10 1212 MMcGuffin.Ayurveda Congress.ppt

4th World Ayurveda CongressDecember 12, 2010December 12, 2010

Michael McGuffin

President, American Herbal Products AssociationPresident, American Herbal Products [email protected]

Facility registrationFacility registration

Ingredients in dietary supplements

Dietary supplement forms

New dietary ingredientsNew dietary ingredients

Label / advertising claims

Good manufacturing practiceGood manufacturing practice

Adverse event reporting

December 12, 2010 1

Adverse event reporting

21 U.S.C. 350(d)

Domestic and foreign facilities that manufacture, Domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. required to register with consumption in the U.S. required to register with the FDA. Register online at Registration of Food Facilities : Register online at Registration of Food Facilities : http://www.fda.gov/Food/default.htm:

U.S. Agent needed; a person residing or maintaining a place of business in the U.S.maintaining a place of business in the U.S.Free (for now)

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21 U.S.C. 321(ff)(1)

(A) Vitamins(A) Vitamins(B) Minerals(C) Amino Acids(C) Amino Acids(D) Herbs and other botanicals(E) Dietary substance[s] for use by man to (E) Dietary substance[s] for use by man to supplement the diet by increasing the total dietary intake.dietary intake.(F) Concentrates, metabolites, constituents, extracts, or combinations of the above

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21 U.S.C. 321(ff)(2) / 350(c)(1)(B)

intended for ingestion in tablet, capsule, powder,

intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form

if not intended for ingestion [in tablet, capsule, if not intended for ingestion [in tablet, capsule, powder, softgel, gelcap, or liquid form], is not represented as conventional food and is not represented for use as a sole item of a meal or of represented for use as a sole item of a meal or of the diet.Limited to oral dosage forms.

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21 U.S.C. 321(ff)(2) Enforcement history: Unallowed forms

Ener-B (1995): Nasally administered Vitamin B-12The ordinary and plain m eaning of the term ingest ion m eans to take into the stom ach and gast rointest inal m eans to take into the stom ach and gast rointest inal t ract by m eans of enteral adm inist rat ion.

Gold root extract (2002): Lozenge or gumAn art icle that is delivered orally, but that exerts its An art icle that is delivered orally, but that exerts its effect pr ior to being swallowed ( for exam ple, a gum or lozenge that st im ulates salivat ion) is not intended for ingest ion.ingest ion.

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21 U.S.C. 321(ff)(2) Enforcement history: Unallowed representation

Celestial s Zingers to Go® Tangerine Orange Wave Herb Tea (2007): Powdered blend containing stevia

The product is represented as a convent ional food The product is represented as a convent ional food within the m eaning of 21 U .S.C. 321( f) .The label declares I ced Tea Mix adjacent to the

words Herbal Supplem ent on the PDPwords Herbal Supplem ent on the PDPThe label states that [ the product is] an easy and

delicious all-natural way to get your daily eight glasses of water [ and] the product is a sunny com binat ion of water [ and] the product is a sunny com binat ion of the flavor of tangy tangerines and juicy oranges with refreshing, naturally caffeine free herb tea.

December 12, 2010 6

21 CFR 190.6

Ingredients that were not marketed in the Ingredients that were not marketed in the United States as of October 15, 1994No master listNo master listMarketer must submit information which is the basis on which the manufacturer or distributor has concluded that a dietary distributor has concluded that a dietary supplement containing such ingredient will reasonably be expected to be safe.reasonably be expected to be safe.Notification due 75 days prior to marketing

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21 CFR 190.6

Notification not required if the NDI is an article Notification not required if the NDI is an article used for food in a form in which the food has not been chemically alterednot been chemically alteredChemical alteration excludes the following physical modifications: minor loss of volatile components, dehydration, lyophlization [sic], components, dehydration, lyophlization [sic], milling, tincture or solution in water, slurry, powder, or solid in suspension

December 12, 2010 8

21 U.S.C. 343(r)(6)

Statem ent of nutr it ional supportSta tem ent of nut r it iona l supportClaims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the U.S.;the U.S.;Describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans;Characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function;Describes general well-being from consumption of a nutrient or dietary ingredient.

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21 U.S.C. 343(r)(6)

The manufacturer of the supplement must have The manufacturer of the supplement must have substantiation that such statement is truthful and not misleading.and not misleading.Required labeling: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, This product is not intended to diagnose, treat, cure, or prevent any disease.Must notify FDA no later than 30 days after the Must notify FDA no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.

December 12, 2010 10

made.

21 CFR 101.93

Many OTC drug indication okay as structure/ Many OTC drug indication okay as structure/ function claims, e.g.:

Antacid claims: For the relief of upset stomachAntacid claims: For the relief of upset stomach

Antiemetic claims: For the relief of nausea

Sleep aid claims: For the relief of occasional Sleep aid claims:sleeplessness

Stimulant claims: Helps restore mental alertness

Laxative claimsLaxative claimsetc.


21 U.S.C. 343(r)(6)

Any statement that claims to diagnose, Any statement that claims to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases even if truthful disease or class of diseases even if truthful and well substantiated.

Antacid claims for recurrent or persistent heartburnSleep aid claims that imply treatment of insomniaSleep aid claims that imply treatment of insomniaStimulant claims that imply treatment of narcolepsy or chronic fatigue syndromeLaxative claims that are promoted for chronic or Laxative claims that are promoted for chronic or persistent constipationCholesterol-lowering claims


Acceptable claims for Ginkgo:Acceptable claims for Ginkgo:Improves memory.Maintains health blood vessel tone.Maintains health blood vessel tone.

Unacceptable claims for Ginkgo:may be effective in treating Alzheimer s may be effective in treating Alzheimer s

disease, as well as dementia.Inhibits the clumping of blood platelets.


Acceptable claims for Garlic:Acceptable claims for Garlic:Healthy circulation.Immune support.Immune support.

Unacceptable claims for Garlic:supports healthy low-density lipoprotein supports healthy low-density lipoprotein

levels....may kill antibiotic-resistant bacteria.a good protective agent against flus and a good protective agent against flus and

colds.


Acceptable claims for Echinacea:Acceptable claims for Echinacea:Supports the immune system.Supports healthy immune function.Supports healthy immune function.

Unacceptable claims for Echinacea:often used to fight colds and infections.often used to fight colds and infections.

Over 300 studies have shown that Echinacea provides wound-healing, anti-inflammatory and anti-viral activity.inflammatory and anti-viral activity.


Acceptable claims for Valer ian:Acceptable claims for Valer ian:promotes restful sleep.

Unacceptable claims for Valer ian:Unacceptable claims for Valer ian:for insomnia.traditionally used for epilepsy.traditionally used for epilepsy.


21 U.S.C. 343(r)

Nutr ient content cla im sN ut r ient content cla im sUse terms like a good source of , high in or low in, or free ofor low in, or free ofMay only be made if FDA has a regulation to establish criteria for use of the claim.Only relevant to nutrients with established daily values (vitamins; minerals)


21 U.S.C. 343(r)

Health claim sH ea lth cla im sDescribes the relationship between a nutrient (in a food or supplement) and a disease or (in a food or supplement) and a disease or health-related condition. Must be preapproved by FDA or based on an authoritative statement (though FDA authoritative statement (though FDA authorizes these also).

Based on significant scientific agreement.Based on significant scientific agreement.


2 1 CFR 1 1 12 1 CFR 1 1 1Final rule published June 25, 2007Effective dates over 3 yearsEffective dates over 3 yearsBased on both food and drug cGMPRequires written procedures and written records Requires written procedures and written records throughout manufacturing operationsKey elements: setting and meeting specifications for identity, purity, strength and specifications for identity, purity, strength and composition


Many sections common/familiar (training; Many sections common/familiar (training; plants and grounds; equipment; etc.)Extensive requirements for written proceduresExtensive requirements for written proceduresEmphasis on setting and meeting specifications:

IdentityPurityStrengthStrengthCompositionLimits on contaminants that may adulterate


§ 111.75 What must you do to determine whether specifications are met?(a) Before you use a com ponent , you m ust :(a) Before you use a com ponent , you m ust :

(1) ( i) Conduct at least one appropriate test or exam inat ion to verify the ident ity of any or exam inat ion to verify the ident ity of any com ponent that is a dietary ingredient , unless you pet it ion the agency under paragraph (a) (1) ( ii) of this sect ion and the paragraph (a) (1) ( ii) of this sect ion and the agency exem pts you from such test ing;


§ 111.75 to determine whether specifications are met§ 111.75 to determine whether specifications are met

(a) Before you use a com ponent , you m ust :(2) Confirm the ident ity of other com ponents (2) Confirm the ident ity of other com ponents

and determ ine whether other applicable com ponent specificat ions established in accordance with § 111.70(b) are m et . To do accordance with § 111.70(b) are m et . To do so, you m ust either:

( i) Conduct appropriate tests or exam inat ions; or( ii) Rely on a cert ificate of analysis from the ( ii) Rely on a cert ificate of analysis from the supplier of the com ponent that you receive, provided that :


§ 111.75 to determine whether specifications are met§ 111.75 to determine whether specifications are met

111.75(a)(2)(ii) [you may rely on a C of A provided:](A) You first qualify the supplier by establishing the reliabilit y of the supplier s cert ificate of analysis through confirm at ion of the the supplier s cert ificate of analysis through confirm at ion of the results of the supplier s tests or exam inat ions;(B) The cert ificate of analysis includes a descript ion of the test or exam inat ion m ethod(s) used, lim its of the test or exam inat ions, exam inat ion m ethod(s) used, lim its of the test or exam inat ions, and actual results of the tests or examinations;(C) You m aintain docum entat ion of how you qualified the supplier;(D) You periodically re-confirm the supplier s cert ificate of analysis; andanalysis; and(E) Your quality cont rol personnel review and approve the docum entat ion set t ing forth the basis for qualificat ion (and re-qualification) of any supplier


qualification) of any supplier

Serious adverse event reportsDomestic address or domestic phone number

needed on label

Responsible person (usually company on label) Responsible person (usually company on label) must submit serious AERs (and new medical info ) to FDA w/in 15 days; keep records for 6 yearsto FDA w/in 15 days; keep records for 6 years

Serious defined ~as for drugs:Death; a life-threatening experience; inpatient hospitalization; Death; a life-threatening experience; inpatient hospitalization; significant or persistent disability; congenital anomaly or birth defect, OR requires, based on reasonable medical judgment, medical or surgical intervention to prevent above


medical or surgical intervention to prevent above

Michael McGuffinMichael [email protected]

American Herbal Products AssociationAmerican Herbal Products Association

THE VOICE OF THE HERBAL PRODUCTS INDUSTRYTHE VOICE OF THE HERBAL PRODUCTS INDUSTRY


10 1212 MMcGuffin.Ayurveda Congress.ppt

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