Chapter 26: Natural/Herbal Products and Dietary Supplements Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved

Chapter 26:Chapter 26:

Natural/Herbal ProductsNatural/Herbal Productsand Dietary Supplementsand Dietary Supplements

Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.

22Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved.

Chapter 26 OutlineChapter 26 Outline

Natural/Herbal Products and Dietary Natural/Herbal Products and Dietary SupplementsSupplements Limited regulationLimited regulation Safety of herbal and nutritional productsSafety of herbal and nutritional products Drug interactionsDrug interactions Standardization of herbal productsStandardization of herbal products Good manufacturing practiceGood manufacturing practice Herbal supplements used in oral health careHerbal supplements used in oral health care


Natural/Herbal Products and Natural/Herbal Products and Dietary SupplementsDietary Supplements

Haveles (pp. 320-321) (Fig. 26-1)Haveles (pp. 320-321) (Fig. 26-1) Herbal medicine refers to the use of a plant’s Herbal medicine refers to the use of a plant’s

seeds, berries, roots, leaves, bark, or flowers seeds, berries, roots, leaves, bark, or flowers for medicinal purposesfor medicinal purposes Herbalism is becoming much more commonplace Herbalism is becoming much more commonplace

in Western medicinein Western medicine Herbal supplements are available without a Herbal supplements are available without a

prescriptionprescription

cont’d…cont’d…


Natural/Herbal Products and Natural/Herbal Products and Dietary SupplementsDietary Supplements

Haveles (p. 320)Haveles (p. 320) Because herbals are considered to be natural Because herbals are considered to be natural

products or dietary supplements, manufacturers products or dietary supplements, manufacturers do not have to prove efficacy in treating or do not have to prove efficacy in treating or preventing a specific disease nor can they preventing a specific disease nor can they make that claimmake that claim They can state that the herbal or natural product can They can state that the herbal or natural product can

be used for general health and well-beingbe used for general health and well-being Most patients do not consider them to be medicine Most patients do not consider them to be medicine

because a prescription is not necessary for their usebecause a prescription is not necessary for their use


Limited RegulationLimited Regulation

Haveles (p. 321)Haveles (p. 321) Dietary Supplement Health and Education Act Dietary Supplement Health and Education Act

(DSHEA)(DSHEA) More than 20,000 herbal and other natural More than 20,000 herbal and other natural

products are available in the United Statesproducts are available in the United States Herbal products are marketed as dietary Herbal products are marketed as dietary

supplements in the United States and are not supplements in the United States and are not required to comply with safety and efficacy required to comply with safety and efficacy regulations imposed on drug productsregulations imposed on drug products




Haveles (p. 321)Haveles (p. 321) DSHEADSHEA

Herbal products are regulated by the DSHEA, Herbal products are regulated by the DSHEA, which exempts vitamins, minerals, and botanical which exempts vitamins, minerals, and botanical products from meaningful U.S. Food and Drug products from meaningful U.S. Food and Drug Administration (FDA) regulationAdministration (FDA) regulation• Before this act, manufacturers had to prove that the Before this act, manufacturers had to prove that the

herbal product was safe and effectiveherbal product was safe and effective

• Today the FDA must prove that the product is unsafeToday the FDA must prove that the product is unsafe




Haveles (p. 321)Haveles (p. 321) Package labelingPackage labeling Other aspects of the DSHEA prevent the use Other aspects of the DSHEA prevent the use

of therapeutic claims on the labelof therapeutic claims on the label All herbal products must be labeled as a dietary All herbal products must be labeled as a dietary

supplementsupplement The DSHEA requires that the following phrase The DSHEA requires that the following phrase

must be included on each natural product’s must be included on each natural product’s label: “This product is not intended to label: “This product is not intended to diagnose, treat, cure, or prevent any disease” diagnose, treat, cure, or prevent any disease”


Safety of Herbal and Nutritional Safety of Herbal and Nutritional ProductsProducts

Haveles (pp. 321-322) (Table 26-1)Haveles (pp. 321-322) (Table 26-1) Most of the herbal products available contain Most of the herbal products available contain

ingredients that produce profound ingredients that produce profound pharmacologic effectspharmacologic effects Some products may have potential therapeutic Some products may have potential therapeutic

effects, and the vast majority cause adverse effects, and the vast majority cause adverse effects and drug interactionseffects and drug interactions

Because some of these products have Because some of these products have pharmacologically active ingredients, the dental pharmacologically active ingredients, the dental health professional should acknowledge this and health professional should acknowledge this and treat the herbal product as a drugtreat the herbal product as a drug


Drug InteractionsDrug Interactions

Haveles (p. 322) (Table 26-2)Haveles (p. 322) (Table 26-2) Herbal products can interact with conventional Herbal products can interact with conventional

drugs and cause disastrous resultsdrugs and cause disastrous results Garlic, gingko biloba, and feverfew can increase the Garlic, gingko biloba, and feverfew can increase the

risk for bleeding when taken in conjunction with risk for bleeding when taken in conjunction with antiplatelet drugs or anticoagulantsantiplatelet drugs or anticoagulants

Ma huang contains ephedrine and can increase Ma huang contains ephedrine and can increase heart rate when given with sympathomimetic drugsheart rate when given with sympathomimetic drugs

St. John’s wort can induce the 3A3/4 isoenzyme of St. John’s wort can induce the 3A3/4 isoenzyme of the cytochrome P-450 systemthe cytochrome P-450 system



Drug InteractionsDrug Interactions

Haveles (pp. 322, 324) (Box 26-1)Haveles (pp. 322, 324) (Box 26-1) Information is available regarding drug Information is available regarding drug

interactions with herbal supplements is limitedinteractions with herbal supplements is limited Until herbal supplements are standardized and Until herbal supplements are standardized and

labeling is accurate and comprehensive, obtaining labeling is accurate and comprehensive, obtaining accurate information on possible interactions will be accurate information on possible interactions will be difficult difficult


Standardization of Herbal Standardization of Herbal ProductsProducts

Haveles (pp. 322-323)Haveles (pp. 322-323) Standardization is the process by which one Standardization is the process by which one

or more active ingredients of an herb are or more active ingredients of an herb are identified and all batches of the herbs identified and all batches of the herbs produced by a single manufacturer contain produced by a single manufacturer contain the same amount of active ingredient the same amount of active ingredient specified on the labelspecified on the label A major consequence of a lack of standardization A major consequence of a lack of standardization

is the variability of the quantity of the known or is the variability of the quantity of the known or supposed active ingredientsupposed active ingredient


Good Manufacturing PracticeGood Manufacturing Practice

Haveles (pp. 323-324)Haveles (pp. 323-324) Good Manufacturing Practice (GMP) standards Good Manufacturing Practice (GMP) standards

were introduced by the FDA in 2003 to ensure were introduced by the FDA in 2003 to ensure that dietary supplements be devoid of that dietary supplements be devoid of adulterants, contaminants, and impurities and adulterants, contaminants, and impurities and that package labels accurately reflect the that package labels accurately reflect the identity, purity, quality, and strength of what is identity, purity, quality, and strength of what is actually inside the packageactually inside the package


Herbal Supplements Used in Oral Herbal Supplements Used in Oral Health CareHealth Care

Haveles (p. 324)Haveles (p. 324) Herbal supplements are used in several Herbal supplements are used in several

different oral health care productsdifferent oral health care products They include essential oils that are used in mouth They include essential oils that are used in mouth

rinses, xylitol, acemannan, oil of cloves, and triclosanrinses, xylitol, acemannan, oil of cloves, and triclosan


AcemannanAcemannan

Acemannan hydrogel is an extract of the aloe Acemannan hydrogel is an extract of the aloe vera plant leaf that has immunomodulating vera plant leaf that has immunomodulating propertiesproperties Available as an over-the-counter topical patch to Available as an over-the-counter topical patch to

reduce the healing time of aphthous ulcerationsreduce the healing time of aphthous ulcerations Thought to cause the ulceration to heal at a faster Thought to cause the ulceration to heal at a faster

pacepace


Essential Oil Mouth RinseEssential Oil Mouth Rinse

Over 20 mouth rinses that contain the Over 20 mouth rinses that contain the essential oils (EOs) thymol, eucalyptol, and essential oils (EOs) thymol, eucalyptol, and menthol have been approved by the menthol have been approved by the American Dental Association (ADA)American Dental Association (ADA) EOs are proposed to have a bacteriostatic effect EOs are proposed to have a bacteriostatic effect

on oral pathogens known to cause plaque and on oral pathogens known to cause plaque and gingivitisgingivitis


Oil of ClovesOil of Cloves(Eugenol)(Eugenol)

Oil of cloves have been used for many years Oil of cloves have been used for many years as a topical analgesic for dental painas a topical analgesic for dental pain No published clinical trials that confirm its efficacyNo published clinical trials that confirm its efficacy


TriclosanTriclosan

Triclosan is an herbal-based product that has Triclosan is an herbal-based product that has been shown to significantly reduce plaque been shown to significantly reduce plaque and gingivitis when compared with placebo and gingivitis when compared with placebo dentifricedentifrice One triclosan-containing product has received the One triclosan-containing product has received the

ADA’s Seal of Acceptance for its antigingivitis ADA’s Seal of Acceptance for its antigingivitis effecteffect


XylitolXylitol

Xylitol is a naturally occurring sweetener Xylitol is a naturally occurring sweetener derived from plants that can be extracted derived from plants that can be extracted from birch bark, raspberries, plums, and corn from birch bark, raspberries, plums, and corn fiberfiber Xylitol cannot be metabolized by Xylitol cannot be metabolized by Streptococcus Streptococcus

mutans mutans to form acidsto form acids Xylitol’s antibacterial effects inhibit the ability of Xylitol’s antibacterial effects inhibit the ability of

microbes to adhere and grow in plaquemicrobes to adhere and grow in plaque

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Chapter 26: Natural/Herbal Products and Dietary Supplements Copyright © 2011, 2007 Mosby, Inc., an affiliate of Elsevier. All rights reserved