Homemark makes the claim in their television adverts, and on the packaging of this product, that the product was "Tested in a FDA CERTIFIED laboratory".
Homemark Detox Footpads, lies, lies and more lies.
This claim is frankly, one major lie. And worse, this has been pointed out to Homemark.
Homemark has submitted certificates to the ASA claiming that the laboratory that did the analysis if FDA registered, according to the certificate supplied.
This certificate appears to be false.
It claims to be issued by:
RCH Pharmaceutical, Cosmetic and Food Analytical Laboratories
2880-A Ana St.(PCT Building)
Rancho Dominguez, CA 90221
An U.S. FDA Registered Laboratory * Pharmaceuticals * Cosmetics * Foods
FDA Registration No.:2030950
I have searched Google for such a company – it does not exist.
I contacted Pacific Continentals Textile Inc, a company based at the same address 2880 E Ana St, Compton, CA 90221-5602, contact phone: (310) 639-1500, who have been operating from these premises for 20 years, and the spokesperson had not heard of this entity.
Note, RCH Pharmaceuticals claim to be based at 2880-A Ana St. Rancho Dominguez, CA 90221, and Rancho Dominguez does not have a street by this name, but the small town next to it Compton, does. Rancho Dominguez and Compton appear to be often confused according to Google searches.
Furthermore, Mr Geoffrey S Clark, Consumer Safety Officer at the FDA (HFZ-220), replied to my query stating:
“Not all laboratories must register with FDA but there are some circumstances (manufacturing & importing are 2 examples) that require registration. However, there is no FDA registered facility with registration # or Owner/Operator # = 2030950.”
|Furthermore, the analytical certificate from the so-called “FDA registered laboratory”, was issued for “Forest Essence Powder / Forest Essence Pad”. This is not the same product as the Detox footpad. Forest Essence Pad is registered with the FDA as a heating or cooling pad for the soles and NOT a detox footpad.|
This is confirmed by my correspondence with the FDA. According to Mr Geoffrey S Clark, if this product was a detox food pad, it would require a different registration.
“According to the limitations of exemption, you are correct that a detoxifying claim would alter the conditions for this device to be legally marketed moving it from step 1a to 1b of the 3 basic steps.
Because this change would represent new indications for use this change would trigger the “Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)” as listed in the classification regulations 8##.9 of Title 21 CFR. The modified device would not be exempt from the 510(k) requirements.
The Quality System Regulation [Part 820] would apply to the modified device unless specifically exempted in the classification regulation. Company A’s current establishment registration & medical device listing would cover the modified device as soon that the 510(k) is cleared.”
In other words, firstly, the so called “FDA registered laboratory” does not exist, and even if it did, the certificate is not for a Detox Foot pad but for a product in the registration category for a device that heats or cools the soles of the feet, or a plaster. (See included FDA letter)
And finally, the use of the FDA name, i.e., “tested by an FDA laboratory” or “tested by an FDA accredited laboratory” or “FDA approved” are all used with the sole intention of deceiving the average consumer into believing that the product has efficacy – as the FDA was involved. The average consumer will not appreciate that all that this may mean is that the product had been tested before use to ensure that the ingredients are safe. So even if the certificate claiming that the laboratory was FDA certified was not fake, as I prove in this submission, then the intention of the claim is misleading as the average consumer will not appreciate that the analysis had nothing to do with whether the product works or not, but simply that the raw ingredients have not been contaminated with heavy metals or bacteria or other noxious substances. For this reason alone, this claim is misleading and I ask the ASA to rule against this claim.
To date (Feb 2010), the ASA has not made a ruling for they do not accept my evidence from the FDA but wish to confirm for themselves – and they claim that the FDA have not responded to their queries yet.