacturer” means any food manufacturer, who

• manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporary stall holder; or distributes foods including in any religious or social gathering except a caterer; or

• such other food businesses including small scale or cottage or such other industries relating to food business or tiny food businesses with an annual turnover not exceeding Rs 12 lakh and/or whose

production capacity of food (other than milk and milk products and meat and meat products) does not exceed 100 kg/ltr per day or

procurement or handling and collection of milk is up to 500 litres of milk per day or

Slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less.

Procedure for registration

• Registration shall not be refused without giving the applicant an opportunity of being heard.

• On completion of the procedures and grant of registration, A registration certificate and a photo identity card shall be issued which shall be displayed at a prominent place.

• The Registering Authority or any officer or agency specifically authorized for this purpose shall carry out inspection of the registered establishment.

Filing of an application

Processing of an application

Either grant or reject registration certificate,

issue notice for inspection

After inspection grant registration

Application Form A

Fees Rs 100/-

Within 7 days of receipt of application

Within a period of 30

days

If no response

Food Business operator may start the

business

procedure for registration of food business

Procedure for licensing • No person (other than petty food businesses) shall

commence any food business without obtaining a valid license.

• Existing Operator holding valid license/registration shall be granted a license within one year of notification of this Regulation.

• No license fee for the remaining period of the validity of the earlier license.

• License for businesses mentioned under Schedule 1, shall be granted by the Central Licensing Authority and all others by State licensing Authority.

• Importers of food items shall obtain a license from the Central Licensing Authority in addition to license taken for any other food business.

Filing of an application

Unique application number

Require additional information on

incomplete application

Either grant or reject license within 60 days of

receipt of completed application or within 30

days of inspection

Inspection of premises after receiving

completed application & issue inspection report

FBO may start

business after 60

days

No inspection

Application Form B Documents + Fess

Improvement notice

Suspension

Cancelation

No improvement

No improvement

Fresh application after

90 days

Procedure for licensing of food business

Packaging and labeling

Labeling is required in the manner as may be specified by regulations:

• Provided that the labels shall not contain any statement, claim, design or device which is false or misleading in any particular concerning the food products contained in the package or concerning the quantity or the nutritive value implying medicinal or therapeutic claims or in relation to the place of origin of the said food products.

• Every food business operator shall ensure that the labeling and presentation of food, including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, does not mislead consumers.

Advertisement

Supreme Court of India has held that commercial advertisement is a fundamental right available to every citizen under Article 19 (1) (a) of the Constitution of India subject to the requirements of Article 19 (2) of the Constitution.

The Advertising Standards Council of India (ASCI) has drafted and implemented a Code for Self-Regulation in Advertising (ASCI Code) in India.

Advertisement guideline provides that-

• It should not be misleading or deceptive.

• Advertisements should not disparage good dietary practice or the selection of options, such as fresh fruit and vegetables that accepted dietary opinion recommends should form part of the average diet.

• Advertisements should not encourage excessive consumption or inappropriately large portions of any particular food.

• Ensure advertisements do not mislead as to the nutritive value of any food.

• The nature of the audience should be taken into account.

• Claims shall be specific to the promoted product/s and accurate.

• Claims in an advertisement should not be inconsistent with information on the label or packaging of the food.

Panalties

¤ Substandard food: Upto Rs. 2.00 lakhs

¤ Misbranded: Upto Rs. 3.00 lakhs

¤ Misleading advertisement : Upto Rs. 10.00 lakhs

¤ Food with extraneous matter: Upto Rs. 1.00 lakhs

¤ Fail to meet the requirements as directed by FSO: Upto Rs. 2.00 lakhs

¤ Unhygienic / unsanitary preparations: Upto Rs. 1.00 lakhs

¤ Adulterant not injurious to health: Upto Rs. 2.00 lakhs

¤ Adulterant injurious to health: Upto Rs. 10.00 lakhs

¤ Unsafe food – but does not cause immediate injury : 6 months imprisonment with fine of Rs.1.0 lakh

Improvements provided for FSSA

• Lay down rules to govern quality and claims of nutraceutical products.

• Recognize list of nutritional ingredients with proven health benefits

• Define the list of permitted health claims and specify quantity of ingredients required to make those claims

• Setup a process for introduction of new nutraceutical products and define the nature and range of evidence required to substantiate product claims.

• Revise RDA (Recommended Dietary Allowance) levels to make them applicable for Indian population's current lifestyle.

• Take measures to ensure availability of adequate resources for implementation and enforcement of regulations

Summary and conclusion

Many nutraceuticals, functional foods and naturally occurring compounds that have been investigated and reported in various studies revealed that these products are extremely active, have profound effect on cell metabolism and often have little adverse effect. It is natural that people’s focus is shifting to a positive approach for prevention of diseases to stay healthy. Nutraceuticals is scientific area generated all over the world. In many cases nutraceuticals offer an advantage over the synthetic drugs under development by the pharmaceuticals industry.

The concept of "nutraceuticals" is still developing in India. It has been defined in the FSSA and it lays down the suggestive structure of the regulation for Foods for Special Purpose and Nutritional Uses. FSS Act based on the learning from international best practices; the Food Safety and Standards (Packaging and Labeling) Regulation, 2011, deals with nutrition and health claims.