La millionnaire de l'homéopathie enfin radiée
La millionnaire de l'homéopathie enfin radiée
Michèle Boisvert vient d'être radiée à vie de l'Ordre des pharmaciens du Québec. Cela faisait plus de 30 ans qu'elle exploitait abusivement de son titre de pharmacienne pour faire de fausses représentations sur l'efficacité de l'homéopathie. Elle aurait fait l'objet d'une bonne douzaine de plaintes, depuis 1994, pour des manquements divers, surtout l'utilisation abusive de son titre dans des publicités. Avertissement après avertissement, elle continuait. B'en là, c'est finit!
« Dans les temps de tromperie universelle, dire la vérité devient un acte révolutionnaire. » George Orwell
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Jean-Francois
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Re: La millionnaire de l'homéopathie enfin radiée
J'ai entendu ça à la radio ce matin et c'est une très bonne nouvelle.Kraepelin a écrit :Elle aurait fait l'objet d'une bonne douzaine de plaintes, depuis 1994, pour des manquements divers, surtout l'utilisation abusive de son titre dans des publicités. Avertissement après avertissement, elle continuait. B'en là, c'est finit!
Jean-François
“Belief is the wound that knowledge heals.” (Ursula Le Guin, The Telling)
("La foi est la blessure que le savoir guérit", Le dit d'Aka)
("La foi est la blessure que le savoir guérit", Le dit d'Aka)
Re: La millionnaire de l'homéopathie enfin radiée
Elle a tout de même l'air de royalement s'en moquer, le site d'homéocan la présente toujours comme pharmacienne.
"Quand elle devient « pure » de toute expérience sensorielle, la raison déraisonne. Elle prétend prouver l’existence de Dieu et l’immortalité de l’âme. Cette folie s’appelle métaphysique. Le métaphysicien est un savant fou. Il veut tout prouver, il ne montre que son insanité." Jean-Baptiste Botul
Re: La millionnaire de l'homéopathie enfin radiée
J'ai plutôt lu "diplômée en pharmacie", ce qui est vrai et que personne ne peut lui enlever.unptitgab a écrit :Elle a tout de même l'air de royalement s'en moquer, le site d'homéocan la présente toujours comme pharmacienne.
« Dans les temps de tromperie universelle, dire la vérité devient un acte révolutionnaire. » George Orwell
Re: La millionnaire de l'homéopathie enfin radiée
Dans sa bio, elle indique diplômée en pharmacie qui fut une des première femme à ouvrir sa propre pharmacie. Ces faits là sont exacts, mais pour qui n'est pas au courant de la radiation de l'ordre, la font toujours passer pour une pharmacienne avec la caution de rigueur et d'efficacité que cela implique.
"Quand elle devient « pure » de toute expérience sensorielle, la raison déraisonne. Elle prétend prouver l’existence de Dieu et l’immortalité de l’âme. Cette folie s’appelle métaphysique. Le métaphysicien est un savant fou. Il veut tout prouver, il ne montre que son insanité." Jean-Baptiste Botul
Re: La millionnaire de l'homéopathie enfin radiée
C'est la limite de toute radication. On ne peut que lui enlever le titre, pas le reste et pas les malhentendus ...unptitgab a écrit :Dans sa bio, elle indique diplômée en pharmacie qui fut une des première femme à ouvrir sa propre pharmacie. Ces faits là sont exacts, mais pour qui n'est pas au courant de la radiation de l'ordre, la font toujours passer pour une pharmacienne avec la caution de rigueur et d'efficacité que cela implique.
« Dans les temps de tromperie universelle, dire la vérité devient un acte révolutionnaire. » George Orwell
Re: La millionnaire de l'homéopathie enfin radiée
C'est le grand problème de ce genre de sanctions: Leur seul effet réel est de "dédouaner" les divers ordres professionnels par rapport à leurs membres dévoyés. Les illuminés et autres escrocs s'en contre-fichent car une radiation n'a in fine aucune incidence sur leurs activités les plus rentables et les plus répréhensibles, à savoir plumer les populations les plus vulnérables du fait de leur crédulité et de leur ignorance.Kraepelin a écrit :C'est la limite de toute radiation. On ne peut que lui enlever le titre, pas le reste et pas les malhentendus ...unptitgab a écrit :Dans sa bio, elle indique diplômée en pharmacie qui fut une des première femme à ouvrir sa propre pharmacie. Ces faits là sont exacts, mais pour qui n'est pas au courant de la radiation de l'ordre, la font toujours passer pour une pharmacienne avec la caution de rigueur et d'efficacité que cela implique.
En résumé (et à mon pas humble du tout avis), tant que les ordres professionnels n'adopteront pas une stratégie sérieuse pour empêcher les dérives de leurs membres et, surtout, pour communiquer efficacement et honnêtement avec les autorités et le public, gourous, charlatans, vendeurs d'orviétans et autres parasites ont de beaux jours devant eux.
"As democracy is perfected, the office of President represents, more and more closely, the inner soul of the people. On some great and glorious day, the plain folks of the land will reach their heart's desire at last and the White House will be adorned by a downright moron." - H. L. Mencken
Re: La millionnaire de l'homéopathie enfin radiée
Elle a aussi reçu une amende de 17,000.00 $ ! Dérisoire comparativement au profit de son entreprise HOMEOCAN. Mais sur ce terrein l'ordre des pharmacien est très "mou". C'est seulement à cause des plaintes répétés du public qu'il a bien fallut qu'il se décide. Il faut savoir qu L'Ordre autorisee et encourage même la vente des produits homéopathiques dans les pharmacies, supposément pour protéger les malades qui auraient besoin de «vrais médicaments». De l'hypocrisie mur à mur!Florence a écrit : C'est le grand problème de ce genre de sanctions: Leur seul effet réel est de "dédouaner" les divers ordres professionnels par rapport à leurs membres dévoyés. Les illuminés et autres escrocs s'en contre-fichent car une radiation n'a in fine aucune incidence sur leurs activités les plus rentables et les plus répréhensibles, à savoir plumer les populations les plus vulnérables du fait de leur crédulité et de leur ignorance.
En résumé (et à mon pas humble du tout avis), tant que les ordres professionnels n'adopteront pas une stratégie sérieuse pour empêcher les dérives de leurs membres et, surtout, pour communiquer efficacement et honnêtement avec les autorités et le public, gourous, charlatans, vendeurs d'orviétans et autres parasites ont de beaux jours devant eux.
« Dans les temps de tromperie universelle, dire la vérité devient un acte révolutionnaire. » George Orwell
Re: La millionnaire de l'homéopathie enfin radiée
En faisant une petite recherche google, j'apprends que la madame s'était déjà fait "chauffer les oreilles" par la FDA en 2013.
September 19th, 2013
Michèle Boisvert, President
Homeolab USA Inc.
3025 boul de l’Assomption Blvd
Montreal, QC H1N 2H2 Canada
Dear Ms. Boisvert:
This letter is to advise you that the United States Food and Drug Administration (FDA) has recently reviewed your firm’s labeling and marketing information for the drug product, “Kids Relief Earache.” Based on our review, the product is in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). As described in more detail below, this product is misbranded under sections 502 and 503 [21 U.S.C. §§ 352 and 353] and in violation of section 301 of the FD&C Act [21 U.S.C. § 331].
The label, website, and other labeling demonstrate the intended uses of your product including, but not limited, to the following:
The product name, “Kids Relief Earache”
“Ferrum phosphoricum 30X......inflammation and fever”
“Belladonna 30X......throbbing pain and inflammation
“Pyrogenium 30X……infection and fever”
“Relieve mild to severe ear pain”
“Soothe throbbing pain & pressure”
“Reduce Inflammation”
Based on these claims, your product is a drug as defined by section 201(g)(1)(B) and (C) of the FD&C Act [21 U.S.C. § 321(g)(1)(B) and (C)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and/or intended to affect the structure or any function of the body.
Although marketed to consumers as an over-the-counter (OTC) drug, Kids Relief Earache is a prescription drug under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Section 503(b)(1) of the FD&C Act [21 U.S.C. 353 (b)(1)] identifies criteria for determining the prescription status of a product. The product listed above is a prescription drug within the meaning of section 503(b)(1) of the FD&C Act because it is intended to treat diseases that require diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in any final monograph or in any approved OTC new drug application.[1] OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed healthcare professional.
Because this product is subject to 503(b)(1) of the FD&C Act, the product is misbranded under section 503(b)(4) of the FD&C Act [21 U.S.C. § 353(b)(4)] in that the label fails to bear the symbol, “Rx only.”[2]
Kids Relief Earache is also misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352 (f)(1)] in that its labeling fails to bear adequate directions for use as that term is defined in 21 C.F.R. § 201.5. The indication for which the product listed above is labeled and marketed, i.e., treatment of ear pain or inflammation, is not appropriate for OTC use. If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication.
Furthermore, the drug is misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that its labeling is false or misleading because it represents the product as suitable for use by consumers to treat a condition which the Agency has found not appropriate for OTC drug treatment, and because it encourages OTC treatment for ear pain, but fails to distinguish among conditions that manifest with ear pain and that can lead to serious injury if not accurately diagnosed and treated by a licensed physician.
Your marketing of this misbranded product violates sections 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
We recognize that your product is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. The definition of “drug” in section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
* * *
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
U.S. Food and Drug Administration
CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51
Silver Spring, MD 20993-0002
OUDLCMail@fda.hhs.gov
Sincerely,
/s/
Thomas J. Cosgrove
Director, Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
September 19th, 2013
Michèle Boisvert, President
Homeolab USA Inc.
3025 boul de l’Assomption Blvd
Montreal, QC H1N 2H2 Canada
Dear Ms. Boisvert:
This letter is to advise you that the United States Food and Drug Administration (FDA) has recently reviewed your firm’s labeling and marketing information for the drug product, “Kids Relief Earache.” Based on our review, the product is in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). As described in more detail below, this product is misbranded under sections 502 and 503 [21 U.S.C. §§ 352 and 353] and in violation of section 301 of the FD&C Act [21 U.S.C. § 331].
The label, website, and other labeling demonstrate the intended uses of your product including, but not limited, to the following:
The product name, “Kids Relief Earache”
“Ferrum phosphoricum 30X......inflammation and fever”
“Belladonna 30X......throbbing pain and inflammation
“Pyrogenium 30X……infection and fever”
“Relieve mild to severe ear pain”
“Soothe throbbing pain & pressure”
“Reduce Inflammation”
Based on these claims, your product is a drug as defined by section 201(g)(1)(B) and (C) of the FD&C Act [21 U.S.C. § 321(g)(1)(B) and (C)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and/or intended to affect the structure or any function of the body.
Although marketed to consumers as an over-the-counter (OTC) drug, Kids Relief Earache is a prescription drug under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. Section 503(b)(1) of the FD&C Act [21 U.S.C. 353 (b)(1)] identifies criteria for determining the prescription status of a product. The product listed above is a prescription drug within the meaning of section 503(b)(1) of the FD&C Act because it is intended to treat diseases that require diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in any final monograph or in any approved OTC new drug application.[1] OTC treatment is inappropriate for ear pain because consumers cannot distinguish its symptoms from those of more serious disorders of the ear or adjacent tissues which are not amenable to OTC treatment and which can lead to serious injury if not accurately diagnosed and treated by a licensed healthcare professional.
Because this product is subject to 503(b)(1) of the FD&C Act, the product is misbranded under section 503(b)(4) of the FD&C Act [21 U.S.C. § 353(b)(4)] in that the label fails to bear the symbol, “Rx only.”[2]
Kids Relief Earache is also misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352 (f)(1)] in that its labeling fails to bear adequate directions for use as that term is defined in 21 C.F.R. § 201.5. The indication for which the product listed above is labeled and marketed, i.e., treatment of ear pain or inflammation, is not appropriate for OTC use. If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication.
Furthermore, the drug is misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that its labeling is false or misleading because it represents the product as suitable for use by consumers to treat a condition which the Agency has found not appropriate for OTC drug treatment, and because it encourages OTC treatment for ear pain, but fails to distinguish among conditions that manifest with ear pain and that can lead to serious injury if not accurately diagnosed and treated by a licensed physician.
Your marketing of this misbranded product violates sections 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
We recognize that your product is labeled as a homeopathic drug with active ingredients measured in homeopathic strengths. The definition of “drug” in section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed over-the-counter (OTC). Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
* * *
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to:
U.S. Food and Drug Administration
CDER/OC/OUDLC
10903 New Hampshire Avenue, WO51
Silver Spring, MD 20993-0002
OUDLCMail@fda.hhs.gov
Sincerely,
/s/
Thomas J. Cosgrove
Director, Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
« Dans les temps de tromperie universelle, dire la vérité devient un acte révolutionnaire. » George Orwell
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