Question 1

Each of the following is true of the FDA Food Safety and Modernization Act of 2010 EXCEPT one.Which is the EXCEPTION?&#10;A)It provides the FDA with mandatory recall authority for all foods.&#10;B)It requires the FDA to issue New Dietary Ingredients guidance.&#10;C)It expands the facility registration obligations.&#10;D)It requires the manufacturer to prove that an herbal product is safe and effective.

Accepted Answer

The FDA Food Safety and Modernization Act of 2010 provides the FDA with mandatory recall authority for all foods,including dietary supplements,it expands the facility registration obligations,and it requires the FDA to issue New Dietary Ingredients guidance.This was true before the Dietary Supplement Health and Education Act (DSHEA)was passed.The DSHEA exempts vitamins,minerals,and botanical products from meaningful FDA regulation.Before that,the manufacturer had to prove that an herbal product was safe and effective.Today,the FDA must prove that the product is unsafe.

Question 2

Which herbal supplement products have been proven effective in protecting against plaque and gingivitis?&#10;A)Acemannan hydrogel (extract of aloe vera)&#10;B)Essential oil mouth rinse&#10;C)Oil of cloves (eugenol)&#10;D)Triclosan&#10;E)Xylitol&#10;F)B and D only

Accepted Answer

More than 20 essential oils in mouth rinses have received the American Dental Association Seal of Acceptance for protection against plaque and gingivitis.One triclosan-containing product has received the American Dental Association's Seal of Acceptance for its antigingivitis effect.Acemannan hydrogel (an extract of aloe vera)has an immunomodulating property that is available in an over-the-counter (OTC)topical patch that reduces the duration of aphthous ulcers.Oil of cloves (eugenol)has been used for many years as a topical analgesic for dental pain and is used widely by dental professionals.There are no published trials documenting its efficacy.Xylitol is a naturally occurring sweetener derived from plants.It is comparable in sweetness to sucrose but cannot be metabolized by Streptococcus mutans to form acids,so it has antibacterial and cariostatic effects.

Question 3

Each of the following is a problem with herbal supplements EXCEPT one.Which is the EXCEPTION?&#10;A)Information about drug interactions with herbal supplements is lacking.&#10;B)The purity and potency of these products are closely regulated.&#10;C)Dosage is not standardized.&#10;D)Package labeling is often incomplete or inaccurate.&#10;E)The product may contain more than one active ingredient.

Accepted Answer

Herbal products can interact with conventional drugs,with disastrous results.Until herbal products are standardized and labeling is accurate and comprehensive,it will be difficult to obtain accurate information on possible interactions.Unfortunately,along with all of the other problems associated with herbal supplements,the purity and potency of herbal supplements are not well regulated.

Question 4

Which is true of eugenol?&#10;A)Used in mouth rinses containing thymol,eucalyptol,and menthol.&#10;B)Extract of aloe vera plant leaf used to treat aphthous ulcers.&#10;C)Historically used in dentistry as a topical analgesic for dental pain.&#10;D)Herbal-based product that significantly reduces plaque and gingivitis.&#10;E)Naturally occurring sweetener with an anticariogenic effect.

Accepted Answer

Oil of cloves (eugenol)has been used in dentistry for topical analgesia for relief of dental pain,but no published clinical trials have confirmed its efficacy.The mechanism of action is unknown,but it is believed that pulpal nerves are somehow affected to reduce pain.Essential oils are mouth rinses containing thymol,eucalyptol,and menthol.Acemannan hydrogel is an extract of aloe vera plant leaf used to treat aphthous ulcers.Triclosan is an herbal-based product that significantly reduces plaque and gingivitis.Xylitol is a naturally occurring sweetener with an anticariogenic effect.

Question 5

Which is the mechanism of action of xylitol for its antibacterial and cariostatic effects?&#10;A)Direct bactericidal effect on Streptococcus mutans&#10;B)Inhibition of the ability of S.mutans to adhere and multiply in plaque&#10;C)Inability to be metabolized by S.mutans as a nutrient source&#10;D)B and C only&#10;E)All of the above

Accepted Answer

Xylitol consumption reduces S.mutans levels,yielding antibacterial and cariostatic effects.Xylitol cannot be metabolized by S.mutans as a nutrient source to produce acids.Xylitol's antibacterial effects inhibit the ability of microbes to adhere and grow in plaque.

Question 6

Which statements are true about natural or herbal substances in the United States?&#10;A)Herbal products marketed as dietary supplements are not required to comply with safety and efficacy regulations imposed on drug products.&#10;B)Manufacturers cannot claim to cure conditions,but they can claim to improve structure or function.&#10;C)The Food and Drug Administration (FDA)can allow a qualified health claim if scientific evidence exists to support the claim.&#10;D)Because a prescription is not necessary for their use,most patients do not consider natural products or dietary supplements to be medicine.&#10;E)All of the above are true.&#10;F)Only A and C are true.

Accepted Answer

Although concerns exist about the safety of natural or herbal substances in the United States,manufacturers do not have to comply with FDA safety and efficacy regulations imposed on drug products.All of the other statements are true as well;the dental health care worker should be knowledgeable about these products.

Question 7

Herbal products in the United States are regulated by which governmental agency?&#10;A)Federal Trade Commission&#10;B)Food and Drug Administration (FDA)&#10;C)Environmental Protection Agency&#10;D)Dietary Supplement and Education Act (DSHEA)&#10;E)US Pharmacopeia

Accepted Answer

Before this act,the manufacturer had to prove that an herbal product was safe and effective.Today,the FDA must prove that the product is unsafe.Herbal products are regulated by the Dietary Supplement and Education Act,which exempts vitamins,minerals,and botanical products from FDA regulation unless they are proven unsafe.

Question 8

The FDA introduced Good Manufacturing Practice standards to ensure that dietary supplements are free of adulterants,contaminants,and impurities and that the labels accurately depict the contents of the package.This testing in mandatory and is enforced by the FDA.

A)Both statements are true.
B)Both statements are false.
C)The first statement is true,the second is false.
D)The first statement is false,the second is true.

Accepted Answer

In 2007,the GMP standards mandated that manufacturers establish quality-control procedures.The FDA introduced good Manufacturing Practice (GMP)standards in 2003 to ensure that dietary supplements are devoid of adulterants,contaminants,and impurities and that package labels accurately reflect the identity,purity,quality,and strength of the ingredients that are actually inside the package.However,testing is left to the discretion of the manufacturer,and the FDA does not inspect all manufacturing facilities for compliance.Only manufacturers that have demonstrated unsafe practices are subject to more frequent inspections.

Question 9

Oil of cloves has been used in dentistry for many years as a topical analgesic for dental pain.Extensive clinical trials have confirmed its efficacy.&#10;A)Both statements are true.&#10;B)Both statements are false.&#10;C)The first statement is true,the second is false.&#10;D)The first statement is false,the second is true.

Accepted Answer

The mechanism of action is unknown,but it is believed that pulpal nerves are somehow affected to reduce pain.Oil of cloves (eugenol)has been used in dentistry for topical analgesia for relief of dental pain,but no published clinical trials have confirmed its efficacy.

Question 10

The FDA has performed much of the research and advanced the knowledge about herbal products and supplements.The German Federal Health Agency established the German Commission E to review and analyze world literature on plant-based products.

A)Both statements are true.
B)Both statements are false.
C)The first statement is true,the second is false.
D)The first statement is false,the second is true.

Accepted Answer

Before 1994,the FDA attempted to propose stricter regulations for the herbal supplement industry;however,aggressive lobbying by the dietary supplement industry and thousands of letters from the general public to Congress blocked the proposed regulation.The German Commission E was originally established by the German Federal Health Agency to review and analyze the world literature on plant-based products.The FDA considers natural products to be dietary supplements;therefore,these manufacturers do not have to meet the same standards as drug manufacturers to prove efficacy in treating or preventing a specific disease,nor can they make that claim.The German Commission E (an expert panel composed of physicians,pharmacists,pharmacologists,and biostatisticians)has contributed much of what is known about herbal products or supplements.

Question 11

An increased risk of bleeding can occur when __________ is taken in conjunction with antiplatelet drugs or anticoagulants.&#10;A)Ma huang&#10;B)Garlic&#10;C)Ginkgo biloba&#10;D)Feverfew&#10;E)St.John's wart&#10;F)All of the above&#10;G)B,C,and D

Accepted Answer

The answer of An increased risk of bleeding can occur...

Question 12

Many consumers consider herbal products to be nontoxic or side effect free because they are often called &#34;natural&#34; remedies.Most herbal products cause no adverse effects and drug interactions.&#10;A)Both statements are true.&#10;B)Both statements are false.&#10;C)The first statement is true,the second is false.&#10;D)The first statement is false,the second is true.

Accepted Answer

The answer of Many consumers consider herbal products to be...

Question 13

The Adverse Events Reporting law requires reporting of &#34;serious&#34; adverse events for&#10;A)both over-the-counter drugs and dietary supplements.&#10;B)over-the-counter drugs but not dietary supplements.&#10;C)dietary supplements but not over-the-counter drugs.&#10;D)neither over-the-counter drugs nor dietary supplements.

Accepted Answer

The answer of The Adverse Events Reporting law requires reporting...

Deck 24: Naturalherbal Products and Dietary Supplements