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INTRODUCTION TO
NEUTRACEUTICALS

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INTRODUCTION

• TWO HUNDRED YEARS AGO, PROCESSED SUGAR WAS ONLY AVAILABLE IN DRUG STORES.

• TODAY, IT IS ONE OF THE MOST SUCCESSFULLY MARKETED NUTRITIONAL CHEMICALS,
ADDICTING CONSUMERS FROM A TIME WHEN THEY ARE VERY YOUNG.

• ON ONE HAND, WE ARE EATING FOOD MATERIAL OF COMPROMISED NUTRITIVE VALUE
BECAUSE OF MILLING AND PROCESSING.

• ON THE OTHER HAND, THERE IS NOT ENOUGH TIME FOR A HEALTHY BALANCED MEAL.

• TO COMPENSATE FOR THESE LOSSES, DIETARY SUPPLEMENTS AND FUNCTIONAL FOODS ARE A
MUST IN TODAY’S LIFESTYLE.

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• DIETARY SUPPLEMENTS REFER TO THE PREPARATIONS INTENDED TO COMPENSATE FOR THE NUTRIENTS

THAT OTHERWISE MIGHT NOT BE SUFFICIENTLY PRESENT IN THE DIET.

• DIETARY SUPPLEMENTS ARE CATEGORIZED AS FOOD IN SOME COUNTRIES, WHILE IN OTHER COUNTRIES

THEY ARE CONSIDERED AS DRUGS OR NATURAL HEALTH PRODUCTS.

• FUNCTIONAL FOODS REFERS TO SUPPLEMENTS THAT HAVE NEW OR MORE INGREDIENTS ADDED,

RESULTING IN ENHANCED FUNCTION AND IMPROVEMENT OF HEALTH.

• THESE TYPES OF FOODS ARE COMPRISED OF PROCESSED FOODS AS WELL AS FOODS ENRICHED WITH

HEALTH PROMOTING ADDITIVES.

• THE SEARCH FOR FUNCTIONAL FOODS, OR FUNCTIONAL FOOD INGREDIENTS, IS ONE OF THE LEADING

TRENDS IN TODAY’S FOOD INDUSTRY.

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• THE TERM NUTRACEUTICAL, A COMBINATION OF THE WORDS “NUTRITION” AND

“PHARMACEUTICAL,”WAS COINED BY DR. STEPHEN L. DEFELICE IN 1989, FOUNDER AND CHAIRMAN OF

THE FOUNDATION OF INNOVATION MEDICINE, CRAWFORD, NEW JERSEY, AND IT REFERS TO THE FOOD

OR FOOD INGREDIENTS THAT HAVE DEFINED PHYSIOLOGICAL EFFECTS.

• THEY DO NOT EASILY FALL INTO THE LEGAL CATEGORIES OF FOOD OR DRUG AND OFTEN RESIDE IN A

GRAY AREA BETWEEN THE TWO.

• THE TERM NUTRACEUTICAL IS BEING COMMONLY USED IN MARKETING BUT HAS NO REGULATORY

DEFINITION.

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HISTORY
• THE TERMINOLOGY “PHYSIOLOGICALLY FUNCTIONAL FOODS” OR SIMPLY “FUNCTIONAL

FOODS” WAS CONCEIVED OVER THREE DECADES AGO IN THE CONTEXT OF NUTRITION

DURING SPACE TRAVEL.

• THE MODERN CONCEPT OF FUNCTIONAL FOOD FOR THE GENERAL POPULATION WAS

PROPOSED BY JAPANESE ACADEMIC SOCIETY IN THE EARLY 1980 S, AND THE LEGISLATION

FOR FUNCTIONAL FOODS WAS FIRST IMPLEMENTED AS FOODS FOR SPECIFIED HEALTH USE.

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.

• THE PURPOSE OF THE FUNCTIONAL FOOD SCIENCE IN EUROPE WAS ON REACH CONSENSUS

ON SCIENTIFIC CONCEPTS OF FUNCTIONAL FOODS IN BY USING THE SCIENCE BASE WHICH

PROVIDES EVIDENCE THAT CERTAIN NUTRIENTS AFFECT PHYSIOLOGICAL FUNCTIONS IN A

POSITIVE MANNER.

• HEALTH CANADA WHICH DEFINES NUTRACEUTICAL AS: A PRODUCT ISOLATED OR PURIFIED

FROM FOODS, AND GENERALLY SOLD IN MEDICINAL FORMS NOT USUALLY ASSOCIATED WITH

FOOD AND DEMONSTRATED TO HAVE A PHYSIOLOGICAL BENEFIT OR PROVIDE PROTECTION

AGAINST CHRONIC DISEASE. EXAMPLES ARE BETACAROTENE AND LYCOPENE.

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• NUTRACEUTICALS ARE CURRENTLY RECEIVING RECOGNITION AS BEING BENEFICIAL IN CORONARY

HEART DISEASE, OBESITY, DIABETES, CANCER, OSTEOPOROSIS AND OTHER CHRONIC AND

DEGENERATIVE DISEASES SUCH AS PARKINSON’S AND ALZHEIMER’S DISEASES.

• THE DSHEA (DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT 1994) DEFINED “DIETARY SUPPLEMENT”

USING SEVERAL CRITERIA.

• A DIETARY SUPPLEMENT: IS A PRODUCT (OTHER THAN TOBACCO) THAT IS INTENDED TO SUPPLEMENT

THE DIET THAT BEARS OR CONTAINS ONE OR MORE OF THE FOLLOWING DIETARY INGREDIENTS: A

VITA-MIN, A MINERAL, AN HERB OR OTHER BOTANICAL, AN AMINO ACID, A DIETARY SUBSTANCE FOR

USE BY MAN TO SUPPLEMENT THE DIET BY INCREASING THE TOTAL DAILY INTAKE, OR A CONCENTRATE,

METABOLITE,

• CONSTITUENT, EXTRACT, OR COMBINATIONS OF THESE INGREDIENTS.

• IS INTENDED FOR INGESTION IN PILL, CAPSULE, TABLET, OR LIQUID FORM.

• IS NOT REPRESENTED FOR USE AS A CONVENTIONAL FOOD OR AS THE SOLE ITEM OF A MEAL OR DIET.
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• IS LABELED AS A “DIETARY SUPPLEMENT.”

 

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NUTRACEUTICALS IN CONTRAST TO PHARMACEUTICALS

• ALTHOUGH THE WORD ‘NUTRACEUTICALS’ IS NOW WELL

UNDERSTOOD AND WIDELY ACCEPTED, IT STILL DOES NOT HAVE ANY

ONE STANDARD DEFINITION.

• THE BEST DEFINITION THAT WE COME ACROSS IS ‘FOOD OR PART OF A

FOOD (INCLUDING DRINKS) THAT PROVIDES MEDICAL OR HEALTH

BENEFITS, INCLUDING PREVENTION OR TREATMENT OF A DISEASE’.

• IN CONTRAST TO THIS, PHARMACEUTICALS FOCUS MORE ON SPECIFIC

ILLNESS OR TREATMENT

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Nutraceuticals Pharmaceuticals

Works on root causes and take longer Relatively more instant in effect
time for recovery

Do not have side effects For severe illnesses have side effects

Focuses on prevention & wellness Focuses on illness & treatment

No prescription needed for buying Sold only on prescription except OTC

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Needs no approval of FDA Needs approval of FDA

 

GLOBAL NUTRACEUTICAL MARKET

• MARKET SIZE

• GLOBALLY, NUTRACEUTICALS MARKET IS GOING TO EXPERIENCE HUGE GROWTH IN THE NEXT

10 YEARS OR SO. KEY DEVELOPED & HEALTH-CONSCIOUS NATIONS ARE PRIMARILY DRIVING

THIS. HOWEVER, EMERGING MARKET CONSUMERS ARE ALSO BECOMING INCREASINGLY

AWARE OF THE BENEFITS OF SUCH PRODUCTS. ALONGSIDE, DISPOSABLE INCOME OF

GENERAL POPULATION IS ALSO INCREASING EXPONENTIALLY IN MANY DEVELOPING NATIONS

INCLUDING INDIA.

1999 2002 2010 2014 2019

38BN 47BN 140BN 140BN 241BN

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GLOBAL NUTRACEUTICAL MARKET

• AS IS EVIDENT, WHILE IN THE INITIAL YEARS, BETWEEN 1999 & 2002 INDUSTRY GREW AT 7%

PER ANNUM, THE NEXT FEW YEARS UP TO 2010 SAW DOUBLE THAT GROWTH AT 14% PER

ANNUM. CURRENTLY AROUND $12-15 BN IS BEING ADDED EVERY YEAR.

• BY 2020, THE WORLD WILL HAVE 1 BILLION POPULATIONS OF 60+ AGES. 70% OF THIS

POPULATION LIVE IN DEVELOPED NATIONS & BALANCE 30% IN DEVELOPING

NATIONS.NUTRACEUTICAL DEMAND WILL GROW AT A STEADY RATE IN DEVELOPED NATIONS.

DEVELOPING NATIONS WITH THEIR PROGRESSIVE DISPOSABLE INCOME WILL SEE A SUDDEN

SURGE IN GROWTH IN THE NEXT 5-10 YEARS.

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GLOBAL NUTRACEUTICAL MARKET

• THE BELOW STRUCTURE DEPICTS GLOBAL KEY & EMERGING GEOGRAPHIES

Region Country Potential

North America US Maturing market, growth with dietary supplements as healthcare
costs increase

Asia-Pacific Japan Pioneers in natural Nutraceuticals & Dietary supplements. Huge
market second to US

China Rapidly growing middle class and increasing disposable income
will greatly expand Nutraceutical segment in China by 2020.

Europe Germany Stringent Government regulation & approval process. Most players
expanding product offerings

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Latin America Brazil Health-conscious, well-informed young middle class would drive

growth

 

US & OTHER MARKETS

• • THE US HAS BEEN THE LARGEST NUTRACEUTICAL MARKET SO FAR AND ALMOST FULLY

MATURE. BETWEEN 2010 & 2015 IT GREW FROM $ 50 BN TO $ 65 BN, A COMPOUNDED

GROWTH OF 10% ANNUALLY.

• • THE US MARKET COMPRISES OF FUNCTIONAL FOOD & BEVERAGES (65%) AND DIETARY

SUPPLEMENTS (35%)

• • THE EUROPEAN MARKET HAS GROWN FROM $ 35 BN IN 2010 TO $ 40 BN IN 2016. IT IS

EXPECTED TO GROW TO $ 51 BN BY 2021. THIS INDICATES AN ANNUAL GROWTH OF 5%.

• • FRANCE, GERMANY & SWITZERLAND ARE THE BIGGEST MARKETS COMPRISING ALMOST 70%

OF THE EUROPEAN MARKET.

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MAJOR GLOBAL PLAYERS

• PARTICIPATION IN NUTRACEUTICALS COMES FROM TWO CRITICAL AVENUES. FIRSTLY,

COMPANIES WHO ARE ALREADY HAVE STRONG EQUITIES IN FOOD & BEVERAGES SECTOR.

• SECONDLY, PHARMACEUTICAL COMPANIES THAT ARE LOOKING AT PREVENTIVE PRODUCTS

FOR CERTAIN RANGE OF AILMENTS.

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INDIAN NUTRACEUTICALS INDUSTRY CURRENT SCENARIO &
FUTURE TRENDS

• GLOBALLY, NUTRACEUTICALS MARKET IS EXPECTED TO WITNESS HUGE GROWTH.

• AT THE TURN OF THE MILLENNIUM, BETWEEN 1999 AND 2002, THE INDUSTRY GREW AT A

CAGR OF 7%.

• SUBSEQUENTLY TILL 2010, IT DOUBLED TO 14%.

• CURRENTLY EVERY YEAR $12-15 BN IS BEING ADDED TO THE GLOBAL REVENUE.

• THE US AND JAPAN HAVE BEEN PIONEERS IN EMBRACING NUTRACEUTICALS.

• WESTERN EUROPE ALSO REPRESENTS A LARGE MARKET, WITH STRONG FOOTPRINTS IN

GERMANY, ITALY AND FRANCE.

• DEVELOPING MARKETS LIKE INDIA, BRAZIL AND CHINA ARE RELATIVELY SMALLER, YET HAVE A

HUGE GROWTH OPPORTUNITY.
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• INDIAN MARKET CURRENTLY HAS A 2-3% SHARE OF THE GLOBAL MARKET.

 

INDIAN NUTRACEUTICALS INDUSTRY CURRENT SCENARIO &
FUTURE TRENDS

• THE INDIAN NUTRACEUTICALS MARKET IS ESTIMATED AT AROUND $ 4 BN IN 2017 AND IS
EXPECTED TO GROW AT A SIGNIFICANT 21% CAGR TO $ 10 BN IN 2022.

• THIS WILL LIKELY BE FUELED BY A SIGNIFICANT 25% PER ANNUM GROWTH IN FUNCTIONAL
BEVERAGES MARKET ACCOMPANIED BY SIMILAR POTENTIAL GROWTH FROM THE OTHER
SEGMENTS.

• MORE THAN 60% OF THIS MARKET IS ACCOUNTED FOR BY DIETARY SUPPLEMENTS. FEW
INDUSTRIES IN INDIA TODAY OFFER SUCH SPECTACULAR GROWTH POTENTIAL.

• KEY PLAYERS IN THE INDIAN MARKET FEATURE BOTH INDIAN AND MULTI-NATIONAL
COMPANIES. MNCS LIKE GSK, HUL, AMWAY, NESTLE, DANONE, KELLOGG’S, AND PEPSICO ARE
TRYING TO AUGMENT THEIR MARKET SHARE AND REINFORCE PENETRATION.

• STRONG INDIAN PLAYERS LIKE ITC, DABUR, HIMALAYA, PATANJALI AND BAIDYANATH ARE ALSO
LAUNCHING NEW PRODUCTS TO REACH OUT TO NEWER SEGMENTS AND GEOGRAPHIES IN

wwwI.DNuloDMiIxA.co.m MANY PLAYERS HAVE STAYED IN IDENTIFIED NICHE MARKETS TO PLAY ON THEIR 19

STRENGTHS.

 

INDIAN NUTRACEUTICALS INDUSTRY CURRENT SCENARIO &
FUTURE TRENDS

• INDIAN CONSUMERS ARE GETTING MORE AWARE OF THEIR FUNDAMENTAL NEEDS FOR

NUTRITION AND PROACTIVE STEPS THEY CAN TAKE TO PREVENT CHRONIC AILMENTS AND

ATTAIN HIGHER WELL-BEING.

• INDIA HAS A SIGNIFICANTLY YOUNGER POPULATION AND THE YOUNGER GENERATION IS

VIGOROUSLY PURSUING MORE ACTIVE LIFESTYLE TO ENJOY FITNESS, TO GUARD AGAINST

OBESITY, DIABETES, CARDIO-VASCULAR PROBLEMS ETC.

• THE ROLE OF OPINION-SHAPERS LIKE GENERAL PRACTITIONERS, FITNESS INSTRUCTORS AND

NUTRITIONISTS CANNOT BE IGNORED.

• IT IS ALSO IMPORTANT TO FORMULATE AN EFFECTIVE COMMUNICATION STRATEGY FOR THE

TARGET AUDIENCE TO EDUCATE THEM ON THE BENEFITS OF THIS CATEGORY.

• SIDE-EFFECTS AND SPURIOUS PRODUCTS ARE TWO KEY CONCERNS AND A POTENTIAL
wwwB.DAuloMRixR.cIoEmR FOR GROWTH FROM ALL STAKEHOLDERS AND NEEDS TO BE QUICKLY ADDRESSED. 20

• IT IS HERE THAT THE REGULATORY MAY WANT TO PLAY A MORE ACTIVE ROLE.

 

INDIAN NUTRACEUTICAL MARKET

• THE INDIAN NUTRACEUTICALS MARKET IS EXPECTED TO GROW FROM $ 4 BN IN 2015 TO $ 10
BN IN 2022. THIS REPRESENTS A HUGE GROWTH OF 21% GROWTH ANNUALLY.

• TRANSFORMATION IN FOOD HABITS, LESS PHYSICAL WORK, MORE OF DESK JOBS HAVE MADE
INDIANS MORE VULNERABLE TO LIFESTYLE AILMENTS. THE AVERAGE URBAN & SEMI-URBAN
INDIAN IS BECOMING MORE CONSCIOUS ABOUT HEALTH & FITNESS. THIS IS PROVIDING A
MASSIVE GROWTH OPPORTUNITY FOR NUTRACEUTICALS IN INDIA.

• THE ENTIRE CATEGORY OF NUTRACEUTICALS IS DIVIDED FUNCTIONAL FOODS, FUNCTIONAL
BEVERAGES & DIETARY SUPPLEMENTS. FUNCTIONAL FOOD & BEVERAGES ACCOUNT FOR
AROUND 35% OF THE MARKET IN INDIA AND WILL EXPERIENCE HIGHER GROWTH IN INDIA IN
THE NEXT FEW YEARS TO COME.

• YEAR 2017 2018 2019 2020 2021 2022

• MARKET 4.00 4.17 5.75 6.90 8.31 10.01

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• CAGR 21%

 


• IN INDIA FUNCTIONAL FOODS ARE REGULATED UNDER “FOOD SAFETY AND STANDARDS (HEALTH

SUPPLEMENTS, NUTRACEUTICALS, FOOD FOR SPECIAL DIETARY USE, FOOD FOR SPECIAL

MEDICAL PURPOSE, FUNCTIONAL FOOD AND NOVEL FOOD) REGULATIONS 2016”, EFFECTIVE

FROM 1JAN 2018.

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.

• AS PER FSSA 2006, “FOODS FOR SPECIAL DIETARY USES OR FUNCTIONAL FOODS OR
NUTRACEUTICALS OR HEALTH SUPPLEMENTS” MEANS:

• (A) FOODS WHICH 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 AND WHICH ARE PRESENTED AS SUCH, WHEREIN 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:–

• (I) 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;

• (II) 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
(WwITwwH.DIuNloM ixP.cEomRMISSIBLE LIMITS); 23

• (III) SUBSTANCES FROM ANIMAL ORIGIN;

 


• (IV) A DIETARY SUBSTANCE FOR USE BY HUMAN BEINGS TO SUPPLEMENT THE DIET BY INCREASING THE

TOTAL DIETARY INTAKE;

• (B) (I) A PRODUCT THAT IS LABELLED AS A ―FOOD FOR SPECIAL DIETARY USES OR FUNCTIONAL FOODS OR

NUTRACEUTICALS OR HEALTH SUPPLEMENTS OR SIMILAR SUCH FOODS WHICH IS NOT REPRESENTED FOR

USE AS A CONVENTIONAL FOOD AND WHEREBY SUCH PRODUCTS 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;

• (II) SUCH PRODUCT DOES NOT INCLUDE A DRUG AS DEFINED IN CLAUSE (B) AND AYURVEDIC, SIDHA AND

UNANI DRUGS AS DEFINED IN CLAUSES (A) AND (H) OF SECTION 3 OF THE DRUGS AND COSMETICS ACT,

1940 (23 OF 1940) AND RULES MADE THEREUNDER;

• (III) 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;

• (IV) DOES NOT INCLUDE A NARCOTIC DRUG OR A PSYCHOTROPIC SUBSTANCE AS DEFINED IN THE SCHEDULE

OF THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES ACT, 1985 (61 OF 1985) AND RULES MADE
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THEREUNDER AND SUBSTANCES LISTED IN SCHEDULES E AND EI OF THE DRUGS AND COSMETICS RULES,

1945;

 


• “FOOD FOR SPECIAL MEDICAL PURPOSE” MEANS FOOD INTENDED FOR –

• (I) PARTICULAR DIETARY USE SPECIALLY PROCESSED OR FORMULATED;

• (II) THE DIETARY MANAGEMENT OF PERSONS AND USED ONLY UNDER MEDICAL ADVICE;

• (III) THE EXCLUSIVE OR PARTIAL FEEDING OF PERSONS WITH A LIMITED, IMPAIRED OR DISTURBED

CAPACITY TO TAKE, DIGEST, ABSORB, METABOLIZE OR EXCRETE ORDINARY FOODSTUFFS OR CERTAIN

NUTRIENTS CONTAINED THEREIN OR METABOLITES; OR

• (IV) OTHER MEDICALLY DETERMINED NUTRIENT REQUIREMENTS, WHOSE DIETARY MANAGEMENT

CANNOT BE ACHIEVED ONLY BY MODIFICATION OF THE NORMAL DIET, BY FOOD FOR SPECIFIC

NUTRITIONAL USE, OR A COMBINATION OF THEM;

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• “FOOD WITH ADDED PREBIOTIC INGREDIENTS” MEANS FOOD THAT CONTAINS ADDED PREBIOTIC

INGREDIENTS WHICH ARE NONVIABLE FOOD COMPONENTS THAT CONFER HEALTH BENEFITS TO

THE CONSUMER BY MODULATION OF GUT MICROBIOTA;

• “FOOD WITH ADDED PROBIOTIC INGREDIENTS” MEANS FOOD WITH LIVE MICRO-ORGANISMS

BENEFICIAL TO HUMAN HEALTH, WHICH WHEN INGESTED IN ADEQUATE NUMBERS AS A SINGLE

STRAIN OR AS A COMBINATION OF CULTURES, CONFER ONE OR MORE SPECIFIED OR

DEMONSTRATED HEALTH BENEFITS IN HUMAN BEINGS;

• PROPRIETARY AND NOVEL FOOD “MEANS AN ARTICLE OF FOOD FOR WHICH STANDARDS HAVE

NOT BEEN SPECIFIED BUT IS NOT UNSAFE”

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CLASSIFICATION OF NUTRACEUTICALS
• DIETARY SUPPLEMENTS

• CONTAINS NUTRIENTS DERIVED FROM FOOD PRODUCTS THAT ARE CONCENTRATED IN LIQUID OR
CAPSULE FORM.

• DSHEA 1994 DEFINED “A DIETARY SUPPLEMENT IS A PRODUCT TAKEN BY MOUTH THAT CONTAINS A
“DIETARY INGREDIENT” INTENDED TO SUPPLEMENT THE DIET.

• THE “DIETARY INGREDIENTS” MAY INCLUDE: VITAMINS, MINERALS, HERBS OR OTHER BOTANICALS, AMINO
ACIDS, AND SUBSTANCES SUCH AS ENZYMES, ORGAN TISSUES, GLANDULARS, AND METABOLITES & CAN
ALSO BE EXTRACTS OR CONCENTRATES, AND IN MANY FORMS SUCH AS TABLETS, CAPSULES, SOFTGELS,
GELCAPS, LIQUIDS, OR POWDERS

• NOT APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) BEFORE MARKETING.

• ALTHOUGH SUPPLEMENTS CLAIM TO PROVIDE HEALTH BENEFITS.

• PRODUCTS USUALLY INCLUDE A LABEL THAT SAYS: “THESE STATEMENTS HAVE NOT BEEN EVALUATED BY
TwHwwE.D FuloOMixO.coDm AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CUR2E7,
OR PREVENT ANY DISEASE.”

 


• FUNCTIONAL FOODS

• ENRICHED FOODS CLOSE TO THEIR NATURAL STATE.

• ENRICHED OR FORTIFIED A PROCESS CALLED NUTRIFICATION.

• SOMETIMES, ADDITIONAL COMPLEMENTARY NUTRIENTS ARE ADDED, SUCH AS VITAMIN D TO MILK.

• HEALTH CANADA DEFINES FUNCTIONAL FOODS AS “ORDINARY FOOD THAT HAS COMPONENTS OR
INGREDIENTS ADDED TO GIVE IT A SPECIFIC MEDICAL OR PHYSIOLOGICAL BENEFIT, OTHER THAN A
PURELY NUTRITIONAL EFFECT.”

• IN JAPAN, ALL FUNCTIONAL FOODS MUST MEET THREE ESTABLISHED REQUIREMENTS: FOODS SHOULD
BE

• (1) PRESENT IN THEIR NATURALLY-OCCURRING FORM, RATHER THAN A CAPSULE, TABLET, OR
POWDER;

• (2) CONSUMED IN THE DIET AS OFTEN AS DAILY; AND

• (3) SHOULD REGULATE A BIOLOGICAL PROCESS IN HOPES OF PREVENTING OR CONTROLLING
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DISEASE.

 


• MEDICAL FOODS

• THE FDA CONSIDERS MEDICAL FOODS TO BE “FORMULATED TO BE CONSUMED OR ADMINISTERED

INTERNALLY UNDER THE SUPERVISION OF A PHYSICIAN, AND WHICH IS INTENDED FOR THE SPECIFIC

DIETARY MANAGEMENT OF A DISEASE OR CONDITION FOR WHICH DISTINCTIVE NUTRITIONAL

REQUIREMENTS, ON THE BASIS OF RECOGNIZED SCIENTIFIC PRINCIPLES, ARE ESTABLISHED BY MEDICAL

EVALUATION.

• MEDICAL FOODS CAN BE INGESTED THROUGH THE MOUTH OR THROUGH TUBE FEEDING.

• MEDICAL FOODS ARE ALWAYS DESIGNED TO MEET CERTAIN NUTRITIONAL REQUIREMENTS FOR PEOPLE

DIAGNOSED WITH SPECIFIC ILLNESSES.

• MEDICAL FOODS ARE REGULATED BY THE FDA AND WILL BE PRESCRIBED/MONITORED BY MEDICAL

SUPERVISION.

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• FARMACEUTICALS

• IS A MELDING OF THE WORDS FARM AND PHARMACEUTICALS.

• IT REFERS TO MEDICALLY VALUABLE COMPOUNDS PRODUCED FROM MODIFIED AGRICULTURAL CROPS

OR ANIMALS (USUALLY THROUGH BIOTECHNOLOGY).

• EXAMPLES:

• BROCCOLI MAY HELP IN THE PREVENTION OF CANCER.

• ANTIOXIDANTS: RESVERATROL FROM RED GRAPE PRODUCTS; FLAVONOIDS INSIDE CITRUS, TEA, WINE,

AND DARK CHOCOLATE FOODS; ANTHOCYANINS FOUND IN BERRIES, VITAMIN C

• REDUCING HYPERCHOLESTEROLEMIA- PSYLLIUM SEED HUSK

• CANCER PREVENTION: BROCCOLI (SULFORAPHANE) FIDDLEHEADS (MATTEUCCIA STRUTHIOPTEUS)

• IMPROVED ARTERIAL HEALTH: SOY OR CLOVE (ISOFLAVONOIDS)

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• LOWERED RISK OF CARDIOVASCULAR DISEASE: ALPHA-LINOLENIC ACID FROM FLAX OR CHIA SEEDS,

OMEGA 3 FATTY ACIDS IN FISH OIL.

 


• VARYING GUIDELINES

• NUTRACEUTICALS IS AN EVOLVING CONCEPT WITH VARYING DEFINITIONS ACROSS THE GLOBE.

• IN CANADA, NUTRACEUTICALS ARE NAMED ‘NATURAL HEALTH PRODUCTS’.

• THEY ARE KNOWN AS “DIETARY SUPPLEMENTS” IN THE US.

• JAPAN CALLS THEM ‘FOODS FOR SPECIAL HEALTH USE’ (FOSHU).

• IN US, CANADA AND IN EU THERE ARE DISTINCT DEFINITIONS AND GUIDELINES FOR DIETARY

SUPPLEMENTS AND FUNCTIONAL FOODS.

• TRADITIONAL AND HERBAL MEDICINES ARE PART OF THE DEFINITION OF DIETARY SUPPLEMENTS IN

CANADA, BUT NOT THE CASE IN JAPAN.

• HERBS AND BOTANICALS FIND PLACE IN NUTRACEUTICALS IN US.

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GENERAL REQUIREMENTS.-( “FOOD SAFETY AND STANDARDS (HEALTH
SUPPLEMENTS, NUTRACEUTICALS, FOOD FOR SPECIAL DIETARY USE, FOOD FOR SPECIAL

MEDICAL PURPOSE, FUNCTIONAL FOOD AND NOVEL FOOD) REGULATIONS 2016”)

• THE ARTICLES OF FOOD SOLD IN CAPSULE FORMAT, HARD OR SOFT OR VEGETARIAN, SHALL COMPLY

WITH THE GENERAL AND QUALITY REQUIREMENTS SPECIFIED IN INDIAN PHARMACOPOEIA:

• APPROVED COLOURS AND ADDITIVES PERMITTED;

• NATURAL FLAVORS OR NATURE IDENTICAL FLAVOURS OR SYNTHETIC FLAVORS IN ACCORADANCE WITH

THE (FOOD PRODUCT STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011.

• FBO MAY DECLARE THE ADDITION OF FLAVOUR ON LABELS OF SUCH PRODUCTS(FOOD SAFETY AND

STANDARDS (LABELLING AND PACKAGING) REGULATIONS, 2011).

• THE TABLETS, CAPSULES AND SYRUPS SHALL FULFIL THE GENERAL QUALITY REQUIREMENTS AND

STANDARDS AS SPECIFIED IN INDIAN PHARMACOPOEIA, BRITISH PHARMACOPOEIA OR UNITED STATES

PHARMACOPOEIA.

• QUANTITY OF NUTRIENTS ADDED TO THE ARTICLES OF FOOD SHALL NOT EXCEED THE(RDA)

RECOMMENDED DAILY ALLOWANCE. SPECIFIED BY THE ‘INDIAN COUNCIL OF MEDICAL RESEARCH’ AND IF
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NOT SPECIFIED BY ICMR, THE STANDARDS LAID DOWN BY INTERNATIONAL FOOD STANDARDS BODY,

NAMELY, CODEX ALIMENTARIUS COMMISSION.

 

GENERAL REQUIREMENTS.-

• HEALTH SUPPLEMENT – INDIVIDUAL NUTRIENT CONTENT SHALL NOT BE LESS THAN FIFTEEN PER CENT

OF THE RDA.

• IF HIGHER NUTRIENT CONTENT CLAIM IS MADE, THE NUTRIENT CONTENT SHALL NOT BE LESS THAN

THIRTY PER CENT OF THE RECOMMENDED DAILY ALLOWANCE.

• ADDITION OF FOOD COLOURS SUBJECT TO THE LEVEL RESTRICTIONS AS MENTIONED IN FOOD

SAFETY AND STANDARDS (FOOD PRODUCT STANDARDS AND FOOD ADDITIVES) REGULATIONS,

2011.

• THE ARTICLES OF FOOD SHALL CONSIST DESIRED LEVEL OF ENERGY, PROTEIN, VITAMINS AND

MINERALS, AND OTHER ESSENTIAL NUTRIENTS REQUIRED FOR RESPECTIVE AGE GROUP, GENDER AND

PHYSIOLOGICAL STAGE IN ACCORDANCE WITH THE GUIDELINES OF ICMR.

• TwHwwE.D uPloUMixR.coImTY OF THE INGREDIENTS USED SHALL BE AS DETERMINED AND NOTIFIED IN THE OFFICIAL 33

GAZETTE BY THE FOOD AUTHORITY FROM TIME TO TIME.

 

GENERAL REQUIREMENTS.-

• IN CASE SUCH STANDARDS ARE NOT SPECIFIED BY FOOD AUTHORITY, PURITY CRITERIA GENERALLY

ACCEPTED BY, INDIAN PHARMACOPOEIA, AYURVEDIC PHARMACOPOEIA OF INDIA, RELEVANT BUREAU OF

INDIAN STANDARDS SPECIFICATIONS, QUALITY STANDARDS OF INDIAN MEDICINAL PLANTS, INDIAN

COUNCIL OF MEDICAL RESEARCH, BRITISH PHARMACOPOEIA, UNITED STATES PHARMACOPOEIA, FOOD

CHEMICAL CODEX, JOINT FOOD AND AGRICULTURE ORGANIZATION OR WORLD HEALTH

ORGANISATION, EXPERT COMMITTEE ON FOOD ADDITIVES OR CODEX ALIMENTARIUS MAY BE ADOPTED.

• THE FBO SHALL INTIMATE THE PURITY CRITERIA ADOPTED FOR INGREDIENTS TO THE FOOD AUTHORITY

INCLUDING ANY CHANGE WHEN ADOPTED.

• THE TOLERANCE LIMIT FOR VARIATION IN CASE OF ARTICLES OF FOOD COVERED IN THESE REGULATIONS

DURING ANALYSIS OF SAMPLES OF FINISHED PRODUCTS, SHALL NOT BE MORE THAN (-) TEN PER CENT

FROM THE DECLARED VALUE OF THE NUTRIENTS OR NUTRITIONAL INGREDIENTS ON THE LABEL .

• TwHwwE.D MuloMAixN.comUFACTURING OF INGREDIENTS AND PRODUCTS COVERED UNDER THESE REGULATIONS SHALL34 BE

CARRIED OUT IN COMPLIANCE WITH THE ESTABLISHED GOOD MANUFACTURING PRACTICES.

 

GENERAL REQUIREMENTS.-

• INGREDIENTS SPECIFIED IN SCHEDULE I, SCHEDULE II, SCHEDULE III, SCHEDULE IV, SCHEDULE VI,
SCHEDULE VII, AND SCHEDULE VIII MAY BE USED IN FOOD.

• ADDITIVES SPECIFIED IN SCHEDULE VA TO SCHEDULE VF MAY BE USED.

• THE FORMULATION OF ARTICLES OF FOOD SHALL BE BASED ON SUPPORTED BY VALIDATED
SCIENTIFIC DATA.

• NO HORMONES OR STEROIDS OR PSYCHOTROPIC INGREDIENTS SHALL BE ADDED IN ANY OF THE
ARTICLES OF FOOD SPECIFIED IN THESE REGULATIONS.

• THE LABEL ON ARTICLES OF FOOD SHALL SPECIFY THE PURPOSE, THE TARGET CONSUMER GROUP
AND THE PHYSIOLOGICAL OR DISEASE CONDITIONS WHICH THEY ADDRESS, RECOMMENDED

DURATION OF USE.

• THE LABEL, ACCOMPANYING LEAFLET OR OTHER LABELLING AND ADVERTISEMENT OF EACH TYPE OF
AwRwwT.DIuCloMLiEx.c oOm F FOOD, SHALL PROVIDE SUFFICIENT INFORMATION ON THE NATURE AND PURPOSE OF35
THE ARTICLE OF FOOD AND DETAILED INSTRUCTIONS AND PRECAUTIONS FOR ITS USE .

 

GENERAL REQUIREMENTS.-

• AN ARTICLE OF FOOD WHICH HAS NOT BEEN PARTICULARLY MODIFIED BUT IS SUITABLE FOR

USE IN A PARTICULAR DIETARY REGIMEN BECAUSE OF ITS NATURAL COMPOSITION, SHALL NOT

BE DESIGNATED AS ‘HEALTH SUPPLEMENT’ OR ‘SPECIAL DIETARY’ OR ‘SPECIAL DIETETIC’ OR BY

ANY OTHER EQUIVALENT TERM.

• THE FOOD AUTHORITY MAY SUSPEND OR RESTRICT SALE OF SUCH ARTICLES OF FOOD THAT

ARE NOT CLEARLY DISTINGUISHABLE FROM ARTICLES OF FOOD FOR NORMAL CONSUMPTION

AND ARE NOT SUITABLE FOR THEIR CLAIMED NUTRITIONAL PURPOSE, OR MAY ENDANGER

HUMAN HEALTH.

• THE FOOD AUTHORITY MAY, AT ANY TIME, DIRECT A FBO MANUFACTURING AND SELLING

SUCH SPECIAL TYPE OF ARTICLE OF FOOD, TO FURNISH DETAILS REGARDING THE HISTORY OF

USE OF THE NOVEL OR MODIFIED INGREDIENTS ADDED AND THEIR SAFETY EVALUATION.

www.DuloMix.com 36

 

GENERAL REQUIREMENTS.-

• THE MERE COMBINATION OF VITAMINS AND MINERALS FORMULATED IN TABLETS, CAPSULES,
SYRUP FORMATS SHALL NOT BE COVERED IN ANY OF THE CATEGORIES OF THESE
REGULATIONS EXCEPT WHEN VITAMINS AND MINERALS ARE ADDED TO AN ARTICLE OF FOOD
OR IN A FOOD FORMAT.

• THE LABELLING ON THE ARTICLE OF FOOD SHALL BE IN ACCORDANCE WITH THE FOOD SAFETY
AND STANDARDS (PACKAGING AND LABELLING) REGULATIONS, 2011.

• THE ARTICLES OF FOOD SHALL CONFORM TO THE FOOD SAFETY AND STANDARDS
(CONTAMINANTS, TOXINS AND RESIDUES) REGULATIONS, 2011.

• NO PERSON SHALL MANUFACTURE, PACK, SELL, OFFER FOR SALE, MARKET OR OTHERWISE
DISTRIBUTE OR IMPORT ANY FOOD PRODUCTS REFERRED TO IN THESE REGULATIONS UNLESS

THEY COMPLY WITH THE REQUIREMENTS LAID DOWN IN THESE REGULATIONS.

• WHOEVER CONTRAVENES THE PROVISIONS OF THESE REGULATIONS SHALL BE LIABLE FOR
wwwP.DuUloMNixI.cSomHMENT. 37

 

CLAIMS.

• THE HEALTH CLAIM IN RESPECT OF AN ARTICLE OF FOOD MAY INCLUDE THE FOLLOWING TYPES,

BUT NOT LIMITED TO

• (I) INGREDIENTS (NUTRIENT OR NUTRITIONAL) FUNCTION CLAIMS;

• (II) ENHANCED FUNCTION CLAIMS;

• (III) DISEASE RISK REDUCTION CLAIMS;

• (IV) HEALTH MAINTENANCE CLAIMS;

• (V) IMMUNITY CLAIMS – INCREASED RESISTANCE (EXCLUDING VACCINES); AND

• (VI) ANTI-AGEING CLAIMS.

www.DuloMix.com 38

 

GENERAL PRINCIPLES FOR QUERY OR CHALLENGE.-

• THE FOOD BUSINESS OPERATOR SHALL-

• (I) PREPARE AND MAKE AVAILABLE THE COMPREHENSIVE PRODUCT INFORMATION, SAFETY AND

CLAIMS SUPPORT DATA AND SHALL PERIODICALLY GET IT REVIEWED AND SCRUTINISED BY A

SCIENTIST OR EXPERT WITH RELEVANT QUALIFICATIONS AND EXPERIENCE;

• (II) ATTACH THE SCIENTIFIC VIEW OF THE REVIEWER ON CLAIMS AND ITS VERACITY ALONG

WITH THE QUALIFICATION AND EXPERIENCE OF THE REVIEWER AS AN ESSENTIAL PART OF THE

DOCUMENT;

• (III) CLARIFY, IN CASE OF A TECHNICAL QUERY FROM THE FOOD AUTHORITY OR ON A PUBLIC

COMPLAINT LODGED WITH THE FOOD AUTHORITY, AND ASSIST THE FOOD AUTHORITY TO

EXAMINE OR AUTHORISE AN APPROPRIATE EXPERT GROUP TO REVIEW THE CASE; AND

• (IV) ALTER OR MODIFY OR STOP CLAIM WHEN DIRECTED BY THE FOOD AUTHORITY WHICH
www.DuloMix.com 39

SHALL BE BASED ON THE OPINION OF AN EXPERT GROUP.

 

HEALTH SUPPLEMENTS.-

• (I) USED TO SUPPLEMENT THE NORMAL DIET OF A PERSON ABOVE THE AGE OF FIVE YEARS.

• (II) SHALL CONTAIN CONCENTRATED SOURCE OF ONE OR MORE NUTRIENTS, (AMINO ACIDS,

ENZYMES, MINERALS, PROTEINS, VITAMINS, OTHER DIETARY SUBSTANCES, PLANTS OR BOTANICALS,

PREBIOTICS, PROBIOTICS AND SUBSTANCES FROM ANIMAL ORIGIN OR OTHER SIMILAR SUBSTANCES

OTHER THAN SUBSTANCES DEFINED AS DRUGS.

• (III) SHALL BE MARKETED IN SINGLE USE PACKAGING IN DOSAGE FORMS NAMELY, CAPSULES,

TABLETS, PILLS, SACHETS; JELLY OR GEL, SEMI-SOLIDS AND OTHER SIMILAR FORMS OR ANY OTHER

FORMS OF LIQUIDS AND POWDERS DESIGNED TO BE TAKEN IN MEASURED UNIT QUANTITIES.

• (IV) SHALL NOT INCLUDE ANY OF THE FOOD PRODUCTS OR CATEGORIES OF ARTICLES OF FOOD

FOR WHICH SPECIFIC STANDARDS HAVE BEEN LAID DOWN IN ANY OTHER PARTS OF THESE

REGULATIONS.
www.DuloMix.com 40

 

HEALTH SUPPLEMENTS.-

• (I) SHALL CONTAIN ANY OF THE INGREDIENTS SPECIFIED IN SCHEDULE I OR SCHEDULE II OR

SCHEDULE IV OR SCHEDULE VII OR SCHEDULE VIII OR ENZYMES ONLY OF SCHEDULE VI.

• (II) THE INGREDIENTS SPECIFIED MAY BE USED IN MANUFACTURING OF HEALTH SUPPLEMENTS

WITHOUT MODIFICATIONS FOR ONE OR MORE OF THESE NUTRIENTS RENDERED NECESSARY BY THE

INTENDED USE OF THE PRODUCT.

• (III) THE QUANTITY OF NUTRIENTS ADDED TO THE ARTICLES OF FOOD SHALL NOT EXCEED THE

RECOMMENDED DAILY ALLOWANCE.

• (IV) THE FOOD BUSINESS OPERATOR SHALL APPLY TO THE FOOD AUTHORITY FOR INCLUSION OF

ANY NEW NUTRIENT WHICH HAS NO HISTORY OF USE IN INDIA.

• (V) THE FOOD AUTHORITY MAY, AFTER PROPER SCIENTIFIC EVALUATION, SPECIFY THE NUTRIENTS

AwPwwP.DRuloOMixV.coEmD BY IT FROM TIME TO TIME. 41

 

HEALTH SUPPLEMENTS(LABELLING)-

• (I) THE LABELLING, PRESENTATION AND ADVERTISEMENT SHALL NOT CLAIM THAT THE HEALTH

SUPPLEMENT HAS THE PROPERTY OF PREVENTING, TREATING OR CURING A HUMAN DISEASE.

• (II) THE STATEMENT BY THE FOOD BUSINESS OPERATOR RELATING TO THE STRUCTURE OR FUNCTION

OR THE GENERAL WELL BEING OF THE BODY MAY BE ALLOWED BY THE FOOD AUTHORITY IF THE

STATEMENT IS SUPPORTED BY THE GENERALLY ACCEPTED SCIENTIFIC DATA;

• (III) EVERY PACKAGE OF HEALTH SUPPLEMENT SHALL CARRY THE FOLLOWING INFORMATION ON THE

LABEL, NAMELY.-

• (A) THE WORDS “HEALTH SUPPLEMENT”;

• (B) THE COMMON NAME OF THE HEALTH SUPPLEMENT,

• (C) A DECLARATION AS TO THE AMOUNT OF THE NUTRIENTS OR SUBSTANCES WITH A NUTRITIONAL

OR PHYSIOLOGICAL EFFECT PRESENT IN THE PRODUCT;

www.DuloMix.com 42

 

HEALTH SUPPLEMENTS(LABELLING)-
• (D) AN ADVISORY WARNING ‘NOT FOR MEDICINAL USE’ PROMINENTLY WRITTEN;

• (E) THE QUANTITY OF NUTRIENTS, IN TERMS OF PERCENTAGE OF THE RELEVANT
RECOMMENDED DAILY ALLOWANCES AND BEAR A WARNING, “NOT TO EXCEED THE
RECOMMENDED DAILY USAGE”;

• (F) A STATEMENT THAT THE HEALTH SUPPLEMENT IS NOT BE USED AS A SUBSTITUTE FOR A
VARIED DIET;

• (G) A WARNING OR ANY OTHER PRECAUTIONS TO BE TAKEN WHILE CONSUMING, KNOWN
SIDE EFFECTS, IF ANY, CONTRAINDICATIONS, AND PUBLISHED PRODUCT OR DRUG
INTERACTIONS, AS APPLICABLE; AND

• (H) A STATEMENT THAT THE PRODUCT IS REQUIRED TO BE STORED OUT OF REACH OF
CHILDREN.

• (4) ADDITIVES USED FOR HEALTH SUPPLEMENT FORMULATION AS SPECIFIED IN SCHEDULE VA
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OR SCHEDULE VE OR SCHEDULE VF.

 

NUTRACEUTICALS.–

• (1) (I) SHALL PROVIDE A PHYSIOLOGICAL BENEFIT AND HELP MAINTAIN GOOD HEALTH.

• (II) A FOOD BUSINESS OPERATOR MAY EXTRACT, ISOLATE AND PURIFY NUTRACEUTICALS FROM

FOOD OR NON-FOOD SOURCES, THAT IS PREPARING AMINO ACIDS AND THEIR DERIVATIVES BY

BACTERIAL FERMENTATION UNDER CONTROLLED CONDITIONS.

• (III) A FOOD BUSINESS OPERATOR MAY PREPARE AND SELL THE NUTRACEUTICALS IN THE FOOD-

FORMAT OF GRANULES, POWDER, TABLET, CAPSULE, LIQUID, JELLY OR GEL, SEMI-SOLIDS AND OTHER

FORMATS AND MAY BE PACKED IN SACHET, AMPOULE, BOTTLE, AND IN ANY OTHER FORMAT AS

MEASURED UNIT QUANTITIES EXCEPT THOSE FORMATS THAT ARE MEANT FOR PARENTERAL

ADMINISTRATION.

www.DuloMix.com 44

 

NUTRACEUTICALS.–

• (2) (I) THE NUTRACEUTICALS SHALL CONTAIN ANY OF THE INGREDIENTS SPECIFIED IN SCHEDULE. (I
OR SCHEDULE II OR SCHEDULE IV OR SCHEDULE VI OR SCHEDULE VII OR SCHEDULE VIII).

• (II) A FBO MAY USE INGREDIENTS SPECIFIED IN THE SCHEDULES RENDERED NECESSARY BY THE
INTENDED USE OF THE PRODUCT;

• (III) THE QUANTITY OF NUTRIENTS, SHALL NOT EXCEED THE RECOMMENDED DAILY ALLOWANCE.

• (IV) A NUTRACEUTICAL WHICH IS NOT PROVIDED IN THESE REGULATIONS BUT ITS SAFETY HAS BEEN
ESTABLISHED IN INDIA OR IN ANY OTHER COUNTRY, SHALL BE MANUFACTURED OR SOLD IN INDIA
ONLY ON PRIOR APPROVAL OF THE FOOD AUTHORITY;

• (V) FBO SHALL APPLY TO THE FOOD AUTHORITY FOR APPROVAL WHICH SHALL BE ACCOMPANIED BY

DOCUMENTED HISTORY OF USAGE OF AT LEAST FIFTEEN YEARS IN INDIA, OR THIRTY YEARS IN THE
COUNTRY OF ORIGIN;

• (VwwIw). DTuloHMiEx. coFmOOD AUTHORITY MAY FROM TIME TO TIME SPECIFY THE NUTRACEUTICALS AS APPROVE4D5
BY IT AFTER UNDERTAKING PROPER SCIENTIFIC EVALUATION

 

NUTRACEUTICALS.–

• (3) (I) NO INGREDIENT OTHER THAN THOSE SPECIFIED IN SCHEDULE VI SHALL BE USED AS NUTRACEUTICAL
AT DAILY USAGE LEVELS SPECIFIED THEREIN;

• (II) THE INGREDIENT FOR WHICH THE STANDARDISATION OF THE MARKER COUMPOUND HAS NOT BEEN
SPECIFIED SHALL COMPLY WITH MANUFACTURER SPECIFICATIONS OR QUALITY REQUIREMENTS AND
PURITY CRITERIA AS SPECIFIED IN REGULATION;

• (III) FOR THE INGREDIENT FOR WHICH THE DAILY MINIMUM AND MAXIMUM USAGE LEVELS HAVE NOT
BEEN SPECIFIED, FBO SHALL ADOPT THE USAGE LEVEL BASED ON RELEVANT SCIENTIFIC DATA AND RETAIN
THE DOCUMENTARY EVIDENCE OF SUCH DATA;

• (IV) FOOD BUSINESS OPERATOR SHALL SUBMIT THE DOCUMENTED SCIENTIFIC DATA TO THE FOOD
AUTHORITY AS AND WHEN CALLED FOR;

• (V) NO FOOD BUSINESS OPERATOR SHALL USE THE EXTRACT OF INGREDIENT AS NUTRACEUTICAL OTHER
THAN THAT SPECIFIED IN SCHEDULE IV;

• PROVIDED THAT THE INGREDIENT OF PLANT OR BOTANICAL ORIGIN SPECIFIED IN SCHEDULE IV AND
www.DuloMix.com 46

SCHEDULE VI MAY BE USED EITHER IN THE GIVEN FORM, OR THEIR EXTRACT, SUBJECT TO THE EXTRACTIVE
RATIOS IN RELATION TO THE DAILY USAGE VALUE.

 

NUTRACEUTICALS(LABELLING)

• (4) (I) THE LABELLING, PRESENTATION AND ADVERTISEMENT SHALL NOT CLAIM THAT THE

NUTRACEUTICAL HAS THE PROPERTY OF PREVENTING, TREATING OR CURING A HUMAN DISEASE, OR

REFER TO SUCH PROPERTIES;

• (II) THE STATEMENT RELATING TO THE STRUCTURE OR FUNCTION OR THE GENERAL WELL-BEING OF

THE BODY MAY BE ALLOWED BY THE FOOD AUTHORITY, IF THE STATEMENT IS SUPPORTED BY THE

GENERALLY ACCEPTED SCIENTIFIC DATA;

• (III) EVERY PACKAGE OF FOOD CONTAINING NUTRACEUTICAL SHALL CARRY THE FOLLOWING

INFORMATION ON THE LABEL, NAMELY:-

• (A) THE WORD “NUTRACEUTICAL”;

• (B) THE COMMON NAME OF THE NUTRACEUTICAL;

• (Cww)w .DAul oMDixE.coCmLARATION AS TO THE AMOUNT OF EACH NUTRACEUTICAL INGREDIENT IN THE PRODUCT47

THAT EITHER HAS A NUTRITIONAL OR PHYSIOLOGICAL EFFECT;

 

NUTRACEUTICALS(LABELLING)

• (D) THE QUANTITY OF NUTRIENT SHALL BE EXPRESSED IN TERMS OF PERCENTAGE OF THE

RELEVANT RECOMMENDED DAILY ALLOWANCES AND SHALL BEAR AN ADVISORY WARNING

‘NOT TO EXCEED THE STATED RECOMMENDED DAILY USAGE’;

• (E) AN ADVISORY WARNING FOR ‘RECOMMENDED USAGE’ ;

• (F) AN ADVISORY WARNING ‘NOT FOR MEDICINAL USE’ PROMINENTLY WRITTEN;

• (G) AN ADVISORY WARNING IN CASES WHERE A DANGER MAY EXIST WITH EXCESS

CONSUMPTION;

• (H) AN ADVISORY WARNING OR ANY OTHER PRECAUTIONS TO BE TAKEN WHILE

CONSUMING, KNOWN SIDE EFFECTS, IF ANY, CONTRAINDICATIONS, AND PRODUCT-DRUG

INTERACTIONS, AS APPLICABLE;

•www(.DI)ul oAMix .ScomTATEMENT THAT THE PRODUCT IS REQUIRED TO BE STORED OUT OF REACH OF CHILDREN48

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND
THOSE PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL

ADVICE. –
• (1) NO FBO SHALL MANUFACTURE, FORMULATE OR PROCESS AN ARTICLE OF FOOD FOR SPECIAL

DIETARY USE UNLESS-

• (I) SPECIALLY PROCESSED OR FORMULATED TO SATISFY PARTICULAR DIETARY REQUIREMENTS WHICH

MAY EXIST OR ARISE BECAUSE OF CERTAIN PHYSIOLOGICAL OR SPECIFIC HEALTH CONDITIONS,

NAMELY:-

• (A) LOW WEIGHT, OBESITY, DIABETES, HIGH BLOOD PRESSURE;

• (B) PREGNANT AND LACTATING WOMEN; AND

• (C) GERIATRIC POPULATION AND CELIAC DISEASE AND OTHER HEALTH CONDITIONS.

• (II) THE FOOD BUSINESS OPERATOR SHALL CLEARLY INDICATE ON THE LABEL WHETHER OR NOT THE

FOOD FOR SPECIAL DIETARY USE IS TO BE TAKEN UNDER MEDICAL ADVICE;
www.DuloMix.com 49

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND
THOSE PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL

ADVICE. –

• (III) A FOOD BUSINESS OPERATOR MAY MANUFACTURE OR SELL AN ARTICLE OF FOOD FOR
SPECIAL DIETARY USE IN SINGLE USE PACKAGING OR IN DOSAGE FORM, NAMELY, GRANULES,
CAPSULES, TABLETS, PILLS, JELLY, SEMI-SOLID AND OTHER SIMILAR FORMS, SACHETS OF
POWDER, OR ANY OTHER SIMILAR FORMS OF LIQUIDS AND POWDERS.

• (IV) A FBO MAY FORMULATE AN ARTICLE OF FOOD FOR SPECIAL DIETARY USE IN FORMATS
MEANT FOR ORAL FEEDING THROUGH A ENTERAL TUBES BUT SHALL NOT BE USED FOR
PARENTERAL USE;

• (V) AN ARTICLE OF FOOD FOR SPECIAL DIETARY USE SHALL NOT INCLUDE THE NORMAL FOOD
ENRICHED OR MODIFIED WITH NUTRIENTS.

www.DuloMix.com 50

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND
THOSE PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL

ADVICE. –

• (I) SHALL CONTAIN ANY OF THE INGREDIENTS SPECIFIED IN SCHEDULES I OR SCHEDULE II OR

SCHEDULE III OR SCHEDULE IV OR SCHEDULE VI OR SCHEDULE VII OR SCHEDULE VIII.

• (II) A FBO MAY USE THE INGREDIENTS SPECIFIED IN THE SCHEDULES IN MANUFACTURING FOOD FOR

SPECIAL DIETARY USE.

• (III) FOR ANY NEW NUTRIENT, WHICH HAS NO HISTORY OF USE IN INDIA OR THAT WITHOUT A

PROOF ESTABLISHING THAT THE NUTRIENT MAY RESULT IN CERTAIN NUTRITIONAL AND

PHYSIOLOGICAL BENEFITS, FBO SHALL APPLY TO THE FOOD AUTHORITY WITH JUSTIFICATION FOR

APPROVAL, AND THE FOOD AUTHORITY MAY, FROM TIME TO TIME SPECIFY THE NUTRIENTS

APPROVED BY IT AFTER PROPER SCIENTIFIC EVALUATION.

• (IV) A FBO MAY ADD THE QUANTITY OF THE NUTRIENTS AT A LEVEL HIGHER THAN THE

RECOMMENDED DAILY ALLOWANCE, BUT NOT EXCEEDING THE LIMITS OF VITAMINS AND MINERALS
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SPECIFIED IN SCHEDULE III.

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND
THOSE PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL

ADVICE. –

• (V) (I) THE ARTICLES OF FOOD USED AS A FORMULA FOOD PRESENTED AS A REPLACEMENT FOR ALL MEALS OF THE
DAILY DIET FOR SLIMMING, WEIGHT MANAGEMENT AND WEIGHT CONTROL PURPOSES SHALL COMPLY WITH THE
FOLLOWING, NAMELY:-

• (A) PROVIDE ENERGY NOT LESS THAN 800 KCAL (3,350 KJ) AND NOT MORE THAN 1,200 KCAL (5,020 KJ);

• (B) THE INDIVIDUAL PORTIONS OR SERVINGS CONTAINED IN THE FORMULA FOOD SHALL PROVIDE APPROXIMATELY
ONE-THIRD OR ONE-FOURTH OF THE TOTAL ENERGY OF THE FOOD IN THE PACK DEPENDING ON WHETHER THE
RECOMMENDED NUMBER OF PORTIONS OR SERVINGS PER DAY IS THREE OR FOUR, AS THE CASE MAY BE,
RESPECTIVELY.

• (II) A FORMULA FOOD PRESENTED AS A REPLACEMENT FOR ONE OR MORE MEALS OF THE DAILY DIET SHALL COMPLY
WITH THE FOLLOWING, NAMELY:-

• (A) PROVIDE ENERGY NOT LESS THAN 200 KCAL (835 KJ) AND NOT MORE THAN 400 KCAL (1,670 KJ) PER MEAL;

• (B) WHEN SUCH PRODUCTS ARE PRESENTED AS A REPLACEMENT FOR THE MAJOR PART OF THE DIET, THE TOTAL
ENERGY INTAKE SHALL NOT EXCEED 1,200 KCAL (5,020 KJ).

• (III) NOT LESS THAN TWENTY FIVE PER CENT AND NOT MORE THAN FIFTY PER CENT OF THE ENERGY AVAILABLE FROM
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THE FOOD, WHEN READY-TO-SERVE, SHALL BE DERIVED FROM ITS PROTEIN CONTENT AND THE TOTAL AMOUNT OF
PROTEIN SHALL NOT EXCEED 125 G PER DAY.

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND THOSE
PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL ADVICE. –

• (IV) THE QUALITY OF PROTEIN SHALL HAVE-

• (A) THE PROTEIN DIGESTIBILITY CORRECTED AMINO ACID SCORE OF 1.0 KNOWN AS, THE REFERENCE PROTEIN;

• (B) THE PROTEIN DIGESTIBILITY CORRECTED AMINO ACID SCORE WHERE LESS THAN 1.0, THE MINIMUM LEVEL SHALL BE
INCREASED TO COMPENSATE FOR THE LOWER PROTEIN QUALITY;

• (C) THE PROTEIN WITH A PROTEIN DIGESTIBILITY CORRECTED AMINO ACID SCORE OF 0.8 OR MORE SHALL BE USED IN
A FORMULA FOOD FOR USE IN A WEIGHT CONTROL DIET; AND

• (V) FOR IMPROVING THE PROTEIN QUALITY, THE FOOD BUSINESS OPERATOR SHALL ADD ONLY L- FORMS OF
ESSENTIAL AMINO ACIDS EXCEPT FOR METHIONINE WHERE DL FORM IS ALLOWED.

• (VI) NOT MORE THAN THIRTY PER CENT OF THE ENERGY AVAILABLE FROM FAT AND NOT LESS THAN THREE PER CENT
OF THE ENERGY FROM LINOLEIC ACID IN THE FORM OF A GLYCERIDE.

• (VII) A FORMULA FOOD REPRESENTED AS A REPLACEMENT FOR ALL MEALS PER DAY, SHALL NOT HAVE LESS THAN A
HUNDRED PER CENT OF THE RECOMMENDED DAILY ALLOWANCE OF VITAMINS AND MINERALS IN THE DAILY INTAKE.

• (VwwIIwI.)D uTloHMiEx. cFomORMULA FOOD FOR SPECIAL DIETARY USE SHALL HAVE ADEQUATE DIETARY FIBER. 53

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND THOSE
PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL ADVICE. –

• (3) (I) NO STATEMENT OR CLAIM SHALL BE MADE ON THE LABEL IMPLYING PREVENTION, CURE OR
TREATMENT OF ANY SPECIFIC DISEASE OR ITS DIAGNOSIS OR OTHERWISE PREVENTING OR INTERFERING
WITH THE NORMAL OPERATION OF A PHYSIOLOGICAL FUNCTION, WHETHER PERMANENTLY OR
TEMPORARILY, UNLESS OTHERWISE APPROVED BY THE FOOD AUTHORITY;

• (II) THE STATEMENT BY THE FOOD BUSINESS OPERATOR RELATING TO THE STRUCTURE OR FUNCTION OR
THE GENERAL WELL-BEING OF THE BODY MAY BE ALLOWED BY THE FOOD AUTHORITY, IF THE STATEMENT
IS SUPPORTED BY THE GENERALLY ACCEPTED SCIENTIFIC DATA;

• (III) EVERY PACKAGE CONTAINING FOOD FOR SPECIAL DIETARY USE SHALL CARRY THE FOLLOWING
INFORMATION ON THE LABEL, NAMELY:-

• (A) THE WORDS “FOOD FOR SPECIAL DIETARY USE” FOLLOWED BY “FOOD FOR………” (MENTIONING THE
PARTICULAR PHYSIOLOGICAL OR HEALTH CONDITION)”;

• (B) A STATEMENT “FOR WEIGHT CONTROL AND MANAGEMENT” IN CLOSE PROXIMITY TO THE NAME OF
THE ARTICLES OF FOOD SPECIALLY PREPARED FOR WEIGHT MANAGEMENT AND CONTROL;

www.DuloMix.com 54
• (C) A STATEMENT THAT THE PRODUCT IS NOT TO BE USED BY PREGNANT, NURSING AND LACTATING

WOMEN OR BY INFANTS, CHILDREN, ADOLESCENTS AND ELDERLY, EXCEPT WHEN MEDICALLY ADVISED;

 

FOOD FOR SPECIAL DIETARY USE, OTHER THAN INFANTS, AND THOSE
PRODUCTS INTENDED TO BE TAKEN UNDER MEDICAL ADVICE. –

• (D) A STATEMENT ON THE TARGET CONSUMER GROUP, RATIONALE FOR USE OF THE PRODUCT AND A DESCRIPTION
OF THE PROPERTIES OR CHARACTERISTICS THAT MAKE IT USEFUL;

• (E) IF THE PRODUCT HAS BEEN FORMULATED FOR A SPECIFIC AGE GROUP, A PROMINENT STATEMENT TO THAT EFFECT;

• (F) A STATEMENT SPECIFYING THE NUTRIENT WHICH IS REDUCED, DELETED, INCREASED OR OTHERWISE MODIFIED,
RELATING TO NORMAL REQUIREMENT, AND THE RATIONALE FOR THE REDUCTION, DELETION, INCREASE OR OTHER
MODIFICATION;

• (G) AN ADVISORY WARNING ‘NOT FOR MEDICINAL USE’ PROMINENTLY WRITTEN;

• (H) A WARNING IN CASES WHERE A DANGER MAY EXIST WITH EXCESS CONSUMPTION;

• (I) A WARNING THAT THE PRODUCT IS NOT FOR PARENTERAL USE;

• (J) A WARNING OR ANY OTHER PRECAUTIONS TO BE TAKEN WHILE CONSUMING, KNOWN SIDE EFFECTS, IF ANY,
CONTRAINDICATIONS, AND PRODUCT-DRUG INTERACTIONS, AS APPLICABLE;

• (K) THE QUANTITY OF NUTRIENTS EXPRESSED IN TERMS OF PERCENTAGE OF THE RECOMMENDED DAILY ALLOWANCE
WHERE IT IS APPROPRIATE;

www.DuloMix.com 55
• (L) INFORMATION ON OSMOLALITY OR OSMOLARITY OR ON ACID-BASE BALANCE WHERE APPROPRIATE; AND

• (M) A STATEMENT THAT THE PRODUCT SHALL BE STORED OUT OF REACH OF CHILDREN.

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (1) (I) FOOD FOR SPECIAL MEDICAL PURPOSE SHALL INCLUDE FOOD SPECIALLY PREPARED FOR

WEIGHT REDUCTION AND INTENDED AS TOTAL REPLACEMENT OF NORMAL DIET.

• (II) A FOOD BUSINESS OPERATOR MAY FORMULATE FOOD FOR SPECIAL MEDICAL PURPOSE IN

FORMAT MEANT FOR ORAL FEEDING THROUGH A ENTERAL TUBES.

• (III) THE ARTICLES OF FOOD FOR SPECIAL MEDICAL PURPOSE SHALL NOT BE USED FOR PARENTERAL

USE.

• (IV) THE ARTICLES OF FOOD FOR SPECIAL MEDICAL PURPOSE, OTHER THAN THOSE INTENDED FOR

INFANTS, MAY EITHER BE NUTRITIONALLY COMPLETE FOOD WHICH, WHEN USED IN ACCORDANCE

WITH THE MANUFACTURER’S INSTRUCTIONS, SHALL CONSTITUTE THE SOLE SOURCE OF

NOURISHMENT FOR THE PERSONS FOR WHOM THEY ARE INTENDED OR NUTRITIONALLY

INCOMPLETE FOOD WITH FORMULATION SPECIFIC FOR A DISEASE, DISORDER OR MEDICAL
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CONDITION, BUT ARE NOT SUITABLE TO BE USED AS THE SOLE SOURCE OF NOURISHMENT.

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (V) FOR THE PURPOSES OF THESE REGULATIONS, THE FOOD FOR SPECIAL MEDICAL PURPOSE MAY BE

CLASSIFIED IN TO FOLLOWING THREE CATEGORIES, NAMELY:-

• (A) ‘NUTRITIONALLY COMPLETE FOOD WITH A STANDARD NUTRIENT FORMULATION’, WHICH WHEN

USED IN ACCORDANCE WITH THE MANUFACTURER’S INSTRUCTIONS, MAY CONSTITUTE THE SOLE

SOURCE OF NOURISHMENT FOR THE PERSONS FOR WHOM THEY ARE INTENDED;

• (B) ‘NUTRITIONALLY COMPLETE FOOD WITH A NUTRIENT-ADOPTED FORMULATION SPECIFIC FOR A

DISEASE, DISORDER OR MEDICAL CONDITION’, WHICH WHEN USED IN ACCORDANCE WITH THE

MANUFACTURER’S INSTRUCTIONS, MAY CONSTITUTE THE SOLE SOURCE OF NOURISHMENT FOR THE

PERSONS FOR WHOM THEY ARE INTENDED; AND

• (C) ‘NUTRITIONALLY INCOMPLETE FOOD WITH A STANDARD FORMULATION OR A NUTRIENT-

ADOPTED FORMULATION SPECIFIC FOR A DISEASE, DISORDER OR MEDICAL CONDITION’, WHICH IS
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NOT SUITABLE TO BE USED AS THE SOLE SOURCE OF NOURISHMENT.

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (2) (I) FOOD FOR SPECIAL MEDICAL PURPOSE SHALL CONTAIN ANY OF THE INGREDIENTS SPECIFIED

IN SCHEDULE I OR SCHEDULE II OR SCHEDULE III OR SCHEDULE IV OR SCHEDULE VII OR SCHEDULE VIII

OR ENZYMES ONLY OF SCHEDULE VI .

• (II) A FOOD BUSINESS OPERATOR SHALL USE ONLY THE INGREDIENTS SPECIFIED IN THE SCHEDULES

REFERRED TO IN CLAUSE (I) OF SUBREGULATION (2) IN MANUFACTURING FOOD FOR SPECIAL

MEDICAL PURPOSE WITHOUT PREJUDICE TO MODIFICATIONS FOR ONE OR MORE OF THESE

NUTRIENTS RENDERED NECESSARY BY THE INTENDED USE OF THE PRODUCT.

• (III) A FOOD BUSINESS OPERATOR MAY APPLY TO THE FOOD AUTHORITY FOR ANY NEW NUTRIENT,

WHICH HAS NO HISTORY OF USE IN INDIA OR THOSE WITHOUT PROOF ESTABLISHING THAT THE

NUTRIENT MAY RESULT IN CERTAIN NUTRITIONAL AND PHYSIOLOGICAL BENEFITS WITH

JUSTIFICATION FOR APPROVAL AND THE FOOD AUTHORITY MAY FROM TIME TO TIME SPECIFY THE

NwwUwT.DuRloIMEixN.coTmS APPROVED BY IT AFTER PROPER SCIENTIFIC EVALUATION. 58

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (IV) THE ARTICLES OF FOOD SPECIALLY PREPARED FOR WEIGHT REDUCTION AND INTENDED AS

TOTAL REPLACEMENT OF COMPLETE DIET SHALL, APART FROM COMPLYING WITH SCHEDULE III,

SHALL ALSO ENSURE THE FOLLOWING, NAMELY:-

• (A) THAT A FORMULA FOOD FOR VERY LOW ENERGY DIET IS PREPARED ACCORDING TO

INSTRUCTIONS, WITH A DAILY ENERGY INTAKE OF 450-800 KCAL AS THE ONLY SOURCE OF

ENERGY;

• (B) THAT NOT LESS THAN 50 G PROTEIN WITH A PROTEIN DIGESTIBILITY CORRECTED AMINO ACID

SCORE OF 1 IS PRESENT IN THE RECOMMENDED DAILY INTAKE OF ENERGY, AND ESSENTIAL AMINO

ACIDS MAY BE ADDED TO IMPROVE PROTEIN QUALITY ONLY IN AMOUNTS NECESSARY FOR THIS

PURPOSE;

• (C) FOR THE PURPOSES OF CLAUSE (B) THE FOOD BUSINESS OPERATOR SHALL ADD ONLY L- FORMS
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OF ESSENTIAL AMINO ACIDS EXCEPT FOR METHIONINE WHERE DL FORM IS ALLOWED.

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-
• (D) VERY LOW ENERGY DIET PROVIDES NOT LESS THAN-

• (I) 3 G OF LINOLEIC ACID; AND

• (II) 0.5 G Α-LINOLENIC ACID IN THE RECOMMENDED DAILY INTAKE WITH THE Α-LINOLEIC ACID

AND LINOLENIC ACID RATIO BETWEEN 1:5 AND 1:15;

• (E) VERY LOW ENERGY DIET PROVIDES NOT LESS THAN 50 G OF AVAILABLE CARBOHYDRATES

IN THE RECOMMENDED DAILY INTAKE OF ENERGY;

• (F) THAT THE FORMULA FOOD FOR SPECIAL MEDICAL PURPOSE HAVE ADEQUATE DIETARY FIBER.

• (V) IN FOOD FOR SPECIAL MEDICAL PURPOSE, NUTRIENTS MAY BE ADDED AT LEVELS HIGHER

THAN THE RECOMMENDED DAILY ALLOWANCE, BUT NOT EXCEEDING THE LIMITS OF VITAMINS

wwwA.DuNloMDix. coMm INERALS AS SPECIFIED IN SCHEDULE III. 60

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (3) EVERY PACKAGE OF FOOD FOR SPECIAL MEDICAL PURPOSE SHALL CARRY THE FOLLOWING
INFORMATION ON THE LABEL, NAMELY:-

• (A) THE WORDS ‘FOOD FOR SPECIAL MEDICAL PURPOSE’ PRINTED IN THE IMMEDIATE PROXIMITY OF THE
NAME OR BRAND NAME OF THE PRODUCT;

• (B) AN ADVISORY WARNING “RECOMMENDED TO BE USED UNDER MEDICAL ADVICE ONLY” APPEARING
ON THE LABEL IN BOLD LETTERS IN AN AREA SEPARATED FROM OTHER WRITTEN, PRINTED OR GRAPHIC
INFORMATION;

• (C) THE STATEMENT “FOR THE DIETARY MANAGEMENT OF ________” (WITH THE BLANK TO BE FILLED IN
WITH THE SPECIFIC DISEASE, DISORDEROR MEDICAL CONDITIONFOR WHICH THE PRODUCT IS INTENDED,
AND FOR WHICH IT HAS BEEN SHOWN TO BE EFFECTIVE) SUPPORTED BY APPROPRIATE SCIENTIFIC, AND
CLINICAL OR EPIDEMIOLOGICAL DATA, AND SUBJECT TO ITS APPROVAL BY THE FOOD AUTHORITY;

• (D) A STATEMENT ‘NUTRITIONALLY COMPLETE’ IF THE FOOD IS INTENDED TO BE USED AS A NUTRITIONALLY
COMPLETE FOOD;

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• (E) A STATEMENT ON THE RATIONALE FOR USE OF THE PRODUCT BY THE TARGET CONSUMER GROUP AND

A DESCRIPTION OF THE PROPERTIES OR CHARACTERISTICS THAT MAKE IT USEFUL;

 

FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (F) A STATEMENT IF THE PRODUCT HAS BEEN FORMULATED FOR A SPECIFIC AGE GROUP;

• (G) A STATEMENT SPECIFYING THE NUTRIENT WHICH HAVE BEEN REDUCED, DELETED, INCREASED OR

OTHERWISE MODIFIED, RELATIING TO NORMAL REQUIREMENTS, AND THE RATIONALE FOR THE

REDUCTION, DELETION, INCREASE OR OTHER MODIFICATION;

• (H) THE QUANTITY OF NUTRIENTS EXPRESSED IN TERMS OF PERCENTAGES OF THE RECOMMENDED

DAILY ALLOWANCES, WHERE IT IS APPROPRIATE;

• (I) INFORMATION ON OSMOLALITY OR OSMOLARITY, RENAL SOLUTE LOAD, POTENTIAL RENAL

SOLUTE LOAD OR ACID-BASE BALANCE, WHEREVER APPLICABLE;

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FOOD FOR SPECIAL MEDICAL PURPOSE.-

• (J) INSTRUCTIONS FOR APPROPRIATE PREPARATION, FEEDING, USE AND STORAGE OF THE PRODUCT
AFTER THE OPENING OF THE CONTAINER;

• (K) A WARNING THAT THE PRODUCT IS NOT FOR PARENTERAL USE; AND

• (L) A STATEMENT THAT THE PRODUCT REQUIRED TO BE STORED OUT OF REACH OF CHILDREN.

• (4) NO FOOD BUSINESS OPERATOR SHALL USE ADDITIVES FOR FOOD FOR SPECIAL MEDICAL
PURPOSE EXCEPT THOSE SPECIFIED IN SCHEDULE VC OR SCHEDULE VD OR SCHEDULE VE OR
SCHEDULE VF.

• (5) NO FOOD BUSINESS OPERATOR SHALL ADVERTISE THE FOOD FOR SPECIAL MEDICAL PURPOSE
FOR USE BY GENERAL PUBLIC.

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SCHEDULES

• SCHEDULE I -LIST OF VITAMINS AND MINERALS AND THEIR COMPONENTS

• SCHEDULE II -LIST OF AMINO ACIDS AND OTHER NUTRIENTS

• SCHEDULE III- VALUES FOR VITAMINS, MINERALS AND TRACE ELEMENTS ALLOWED TO BE USED IN FOOD FOR SPECIAL
DIETARY USE AND FOOD FOR SPECIAL MEDICAL PURPOSE (OTHER THAN THOSE INTENDED FOR USE IN INFANT
FORMULA) (RDA)

• SCHEDULE IV -LIST OF PLANT OR BOTANICAL INGREDIENTS

• SCHEDULE VA- LIST OF FOOD ADDITIVES FOR HEALTH SUPPLEMENTS, NUTRACEUTICALS AND FOOD WITH ADDED
PROBIOTICS AND PREBIOTICS

• SCHEDULE VB- LIST OF FOOD ADDITIVES FOR FOODS FOR SPECIAL DIETARY USE AND FOOD WITH ADDED
PROBIOTICS AND PREBIOTICS

• SCHEDULE VC- LIST OF FOOD ADDITIVES FOR FOODS FOR SPECIAL MEDICAL PURPOSE (OTHER THAN THOSE
PRODUCTS INTENDED FOR FOODS FOR INFANTS) AND FOOD WITH ADDED PROBIOTICS AND PREBIOTICS

• SwCwHw.DEuDloMUixL.cEom VD – LIST OF FOOD ADDITIVES FOR FOODS FOR SPECIAL MEDICAL PURPOSE (OTHER THAN THOSE 64

INTENDED FOR INFANT FOODS); FORMULA FOR SLIMMING PURPOSE AND WEIGHT REDUCTION AND FOOD WITH
ADDED PROBIOTICS AND PREBIOTICS

 

SCHEDULES
• SCHEDULE VE – LIST OF FOOD ADDITIVES TO BE USED (AT GMP LEVELS) FOR- (I)

NUTRACEUTICALS, (II) FOODS FOR SPECIAL DIETARY USE OTHER THAN FOODS FOR INFANTS,
(III) FOODS FOR SPECIAL MEDICAL PURPOSE, (IV) FOODS WITH ADDED PROBIOTIC
INGREDIENTS AND PREBIOTIC INGREDIENTS, (V) SPECIALTY FOODS CONTAINING PLANT OR
BOTANICAL INGREDIENTS, AND (VI) HEALTH SUPPLEMENTS

• SCHEDULE VF- LIST OF FOOD ADDITIVES TO BE USED IN FORMATS SUCH AS TABLETS,
CAPSULES AND SYRUPS (I) NUTRACEUTICALS, (II) FOODS FOR SPECIAL DIETARY USES OTHER
THAN FOODS FOR INFANTS, (III) FOODS FOR SPECIAL MEDICAL PURPOSE, (IV) FOODS WITH
ADDED PROBIOTIC INGREDIENTS AND PREBIOTIC INGREDIENTS, (V) SPECIALITY FOODS
CONTAINING PLANT OR BOTANICAL INGREDIENTS, AND (VI) HEALTH SUPPLEMENTS

• SCHEDULE VI -LIST OF INGREDIENTS AS NUTRACEUTICALS

• SCHEDULE VII- LIST OF STRAINS AS PROBIOTICS (LIVE MICRO-ORGANISMS)

• SCHEDULE VIII- LIST OF PREBIOTIC COMPOUNDS
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REGISTRATION PROCESS BY US FDA

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REGISTRATION PROCESS UNDER FSSR IN INDIA

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REGISTRATION PROCESS UNDER FSSR

In form C

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FOOD SAFETY AND STANDARDS (IMPORT)
REGULATIONS, 2017.

• NO PERSON SHALL IMPORT ANY ARTICLE OF FOOD WITHOUT AN IMPORT LICENSE FROM THE

CENTRAL LICENSING AUTHORITY

• NO ARTICLE OF FOOD SHALL BE CLEARED FROM THE CUSTOM UNLESS IT HAS A VALID SHELF

LIFE OF NOT LESS THAN SIXTY PER CENT AT THE TIME OF IMPORT.

• FOOD IMPORTER SHALL REGISTER HIMSELF WITH THE DIRECTORATE GENERAL OF FOREIGN

TRADE AND POSSESS VALID IMPORT-EXPORT CODE.

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IMPORT

• FOOD IMPORTER SHALL INFORM THE CENTRAL LICENSING AUTHORITY AND THE AUTHORISED
OFFICER OF ANY SUSPENSION, REVOCATION OR CANCELLATION OF THE CERTIFICATE OF
IMPORTER-EXPORTER CODE, GRANTED IN ITS FAVOUR BY THE DIRECTORATE GENERAL OF
FOREIGN TRADE NOT LATER THAN THREE WORKING DAYS FROM THE DATE OF SUCH ORDER
OF SUSPENSION, REVOCATION OR CANCELLATION.

• WHEN THE CERTIFICATE OF IMPORTER – EXPORTER CODE GRANTED BY THE DIRECTOR
GENERAL OF FOREIGN TRADE IS SUSPENDED, REVOKED OR CANCELLED, THE IMPORT LICENSE
GRANTED UNDER THE FOOD SAFETY AND STANDARDS (LICENSING AND REGISTRATION OF
FOOD BUSINESSES) REGULATIONS, 2011 SHALL BE DEEMED TO HAVE BEEN CANCELLED

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IMPORT
• UPON ARRIVAL OF THE FOOD CONSIGNMENTS IMPORTER/HIS AGENT SHALL FILE AN INTEGRATED DECLARATION

FORM SPECIFIED BY THE CUSTOMS.

• CUSTOMS TO FORWARD SAID FORM TO THE FOOD IMPORT CLEARANCE SYSTEM OF FOOD SAFETY AND STANDARDS
AUTHORITY OF INDIA.

• PROCESS BY FSSAI

• (A) AUTHORISED OFFICER SCRUTINISE THE FORM AND MAY SEEK CLARIFICATION IF REQUIRED;

• (B) UPON SATISFACTORY SCRUTINY, THE APPLICANT SHALL PAY THE FEES AS SPECIFIED BY THE FOOD AUTHORITY FOR
SCRUTINY OF DOCUMENTS, VISUAL INSPECTION AND DRAWING OF SAMPLE;

• (C) WHERE A SINGLE BILL OF ENTRY IS MADE UP OF ARTICLES OF FOOD CONSIGNMENT CONSISTING OF MULTIPLE
CATEGORIES OF ARTICLES OF FOOD, INSPECTION FEE SHALL BE PAID FOR EACH CATEGORY OF ARTICLES OF FOOD;

• (D) THE FOOD AUTHORITY SHALL SPECIFY AND REVIEW THE INSPECTION FEE FROM TIME TO TIME;

• (E) ON RECEIPT OF THE FEES, THE AUTHORISED OFFICER SHALL INTIMATE THE DETAILS OF DATE AND TIME OF
INwwSwP.DEulCoMTixI.OcomN TO THE FOOD IMPORTER TO FACILITATE THE PRESENCE OF THE FOOD IMPORTER OR HIS CUSTOM HO7U1 SE
AGENT/ AUTHORISED REPRESENTATIVE AT THE TIME AND PLACE OF INSPECTION.

 

IMPORT

• IMPORTER SHALL ASSIST IN INSPECTION, SAMPLING AND CLEARENCE PROCESS.

• VISUAL INSPECTION REPORT IN FORM I

• COMPLIANCE WITH STANDARDS FOR PACKAGING AND LABELLING .

• FOOD IMPORT CLEARANCE FOR SPECIFIC PURPOSES FOR PERSONAL USE SHALL SUBMIT THE

DECLARATION IN FORM- 7. FOOD ARTICLE IMPORTED IN BULK FOR RE-EXPORT AFTER

PROCESSING IMPORTER SHALL DECLARE IN FORM – 8 REGARDING THE CAPTIVE OR END USE

OF THE IMPORTED PRODUCT

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IMPORT

• THE CLEARANCE OF FOOD IMPORT FOR THE PURPOSES OF RESEARCH AND DEVELOPMENT

MAY BE ALLOWED SUBJECT TO –

• (A) THE IMPORT BEING UNDERTAKEN BY A LICENSED FOOD IMPORTER; (B) DECLARATION BY

THE FOOD IMPORTER IN FORM – 9 TO THE EFFECT THAT THE IMPORTED ARTICLES OF FOOD

SHALL BE UTILISED FOR AFORESAID PURPOSE ONLY;

• (C) NOT RELEASED INTO THE DOMESTIC MARKET OR USED FOR TEST MARKETING OR MARKET

RESEARCH PURPOSES.

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IMPORT

• STORAGE FACILITIES FOR IMPORTED FOODS – (1) NO CONSIGNMENT OF FOOD ARTICLES SHALL BE

STORED IN A MANNER THAT ONE TYPE OF ARTICLES OF FOOD COME IN CONTACT WITH OTHER

TYPE OF ARTICLES OF FOOD.

• STORED IN ACCORDANCE WITH THE SPECIFIED STORAGE CONDITIONS

• THE PORT AUTHORITIES AND CUSTODIAN OF FREIGHT STATIONS SHALL ENSURE ADEQUATE AND

CONDUCIVE STORAGE INFRASTRUCTURE

• IN CASE OF IMPORTED ARTICLE OF FOOD WHICH REQUIRES SPECIAL STORAGE CONDITION, THE

AUTHORISED OFFICER SHALL VERIFY THE TRUE STORAGE CONDITIONS REQUIRED FOR THE

CONSIGNMENT.

• THE AUTHORISED OFFICER MAY ISSUE A NO OBJECTION CERTIFICATE TO THE IMPORTER IF HE IS

SATISFIED ON THE BASIS OF THE ANALYSIS REPORT CONFORMING TO STANDARDS.

• THE IMPORTER OR CUSTOMS SHALL ENSURE SALE ONLY AFTER CLEARANCE BASED ON NO
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OBJECTION CERTIFICATE.

 

IMPORT

• SAMPLING OF IMPORTED FOOD IN RESPECT OF IMPORTED ARTICLE OF FOOD.-

• SHALL HAVE VALID BALANCE SHELF LIFE.

• SHALL DRAW TWO PARTS OF FOOD SAMPLE OF EACH DESCRIPTION OR MEASURES (EXCEPT FOR

ASEPTIC SEALED PACKAGES);

• FORWARD TO THE FOOD ANALYST SUCH QUANTITY OF SAMPLE AS SPECIFIED

• SEAL THE SAMPLES;

• ANALYSIS BY FOOD ANALYST

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DOCUMENTS TO BE ENCLOSED WITH NEW APPLICATION FOR
LICENSE/IMPORT LICENSE TO STATE/CENTRAL LICENSING

AUTHORITY
▪ FORM-A FORM B

▪ BLUEPRINT/LAYOUT PLAN OF THE PROCESSING UNIT

▪ LIST OF DIRECTORS

▪ NAME AND LIST MACHINERIES TO BE USED IN THE PROCESS

▪ PHOTO I.D AND ADDRESS PROOF

▪ LIST OF FOOD CATEGORY DESIRED TO BE MANUFACTURED.

▪ AUTHORITY LETTER WITH NAME AND ADDRESS OF RESPONSIBLE PERSON

▪ ANALYSIS REPORT

▪ PROOF OF POSSESSION OF PREMISES

▪ PARTNERSHIP DEED/AFFIDAVIT/MEMORANDUM & ARTICLES

▪ NOC FROM MANUFACTURER

▪ FOOD SAFETY MANAGEMENT SYSTEM PLAN OR CERTIFICATE

▪ SOURCE MATERIALS

▪ PESTICIDE RESIDUES REPORT OF WATER
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▪ RECALL PLAN

▪ NOCS