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Author Topic: FDA.gov kicks homeopaths in the ass!  (Read 4318 times)

Krant

  • Jr. Member
  • *
  • Posts: 300
FDA.gov kicks homeopaths in the ass!
« on: August 09, 2012, 09:48:14 AM »

It is, aside of all the other important facts, very disturbing to see that "homeopathic remedies" by this company can contain glass particles.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314629.htm

[*quote*]
U.S. Department of Health and Human Services
FDA, U.S. Food and Drug Administration

> Home
> Inspections, Compliance, Enforcement, and Criminal Investigations
> Enforcement Actions
> Warning Letters

Enforcement Actions

    Warning Letters
        2012

-
A Nelson & Co., Ltd. 7/26/12


[begin letter]
    
Department of Health and Human Services logoDepartment of Health and Human Services
   Public Health Service
Food and Drug Administration
    Silver Spring MD 20993

Warning Letter

VIA UPS MAIL

 WL: 320-12-022

July 26, 2012

Mr. Najib Fayad
Chief Operations Officer
A Nelson & Co., Ltd
5-9 Endeavour Way
Wimbledon, London SW19 8UH
United Kingdom

Dear Mr. Fayad:

During our November 14 to 17, 2011, inspection of your pharmaceutical manufacturing facility, A Nelson & Co., Ltd., located at 5-9 Endeavour Way, Wimbledon, London, United Kingdom, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. These drugs are also misbranded under Sections 503 and 301 of the Act.

We have reviewed your firm’s response of December 07, 2011, and note that it lacks sufficient corrective actions.

The following are examples of violations that our investigators observed during the inspection:

CGMP VIOLATIONS

1. Your firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess [21 C.F.R. § 211.100(a)].

Three examples of violations of § 211.100(a) are as follows:

a. During the inspection, the investigator observed glass fragments present during the manufacture of Kali Phos 30 c Clikpak, Batch #36659. Specifically, glass fragments were observed in the Clikpak Assembly (b)(4) enclosed area where open glass vials are inserted into the outer plastic Clikpak sheaths and move uncovered on the conveyance mechanism. Your firm failed to implement adequate measures to prevent glass contamination and had no documentation to demonstrate that appropriate line clearance and cleaning is conducted following occurrences of glass breakage, which has been a recurring problem.

Your response indicates that a planned process deviation was put in place until a failure mode effect analysis risk assessment could be completed, which was to occur by March 2012. The objective of this risk assessment was to determine the required engineering upgrades to help keep glass out of the drug product. Your response also mentioned that no complaints were received for glass found in the product. Your response is found unacceptable as quality can not be added to a product that has been already manufactured and released for distribution. We are concerned that you may have released product for distribution without fully investigating the root cause of the presence of glass fragments, implementing a corrective and preventive action plan, and evaluating impact on all products manufactured using this line. Please note that the lack of current customer complaints alone is neither a verification of a robust quality system nor that you have appropriate process controls in place to conclude that glass fragments may not be present in your products.

In your response to this letter, you should provide a risk assessment for all products in the U.S. market that are within expiry. Please also include supporting data that any engineering upgrades you have undertaken to improve the processing line are effective in preventing glass particles from entering your products.

b. The investigator also observed for Batch #36659 that one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly. Your firm lacked controls to ensure that the active ingredient is delivered to every bottle.

Your response indicates that the line speed was “unusually” high, and you state that you have corrected the problem to prevent recurrence. However, your response is inadequate because it does not provide a risk assessment for the U.S.-distributed products previously manufactured on the faulty line.

Please provide a risk assessment for all products within expiry, distributed to the U.S., manufactured on the line at high speed. Additionally, provide evidence that the line has been successfully validated to ensure each bottle contains the appropriate dose of active homeopathic drug solution.

c. The dosing process has not been validated appropriately. Specifically, your surrogate validation study, “Medication of un-medicated pillules with (b)(4),” visually demonstrates the variability of the amount of (b)(4) for the pillules in one vial. Your firm lacks control of the variation for the amount of the active ingredient in the pillules.

The validation study demonstrated that pillules at the top of the bottle contain more active ingredient than pillules at the bottom. There are no controls in place to ensure that the dosing procedure is homogenous and reproducible.
 
Please provide evidence that the dosing process is uniform, as well as a risk assessment for all Clikpak products, distributed to the U.S., dosed with an inconsistent or excessive amount of active ingredient, regarding their safety for consumers.

2. Your firm does not have laboratory records that include complete data derived from all tests necessary to assure compliance with established specifications and standards [21 C.F.R. § 211.194(a)].

For example, in some cases, the analytical testing documentation for raw materials did not include sample solution preparations, sample weight, the method number used, the initials of the analyst who performed the test, and the date of the analysis.

Your response indicates that the laboratory will stop using notebooks and replace them with analytical test forms and that a project team will prioritize the new analytical forms and plan for full implementation by the end of 2012. Your response is inadequate because it does not include an interim plan to ensure adequate documentation in the notebooks prior to the implementation of the new forms.

Please provide evidence that laboratory analyses will be documented adequately prior to the implementation of the new analytical forms. Your response should also include a list of the specific SOPs and laboratory records that you plan to revise to ensure all records of test data are complete.

3. Your firm has failed to calibrate instruments and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met [21 C.F.R. § 211.160(b)(4)].

Two examples of violations of § 211.160(b)(4) are as follows:

a. Your firm does not have an established written program to calibrate/qualify the Perkin Elmer Clarus gas chromatograph (GC) at suitable intervals.

b. Your firm did not calibrate and qualify the Jasco high performance liquid chromatography (HPLC) instrumentation adequately, in that there is no periodic qualification or evaluation of the pump, oven, injector, or detector. The “Use and Calibration of HPLC” procedure does not include criteria to define adequate calibration of the instrument.

Your response indicates that a use, maintenance, and qualification procedure for the GC will be separated from the procedure for the “Determination of (b)(4) and (b)(4) by Gas Chromatography” by March 2012. Additionally, your response indicates that the HPLC procedure will be revised to include operational performance and acceptance criteria by March 2012.

Please provide an analysis of your analytical data used to release raw materials for production of products in U.S. distribution and provide evidence that you are in compliance with 21 C.F.R. § 211.184.

We remind you that you are responsible for ensuring that your firm’s drug manufacturing operations comply with applicable requirements, including CGMP regulations. FDA expects A Nelson & Co., Ltd. to undertake a comprehensive and global assessment of your manufacturing operations to ensure that your processes, and ultimately, the drug products you manufacture, conform to FDA requirements.

MISBRANDING VIOLATIONS

FDA reviewed your firm’s labeling information for products including, but not limited to: “Arnica” and “Arnileve.” Based on our review of the labeling for these products at www.nelsonsnaturalworld.com and www.nelsonsttores.com, these products are misbranded under Sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §§ 353 and 331).

Misbranding [§§ 503(b)(4) and 301(a)]

According to the labeling on your website, www.nelsonsnaturalworld.com, the above listed products are intended to cure, mitigate, treat, or prevent diseases, or to affect the structure or function of the body. Your product labeling documents the intended uses of your products including, but not limited to the following:

Arnica: “Homeopathy, such as the homeopathic remedy Rhus tox and Arnica, has been traditionally used to help relieve the symptoms of rheumatoid and osteoarthritis.”

Arnileve: “Apply Arnileve Arnica Cream liberally to the affected area in order to reduce inflammation and hasten recovery time.”

Based on the above labeling and claims, these products are drugs under section 201(g)(1)(B) of the Act (21 U.S.C. § 321(g)(1)(B)), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man, and under section 201(g)(1)(C) of the Act (21 U.S.C. § 321(g)(1)(C)), because they are intended to affect the structure or any function of the body.

Section 503(b)(1) of the Act (21 U.S.C. 353(b)(1)) identifies criteria for determining the prescription status of a product. The products listed above are prescription drugs within the meaning of section 503(b)(1) of the Act because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Because they may be dispensed only by prescription of a licensed practitioner, these products are misbranded under Section 503(b)(4) of the Act (21 U.S.C. § 353(b)(4)) in that their labels fail to bear the symbol, "Rx only."1 Your marketing of these misbranded products violates Sections 301(a) and (k) of the Act (21 U.S.C. §§ 331(a) and (k)).

We recognize that these products are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths. The definition of "drug" in section 201(g)(1) of the 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 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 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 OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.2

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. If you wish to continue to ship your products to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.

Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. In addition, failure to correct these violations may result in FDA refusing admission of articles manufactured at A Nelson & Co., Ltd., located at 5-9 Endeavour Way, Wimbledon, London, United Kingdom, into the United States. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act [21 U.S.C. § 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to Current Good Manufacturing Practice within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)].

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 and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute the drug products manufactured at this facility, and provide the dates and reasons you ceased production. Please identify your response with FEI # 1000568184.

If you have questions or concerns regarding this letter, contact Allison A. Aldridge, Ph.D., Compliance Officer, at the below address and telephone number.

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51, Room 2258
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-0483
Fax: (301) 847-8741

Sincerely,

/Steven Lynn/
Steven Lynn
Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research


1 The Agency’s guidance, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15),” states that, in accordance with § 503(b)(1) of the Act, homeopathic drug products offered for conditions that require diagnosis or treatment by a licensed practitioner must bear the prescription legend, "Caution: Federal law prohibits dispensing without prescription.” This guidance was issued by the agency in 1988. In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended § 503(b)(4) of the Act to require that the label of a prescription drug must bear the symbol “Rx only.”
 
2 We note that the CPG also states that, if the HPUS specifies a distinction between nonprescription (OTC) and prescription status of a product based on strength (e.g., 30X), and that distinction is more restrictive than section 503(b) of the Act, the more stringent criteria (i.e., the HPUS criteria) will apply. It follows from this that, if the HPUS specifies a distinction between OTC and prescription status based on strength, and that distinction is less restrictive than section 503(b) of the Act, the section 503(b) criteria will apply regardless of the HPUS distinction.
[end letter]
 
Page Last Updated: 08/07/2012

FDA
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA

U.S. Department of Health & Human Services
[*/quote*]
Logged

Flortiz

  • Jr. Member
  • *
  • Posts: 13
FDA.gov ready to kick Dana Ullmann in the ass!
« Reply #1 on: August 11, 2012, 06:16:09 PM »

The US-based fraudster and snakeoil-dealer Dana Ullman sells "homeopathic remedies" which are produced by the very British company A.Nelson Ltd. which got a kick in the ass by the US FDA because Nelson's "homeopathic remedies" can contain glass shards.

Confronted with the facts, Dana Ullman denies, cheats, lies.... The very same tactics he uses all day long.

Dana Ullman is afraid like hell as some of the investigative tweeps are real bright. So he barred his account's visibility:

https://twitter.com/HomeopathicDana

[*quote*]
Tweets
@HomeopathicDana's account is protected.

Only confirmed followers have access to @HomeopathicDana's Tweets and complete profile.
Click the "Follow" button to send a follow request.
[*/quote*]

We don't need such foolish toys. This is the internet! Here is an even more detailed view of the goings-on:

https://twitter.com/#!/search/realtime/%40HomeopathicDana

[*quote*]
Aribert Deckers Aribert Deckers ‏@aribertdeckers

RT @JHepplestone @HomeopathicDana @lecanardnoir Maybe the water remembers having shards of glass in it?
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Peter Vintner Peter Vintner ‏@pvandck

@HomeopathicDana Name 1 #homeopathy product you sell that has ever incontrovertibly cured anything at all... yeah, I thought so! Fraudster.
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28s Peter Vintner Peter Vintner ‏@pvandck

@aribertdeckers Only Dana scam victims & arse lickers have access to medical fraudster @HomeopathicDana's tweets and complete profile.
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5m James Hepplestone James Hepplestone ‏@JHepplestone

@HomeopathicDana @lecanardnoir Maybe the water remembers having shards of glass in it?
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15m Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@HomeopathicDana "Only confirmed followers have access to @HomeopathicDana's Tweets and complete profile." Dana Ullman in wild panic.
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18m Anne Anne ‏@PlanxtyAnne

@HomeopathicDana those who investigate 'quacks' must have a blind spot when it comes to the FDA & $3 bill fines for pharma 'research'..
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18m Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@HomeopathicDana "@lecanardnoir Name one product that we sell that has shards of glass in them." a) THIS IS YOUR JOB,you fraud. YOU sell it
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22m Gethin Hopkin Gethin Hopkin ‏@GPHopkin

@HomeopathicDana so if I start taking homeopathic medicines I can win olympic golds? Please tell me more.
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28m Andy Lewis Andy Lewis ‏@lecanardnoir

I laugh so much over @HomeopathicDana's blatant denialism. He is such a cartoon character. Pity he harms people with his nonsense.
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34m Tom Armstrong Tom Armstrong ‏@goatamongsheep

@nikki_roberts @HomeopathicDana @lecanardnoir Well it cures thirst, on account that it is, after all, mostly WATER (HT @daraobriain).
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34m CaPPsiE CaPPsiE ‏@cappsie

@zeno001 @homeopathicdana @lecanardnoir FDA: approval processes need examination. Infrastructure needs examination. Reboot required.
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34m Dirk Thrust Dirk Thrust ‏@lennylaw

@HomeopathicDana You, sir, have been well and truly pwned (as they say) by @lecanardnoir so back out now.
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35m Andy Lewis Andy Lewis ‏@lecanardnoir

Its just a thought @HomeopathicDana. Will you resort to your usual bluster or take this seriously? What sort of person are you?
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36m Riddle Like Riddle Like ‏@endless_psych

@HomeopathicDana @lecanardnoir You know any remedy made in a glass container will contain traces of silicates yeah?
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36m Nicola Roberts Nicola Roberts ‏@nikki_roberts

@HomeopathicDana @lecanardnoir name one product that you sell that has any proven medicinal benefit...hmmm?!
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37m CaPPsiE CaPPsiE ‏@cappsie

@HomeopathicDana @lecanardnoir Name one homeopathic product that has been proven to work scientifically and pharmacologically...
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37m Alan Henness Alan Henness ‏@zeno001

@lecanardnoir @HomeopathicDana That's what a *responsible* homeopath would do, isn't it?
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38m Alan Henness Alan Henness ‏@zeno001

@HomeopathicDana @lecanardnoir Oh look! Your FDA is keeping you safe from them: http://www.accessdata.fda.gov/cms_ia/importalert_189.html
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37m Andy Lewis Andy Lewis ‏@lecanardnoir

.@HomeopathicDana Perhaps you can use your platform to alert users of such products in the USA of these concerns?
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39m Andy Lewis Andy Lewis ‏@lecanardnoir

.@HomeopathicDana I refer you to http://qako.me/QJ9awV. You have been aware of these issues for a little while now.
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49m Andy Lewis Andy Lewis ‏@lecanardnoir

Hey @HomeopathicDana Still no thoughts on the shards of glass in the homeopathy products you sell?
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3h Guy Chapman Guy Chapman ‏@SceptiGuy

@Jinzang @pvandck Ha! @HomeopathicDana is a fraud, he misrepresents, cherry-picks and outright lies!
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3h Bernie Simon Bernie Simon ‏@Jinzang

@pvandck @HomeopathicDana regularly links to studies of #homeopathy if you are interested in the subject
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6h Homeopathy Heals Me Homeopathy Heals Me ‏@HomHeals

Actor Martin Sheen Examines Homeopathy http://tinyurl.com/8eg53bg @JPDHomeopathy @CarusoHomeopath @HomeopathicDana @DebbyBruck
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10 Aug DebbyBruck DebbyBruck ‏@DebbyBruck

Nancy's #Homeopathy Daily @DrNancyMalik @HomeopathicDana @AnnaHomeopath @HomeopathicRx @mary_aspinwall @AnnaHomeopath ▸ http://paper.li/DrNancyMalik/homeopaths
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10 Aug Drew Burdett Drew Burdett ‏@DrewBurdett

@HomeopathicDana I guess it makes a change from people questioning their plausibility. Or whether they work. Or if they are unethical.
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10 Aug Richard Tomsett Richard Tomsett ‏@richardtomsett

MT @nullifidian: .@HomeopathicDana If you have a preprint [of Colau et al homeopathy trial], I’d be more than happy to see it.
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10 Aug Dan Buzzard Dan Buzzard ‏@DanBuzzard

@lecanardnoir @HomeopathicDana Athletes do need to drink water/homeopathy. #homeopathy
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10 Aug Atheist biker Atheist biker ‏@gentley1300

@HomeopathicDana @lecanardnoir are you claiming that homeopathy makes him run faster? I notice nothing shows up on his drug tests #woowoo
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10 Aug Paul Morgan Paul Morgan ‏@drpaulmorgan

.@HomeopathicDana Are you happy selling your customers shards of glass in your "magic" sugar pills? Yes or no. @lecanardnoir
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10 Aug The Salted Slug The Salted Slug ‏@saltedslug

RT @bnzss @lecanardnoir how do you fuck up a sugar pill? @HomeopathicDana <- seriously, how DO you fuck that up?
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10 Aug Lisa Chalkley Lisa Chalkley ‏@living_as_if

@HomeopathicDana Yeah cos Big Alt Med is oh so different to Big Pharma *kerching* @lecanardnoir
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10 Aug James Smith James Smith ‏@smithware

.@HomeopathicDana @lecanardnoir Who are these people you imagine don't question the safety of big pharma drugs? Where do they hail from?
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10 Aug Mick Vagg Mick Vagg ‏@mickvagg

@HomeopathicDana @lecanardnoir Yep those glass shards are totally safe, do you agree?
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10 Aug Al Storer Al Storer ‏@Al__S

@HomeopathicDana um, you're the one engaged in double standards. FDA just trying to apply bare minimum of safety and maufacturing standards
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10 Aug Ben Ben ‏@bnzss

@lecanardnoir how do you fuck up a sugar pill? @HomeopathicDana
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10 Aug James Davies James Davies ‏@cosmicpop

@HomeopathicDana @lecanardnoir Dana - you'd probably love this book: http://www.amazon.co.uk/gp/product/0007350740?ie=UTF8&camp=3194&creative=21330&creativeASIN=0007350740&linkCode=shr&tag=bs0b-21&qid=1344555186&ref_=sr_1_4&sr=8-4
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

That was @HomeopathicDana's considered response to the concern that he is selling products with serious manufacturing defects.
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10 Aug nullifidian nullifidian ‏@nullifidian

.@HomeopathicDana Nope, I just haven’t seen one yet. Including this. If you have a preprint, I’d be more than happy to see it.
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10 Aug nullifidian nullifidian ‏@nullifidian

.@HomeopathicDana How do you know it’s “good”? It hasn’t even been published.
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10 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@HomeopathicDana "Another good study shows efficacy of homeopathy...now for menopause: http://www.ncbi.nlm.nih.gov/pubmed/22852580" Plain bullshit and lies!
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

So @HomeopathicDana happy to use his time asserting Usain Bolt loves homeopathy, but not take safety concerns about his product seriously.
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10 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@Neuro_Skeptic "Getting a straightanswer out of @HomeopathicDana is" impossible,he is a dangerous fraudster.A job for the FDA @lecanardnoir
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10 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@Al__S That fraudster @HomeopathicDana is really dangerous: his "remedies" can contain glass particles and he makes lethal healh claims.
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10 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@lecanardnoir "@HomeopathicDana calls me a 'denialist'" Not irony,but typical Scientology warfare: to accuse others of what he does himself
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10 Aug Mick Vagg Mick Vagg ‏@mickvagg

@lecanardnoir @homeopathicdana Good point, you'd have to be concerned Dana. Integrity wold demand it...
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

The irony is that @HomeopathicDana calls me a 'denialist'. Let's see how long he denies the existence of the Nelsons scandal.
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10 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@lecanardnoir I wait for the day the FDA will crack down on that rotten liar,forger,and fraudster @HomeopathicDana and smash him to pieces
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10 Aug Tich Partymore Tich Partymore ‏@TPartymore

@lecanardnoir @HomeopathicDana :) hilarious
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10 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@lecanardnoir @HomeopathicDana also sells the stuff Boiron was successfully sued for,AND he makes fraudulent health claims.He is a criminal
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Its going to be fun watching @HomeopathicDana desperately ignore the Nelsons problem and the fact he sells their products.
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10 Aug JP JP ‏@gardenowl

@lecanardnoir Perhaps they would cure glass-induced lacerations, if fine enough / @homeopathicdana
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10 Aug Karen Karen ‏@erzsebel

@lecanardnoir @HomeopathicDana perhaps glass also has some sort of useful memory?
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Maybe @HomeopathicDana thinks the shards of glass are necessary. He has gone on about the silica hypothesis before. http://qako.me/P9nKhx
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10 Aug Matt Fellows Matt Fellows ‏@MattFellows

@Al__S @HomeopathicDana Wouldn't they cure Cuts and Lacerations? Oh noe - only if you were to dilute them - my bad...
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10 Aug Al Storer Al Storer ‏@Al__S

it is almost as if @HomeopathicDana doesn't care that he might be selling pills with broken glass in them
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10 Aug Neuroskeptic Neuroskeptic ‏@Neuro_Skeptic

@lecanardnoir Getting a straight answer out of @HomeopathicDana is like getting a molecule of active ingredient out of a homeopathic remedy
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Come on.You are there. @HomeopathicDana - what is your reaction to the Nelsons/shards of glass/poor manufacturing scandal?
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

@HomeopathicDana Let's see him say that, eh?
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

So let's see if @HomeopathicDana ignores this safety concern. Does he care more about his profits or his customers? No bets.
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

.@HomeopathicDana And while you are at it, will you be withdrawing your sale of Nelsons products and warning your readers? Yes/No
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

@HomeopathicDana Yes and a self publicist. Like you. Show me Bolt's personal recommendation for homeopathy. Any reference will do.
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10 Aug Martin Cox Martin Cox ‏@martincox

@HomeopathicDana The article doesn't say that. Why do you 'headline' your tweet with that?
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Will @HomeopathicDana withdraw the Nelsons products he sells until he can be assured of their quality and lack of danger to his customers?
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Will @HomeopathicDana condemn Nelsons Homeopathy for exporting to the US products with glass shards, poorly manufactured, mislabeled?
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10 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Challenge for homeopaths including @HomeopathicDana. Find any statement from Usain Bolt where he recommends homeopathy. Any. #homeopathy
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9 Aug Richard Tomsett Richard Tomsett ‏@richardtomsett

@HomeopathicDana though interesting to know you think it's "good science" before the full paper is available...
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9 Aug Richard Tomsett Richard Tomsett ‏@richardtomsett

@HomeopathicDana re. Colau et al study: suspiciously small and similar standard deviations; will await publication of full paper
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9 Aug Paul Phillips Paul Phillips ‏@MuchConfused

@Aarghyoukidding @homeopathicdana So those who ask for proof are "arrogant" and "blind"? Keep on quacking that man!
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9 Aug Peter Vintner Peter Vintner ‏@pvandck

@Aarghyoukidding I've asked @HomeopathicDana many times for a documented case study. He knows he can't do it and always bullshits instead.
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9 Aug Lisa Lisa ‏@Aarghyoukidding

@pvandck @HomeopathicDana Yeah, I know they all are. I just don't want it to be said that I never give them a chance to offer proof.
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9 Aug Homeopathy Heals Me Homeopathy Heals Me ‏@HomHeals

India wants AYUSH (and Homeopathy) to be Globally Recognised http://tinyurl.com/cpdllab @HomeopathicDana @DebbyBruck @ellenkramer
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9 Aug Peter Vintner Peter Vintner ‏@pvandck

@Aarghyoukidding @HomeopathicDana is a fraud. He promotes superstition for profit. Evidence undermines his business model. #homeopathy
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9 Aug Peter Vintner Peter Vintner ‏@pvandck

@Aarghyoukidding @HomeopathicDana is an fraud. He can't provide 1 documented case study of #homeopathy incontrovertibly curing anything.
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9 Aug Lisa Lisa ‏@Aarghyoukidding

@MuchConfused “@HomeopathicDana: .@Aarghyoukidding Get beyond scientific arrogance. You'll be better for it. Really.”he also called me blind
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9 Aug Lisa Lisa ‏@Aarghyoukidding

“@HomeopathicDana: .@Aarghyoukidding Get beyond scientific arrogance. You'll be better for it. Really.”
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9 Aug Paul Phillips Paul Phillips ‏@MuchConfused

@HomeopathicDana And the irony of being accused of making stuff up by a homeopathist isn't lost on me! Ttfn xx
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9 Aug BigDaveSB BigDaveSB ‏@BigDaveSB

@lecanardnoir @homeopathicdana Yes, he's a fraud or is acting like a child, as far as I can see http://furtherthoughtsfortheday.blogspot.co.uk/2011/01/homeopathy-overdoes-frauds-and-children.html?m=1
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9 Aug Paul Phillips Paul Phillips ‏@MuchConfused

@HomeopathicDana You should be the type specimen for the quack - master of ad hom attacks and aversion to answer straight questions
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9 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

The only reason I can think that @HomeopathicDana does not answer questions is that he knows homeopathy is absurd & answering exposes that.
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9 Aug Paul Phillips Paul Phillips ‏@MuchConfused

@HomeopathicDana Citing Lisa's "arrogance" not an attempt to undermine the point she made? I won't even mention the condescending tone.
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9 Aug Paul Phillips Paul Phillips ‏@MuchConfused

@HomeopathicDana @aarghyoukidding Get beyond the ad hom attacks and answer a question for once. You'll be better for it. Really.
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9 Aug Adam Jacobs Adam Jacobs ‏@adam_j666

@HomeopathicDana Sigh. You are *so* predictable. cc @lecanardnoir
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9 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

I'm pretty sure @HomeopathicDana knows homeopathy is absurd. That is why he refuses to answer these questions. http://qako.me/O4laJX
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9 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

@HomeopathicDana If that were true, you would easily answer the questions and put them right. I think you cannot answer them.
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9 Aug Exeter Skeptics Exeter Skeptics ‏@exeskeptics

@lecanardnoir @HomeopathicDana I thought it said Homoeopathic Diana - like one of those parody accounts @DianaInHeaven
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9 Aug Peter Vintner Peter Vintner ‏@pvandck

@lecanardnoir @HomeopathicDana It's fair to say very many homeopaths don't know much about #homeopathy. If they did they wouldn't sell it.
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9 Aug Adam Jacobs Adam Jacobs ‏@adam_j666

@lecanardnoir I expect @HomeopathicDana will claim that homeopathy is exempt from the scientific method, and therefore exempt from questions
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9 Aug Jonathan Knowles Jonathan Knowles ‏@profjcknowles

MT @lecanardnoir: Obv @HomeopathicDana does not know that much about homeopathy, otherwise he would have ans these Q's http://qako.me/O4laJX
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9 Aug Aribert Deckers Aribert Deckers ‏@aribertdeckers

.@lecanardnoir "Obviously @HomeopathicDana does not know that much about homeopathy" ,which was shown in detail here: http://transgallaxys.com/~kanzlerzwo/index.php?topic=7231
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9 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

Obviously @HomeopathicDana does not know that much about homeopathy, otherwise he would have answered these questions. http://qako.me/O4laJX
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9 Aug Sophia Cyrus Sophia Cyrus ‏@MyAZHomeopath

“@HomeopathicDana: Homeopathic medicine and nanomedicines. The power of nanodoses is throughout nature: http://www.ncbi.nlm.nih.gov/pubmed/22755043
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9 Aug Graeme Unknown Graeme Unknown ‏@Bevaux

@lecanardnoir @HomeopathicDana I hope you realize that you will never get a sensible, accurate, and scientific answer to these questions.
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9 Aug Elsah Cort, RN Elsah Cort, RN ‏@thedeeperwell

The Deeper Well :: Daily Collage is out! http://bit.ly/eiJWHi ▸ Top stories today via @HomeopathicDana @bobcesca_go
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9 Aug Andy Lewis Andy Lewis ‏@lecanardnoir

As one of the more knowledgeable homeopaths @HomeopathicDana would you care to answer these questions? http://qako.me/O4laJX
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6 Aug Guy Chapman Guy Chapman ‏@SceptiGuy

@Aarghyoukidding @LeslieBattenND @_forcesofnature @homeopathicdana Sure, but that story did not mention homeopathy.
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6 Aug Lisa Lisa ‏@Aarghyoukidding

@LeslieBattenND @sceptiguy @_forcesofnature @homeopathicdana doctors know the value of placebo too
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6 Aug Leslie Batten Leslie Batten ‏@LeslieBattenND

@SceptiGuy @_forcesofnature @homeopathicdana @aarghyoukidding Take it up with the MDs using it and the patients for whom it helps.
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6 Aug Guy Chapman Guy Chapman ‏@SceptiGuy

@LeslieBattenND @_forcesofnature @homeopathicdana @aarghyoukidding I understand the principles of #homeopathy. It's bogus.
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6 Aug Leslie Batten Leslie Batten ‏@LeslieBattenND

@SceptiGuy @_forcesofnature @homeopathicdana @aarghyoukidding If you understood the principles of homeopathy, you would recognize its use.
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6 Aug Guy Chapman Guy Chapman ‏@SceptiGuy

@_forcesofnature @LeslieBattenND @HomeopathicDana @Aarghyoukidding It doesn't mention #homeopathy. Quack caught lying shock! Pictures at 11!
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6 Aug Guy Chapman Guy Chapman ‏@SceptiGuy

@_forcesofnature @LeslieBattenND @HomeopathicDana @Aarghyoukidding Some are, most do not use such blatant quackery though.
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6 Aug Forces of Nature USA Forces of Nature USA ‏@_forcesofnature

RT @LeslieBattenND: @HomeopathicDana @Aarghyoukidding This in The Wall Street Journal - MDs are using #homeopathy http://tiny.cc/dpqhiw
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6 Aug Marc Alberts Marc Alberts ‏@marcalberts

@HomeopathicDana @DJGrothe I suspect DJ already knows something, but just wants confirmation
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[*/quote*]


There are no excuses. There are no backdoors. Dana Ullman is a case for the next FDA raid.


[fixed missing URL and note, ET]
« Last Edit: August 13, 2012, 03:34:34 AM by el_Typo »
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Flortiz

  • Jr. Member
  • *
  • Posts: 13
Re: FDA.gov kicks homeopaths in the ass!
« Reply #2 on: August 11, 2012, 06:23:23 PM »

Confronted with the facts, Dana Ullman denies, cheats, lies.... The very same tactics he uses all day long.



Darn! Can't edit. HELP!

[fixed, ET]
« Last Edit: August 13, 2012, 03:36:05 AM by el_Typo »
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