Regeneca News

Regeneca Issues Recall of Entire Product Line

Press Release | 3/11/2017

The company has presently ceased doing business in the United States.

Consumers who have purchased Regeneca products subject to this recall are advised to immediately stop using the product and are urged to return it to the place of purchase for a possible exchange. Consumers with questions may contact the company via email to support@regeneca.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Regeneca Shutting Down

Npros.com | 2/2/2017

DMAA, also known as methylhexanamine or geranium extract, is a stimulant considered by the FDA to be a health risk to consumers, especially if combined with caffeine and other ingredients. In 2012, the FDA sent Nicosia a warning letter telling him to stop selling RegeneSlim products containing DMAA. The company recalled RegeneSlim in 2014. However, inspections of Regeneca's manufacturing operations uncovered repeated violations of the FDCA and in November 2015, the Department of Justice filed the complaint that prompted the consent decree.

Regeneca agreed to adhere to the consent decree and shut down its operations to settle the litigation. If it seeks to reopen in the future, the company must prove to the FDA that its manufacturing processes are in compliance with the law. The settlement is pending judicial approval.

Regeneca Given Distribution Rights for CardioMap

Press Release | 6/19/2015

“We are very excited about this deal, as the distribution with Regeneca Worldwide offers an incredible opportunity for the advancement of this technology in terms of awareness and applicability in the daily lives of individuals,” stated Vladimir Podlipskiy, the Chief Science Officer of VE Science Technologies LLC. “CardioMap provides the basis for an analysis of a person’s heart health condition. This analysis is achieved through an examination that measures heart performance and visualizes the results in dynamic, colorful heart portraits generated through an online service. This invaluable service addresses unmet needs in early screening and monitoring for heart disease, and other health related conditions.”

“CardioMap provides a way for our distributors to instantly demonstrate the effectiveness of the Regeneca product line, with individualized data for our consumers,” said Trent Staggs, President of Regeneca Worldwide, Inc.

CardioMap depicts disease or stress levels as a 3D image supplementing the line drawing electrocardiogram. The system evaluates the stability of current heart conditions. It is highly portable and provides a rapid analysis in 30 or 60 seconds. The device is connected through the Internet to the central server that converts the electric conductivity of the cardiac tissue into a three-dimensional, color-coded and easy-to-interpret visual portrait. This heart portrait allows customers and physicians to observe the condition of the heart muscle and the intensity of the heart stress load quickly and easily.

Regeneca Worldwide Announces New President

Press Release | 5/21/2015

“We are thrilled to have Trent Staggs join the Regeneca team and lead the company’s operations,” said Chairman Matt Nicosia. “Mr. Staggs has over ten years of experience in the direct sales industry and will be a key resource in directing the growth of the company domestically and guide the company as we commence international expansion.”

Mr. Staggs has demonstrated the leadership necessary to run both successful start-up and Fortune 500 organizations in the Direct Sales, Finance and Technology industries. Prior to becoming Regeneca’s President, he was on the executive team at Unicity International, a direct sales company that operates in over 30 markets, serving as their VP Technology. In that role, he was responsible for providing strategic direction and leadership of global integrated systems, software and IT infrastructure, which included the creation of mobile and web applications for their distributors worldwide. Mr. Staggs received his Bachelor of Arts degree from the University of Utah and received his MBA from the Marriott School of Management at Brigham Young University.

“I’m excited to be working with such an innovative, and well-respected company,” stated Mr. Staggs. “Regeneca offers a high-quality line up of products that center on regeneration at the cellular level, and those that have taken their products have reported greater health and wellness in their physical, mental and emotional aspects of their lives. Regeneca has also pioneered the merging of direct response marketing with network marketing, eliminating the age-old problems in the network marketing industry of both brand awareness and limited prospect pools.”

Regeneca has seen their revenue grow over 400% from 2013 to 2014 and looks to continue such phenomenal growth in 2015 as they bring on new products and new markets. New markets will include the Philippines, Mexico and the Dominican Republic this year.

Regeneca Worldwide Recalls RegenESlim Capsules

Press Release | 8/10/2014

RegeneSlim is purchased by and distributed through a direct sales force within the United States and Puerto Rico, and through online sales, for both personal consumption and retail sales.

RegeneSlim is packaged in approximately 3 ½” by 3” green and white sachets that contain 2 capsules, with the name RegeneSlim displayed prominently on the front of the sachet.

There have been no illnesses reported to date.

This voluntary recall was the result of FDA analysis confirming the presence of DMAA in RegeneSlim and our company’s sampling. The company continues their investigation as to what caused the problem.

FDA Sends Warning Letter to Regeneca

Npros.com | 9/13/2012

According to the Dietary Supplement Health and Education Act of 1995, an NDI must show that ingredient has a history of use and evidence that establishes that the ingredient is reasonably expected to be safe when used as recommended. The letter also stated that even if the required NDI notification had been submitted, the agency has no evidence that establishes DMAA as reasonably expected to be safe, saying that "to the best of FDA's knowledge, there is no history of use or other evidence of safety establishing that dimethylamylamine [DMAA] will reasonably be expected to be safe as a dietary ingredient. In fact, dimethylamylamine narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack)."

The letter closed with a warning that if Regeneca didn't immediately cease distribution of RegeneSlim, the agency could seize the product and file an injunction against the company.

Regeneca Issues a Voluntary Recall of RegenErect

Press Release | 2/28/2012

Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenErect via sales made over the internet to consumers in the United States of America and Puerto Rico, and given as samples at public events.

RegenErect, is a blue capsule sold individually in foil packets with a UPC code of 816860010055. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenErect product above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (949) 281-2600 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Regeneca Issues a Voluntary Recall of RegenArouse

Press Release | 2/12/2012

Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.

RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and had received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. The Company learned today that there was an error on this test and has thus made the decision to issue a voluntary nationwide recall on this lot of RegenArouse. Regeneca, Inc. is committed to improving its products and avoiding future recall issues by improving its existing testing procedures.

Regeneca, Inc. advises any customers in possession of the RegenArouse product matching the lot number above to return any unused product for an exchange, or a full refund, to the company directly. Customers can call (800) 690-6958 (Monday through Friday from 8am to 6pm Pacific Time) for instructions on the return and exchange/refund process.

Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: http://www.fda.gov/MedWatch/report.htm Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Regeneca Releases Letter to Shareholders and Distributors

Press Release | 1/11/2012

Highlights of the letter include:

"Our pre-launch was successful and resulted in a dramatic increase in sales in the months of February, March and April...As we were preparing to release RegeneSlim, we suffered our first major challenge, the recall of two lots of RegenErect. We handled the recall by offering an exchange or refund to all customers returning recalled product without negatively affecting awarded commissions. These returns caused a substantial hit on our resources. Soon after the recall, we released RegeneSlim and a new daily formulation of RegenErect. During this time, we were also completing a lot of technical work surrounding the integration of our direct response and network marketing programs. RegeneSlim has been well received by our distributor base. However, our second formulation of RegenErect did not have the same impact as our first formulation and was not a success. We learned from this experience that the market desires an impact male enhancement product rather than a daily pill.

Our next focus was on developing a new impact formulation for our male enhancement product. We developed a new formulation which has been well received by our distributor base. This product was released in late September leading up to our Launch Event in Las Vegas on November 11, 2011...

Given the initial success of our new formulation of RegenErect and the seasonality involved in the production process, we exhausted our inventory in mid-December, and, as a result, sales of RegenErect have been suspended temporarily. We are currently in the process of bringing the production of RegenErect in house. We believe we will have inventory available for shipment again in February 2012. This interruption in sales is causing another strain on resources and our sales momentum. Our new processes will ensure that we no longer have seasonality issues with our supply chain.

Given all the events of 2011, the Company has accomplished many things to set itself up for success in 2012. We have created a cost-effective online direct response campaign for RegeneSlim. Our back-end IT systems have been updated to fully support the merging of our direct response and network marketing activities. We have completed financial audits for 2009 and 2010 and filed all SEC-required financial filings to become fully reporting and current as of December 2011. We have begun work to bring production of our male and female intimacy products in house which will provide the Company with inventory stability and reduced costs. We have diversified our product offerings to include RegeneSlim, RegenErect, RegeneBlend and RegenArouse. We have also completed our professionally-produced Opportunity Video to provide our distributors with a key tool in their recruitment efforts.

As management looks to 2012, we are seeing explosive growth with our impact weight-loss product RegeneSlim. We are planning on a large increase in our direct response marketing activities. The Company has been able to integrate, both technologically and philosophically, the concept of creating customers via commercials and other types of direct response advertising, and then turning such customers into leads for and customers of our distributors. This model gives us a huge advantage over competitors both in network marketing and in direct response...The Company will expand its product line within the current categories of natural products for both wellness and intimacy, starting with building a line of complimentary products to go along with RegeneSlim. We also look forward to the international expansion of our business in both Latin America and Asia. Management feels it will be necessary to complete and continue financing throughout the year to support these objectives. To that end, the Company is planning a move from the Pink Sheets to the Bulletin Board which will make us available to a wider range of the investment community and new financing opportunities.

We look forward to a successful and rewarding year for our shareholders, our distributors, and our employees.

Sincerely,

Matthew Nicosia, President, CEO and Chairman and Dan Kerker, CFO

Regeneca Announces Mobile Technology for Distributors

Press Release | 11/27/2011

Chairman and CEO Matt Nicosia added, "This first-to-market advantage allows our distributors to increase their sales cycles, makes the entire signup process easier, and increases sales for the company. The home based sales representative needs these tools to not only build credibility, but to do so anywhere, any time. This integration of mobile purchasing and transacting, coupled with the ability for distributors to have their own QR codes to drive consumers to their own self replicated websites, is adding to our momentum and is resulting in increasing exposure to Regeneca's products and business model. This technology, and being the first to integrate, is another competitive advantage in our direct response network marketing model with which we are penetrating a combined $227 billion market."

Regeneca Announces Successful Launch

Press Release | 11/14/2011

IRVINE, Calif., Nov 14, 2011 -- Regeneca(TM), Inc. today announced that it has successfully launched the Company's Direct Response Network Marketing business after a prelaunch period that started in February of this year. The Company had its inaugural launch event at the Monte Carlo Hotel and Casino in Las Vegas, Nevada on November 11th and 12th.

Chairman and CEO Matt Nicosia added "Our launch event this past weekend at the Monte Carlo Hotel and Casino in Las Vegas featured leaders from around the world as we successfully launched our Direct Response Network Marketing business. The Company looks forward to great success in 2012. The theme of the event was Mission Possible, and we laid out our plans for 2012 as we look to expand distribution in the multi-billion dollar male enhancement market with RegenErect, our natural male enhancement product that increases intimacy and satisfaction. RegeneSlim, our all-natural appetite suppressant, was also featured, and the winner of RegeneSlim's Biggest Winner contest was announced. For more details on the event, please check out our Corporate Facebook page at http://www.facebook.com/RegenecaInc ."

Regeneca Starts Shipping New Improved Formulation for RegenErect

Press Release | 9/27/2011

Chairman and CEO Matt Nicosia added, "We are pleased with the operational speed at which the company has taken this product from bench top to manufacturing, and we look forward to great success with our new and improved RegenErect(TM). RegenErect(TM) is offered through our website at www.regenerect.com and is available through our Independent Business Owners.

"In October, we will be shipping a sample of our new formula of RegenErect to all customers in our database. We encourage all shareholders to call the investor relations telephone number on this press release and find out how you can also get a sample of this breakthrough product in men's health."

Regeneca(TM), Inc. was formed to create and commercialize premium products that help to improve health and fight the signs and symptoms of aging for a complete life of wellness and happiness, including our natural male enhancement product - RegenErect(TM). We do this while drawing our products from the earth in an ethical strategy that will emphasize regrowth, reforestation and recycling. This is our "Whole Earth Whole Body" approach to health. More information can be found about Regeneca(TM), Inc. at www.regeneca.com.

CONTACT: Regeneca(TM), Inc. 1 Technology Drive, Suite C-515, Irvine, CA 92618 Investor Relations 949-281-2600 extension 7

Regeneca Announces Response to FDA Warning Letter

Press Release | 7/24/2011

Regeneca, Inc. (Pink Sheets:RGNA - News) has submitted a Response Letter to the FDA Warning Letter received on May 27, 2011. The letter outlines the actions taken by Regeneca to ensure the compliance of its products and marketing materials related to RegenErect, Regeneca's male enhancement product.

Regeneca's CEO Matt Nicosia commented, "We feel that we have taken all of the necessary steps to address the issues and concerns in the warning letter received from the FDA. The male enhancement market in the United States continues to grow. The fact is that most males over the age of 25 experience decreased sexual performance, and there is considerable demand for natural male enhancement products. Our product, RegenErect, is positioned to take advantage of this market need through our Direct Response Network Marketing model."

About RegenErect

RegenErect is an all-natural dietary supplement that enhances the sexual experience 365 days a year with no adverse side effects. More information can found about RegenErect at www.regenerect.com.

About Regeneca, Inc.

Regeneca, Inc. (Pink Sheets:RGNA - News) was formed to create and commercialize premium products that help to improve health and fight the signs and symptoms of aging for a complete life of wellness and happiness, including our natural male enhancement product - RegenErect. We do this while drawing our products from the earth in an ethical strategy that will emphasize regrowth, reforestation and recycling. This is our "Whole Earth Whole Body" approach to health. More information can be found about Regeneca, Inc. at www.regeneca.com.

FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements, including, but not limited to, statements regarding Regeneca, Inc. and their plans, products and related market potential. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in Regeneca, Inc.'s filings with the Securities and Exchange Commission, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Regeneca undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

FDA Issues Warning Letter to Regeneca

Npros.com | 6/8/2011

The FDA warning letter details the fact that Regenerect is labeled as a dietary supplement, but that the labeling statement makes it clear that Regenerect is a drug because it is used to prevent, treat, or curse a condition of the body.

Citing several significant violations, the letter warns Regeneca and Adam Gilmer to take "prompt actions to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice."

Regeneca Press Release

Npros.com | 5/12/2011

Ethos Environmental, Inc. (Pink Sheets:ETEV), which recently merged with Regeneca International, Inc., is hosting an Infomercial Premiere and Direct Response Marketing Program Launch in Southern California on May 20-21, 2011.

The event is open to Independent Business Owners (IBOs), customers of Regeneca International, and any other interested parties. IBOs can find details in the back office. The Company encourages all interested parties to attend. Please send an email to info@regeneca.com to inquire about purchasing tickets to the event.

CEO Matt Nicosia added the following, "This media premiere is the beginning of what we call the Direct Response Network Marketing model. We invite all distributors to be at the event and experience the momentum that will be created as we add credibility and customer acquisition to our distribution model."

The following events are as scheduled:

Friday, May 20: Open House Welcome Reception, 5:00 PM - 6:30 PM at the Regeneca corporate offices at 1 Technology Drive, Suite C-515, Irvine, CA 92618.

Saturday May 21: Direct Response Media Launch, 9:00 AM - 12:00 PM at The Fairmont Newport Beach, 4500 MacArthur Boulevard, Newport Beach, CA 92660.

For additional details, please contact the company directly at the number provided below.

About Ethos Environmental, Inc.

Ethos Environmental, Inc. (Pink Sheets:ETEV) developed and manufactured award-winning fuel-based eco-friendly solutions. Upon merging with Regeneca International, Inc. in December 2010, Ethos Environmental has adopted the business strategy and product focus of Regeneca International, Inc. Regeneca(TM) International, Inc. was formed to create and commercialize premium products that help to improve health and fight the signs and symptoms of aging for a complete life of wellness and happiness, including our natural male enhancement product - RegenErect. We do this while drawing our products from the earth in an ethical strategy that will emphasize re-growth, reforestation and recycling. This is our "Whole Earth Whole Body Approach to Health." More information can be found about Regeneca International, Inc. at www.regeneca.com.

FORWARD-LOOKING STATEMENTS

This press release may contain forward-looking statements, including, but not limited to, statements regarding Ethos Environmental, Inc., Regeneca International, Inc. and their plans, products and related market potential. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in Ethos Environmental, Inc.'s filings with the Securities and Exchange Commission, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Ethos and Regeneca undertake no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.

Regenerect Recall Press Release

Npros.com | 5/6/2011

What: Regenerect

Why: Contains Sulfoaildenafil, an analogue of Sildenafil, a prescription drug used in the treatment of male Erectile Dysfunction

Scope: Nationwide

Ethos Environmental is conducting a nationwide recall of the company’s dietary supplement sold under the brand name Regenerect with the following Lot Numbers:

•100521 - blue capsule sold individually in foil packets, expires 5/2012.

•112850 - clear capsule sold individually in foil packets, expires 11/2013.

Ethos Environmental is conducting the recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Further, ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Ethos Environmental distributed Regenerect via sales made over the internet to consumers in the United States and Puerto Rico.

Any customers in possession of the Regenerect product matching the lot numbers above are advised to return any unused product for exchange or a full refund to the company directly. Customers can call (866) 925-9553, Monday through Friday from 6 a.m. to 6 p.m. Pacific time, for instructions on the return and exchange/refund process.

Any adverse reactions experienced with the use of this product and/or quality problems should be reported to the FDA's MedWatch Program by:

•Online: www.fda.gov/medwatch/report.htm •Fax: 800-FDA-0178 •Phone: 800-FDA-1088 •Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to: MedWatch U.S. Food and Drug Administration 5600 Fishers Lane Rockville, MD 20852-9787

Regeneca-Ethos Environmental Press Release

Press Release | 2/2/2011

IRVINE, Calif., Jan. 31, 2011 (GLOBE NEWSWIRE) -- Ethos Environmental, Inc. (Pink Sheets:ETEV) management announced today the Company's direct response network marketing strategy and its product RegenErect tm, a natural male erectile stimulant, will be featured at the Company's first celebration event at the Palms Hotel in Las Vegas, February 11 th through the 13 th for Independent Business Owners and Shareholders. Ethos Environmental Inc., through Regeneca International, Inc., has developed a commercialization model that combines the best of Direct Response, brand promotion and consumer acquisition, with the high-touch relationship-retention driven sales of Network Marketing. Our corporate creed is to provide consumers with products that are natural and premium quality and must fit the highest standard of conservation and reduced carbon footprint. The products must work to preserve and improve the user's health. We utilize recycled and recyclable materials wherever possible to preserve the land - ensuring the efficacy, safety and quality of the products without frills and excess paper goods. Our methods don't just apply to the production of our products. Our packaging, distribution and marketing strategies are designed to engage directly with consumers. This reduces unnecessary expense, energy waste and cost. Our products are designed with our corporate creed in mind - unique, efficacious, earth-friendly premium products and service. Our products truly help you and your body to regenerate itself. This is our commitment to the Whole Earth, Whole Body approach to health. RegenErect tm is a proprietary blend of natural ingredients. Challenging consumers to try it themselves to determine if it is " Better than Viagra tm*? " Doctor recommended RegenErect tm offers a natural alternative to drug-based erectile stimulants. RegenErect tm is the lead product in the Regeneca portfolio. The Company has launched consumer awareness through its website at www.regenerect.com . As the anchor product of the Company, RegenErect tm will create brand awareness and marketing momentum that will propel a family of other unique and effective natural products. The launch campaign will focus on an infomercial and other direct-to-consumer offers, followed by an auto-ship program available to consumers at preferred customer prices. *Viagra is a registered trademark of Pfizer Corporation