The product liability attorneys at
SHOOP | A PROFESSIONAL LAW CORPORATION represent individuals injured by E-cigarettes. These products have only
been available in the United States since mid-2006. As such, there exists
limited research on their various health risks. The U.S. Food and Drug
Administration ("FDA") has determined that the tobacco solution
used in e-cigarettes contains a toxic chemical found in antifreeze and
several carcinogenic materials.
Moreover, among all alternative tobacco products, these various e-cigarettes
are the least regulated, generally containing no warning labels and can
be sold to people of any age group. A recent report from the federal government
estimates that approximately two and a half million Americans used electronic
cigarettes in the year 2011, alone.
It additionally appears that numerous of these E-cigarettes are manufactured in China.
FDA Warning Letter
Recently, on or about September 9, 2010, the FDA issued a press release
underscoring that FDA had issued warning letters to five (5) E-cigarette
distributors for various such violations of the FDCA, including unsubstantiated
claims, poor manufacturing practices, and using the devices as delivery
mechanisms for active pharmaceutical ingredients.
FDA concluded further that these various companies were and are subject
to FDA regulation as the companies, themselves, claim and warrant that
there exists sufficient evidence that the product aids users in quitting
smoking cigarettes. According to the FDCA, manufacturers cannot represent
that its drug(s) can treat or ameliorate disease unless that particular
drug('s) safety and effectiveness are clinically proven.
For a drug to attain FDA approval, manufacturers must demonstrate and prove
to FDA that the product is safe and effective for its intended use. The
manufacturer must also establish that its manufacturing methods are adequate
to preserve the strength, quality and purity of the product - or otherwise
in conformity with current good manufacturing practices ("cGMPs").
FDA has concluded additionally that such E-cigarette products addressed
in the warning letters to the distributors, and similar products, are
subject to FDA regulatory scheme as drugs, themselves. Under the FDCA,
a company cannot claim that its drug can treat or mitigate a disease (e.g.
ameliorating nicotine addiction) unless the drug's safety and effectiveness
have been proven.
The various companies receiving these aforementioned, FDA warning letters
were, as follows:
- E-CigaretteDirect LLC
- Ruyan America Inc.
- Gamucci America (Smokey Bayou Inc.)
- E-Cig Technology Inc.
- Johnson's Creek Enterprises LLC
Additionally, some companies, above-listed, further received warning letters
addressing alternate violations. For instance, FDA maintained that E-Cig
Technology markets drugs in unapproved liquid forms, such as tadalafil,
an erectile dysfunction drug, and rimonabant, a weight loss drug that
has not been approved for use in the United States. These liquid pharmaceuticals
are designed to refill cartridges used in e-cigarettes so that the drugs
can be vaporized and inhaled.
FDA further cited Johnson Creek Enterprises, which sells "Smoke Juice,"
a liquid form solution utilized in refilling empty cartridges in E-cigarettes.
Significant deficiencies in the manufacturing process were noted in the
letter, including but not limited to failing to establish quality control
("QC") and test protocols as required pursuant to the FDCA.
For further information regarding FDA analysis of E-Cigarettes, you can
find a link here:
Around February of 2012, a Florida man suffered severe burns, lost teeth
and lost a section of of his tongue while an E-cigarette exploded in his
mouth. This particular explosion was linked to a faulty battery. FDA investigators
did not determine the brand of E-cigarette, but it was believed to be
a rechargeable one.
product defect attorneys at SHOOP | A PROFESSIONAL LAW CORPORATION continue to investigate
and represent injured victims of E-cigarettes. If you or a loved one has
been injured by these products, please call us today to discuss your legal
rights. This is
CALL US TODAY AT (866) 884-1717