NAD Recommends Vestagen Discontinue Claims that Company’s ‘VESTEX’ Hospital Scrubs Protect Patients, Medical Personnel from Dangerous Contaminants; Finds Company can Support Certain Medical Device Claims

New York, NY – July 27, 2016 – The National Advertising Division has recommended that Vestagen Protective Technologies, Inc., discontinue certain advertising claims for the company’s Vestex fabric, including claims that garments made with Vestex fabric protect healthcare workers and their patients from pathogens, dangerous contaminants and healthcare-associated infections. The claims at issue were challenged by Strategic Partners, Inc. (SPI), the maker of competing scrubs and other hospital garments.

Vestagen agreed to permanently discontinue certain claims during the course of the proceedings. However, NAD routinely reviews all claims that are “live” at the time that the challenge is filed.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

NAD reviewed claims that included:

• Vestex transforms healthcare garments into apparel that helps guard workers and patients from pathogens and other contaminants.
• Vestex is effective against MRSA.
• Vestex provides protection from pathogen transmission.
• Vestex is effective against a broad range of bacteria, including disease-causing bacteria.
• Garments with Vestex fabric lead to a safer environment.
• Vestex fabric is registered with the FDA as a Class 1 medical device.
• Vestex is clinically proven to prevent or reduce the acquisition and retention of contaminants on clothing, reducing methicillin-resistant Staphylococcus aureus (MRSA), by 99.99% compared to traditional uniforms.

The claims at issue appear in internet and print advertising and in marketing and promotional materials.

In reviewing all the claims at issue, NAD concluded that the advertiser’s language reasonably conveyed the unsupported message that Vestex garments prevent transmission of healthcare-associated infections (HAIs), MRSA, contaminants, pathogens and disease-causing bacteria to healthcare workers.  Claims from the advertiser’s website link the rates of illness of healthcare professionals, the prevalence of their exposure to body fluids resulting in bacterial colonization on apparel, pathogen transmission, and the protection from illness.

In support of its claims, the advertiser primarily relied on a published peer-reviewed study to assess the effectiveness of Vestex antimicrobial scrubs in limiting the bacterial burden on healthcare workers’ hands and clothing in a clinical setting, and on U.S. Food and Drug Administration (FDA) classification language and Environmental Protection Agency (EPA) Registration regulations and guidance. The study was commissioned by Vestagen.

NAD noted in its decision that the advertiser’s study – the Bearman Study – drew tentative conclusions about the potential clinical utility of apparel with antimicrobial properties, that “the impact of antimicrobial scrubs on HAIs remains unknown,” and found that “a prospective trial is needed to assess the incremental impact of antimicrobial impregnated apparel on the control of hospital acquired infections.”

NAD concluded that the Bearman Study did not constitute competent and reliable evidence sufficient for advertising claim substantiation purposes – particularly the health claims made by Vestagen. NAD concluded that the study was insufficient to substantiate Vestagen’s “clinically proven” or “proven” claims promising specific results from use of its product.

NAD recommended that the advertiser discontinue claims, including “clinically proven” claims, premised on the Bearman Study as they relate to Vestex and its impact on healthcare-associated infections. NAD further recommended that the advertiser discontinue the use of excerpts from the Bearman Study on its website and other advertising and sales materials. NAD also recommended that the advertiser discontinue its description of the Bearman Study as “evidence-based” or as employing an “evidence-based approach.”

NAD concluded that the advertiser provided a reasonable basis for its claims that its “surgical apparel, scrub suits” protect against “microorganisms, body fluids, and particulate material.” However, NAD recommended that the advertiser modify and more narrowly tailor such claims premised upon its FDA classification to more accurately set forth that its Vestex “surgical apparel, scrub suits” protect against “microorganisms, body fluids, and particulate material on the fabric,” and discontinue use of the terms “pathogens” and “dangerous contaminants,” make clear that the provided protection is due to its fluid barrier properties and avoid the implication that the product protects the surgical patient and operating room personnel’s health via its antimicrobial properties.

NAD further concluded that the advertiser provided a reasonable basis for its EPA-permissible non-public health claims such as “Product contains an antimicrobial to inhibit the growth of bacteria/fungi (or microorganisms) on the fabric,” or “Antimicrobial properties built in to protect the garment …”

However, NAD recommended that the advertiser further qualify its non-public health claims by use of language such as “This product does not protect users or others against disease-causing bacteria. Always clean this product thoroughly after each use,” or “This product does not protect users or others against bacteria, viruses, germs or other disease organisms. Always clean this product thoroughly after each use.”

NAD also recommended that the advertiser discontinue claims that Vestex:

• “helps guard workers and patients from pathogens and other contaminants” when referring to its product’s fluid barrier properties
• “has the ability to transform healthcare garments into apparel that helps guard workers and patients from pathogens and other contaminants” and “a broad range of bacteria including disease-causing bacteria” and “protects against pathogen transmission”
• “help[s] protect healthcare workers and their patients from unanticipated exposure to the dangerous contaminants they encounter every day”
• “is effective against MRSA”
• “garments with Vestex fabric lead to a safer environment” and similar claims

NAD also recommended the advertiser discontinue the claim “with Vestex … 99% of pathogens [are] destroyed – reducing risk of contact with the wearer and those around them.”

Finally, NAD recommended that any articles authored by current or former employees that appear at the company’s website, in advertising and sales materials or on its blog, clearly and conspicuously disclose the material connection to the advertiser and/or be labeled as advertising.

Vestagen, in its advertiser’s statement, said the company “agrees to comply with NAD’s decision and recommendations, and will work within the framework of allowable language and claims afforded our technology given the regulatory pathway earned.”

“NAD’s mission to ensure accurate advertising buoys our commitment to the advancement of healthcare worker uniforms and patient apparel,” the company added.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.