Homemark Detox Foot Pads

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Posted 11 August 2010

I have previously posted that Homemark continues to suggest that the FDA has approved these footpads, or that they were tested in an FDA approved laboratory. I have previously posted that the FDA have categorically stated that these claims are false. The ASA has shown my letter to Homemark who have dismissed it, and the ASA, not trusting me, have been trying to get a personal response from the FDA, to no avail they inform me. Out of frustration, I tried the FDA again, and on 10 August 2010, they responded (remember, Homemark have been using these claims for years!)

 This is in response to your Email below to the FDA, Division of Small Manufacturers, International and Consumer Assistance (DSMICA). I apologize for the delay in responding to your Email. FDA does not approved “laboratories”.  As previously mentioned to you before by Mr. Geoff Clark (now retired from FDA), our records do not reflect an active registered facility under registration #2030950. Also please note under medical device regulation 807.39, “Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.39 In regards to the product mentioned “Detox foot pads”.  I did find a registered establishment in China who has a medical device listing for a detox foot pad.  www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=183664&lpcd=FRL   This medical device is listed by the establishment under medical device regulation 880.5300, medical absorbent fiber.  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRsearch.cfm?FR=880.5300 (Note – not a detox footpad which will require a different and formal registration)  Again, please note mentioned above that establishment registration and medical device listing does not denote approval of a medical device or the registered establishment. The best way for a manufacturer to get a written response regarding the regulatory classification for a medical device is to submit a 513(g) request for medical device classification.  Guidance is available on the FDA medical device website on what a 513(g) is and how to submit a 513(g) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209841.htm and the fees http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm209852.htm I hope you find this information helpful. Warmest regards, xxxx xxxx Division of Small Manufacturers, International and Consumer Assistance (DSMICA) Office of Communication, Education, and Radiation Programs (OCER) Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA) Phone: 301-796-5709 Fax: 301-847-8149

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2 Responses to Homemark Detox Foot Pads

  1. Katy Chance 2 February, 2014 at 10:23 am #

    I am SO glad it is not only me that finds this infuriating. I attempted to go through the ASA and the BCCSA a few years ago about these things, after reading Ben Goldacre’s book Bad Science, and was also dismissed. They referred me to a website that said ‘they’re fine’. That’s one website, written by a ‘doctor’ who endorses the products! I think we need to target all the pseudo-chemists – Clicks, Dischem etc – who continue to sell these as valid ‘medical’ applications.
    When I saw the ‘FDA Approved’ ad this week, I couldn’t believe what I was seeing. I am attempting to go onto the FDA’s website to alert them to the fact that their name and logo is being used in this way. That said, after reading Goldacre’s Bad Pharma, the FDA may well be getting some sort of financial recompense for actually endorsing them – nothing surprises me about the pharmaceutical industry!

    • Harris 2 February, 2014 at 10:38 am #

      Sadly some years ago, the ASA accepted the evidence of the homeopath, Frederick Motz, who claimed the product works – in spite of the FDA banning an equivalent product. By coincidence, last night I saw an advert which claims that the product is FDA approved when in fact, all that they can claim is that the product was tested by an FDA approved lab (which I showed to be a lie), and only tested according to the documents, to be free of toxins. Nothing else. Sadly, our next recourse, the Consumer Protection Act, is ineffectual at present.

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