Download 2002 Memorandum OfC 17

DEPARTMENT
OF HEALTH
& HUMAN SERVICES
Public Health Service
Food and Drug Administration
Memorandum
Date:
OfC 17
2002
From:
Consumer Safety Officer, Division of Standards and Labeling Regulations, Office
of Nutritional Products, Labeling and Dietary Supplements, HFS-821
Subject:
75Day Premarket Notification of New Dietary Ingredients
To:
Dockets Management Branch, HFA-305
Subject of the Notification:
El Jack
Firm:
Herbal Powers, Inc.
Date Received by FDA:
March 18, 2002
90-Day Date:
June 16,2002
In accordance with the requirements of section 4 13(a) of the Federal Food, Drug, and
Cosmetic Act, the attached 75-day premarket notification and related correspondence for the
aforementioned substance should be placed on public display in docket number 953-03 16 as
soon possible since it is past the 90-day date. Thank you for your assistance.
Attachments
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
College Park, MD
Annie Eng
Herbal Powers, Inc.
2 138 West Jackson Suite #2
Chicago, Ilinois 60612
Dear Ms. Eng:
This letter is in responseto two separatenotifications you submitted to the Food and Drug
Administration (FDA) pursuantto 21 U.S.C. 35Ob(a)(2).FDA received and filed the
notifications on March 18,2002. Each notification concernsa different botanical that you
assertis a new dietary ingredient. Proposedproduct namesand the Latin binomial names
for the ingredients are listed below as statedin your notifications, with the exception that
the speciesnamesare not capitalized:
l
l
Lamila capsule270 mg [Labi.siupumiZu F. Vi111
El Jack capsule290 mg [Eurycoma ZongifoliuJack ]
Earlier, you submitted notifications for El Jack and Lamila that were dated
28,2002, and were receivedand filed by FDA on February26,2002.
Mr. Gary Goody on my staff contactedyou by phone to requestclarification regardingthe
namesfor El Jack and Lamila and you respondedwith the authors’names as indicated
above. The author designation,F. Vill, you submitted for the Latin binomial nameLabisiu
pumih is incorrect. The correct Latin binomial name and author designation for this plant
is Lubisiu pumilu Benth. & Hook. f. For the purposesof this letter, Lubisiu pumilu will be
used to refer to the plant sourceof Lamila.
January
Your notification statesthat Lamila will contain 270 mg per capsuleof powdered whole
plant of Lubisiupumilu. The proposedlabel will instruct consumersto take 2 capsules
twice daily one hour before meals. The indicated conditions of use and the proposedtext
of the label submitted for Lamila include the following statements:may help alleviate
fatigue; soothemenopausalsymptoms;harmonize female reproductive system and
menstrualcycle; enhancewomen’soverall vitality and youthfulness; strengthenuterus;
firm breast;enhanceoverall postpartumrecovery; and tighten pelvic muscle after delivery.
The proposedlabel also includes cautionary statementsfor potential consumersto consult
a medical professionalif they are taking a prescription medicine, are pregnant or nursing a
baby, and to,immediately seek the advise of a healthcareprofessional in caseof accidental
ingestion or overdosage.
0
Your other notification statesthat El Jack will contain 290 mg per capsule of powdered
root of EurycomuLongifoliu Jack with label instructions to take 2 capsulesdaily. The
indicated conditions of use for El Jack include the following statements:may help increase
the efficiency of the healing systemby supporting a healthy immune system; improve
overall energylevels; reduce fatigue and exhaustion; enhanceoverall male
ia
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-.I
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sexual vitality; improve appetiteand digestion; and tone skin and muscle. The proposed
label also includes cautionarystatementsfor potential consumersto consult a medical
professional if they are taking a prescriptionmedicine, arepregnant or nursing a baby, and
to immediately seekthe advise of a healthcareprofessionalin caseof accidental ingestion
or overdosage.
The statement “help increasethe efficiency of the healing system”may causeEl Jack to be
representedas a drug. Under 21 U.S.C. 321(g)(l)(B), a drug is defined as an article
intended for use in the diagnosis,cure, mitigation, treatment,or prevention of diseasein
man or other animals. Therefore,if you intend to make claims of this nature and you want
El Jack to be evaluatedfor its use in the treatmentof a disease,you should contact FDA’s
Center for Drug Evaluation and Research,Office of Compliance,HFD-3 lo,7520 Standish
Place, Rockville, Maryland 20855.
The law at 21 U.S.C. 350b(a)(2)requiresthat a manufactureror distributor submit certain
information to FDA at least 75 daysbefore a new dietary ingredient or a dietary
supplement containing it is introduced or delivered for introduction into interstate
commerce. This information must include the basis on which the manufacturer or
distributor has concludedthat the new dietary ingredient or a dietary supplement
containing it will reasonablybe expectedto be safe. FDA reviews this information to
determinewhether it provides an adequatebasis for such a conclusion. Under
21 U.S.C 350b(a)(2), there must be a history of use or other evidence of safety establishing
that the dietary ingredient, when used under the conditions recommendedor suggestedin
the product’s labeling, will reasonablybe expectedto be safe. If this requirement is not
met, the new dietary ingredient or dietary supplementcontaining it is deemedto be
adulteratedunder 21 U.S.C. 342(f)(l)(B), becausethere is inadequateinformation to
provide reasonableassurancethat the new dietary ingredient does not present a significant
or unreasonablerisk of illness or injury.
FDA carefully consideredthe information in your notifications. We have significant
concernsabout the basis upon which you concluded that a dietary supplement containing
Euryoma Zongijblia or Labisia pumiln is reasonablyexpectedto be safe when used as
recommendedor suggestedin the products’labeling. These concernsfor each ingredient
are discussedbelow.
El Jack
The history of use information provided in your notification statesthat Eurycoma
longijidia is indigenous to SoutheastAsia and Indo-China and has been used by the locals
in folk medicine as a febrifuge and a remedy for “intermittent fevers.”It also refers to
Eurycoma longifolia as a “tree of 100 remedies,” This history of use information lacks
details on the amount, frequency and duration of use for the botanical and whether the
plant parts or preparationused are the same as what you intend to market in El Jack.
Without thesedetails, it is not possible for FDA to determine how this information relates
to your product.
a
Your notification also includes a photocopy and translation of a registration held by
Tomrich Marketing with the Drug Control Authority of Malaysia for “E.L. Jack Capsule”
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for the following approvedindication: “traditionally used for improving energy,reduce
body fatigue and enhanceoverall performance”.You assertin your notification, but
without supporting documentation,that over “20 million capsulesof E.L. Jack Capsules
have been sold in Asia since 1997and that therehave beenno seriousside effects or drug
interactions reportedto datewhen usedas directed.”FDA is not aware of any systematic
collection of data relatedto adverseeffects occurringin individuals using E.L. Jack
capsules. Further, absenceof adverseeventreportsdoesnot necessarilymean a particular
product or ingredient has not beenor is not likely to be associatedwith an adverseevent,
nor does it provide adequateevidenceof safetyfor El Jack.
Your notification also includescopiesof what appearto be promotional materialsand
newspaperclippings from unidentified sourcesintermixed with researchpublications of
invitro and invivo animal studies. Sourcesare not provided for severalof the research
publications. Medicinal benefitsfor Eulycoma longzfilia statedin the materials include
the following: aphrodisiac,androgenic,antiviral, antimalarial,antipyretic, antihistaminic,
antiulcer, antianxiety, anticancertumor, antihypertensive,antidysentery,and others. None
of the papersdirectly assesssafetynor do they provide any safety data for exposureof
Eurycoma ZongzifZia in humans. Furthermore,since the relationshipbetweeninvitro,
animal and human exposureis unknown, the applicability of theseresults to humansis
unclear. Of additional concernis the possibility that Eurycoma Zongz~Ziu may increase
testosteronelevels, as suggestedby the Kwan et. al. paper. If this were confirmed in
humans,it could pose a safetyrisk in men with prostatecanceror other medical conditions.
A Certificate of Analysis included in your notification for the Malaysian Eurycoma
ZongifoZiacapsuledrug product indicatesthat it was assayedfor glucocorticosteroids,but
not for testosteroneor any other androgeniccompounds. In summary,your notification
has provided Ii0 data or publicationsthat can be used to assessthe safety of El Jack capsule
when used as youdirect.
Lamila
Your notification statesthat Labisiu pumiZu is indigenousto SoutheastAsia and has been
usedby the local women for vitality and restoring youthfulness.This history of use
information lacks details on the amount, frequencyand duration of use for the botanical
and whether the plant parts and preparationused are the sameas what you intend to market
in Lamila. Without these details, it is not possible for FDA to determinehow this
information relatesto your product.
Your notification also includes a photocopy and translation of a registration held by
Tomrich Marketing with the Drug Control Authority of Malaysia for “Labisia pumila
capsules”for the following approvedindication: “traditionally used for improving energy
and women’shealth.” You assertin your notification, but without supporting
documentation,that over 2 million capsulesof Labisia pumila capsuleshave been sold in
Asia since 1999and that there have been no serious side effects or drug interactions
reportedto datewhen used as directed. FDA is not aware of any systematiccollection of
datarelatedto adverseeffects occurring in individuals using Labisia pumila capsules.
Further,absenceof adverseevent reports does not necessarilymean a particular product or
ingredienthasnot been or is not likely to be associatedwith an adverseevent, nor does it
provide adequateevidence of safety for Lamila.
Page 4 - Ms. Annie Eng
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Also attached to your notification arewhat appearto be promotional materials and other
articles from unidentified sources.The materialsinclude statementsof medicinal usesfor
Labisia pumiZa that includebut arenot limited to the following: treat dysmenorrhea,
rheumatism, gonorrhea,and dysentery;supporthealthy vaginal flora to prevent irritation
and infections; speedup healingof the womb and birth canal after childbirth; strengthen
the uterus and bladder from slipping out of place; and alleviate flatulence. The articles state
that Labisia pumila containsphytoestrogens.
However, the notification contains only one
abstractby Jamal et. al. that mentionsthe presenceof weak phytoestrogensin Labisia
pumil, but no data is provided.A Certificate of Analysis for the Labisiapumila drug
product by Tomrich Marketing indicatesthat assayswere performedfor glucocosteroids
but not for estrogensor other compoundsknown to have estrogenicactivity. In summary,
there is no information in the materialssubmittedin your notification to assessthe safety
of Labisia pumila when used as you direct.
Conclusions
For the reasonsdiscussedabove,the information in your notification on Lamila doesnot
provide an adequatebasisto concludethat it will reasonablybe expectedto be safewhen
used under the conditionsrecommendedor suggestedin the product’slabeling. Also as
statedabove,becausethe information in your submissionindicatesthat El Jack is
representedas a drug and not a dietary supplement,it would be subject to regulation as a
drug. Notwithstanding, even if it could be arguedthat El Jack is a dietary supplement,the
information in your notification doesnot provide an adequatebasis to conclude that it will
reasonablybe expectedto be safewhen used under the conditions recommendedor
suggestedin the product‘slabeling. Therefore,Lamila and El Jack may be adulterated
under 21 U.S.C. 342(f)(l)(B) as dietary supplementsthat contain the new dietary
ingredientsLabisia pumila or Eurycoma longifolia for which there is inadequate
information to provide reasonableassurancethat such ingredientsdo not presenta
significant or unreasonablerisk of illness or injury. Introduction of such products into
interstatecommerceis prohibited under 2 1 U.S.C. 331(a) and (v).
Your notifications will be kept confidential for 90 days after the filing date. After June 16,
2002, the two notifications will be placed on public display at FDA’s Docket Management
Branch in docket number 95S-0316. However, any trade secretor otherwise confidential
commercialinformation in the notifications will not be disclosedto the public. Prior to
June 16,2002, YOUmay wish to identify in writing specifically what information you
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believe is proprietary in eachof your notifications for FDA’sconsideration.Nevertheless,
our Center’sFreedomof Information Officer hasthe authority to make the final decision
about what information in the notifications shouldbe redactedbefore they are posted at
Dockets.
Pleasecontact us at (301) 436-2371,if you have questionsconcerningthis matter.
Sincerelyyours,
Felicia B. Satchel1
Director
Division of Standards
and Labeling Regulations
Office of Nutritional Products,Labeling
and Dietary Supplements
Gary Coody
FDA
5 100 Paintbranch Pkwy
HSF 805
College Park, MD 20740-383 5
Dear Gary,
I have enclosed 4 copies of new letter for Eyrycoma Longifolia and 4 copies of new letter
for Labisia Purnila. These new letters contain the latin author name for each botanical.
Please disregard the old letters. Thank you.
Sincerely,
Herbal Powers Inc. ’
2138 W. Jackson
Suite # 2
Chicago, IL 60612
H(312)280-1032
C(312)505-1318