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Problems with AFCA - Artificial Colors, Additives &

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ARTIFICIAL COLORS, FLAVORS & ADDITIVESDo they matter ?

Dr. Gaurav Gupta, Pediatrician, Ex PGIMIAP, MAAP (USA),Consultant FORTIS, Charak Clinics

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HISTORY 1500.B.C.-Food & Drug

Colors.

Mid. of Ninteenth century-

Natural Sources.

20th - Synthetic Colors

(Aniline).

In 1975, Dr. Feingold

proposed link between food

additives and hyperactivity

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NEED FOR COLORS & FLAVORS

Psychological Benefits

Maintain product consistency

Identification - Manufacturing &

Distribution

Reduce contamination risk

Unattractive medication –

Acceptable.

Patient compliance – combination

of color and flavor.

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The GRAS list

Three classes of AFCA (Artificial Food Colors & Additives) – Colors, Additives, Flavors

The U.S. FDA has a list of food additives generally recognized as safe.

Regarded as safe by the scientific community. These substances are put on the GRAS list,

which contains approximately 700 items.

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Vulnerability in children

• Young children serve as first victims of any environmental contamination

• Immaturity of enzymatic detoxifying mechanism

• Incomplete excretory organs

• Partial development of physiological barriers (BBB).

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Most Important & well studied SIDE EFFECT OF ARTIFICIAL COLOURS

Attention Deficit Hyperactivity Disorder (ADHD)

Symptoms:Lack of concentration, distractibility, excitability, impulsiveness, temper tantrum, anxiety, antisocial behavior, difficulties with coordination, disabilities of both cognitive and learning functions.J.Human Nutr,34:167-174,1980 Report on Colour Additives. FACT, June, 1987

Pediatrics. 1978 Jun;61(6):811-7.

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School-going Hyperactive

ChildrenRestlessness, inattentive,

poor academic performance,

distractible, aggressive and

anti-social tendencies.

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What evidence have we got?

Do artificial food colors promote hyperactivity in children with hyperactive syndromes? A meta-analysis. Journal of Developmental & Behavioral Pediatrics. 2004

The effects of artificial food colourings and benzoate preservative challenge on hyperactivity in a general population sample of preschool children. Arch Dis Child. 2004

Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community. Lancet Nov 2007

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Interesting thing about these studies !

Preservatives used as a challenge…. sunset yellow, 5 mg; carmoisine, 2.5 mg; tartrazine, 7.5 mg; and ponceau 4R, 5 mg and 45 mg of sodium benzoate.

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What I found in my “samples”?Medicine Additive Company

Waltuz Br Tartrazine Wallace

Relent Sunset Yellow Dr. Reddy’s

Chericof Ponceau4R Ranbaxy

Zanocin Sunset Yellow Ranbaxy

Zithrox Sunset Yellow Macleods

Calcium Sandoz Sunset Yellow Novartis

Pedicloryl Sunset Yellow Dr. Reddy’s

Nizonide Ponceau4R Lupin

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The art of medicine consists of amusing the patient while nature cures the disease -- Voltaire

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OTHER SIDE EFFECTS

OF ARTIFICIAL

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1. Artificial colors cause skin rashes in Children.Clinical Pediatrics, Vol. 37, No. 10, 601-607 (1998)

2. Tartrazine, Erythrosine, Sunset yellow, Ponceu 4 R, Amaranth, Fast red E, Allura red, Brilliant Blue.

Inhibit mitochondrial respiration - Oxidative stress.The Chinese journal of physiology2001 Mar 31; 44(1):1-11.

Wei YH, Lu CY, Ma YS, Lee HC.3. Azo dyes (Amaranth & Sunset yellow) - Genotoxicity.

Environmental health perspectives 1994 October; 102(Suppl 6): 119–122.

4. Allergy to tartrazine in psychotropic drugs. The Journal of clinical psychiatry 2000 Jul;61(7):473-6

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Additive Made From Problems

Tartazine Coal Tar – Industrial Waste 1: 10,000 risk of UrticariaADHD, possible risk of cancer

Allergy

Quinoline Yellow Synthetic Coal Tar dye Asthma, ADHD, Rashes

Sunset Yellow Naphthalene-6-sulfonate Cancer risk, Nasal congestion, Asthma, decreased appetite

Amaranth Azo dye Asthma, Eczema, Hyperactivity. Birth Defects and Fetal Death!

Ponceau 4R Synthetic coal tar and azo dye

1:10,000 allergic, potential carcinogen

Erythrosine Coal Tar Sensitivity to light, learning difficulties, thyroid cancer.

Other uses: to kill maggots & flies!

Benzoic Acid Synthetic benzoin derivative

Hypersensitivity reaction, asthma, ? Neurological

http://mbm.net.au/health/guide.htm

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TARTRAZINE TERRORSCoal-tar – Industrial waste.

Hyperactivity/ADHD

Asthma, Urticaria, Angio-oedema . The Journal of asthma 1985;22(3):139-43.

Deficiency of Vitamin B6 and Zinc.

Migraine, Thyroid cancer, Eosinophilia, and Lupus.

Cross – sensitivity in Aspirin sensitive and NSAID

sensitive patients Allergy to tartrazine in psychotropic drugs J Clin Psychiatry. 2000 Jul;61(7):473-6

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Banned in USA, Austria and Norway.

Used in Febrex syrup, Ambrodil- S syrup, Shelcal kid, Tus-Q X syrup, etc.

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SUNSET YELLOW FCF Side Effects : Urticaria, rhinitis, nasal

congestion, allergy, hyperactivity, kidney tumours, abdominal cramps & Quincke’s oedema.

Usage is banned in Norway.

Present in Relent, Zanocin, Zithrox, Pedicloryl, Calcium Sandoz

Ref-Martindale,32nd Edition, pg 1001.

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CARMOISINE

Side Effects : Carcinogenic, Hyperactivity,Cross sensitivity with aspirin.

Contraindicated : AsthmaticsBanned in USA, Austria, Norway &

Sweden.Used- Calpol, Cobadex, Febrex plus

syrup & drops,etc.

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Inhibitor: Dopamine uptake - Hyperactivity

Side Effects: Childhood hyperactivity, Photosensitivity,

Erythroderma.

Banned in USA and Norway

Used in Shelcal suspension, Macalvit, Dexorange, etc.

ERYTHROSINE

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PONCEAU 4 R Animal study : Hepatoma, Reticulum cell sarcoma,

pulmonary lymphosarcoma, adenocarcinoma, mammary fibroadenoma.

Side Effect : Oxidative stress.

Banned in USA & Norway.

Used in Wikoryl syrup & drops, Sinarest drops, Febrex syrup, etc.

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QUINOLINE

Side Effect – Hyperactivity in children

Banned in USA, Austria and Norway.

Used in Cavit Syrup, Digene, Mahacef etc.

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DRUG ADDITIVES

Benzyl Alcohol

Lactose

Propylene Glycol

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Benzyl AlcoholPreservative

Adverse effects- Gasping baby syndrome- Gasping

respirations,metabolic acidosis and haematological abnormalities.

Kernicterus, Intraventricular Hemorrhage. Hypersensitivity, Dermatitis. US FDA, AAP- Avoid benzyl Alcohol.

Important reason why we avoid giving Diazepam injection in Neonatal Seizures

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Lactose

Filler in tablets & capsules.

Lactose intolerant individual

Diarrhoea, Dehydration, Cramps, etc.

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Propylene Glycol A commonly used solvent in Paracetamol syrup Adverse effects - Respiratory problems, lactic

acidosis, low blood pressure, haemolysis, hyperosmolality, skin rashes & CNS toxicity in Children.

1000 mg of PG is needed for dissolving 100 mg of Paracetamol

Concentration of PG exceeds far above that recommended by FDA/WHO expert committees.

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Other flavors:Calcium dihydrogen,L-glutamate, Disodium guanylate,

Disodium inosinate: Avoid : Hyperactivity, Asthma,Aspirin sensitivity & Gout.

ARTIFICIAL FLAVORS

Synthetic Raspberry Flavoring :Vanillin, Ethyl vanillin, Alphainone, Maltole, Dimethyl sulphide & dimethyl N-pyrrole, etc.

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Here is the list of ingredients for artificial strawberry flavour 

amyl acetate, amyl butyrate, amyl valerate, anethol, anisyl formate, benzyl acetate, benzyl isobutyrate, butyric acid, cinnamyl isobutyrate, cinnamyl valerate, cognac essential oil, diacetyl, dipropyl ketone, ethyl

acetate, ethyl amyl ketone, ethyl butyrate, ethyl cinnamate, ethyl heptanoate, ethyl heptylate, ethyl lactate, ethyl methylphenylglycidate, ethyl nitrate, ethyl propionate, ethyl valerate, heliotropin, a-ionone,

hydroxyphenyl-2-butanone (10 percent solution in alcohol),

isobutyl anthranilate, isobutyl butyrate, lemon essential oil, maltol, 4-

methylacetophenone, methyl anthranilate, methyl benzoate, methyl cinnamate, methyl heptine carbonate, methyl naphthyl ketone, methyl salicylate, mint essential oil, neroli essential oil, nerolin, neryl isobutyrate, orris butter, phenethyl alcohol, rose, rum ether, g-undecalactone, vanillin, and solvent.  

Yummmmy!

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WHY DO PHARMACEUTICAL COMPANIES USE THESE

AGENTS? Low cost substitute,

FDA/WHO.

Food Manufacturers.

Children – Guinea pigs.

 

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IS THERE AN ALTERNATIVE

TO ARTIFICIAL COLORS &

FLAVORS?

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Natural ColorsAnd

Flavors

Better & Safer Alternatives

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Natural Colors Annatto Anthrocyanin Carotenoids Carotene Chlorophyll Curcumin Iron oxides Riboflavin Titanium dioxides

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Carotenoids

Yellow & Red colors.

Sources- Sweet potatoes, spinach and tomatoes. Antioxidant - Cancer research.

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Carotene

Yellow to Orange colors.

Sources: Carrots, yellow or orange fruits.

Rich in Vitamin A.

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Chlorophyll

Green coloring agent.

Occurs naturally in all plants

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Curcumin•Extracted from turmeric.•Coloring and medicinal uses•Wound healing•Antiulcer•Anti inflammatory•Antimicrobial & antiviral •Hepatoprotective•Antioxidant•No toxicity.

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Riboflavin (Vitamin B2)

Yellow to Orange colors.

Sources- Leafy vegetables, Eggs, Milk & Wheat.

Safe & Beneficial for health.

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Sweet Orange Oil

• Sweet orange fruit peel

Stress reducing agent

Aroma therapy: Peace of mind

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Chocolate Flavor

Cocoa seeds

Psychological Benefits.

Patient Compliance.

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ADVANTAGES OF NATURAL COLORS & FLAVORS

1) Sensitivity rare.

2) Allergic side effects rare.

3)Additional Medicinal Properties(Role of natural color additives in food allergy, Lucas CD,

Hallagan JB, Taylor SL. Adverse Food Nutrition Res. 2001;43: 195-216

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• Natural Colors & Flavors Are Costly But Definitely Not Costlier Than Health!• Then Why To Compromise?

CONCLUSION

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REMEMBER

ARTIFICIAL COLORS ,

FLAVORS AND

ADDITIVES MAY BE A

LITTLE CHEAPER.

BUT THEY EXTRACT A

BIG PRICE IN TERMS OF

OUR & CHILDREN’S

HEALTH.

GO NATURAL."If you think you're too small to be effective, you've never been in bed with a mosquito."

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