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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 Rage2 - Ms. Annie Eng -.I a 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” Page 3 - Ms. Annie Eng 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 a 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 Page 5 - Ms. Annie Eng 0 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