the activity on botanicals of the italian “commission on

The activity on Botanicals of the Italian “Commission on Dietetics and Nutrition”

Maria Laura ColomboMember of the Commission on Dietetics and NutritionDept. Drug Science and Technology - University of Torino, Italy

PreambleAs it is known, in Italy the plant component in food supplements is markedly important and sometimes even predominant over other ingredients.In Italy there is a strong herbal tradition.

The work of the Italian Commission in recent years have addressed many issues related to the plant component in food supplements

Retrieval of bibliographic sources in support of the traditional use

First step: A list of historic references on traditional uses of plants has been drawn up

Subsequently more recent literature data on the traditional uses of plants has been examined

A fairly comprehensive list of references was thus obtained, certainly not complete and certainly the list can be implemented

Tentative enunciation of the biological effects of plants, algae and fungi in food supplements

The bibliographic study on traditional uses of plants, gave the basis to formulate tentative enunciations on the biological activity of plants and their extracts.

The biological plant-related effects have been then reported in the National List of Allowed Plants, when possible.

Some plants on which the Commission worked

Scientific evidence to support the recommendations for some plants

Since it is known that some plants may give adverse effects if taken without care, it was decided to investigate the problem and whether there was a scientific basis.

The choice has focused on plants already known to possess molecules that can trigger adverse effects

Citrus aurantium var. amara L. Citrus x aurantium subsp. amara (Link) Engl.

Citrus aurantium var. amara L. Citrus x aurantium subsp. amara (Link) Engl.

MINISTERO della SALUTE - CIRCOLARE 18 luglio 2002, n.3 Applicazione della procedura di notifica di etichetta di cui all'art. 7 del decreto legislativo n.

111/1992, ai prodotti a base di piante e derivati aventi finalità salutistiche

L'apporto giornaliero di sinefrina con le quantità d'uso indicate non deve essere superiore a 30 mg corrispondenti a circa 800 mg di Citrus aurantium con un titolo del 4% di tale sostanza.Avvertenze:Non superare la dose giornaliera consigliata. In presenza di cordiovasculopatie e/o ipertensione, prima di assumere il prodotto, consultare il medico.Si sconsiglia l'uso del prodotto in gravidanza, durante l'allattamento e al di sotto dei 12 anni.

Ephedrine and synephrine are similar in molecular structure to sympathomimetic amines

Sympathomimetic amines: well-konwon compounds•Weaton & Stewart (1970) The distribution of tyramine, N-methyltyramine, hordenine, octopamine, and synephrine in higher plants. Lloydia 33: 244-54•Boulton & Wu (1972) Biosynthesis of Cerebral Phenolic Amines. I. In Vivo Formation of p-Tyramine, Octopamine, and Synephrine. Can. J. Biochemistry 50: 261-267

http://list.wada-ama.org/2013List S6. Specified Stimulants

Updated Citrus aurantium var. amara quantity in food supplements: year 2012

1. Occorre indicare in etichetta la titolazione in sinefrina2. L'apporto massimo di sinefrina non deve superare i 30 mg/die, corrispondenti a circa 800 mg di Citrus aurantium titolato al 4% in sinefrina3. L’apporto massimo di octopamina, come indice della presenza naturale di altre amine, non deve superare 1/8 di quello della sinefrina.AVVERTENZA SUPPLEMENTAREPer fructus, fructus immaturus, pericarpium, aetheroleum“Si sconsiglia l'uso del prodotto in gravidanza, durante l‘allattamento e al di sotto dei 12 anni.Consultare il medico prima dell’uso se le condizioni cardiovascolari non sono nella norma.”

Pelargonium graveolens L’Hér. and 1,3-dimethylamylamine (DMAA)

Pelargonium graveolens L’Hér. essential oil and 1,3-dimethylamylamine (DMAA)

1,3-dimethylamylamine (DMAA)

Phytochemical analysis on Pelargonium graveolens true plant

•Essential oil obtained according to European Pharmacopoeia method

•GC- MS analysis of the essential oil fraction

•Absence of DMAA in P. graveolens essential oil

4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50

5000000

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AbundanceDMAA Standard

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5000000

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Olio essenziale camp. 1

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5000000

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5000000

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5000000

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5000000

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AbundanceDMAA Standard

4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50

5000000

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4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50

5000000

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4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50

5000000

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4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50

5000000

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4.00 4.50 5.00 5.50 6.00 6.50 7.00 7.50 8.00 8.50 9.00 9.50

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1,3-dimethylamylamine (DMAA)

“As a reminder some stimulants may be available under several other names, for example “methylhexaneamine”, sometimes presented as dimethylamylamine, pentylamine, geranamine, Forthane, 2-amino-4-methylhexane, geranium root extract or geranium oil.”

SUBSTANCES AND METHODS PROHIBITED IN COMPETITION

S6 : Stimulants - http://www.wada-ama.org2013 Summary of Modifications

Hypericum perforatum L.

Hypericum perforatum L.

Translucent dots

Ancient traditional use of H. perforatum flower heads

. H. perforatum oil

H.perforatum digestive liqueur

Much more recently, the late eighties, the use of Hypericum extracts for

internal use to combat mood swings

MINISTERO della SALUTE - CIRCOLARE 18 luglio 2002, n.3 Applicazione della procedura di notifica di etichetta di cui all'art. 7 del decreto legislativo n.

111/1992, ai prodotti a base di piante e derivati aventi finalita' salutistiche.

Occorre sempre riportare la titolazione in ipericina, il cui tenore va indicato in etichetta per quantità di assunzione giornaliera consigliata.L'apporto giornaliero di ipericina non deve superare i 21 mcg/die, tenore che corrisponde a 7 mg di iperico con un titolo dello 0,3% di tale sostanza.

Il predetto limite di 7 mg vale anche in caso di impiego di iperico a tenore ridotto di ipericina. Tale quantitativo, infatti, fornisce sufficienti garanzie per un uso alimentare della pianta, considerando che i suoi effetti farmocologici sembrano ascrivibili a vari principi attivi e che livelli più elevati comportano il rischio di interferenze con l'attività di alcuni farmaci.

“However, a major change took place from 1998, when the quite unstable component of SJW, hyperforin, became stabilized in many products leading to a 10–20-fold increased amount of hyperforin into the product. Moreover, the first reports of clinically significant drug interactions of St. John’s wort coincided with the availability of hyperforin enriched products.”

Eur J Clin Pharmacol (2006) 62: 225–233

Hyperforin is a prenylated phloroglucinol derivative

Hypericin: naphthodianthrone, a red-colored anthraquinone-derivative

Updated H. perforatum quantity in food supplements: year 2009

L’ apporto giornaliero di ipericina, da indicare in etichetta, non deve superare 0,7 mg. Rapporto iperforine/ipericina non superiore a 7, comprendendo nella voce “iperforine” la somma dell’iperforina e dell’adiperforina presenti nell’estratto.

AVVERTENZA SUPPLEMENTARE: “Se si assumono dei farmaci, prima di utilizzare il prodotto chiedere il parere del medico perchè l’estratto di iperico può interferire sul loro metabolismo inibendone anche l’attività. L’estratto di iperico è controindicato in età pediatrica e nell’adolescenza”.

Actaea racemosa L. [syn. Cimicifuga racemosa (L.) Nutt.]

Actaea racemosa L. [syn. Cimicifuga racemosa (L.) Nutt.]

Actaea racemosa (black cohosh) syn. Cimicifuga racemosa) is a species of flowering plant of the family Ranunculaceae.

It is native to eastern North America from the extreme south of Ontario to central Georgia, and west to Missouri and Arkansas.

The roots and rhizomes have long been used medicinally by Native Americans.

Actaea racemosa L. syn. Cimicifuga racemosa [L.] Nutt.

Black Cohosh

Hypogeous organs – the drug

Lloyd and Lloyd, 1884-1887: Drugs and Medicines of North America.Scanned version copyright © 2002-2013 Henriette Kress.

Caulophyllum thalictroides (L.) Michx.Blue cohosh = vicariant species

Actaea cimicifuga L. (syn. Cimicifuga foetida L.)

vicariant species

A. cimicifuga, native to Europe, Siberia, China and Pakistan.It is used in Chinese medicine.

Jiang B, Ma C, Motley T, Kronenberg F, Kennelly EJ.

Phytochemical fingerprinting to thwart black cohosh adulteration: a 15 Actaea species analysis.

Phytochem Anal. 2011 Feb 19. doi: 10.1002/pca.1285.

Phenomenex

Dionex, Agilent, Shimadzu, etc.

Ginkgo biloba L.

Ginkgo biloba L.

Reasons that led to the definition of warnings

Spontaneous Bleeding Associated with Ginkgo biloba

Spontaneous bleeding is one of the most concerning potential side effects associated with ginkgo. There are several published case reports linking ginkgo to episodes of minor to severe bleeding; however, not all case reports clearly establish ginkgo as the cause of bleeding.

http://naturaldatabase.therapeuticresearch.com/

www.farmacovigilanza.org/

AVVERTENZA SUPPLEMENTARE:“Se si stanno assumendo farmaci anticoagulanti o antiaggreganti piastrinici, consultare il medico prima di assumere il prodotto. Si sconsiglia l'uso del prodotto in gravidanza e durante l'allattamento.”

Ginkgo biloba L.ANTICOAGULANT/ANTIPLATELET HERBS AND SUPPLEMENTS: Theoretically, concomitant use of ginkgo with other herbs and supplements that affect platelet aggregation could increase the risk of bleeding.http://naturaldatabase.therapeuticresearch.com/

and other recommandations on some classes of compounds: isoflavone, catechins from green tea, flavonoids, Serenoa repens (W.Bartram) Small, etc.

The Italian “Commission on Dietetics and Nutrition”examined some questions concerning applications for Novel Food : Echinacea species, Ajuga reptans L., Aloysia citriodora Palau

Albrecht Dürer, "La grande zolla", 1503

Thank you for your kind attention

the activity on botanicals of the italian “commission on

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