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FDA using Big Muscles to Shut Down E-Cigarette Companies

Posted on 10th Sep 2010 @ 6:37 AM

FDA Warning letter warns e-cigarette companies to comply with all drug advertising and testing mandates.

The FDA sent out letters yesterday to 5 electronic cigarette companies warning them of non-compliance.  E-CigaretteDirect, LLC, based in Colorado, was 1 of 5 companies that responded to the FDA claiming that the FDA “is misinterpreting language on its website and testimonials from customers as promoting e-cigarettes as a stop-smoking aid.”

“Nowhere on our site does it claim that electronic cigarettes are a smoking cessation device”, states Gina King, a representative for the E-CigaretteDirect.com. 

The warning from the FDA states that E-Cigarette Direct is marketing their products as drugs, describing drugs as: “intended to affect the structure or function of the body and to mitigate, treat, or prevent disease”. 

“Under that definition, water would be considered a drug” retorts King. 

While the FDA claims it has the authority to regulate e-cigarettes as drug-delivery devices, some sellers contend the products should be regulated as a tobacco product, which would follow the same restrictions as traditional cigarettes and tobacco products.

 



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Warning: E-CigaretteDirect, LLC products are offered as an alternative to tobacco cigarettes. E-CigaretteDirect, LLC products are intended for use by persons of legal smoking age, not by nonsmokers or by children, women who are pregnant or breastfeeding, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma. Consult a physician if you experience nicotine misuse symptoms such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat. If you smoke tobacco products, you are encouraged to stop. E-CigaretteDirect, LLC products are not a smoking cessation product and have not been tested as such. Please keep E-CigaretteDirect, LLC products out of the reach of children and pets; ingestion of certain pieces can present a choking hazard, and ingestion of the non-vaporized concentrated ingredients in the cartridges can be poisonous. This product and the statements made within have not been evaluated by the US Food and Drug Administration or any international health organization unless otherwise noted in E-CigaretteDirect, LLC materials. These statements and E-CigaretteDirect, LLC products are not intended to diagnose, treat, cure, or prevent any condition, disorder, disease or physical or mental conditions and should not be used as a substitute for your own physician's advice. E- CigaretteDirect, LLC com products are manufactured to E-CigaretteDirect, LLC (USA) supplier standards, distributed globally, and made in China. Warnings: Nicotine is addictive and habit forming; very toxic by inhalation, in contact with the skin and if swallowed; danger of serious damage to health by prolonged exposure if swallowed; irritating to eyes and skin; may cause sensitization by skin contact; may cause harm to the unborn child; vapors may cause drowsiness or dizziness; very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment; after contact with skin, wash immediately with plenty of water and seek medical advice; in case of accident or if you feel unwell, seek medical advice (show the label where possible): this material and its container must be disposed of in a safe way; use appropriate containment to avoid environmental contamination. Warning for California residents regarding Proposition 65: This product contains nicotine, a chemical known to the State of California to cause birth defects or other reproductive harm.