Unauthorized marketing and distribution of masks claiming to provide “N99 protection against Covid-19”?

AS OF 1-27-2021 ALL LEAF CONSUMERS ARE ENCOURAGED TO JOIN LOSTLEAFBACKERS FOR UPDATES ON THE LAWSUIT.

The current pandemic has given rise to fraudulent activity concerning “masks” marketed as personal protection equipment (PPE). This note highlights an Indiegogo campaign by Redcliffe Medical Devices, Inc., marketing transparent facemasks as providing “uncompromising protection against Covid-19.”

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).

Since the start of the promotional campaign, on or about May 23, 2020, 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,” press releases (carried through prominent news sites such as C-Net), web commercials, and videos uploaded to Vimeo.

Website Ads

Co-founder Alex Lightman (https://vimeo.com/420198294).

Video Transcript: “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. It’s got an invisible exhaust valve and activated carbon filter, aerospace grade HEPA filter and UV-C power-start technology…. our filter is 100% recyclable, 100% washable and renewable, and it stops 99.9997 percent particles down to 0.3micron particles. So this is the N99+ standard.”

Masks vs Respirators

Generic 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 to the wearer (PPE).

NIOSH CERTIFICATION REQUIREMENTS

42 CFR PART 84 – CDC/NIOSH REGULATIONS

The Meaning of NIOSH Approval

NIOSH approval is issued only to complete respirators from an approved mfg facility. A NIOSH approval applies to a specific respirator model that is made up of the components included on the NIOSH approval label. The issuance of an approval number to a respirator does not allow the manufacturer to modify the respirator in ways that affect form, fit or function, or to make claims of NIOSH approval for features outside of those certified by NIOSH.

Can I distribute ‘N95 Exhaust Filters’?

NIOSH does not approve “N95 filters” as an isolated component as overall fitness and safety depends on more than just filter efficiency. Further, NIOSH does not provide retroactive approvals.

§84.30: Scope of Approval. “The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators.” “The Institute will not issue certificates of approval for any respirator component or for any respirator subassembly.”

§84.170 “(2) Non-powered respirators are classified into three series: N-, R-, and P-series. N-series filters are restricted to use in workplaces free of oil aerosols. (3) Respirators are further classified according to the efficiency level of the filter(s) as tested according to the requirements of this part. (i) N100, R100, and P100 filters must demonstrate a minimum efficiency level of 99.97 percent. (ii) N99, R99, and P99 filters must demonstrate a minimum efficiency level of 99 percent. (iii) N95, R95, and P95 filters must demonstrate a minimum efficiency level of 95 percent.”

Leaf masks do not hold NIOSH approval. These are not “N95 filters.”

Manufacturing Approval Process

Step 1. The entity that controls the design and manufacturing of the respirator must request a Manufacturer’s Questionnaire. After completion of the questionnaire, NIOSH will review the information provided and, if the responses are satisfactory, assign a 3-letter manufacturer code. This code does not imply NIOSH approval (the code simply allows the mfg to submit a Respirator Approval Request).

Step 2. NIOSH reviews Application Form, Questionnaire, and Product Quality Manual.

Step 3. NIOSH conducts a site inspection.  [2-day domestic audit—$5,000/site and 2-day international audit—$10,000/site]

Step 4. NIOSH inspects mfg test equipment and facility equipment.

Step 5. NIOSH reviews records maintenance.

Step 6. NIOSH conducts testing at a NIOSH Lab (PA and WV) of random respirators collected from the production line.

Step 7. NIOSH corresponding fees must be paid.

Step 8. NIOSH Approval Granted. NIOSH logo and test approval code must be imprinted on the mask itself, along with model no., lot no., and filter designation (N95/99/100).

NIOSH Fee Schedule

  1. Quality Assurance Maintenance (site audit): $3,000/year domestic site

2. Records Maintenance: $50/year

3. Maintenance of Testing and Approval Facilities: $34/site/year

4. Maintenance of Test Equipment: $36/year

List of NIOSH Approved Facepiece Respirators

FDA REQUIREMENTS

21 CFR CH.1 and CH. 9 – FDA

In addition to NIOSH-approval, respirators intended for “medical purposes“, require FDA-clearance/approval. “Medical purpose” includes indications of prevention of specific diseases in active status (i.e., “COVID-19“); devices 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 or botanicals); containing UV disinfectant technologies. Note: if the product contains an antimicrobial (a pesticide)—even if the maker does not make antimicrobial claims—the product needs FDA 510(k) pre-market review, then clearance/approval prior to being marketed.

REDCLIFFE’s STATEMENTS TO CONSUMERS

Leaf “masks” as originally advertised – May 2020
03-06-2021
09-27-2020
12-31-2020

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 ads and website From May 13,2020 through March 2021

Emergency Use Authorization for N95+ Respirators Originating in China…

Leaf “masks” are manufactured in China. They do not have the NIOSH approval and FDA clearance required for products containing antimicrobial coating and embedded UV disinfection.

US Federal and State Legislation

The marketing and distribution of face masks claiming “N95/99/100 filtration and protection against Covid-19” violates federal regulations and State laws and may impose undue risks for consumers.

Redcliffe Medical Devices, Inc. Corporate ID: 8024 39645. Official address: 3000 Town Center, Suite 1550, Southfield, MI, 48075.

support4backers@leaf.healthcare; lalit@leaf.healthcare; shop@leaf.healthcare; backers@leaf.healthcare

AS OF 1-27-2021 ALL LEAF CONSUMERS ARE ENCOURAGED TO JOIN LOSTLEAFBACKERS FOR UPDATES ON THE LAWSUIT.

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