FDAAPPROVES.COM Launch by USAcig and Hop-on
'FDA has no authority over electronic cigarettes.'
TEMECULA, Calif., March 30 /PRNewswire/ -- USAcig and Hop-on, Inc. a Nevada Company, (Pink Sheets: HPNN) is the only U.S. Public Company that is currently shipping Electronic Cigarettes in the U.S. Overseas manufacturers' shipments of Electronic Cigarettes were denied United States entry in late September 2008. On October 29, 2008, the FDA issued "Detention" notices on grounds the shipments "appear to be adulterated, misbranded or otherwise in violation" of the Food, Drug and Cosmetic Act (FDCA).
After an information exchange regarding the shipments, the FDA issued a "Correspondence" on December 23, 2008, stating its conclusion that these products and their component parts appear to be intended to affect the structure or function of the body and were an "unapproved drug-device" combination and were in direct violation under the FDCA. Based on this conclusion, FDA issued "Refusal of Admission" notices on March 16, 2009, for both shipments and directed the "products must be exported or destroyed under Customs supervision within 90 days."
Following this aggressive maneuver by the FDA, the two specific electronic cigarette suppliers being denied their shipments into the U.S., brought suit against the federal government.
In their defense, the suppliers and manufacturers argued electronic cigarettes are designed as an "alternative" method of using traditional tobacco products. They are designed to resemble the "adult" experience of smoking, without combustion or the use of cancerous by-products. The nicotine mixture vaporized and inhaled by the user is inhaled in the same physical manner a traditional smoker would inhale tobacco smoke, except without the flame, tar, heat, carbon monoxide and harmful carcinogens found in traditional cigarettes.
The FDA in turn argued electronic cigarettes are in fact a combination drug-device, and therefore subject to stricter safety standards than cigarettes.
U.S. District Judge Richard J. Leon was appointed to hear the case brought by the two domestic electronic cigarette suppliers.
Judge Leon rejected the "drug-device" reasoning, agreeing with manufacturers that Electronic Cigarettes are "the functional equivalent of traditional cigarettes."
Leon was harsh in his final assessment of the FDA's confiscation of e-cigarettes imported by the companies. Siding with the two e-cigarette makers, he called the FDA's action "another example of the FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices... Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable."
The FDA does have regulatory authority over some non-tobacco products, such as nicotine gum based on the fact they are considered devices used to help smokers quit. However, Leon agreed with the e-cigarette companies that contended the product is another type of cigarette, not a drug device regulated by FDA.
The FDA recently gained the power to regulate tobacco-based cigarettes, but since electronic cigarettes don't contain tobacco, they don't fall under that regulation.
Jay Pignatello, President of Hop-on, stated, "This opens up the door for our company so that no bureaucracy will slow down our progress of launching our products in the U.S. Our goal with USAcig is to prove our products are safe, affordable, and profitable for our company. We have not experienced any issues with importing our electronics into the U.S. market. Our product is better, less expensive, and the technology behind our cigarettes is made in America!"
About Hop-on, Inc.
Hop-on, Inc. (Pink Sheets:HPNN.pk - News) offers multi-media services and has secured licensing agreements from essential patent holders for GSM, CDMA and WIFI technologies. Since its inception, known for developing the world's first disposable cell phone, Hop-on currently remains one of the few U.S.-based manufacturers of cellular technology. The Company also distributes The Electric Cigarette and the Electric Cigar.
About USAcig, Inc.
USAcig, Inc. is the only U.S.-based manufacturer making the actual nicotine cartridges/products in the U.S. The Electric Cigarette™ is an alternative to traditional tobacco products. It is a battery-powered device providing inhaled doses of nicotine by delivering vaporized water, propylene glycol, nicotine solution and other non-carcinogens. In addition to nicotine delivery, this vapor also provides a flavor and physical sensation similar to that of inhaled tobacco smoke, while no tobacco, smoke, or combustion is actually involved in its operation. USAcig, Inc. is a U.S.-based manufacturer of "The Electric Cigarette™" and "The Electric Cigar™". USAcig, Inc. manufactures its cartridges in the United States and the electronics are manufactured in China. USAcig, Inc. also has U.S.-based doctors on its board monitoring and supervising medical related issues or opportunities. For more information, visit http://www.USAcig.com/.
Forward-Looking Statements
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933, and are subject to Rule 3B-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and other results and further events could differ materially from those anticipated in such statements. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements
SOURCE USAcig, Inc.
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