HOBOKEN, NJ, United States, via ETELIGIS INC., 12/22/2014 – – Optigenex Inc., (OTC Pink: OPGX) (PINKSHEETS: OPGX), the maker of ac-11®, a patented, all natural botanical extract popular in advanced formula dietary supplements and topical skin care products marketed worldwide, issued a caution to consumers today to be aware of certain health, wellness and beauty products purporting to contain Optigenex’s proprietary ac-11® ingredient being marketed without the approval and authorization of Optigenex as the trademark and technology owner. The company stated that it has commenced legal action to stop further manufacturing of these products and cause their withdrawal from the market, and said that it will likely take separate legal action against distributors and resellers who, after notification, knowingly choose to continue selling the unauthorized products in violation of the company’s rights.
The unauthorized products involved, said the company, are a weight loss “powdered shake” called FUSION powered by ac-11®, a liquid oral dietary supplement called PURPLE PLUS with ac-11®, an oral dietary supplement in capsule form called PURPLE CAPS with ac-11®, a dietary supplement in oral “strip” form called PURPLE STRIPS with ac-11®, a topical skin care product called AEDRÉ SERUM with ac-11® and a system of topical skin creams under the name ACTIVAR® with ac-11®, which are sold in separate Day, Night and Eye care formulas.
Focusing on FUSION, Optigenex’s president and CEO, Daniel Zwiren said the company was not aware of the weight loss product until after it was introduced. According to Mr. Zwiren, neither the product nor, more importantly, its formula, was ever pre-submitted by the manufacturer to Optigenex for review, even though Optigenex review and approval is contractually required, as he explained, for all products containing ac-11®. Mr. Zwiren stated the company, having subsequently investigated the FUSION formula on its own, discovered significant flaws in it. Thus, he said, FUSION would have been disapproved had it actually been submitted to Optigenex as required.
“FUSION, in particular, troubles us,” Mr. Zwiren continued, “because, according to the literature we’ve seen, the product delivers just 125 mg of ac-11® daily if taken in accordance with label instructions for use. Published science on ac-11® shows that the effectiveness of our unique, patent protected ac-11® technology in assisting the body naturally to repair cellular DNA critically depends on the average adult user taking no less than 250 mg daily. All of our current licensees for ac-11® are aware of the published minimums and, as the sole owner and licensor of ac-11® in the world, Optigenex requires strict compliance, so that customers will receive the many benefits of ac-11® they expect when buying products bearing the ac-11® trademark.”
Mr. Zwiren went on to say, “More than anything else, Optigenex wants consumers to be aware that, as far as Optigenex can determine, the unauthorized FUSION formula does not align with the published science of ac-11®. Accordingly, and again as far as we can determine, given that the manufacturer has not shared information with us, the FUSION product in all likelihood does not deliver the research-validated health benefits that have long been associated with our ingredient and have come to be identified with the ac-11® name.”
In releasing its statement, the company clarified that the reason other products are mentioned, in addition to FUSION, as being unauthorized relates, not to formulas, but to numerous labeling and marketing deficiencies, including, most importantly, erroneous therapeutic claims for ac-11® made in product advertising that was not pre-submitted for review and approval by Optigenex.
Addressing the unauthorized products as a whole, Mr. Zwiren stated that they are being sold worldwide via networks of independent distributors in the direct to consumer/multi-level marketing (MLM) channel and possibly other channels. As to the individual distributors, he said, most are aware that Optigenex at one time supported the products in question, except for FUSION, which, Mr. Zwiren emphasized, the company neither knew about nor has ever supported. With today’s announcement, Mr. Zwiren said, the company hopes these distributors will understand the reason why Optigenex no longer supports these products and, thus, why they are now no longer authorized.
“We’ve taken steps in court in the United States to stop further manufacturing of the unauthorized ac-11® products, said Mr. Zwiren, “but because we are concerned that individual distributors and resellers may not be aware of the facts regarding FUSION or why the other products we have identified are no longer unauthorized, we are in the process of notifying as many of them as we can locate. Thereafter, we will consider appropriate legal recourse against anyone who, despite notice, continues knowingly to violate our trademark and patent rights by selling these products.”
In concluding, Mr. Zwiren noted that the company recently has received undocumented reports that FUSION is now being sold in some regions without reference on the label to ac-11®. “Whether or not in response to the legal steps we have taken, we hope this news is true and that it means that the manufacturer and its distributors are now taking steps of their own to cease and desist from further unlicensed use of ac-11® in their products,” said Mr. Zwiren, “but we have received no confirmation of the reports and, to the best of our knowledge, FUSION in its so-called “powered by ac-11®” form is still being sold in many places worldwide.”
Optigenex is a formulator, distributor and provider of proprietary, next generation dietary supplements, skin care products and bulk ingredients that feature ac-11® as a core platform technology. Formerly known as C-MED-100®, ac-11® is a patented, bioactive and water soluble ingredient derived from Uncaria tomentosa, a medicinal herb found in the rain forests of Peru and Brazil.
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The statements contained in this press release have not been evaluated by the Food and Drug Administration. The Products or ingredients mentioned herein are not intended to diagnose, treat, cure or prevent any disease.
SOURCE: Optigenex Inc.