FDA Approves New Prescription Silver Wound Dressing Gel

FDA Approves New Prescription Wound Dressing Gel

As anyone who reads this blog regularly already knows, I’m not a big fan of the FDA. They are slow, cumbersome and heavy-handed when dealing with anything that smells like a supplement with claims.

I have to admit however, that I was recently surprised to learn that a week ago, it approved two products created using American Biotech Lab’s patented nano-catalytic SilverSol Technology.

Both products are manufactured by ABL,LLC in Alpine, Utah and licensed to various companies including Nutronix International under various name brands. One of the name brands is the 24ppm Silver Solution Gel distributed by Nutronix International.

It is a company and product that I have referred to many times in various blog posts. Not just because I earn a small commission on every sale of this product at my Nutronix Website but primarily because the company works really hard to market effective products. Two of my favorites are the New Silver Solution liquid and New Silver Solution Gel.

The Gel has been approved as an antibacterial silver wound dressing gel as a prescription 510(k) medical device throughout the United States.

I feel a little vindicated here since I have written so much on this blog and elsewhere about the SilverSol Technology, the Gel and the 14ppm New Silver Solution liquid.

There really is a large difference between older silver products still marketed all over the internet and the New Silver Solution liquid and gel. You can read the announcement below out of Salt Lake City, UT below and the FDA statements.

Good Health to You,

Bruce Santucci

Top Wellness Products

SALT LAKE CITY (November 17, 2009)—American Biotech Labs, LLC (ABL), developer of a new class of products based on the company’s patented nano-catalytic SilverSol Technology®, today announced that the company has obtained clearance by the U.S. Food and Drug Administration (FDA) to market its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510(k) medical device throughout the United States.

Clifton Mining Company is a major shareholder in American Biotech Labs. ASAP® Antibacterial Silver Wound Dressing Gel is now cleared as a 510(k) medical device “for use in the management of 1st degree burns, stasis…pressure…(and) diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites”; new ASAP product “has been shown (in laboratory tests) to inhibit the growth of…Staph…E. coli…MRSA and VRE as well as…Candida.

The FDA 510(k) medical device clearance enables ABL to market its ASAP Antibacterial Silver Gel “for use in the management of 1^st and 2^nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.”

In addition, according to the draft package insert, the new product “has in laboratory tests been shown to inhibit the growth of microorganisms such as Staph…E. coli…MRSA and VRE; as well as fungi such as Candida albicans.”

The product utilizes ABL’s innovative SilverSol Technology®, which has garnered multiple patents in the U.S. and several countries throughout the world, including a broad-use patent that provides the company with exclusive rights to use its silver-based products to combat many of the world’s most destructive pathogens.

ABL has performed extensive anti-microbial studies against bacteria, yeast, fungus and other pathogens. Information about these studies is available at the research section of the ABL Website, ABL research

“The FDA’s decision to grant clearance for the ASAP Antibacterial Silver Wound Dressing Gel as a prescription device is an extraordinary validation for our company and its patented processes and uses,” said Dr. William Moeller, a Managing Director of American Biotech Labs. “This is a major step forward in our mission of using our products to improve lives by combating many of the world’s most deadly pathogens.

This is the second ABL product to obtain FDA clearance; in April, 2009, the company’s ASAP Wound Dressing Gel received clearance as a 510(k) over-the-counter medical device. American Biotech Labs (ABL) founded in 1998, utilizes patented processes and SilverSol Technology to create singularly powerful and effective nano-catalytic silver products.

In extensive testing performed by a variety of respected laboratories and researchers, ABL’s silver hydrosol has consistently demonstrated the ability, without any known toxic side effects, to destroy a wide range of bacteria, viruses, yeast, and molds.

ABL products have been approved by the Environmental Protection Agency (EPA) as a disinfectant for dental water lines, and as a surface disinfectant for bacteria, yeast and mold in hospital, residential, commercial and industrial settings; and has been cleared by the U.S. Food and Drug Administration (FDA) for wound care.

The company’s products have been the subject of multiple peer-reviewed articles in professional journals. The company’s products are sold worldwide as EPA approved disinfectants, FDA cleared wound care products, cosmetics, and also supplements.

The supplement and cosmetic products are sold nationally at health food stores and by medical professionals under the Silver Biotics and ASAP Solution brands, and through a variety of private labels like the New Silver Solution from Nutronix International.

Source:Kimball Thomson, Next Phase Communications (for American Biotech Labs), November 17, 2009; Email: Thomson