The information provided on this website does not, and is not intended to, constitute legal advice. Instead, all information, content, and materials available on this site are for general informational purposes and as a collection of consumer notes and experiences.
AS OF 1-27-2021 ALL LEAF CONSUMERS ARE ENCOURAGED TO JOIN LOSTLEAFBACKERS GROUP FOR UPDATES ON THE LAWSUIT.
Since 2014, US Courts have interpreted crowdfunding terms as a binding contract subject to pertinent legal prescriptions ranging from consumer laws (Lanham Act–Deceptive Advertising), to contract, to tax laws. Further, marketing and distribution of masks representing special filtering efficiencies and/or prevention of diseases in active status (i.e, “Covid-19”) must comply with federal regulatory schemes by CDC/NIOSH (42 CFR Part 84) and the FDA (21 CFR).
Under “Health and Wellness, Medication and Dietary Supplements” [Community Guidelines for Campaign Owners], Indiegogo expressly prohibits “any item claiming to cure, treat, or prevent an illness or serious medical condition” or “products making false or misleading health claims, or being touted as miracle cures.”
Given the prohibitions, why IGG entertained the campaign of a highly regulated Class II medical device promoting broad claims of Covid-19 prevention remains an open question.
Filing a chargeback dispute directly with your credit card company. Here’s a Rebuttal Template to help. First send an email notification to the merchant requesting a refund (keep copy for your file). US consumers file a brief charge dispute directly with their ccard company→ IGG sends in their notes challenging the dispute → consumer files a rebuttal by mailing explanations/documents within 10-15 days (be sure to mail your docs with a tracking no.). The deadline for filing a chargeback dispute is normally 120 days from the latest delivery date provided by the merchant.
Images of the mask were photoshopped and presented without disclaimers (Ex. “Pictures shown are for illustration purposes only. Actual product may vary.”).
Claims of N99+ Efficiency and ‘N95 Exhaust Filters’
Cloth face masks and surgical masks are loose fitting products used as source control. In contrast, respirators have a tight fit to the face and provide respiratory protection for the wearer.
CDC/NIOSH regulates respirators under “N” classification and 95/99/100 efficiency. The institute does not approve “N95 filters” as an isolated component. Filtering results only provide a check of the filter efficiency level of the respirator and cannot be used to influence sales or to make any claims of N95+ equivalency. NIOSH does not provide retroactive approval.
The only SGS filtration report provided by Redcliffe in support of its claims of protection against Covid-19 was altered to conceal the fact that the test result belonged to another company. Swiss Lab SGS noted (9-2-2020): “Report No. GZF20-002369-02 was not issued to Redcliffe Healthcare. Furthermore the use of this partial SGS report is not permitted on Indiegogo’s website. We will take the appropriate action to have this document removed and thank you for bringing it to our attention.”
Mislabeling/Misbranding – FDA-Regulated Devices
In addition to NIOSH-approval, respirators intended for “medical purposes” as defined by the code, require FDA-clearance. They include respirators indicating prevention of specific diseases (i.e., “COVID-19”); labeled or represented as filtering specific amounts of viruses or bacteria, or reducing and/or killing viruses and bacteria; containing biologicals (e.g., antimicrobial/antiviral coating technologies or botanicals).
These claims require that the product undergoes FDA 510(k) pre-market review. To note: if the product contains an antimicrobial — even if the maker does not make antimicrobial claims — the product needs 510(k) pre-market review.
In the Project Owner’s website as well as at Indiegogo’s website, Redcliffe made representations as to the masks providing “uncompromising protection” against Covid-19. These representations were made in writing under the “Story” tab, in the form of customer “Updates,” as well as videos uploaded to Vimeo: “I’d like to introduce you to Leaf mask…. it’s a state-of-the art U-series HEPA filtration that has active sanitization at the push of a button. And is a transparent mask and protects you from dust and pollution and microbes, and it’s got a 99.9997 percent filtration of things down as small as 0.3 microns…So this is the N99+ standard.”
ACTUAL FDA CODE SYSTEM
—N95 Filtering Facepiece Respirator – Class II, Code MSH. Not exempt from 510(k) pre-market review and clearance if (a) the respirator claims to prevent specific diseases or infections; or (b) the respirator is labeled or otherwise represented as filtering, reducing or killing specific amounts of viruses, bacteria, or fungi.
—N95 Filtering Facepiece Respirator with Antimicrobial/Antiviral Agents – Class II, Code OUK. Requires 510(k) pre-market review and clearance. It is intended to prevent specific diseases or infections; or, is labeled or represented as filtering, reducing or killing specific amounts of viruses, bacteria, or fungi.
PAPR – Powered Air Purifying Respirators. Class II, Code NZJ. Help reduce the aerosol concentration inhaled by the wearer to at least 1/25th of that in the air. Cost US$1,400-$1,900
21 CFR §807.39. Misbranding by reference to establishment registration. [FDA] 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.
“The FDA logo is for the official use of the U.S. Food and Drug Administration (FDA) and not for use on private sector materials. To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.”
Redcliffe Medical Devices, Inc. has a business registration with the FDA (30170 60261) in 2020. Note that the registration QKR specifically “excepts N95 respirators.”
Claims on UV Technology
UV light is a novel, untested technology in respirators, imposing serious risks to human health–burns from radiation can appear within seconds. Ron Hofmann, president of the International Ultraviolet Association: “UV-C does have a helpful role to play during the current pandemic: as a disinfectant tool. This is because UV-C radiation doesn’t just damage human DNA; it also harms genetic material in all other living things on Earth.” (July 2020)
—ALERT! If you have suffer any injuries as a result of UV product radiation take photos, contact a doctor and consult with a personal injury lawyer. Report the device to: firstname.lastname@example.org
Product Readiness and Production Capacity
One other issue in communications with Redcliffe Medical Devices, (www.leaf.healthcare –MI, 2020) is that the company appears to have traded its products under a domain name that included the trademark of a prominent, preexisting company, Leaf Healthcare Inc. (www.leafhealthcare.com, currently http://www.sn-leaf.com, CA, 2011). Leaf Healthcare, CA, is a patient-monitoring device company owned by the global medical group Smith+Nephew. Many consumers were thereby confused as to the actual source of Redcliffe’s “Leaf mask.”
FDA (email): FDA-COVID-19-Fraudulent-Products@fda.hhs.gov
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