After a two year legal campaign by the FDA to intervene in the electronic cigarette industry and move the devices to regulation as ‘drug devices’ effectively getting them banned from the marketplace, it finally announced on Monday its decision to stop fighting repeated court decisions in favour of the industry and regulate the marketing of e-cigs under the Tobacco Control Act.

On its website Monday the FDA stated “The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products,  as those terms are defined in the FD&C Act.  The court held that e-cigarettes and other products made or derived from tobacco can be regulated as  “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes. The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.”

The decision should now open the market to ’serious’ suppliers and eliminate the fly by nights who offer teen enticing flavours and health claims in their marketing.

The decision was welcomed by inLife LLC, one of the first suppliers of electronic cigarettes to the US market and whose Regal 2 e-cig is seen as a market leader in the industry.

For more information about inLife:

UK : inLife UK

Spain (Español) (English)

Rest Of Europe: inLife Europe

The MHRA, the body responsible for regulating medicines in th UK has extended the period of consultation over its paper on electronic cigarettes and how they should be regulated.

At the moment, little regulation is in place over this relatively new industry and there is speculation on whether the MHRA should regulate the product as a cessation device considering suppliers of the product claim it is no such thing and is in fact a logical alternative to tobacco smoking as it does not contain the thousands of harmful chemicals and carcinogens that tobacco contains.

The MHRA are under pressure from the pharmaceutical industry who see the e-cig as an extremely viable alternative to their billion dollar industry of nicotine patches and gum which, whist found to be virtually ineffective as a form of quitting tobacco, do find themselves regulated by the MHRA.

In the USA recently, the appeals court has ruled in favour of classing electronic cigarettes as tobacco products, limiting the involvement of the FDA (the US goverining body) to regulating how the products are marketed.

Because of this ongoing enigma, the MHRA has extended its consultation period allowing the sale of the products to continue under the eye of the Trading Standards legislation currently in place to safeguard the public.

inLife Regal 2 Electronic cigarettes are the only e-cigs (to the knowledge of this author) that manufacture their nicotine cartridges in an FDA registered facility to ensure the pharmaceutical grade nature of the ingredients used.

In light of a recent ‘Panorama’ programme on the BBC in which ‘cheap’ tobacco cigarettes made in China were found to contain 30 times the level of lead and arsenic found in normal cigarettes, it is always good to know what you are putting in your body!

Electronic cigarettes cartridges should contain only Propylene Glycol, Glycerol, Water, Food Essence/flavouring & Nicotine. None of these ingredients have been found to cause cancer and all of them can be found in everyday food products.

The inLife Regal 2 was highlighted recently by Josh Harris of The Discovery Channel’s No.1 rated show – ‘The Deadliest Catch’. Since the death of his father, Capt. Phil Harris from a smoking related stroke just over a year ago, Josh has been touring the US on an roadshow highlighting the dangers of smoking and how the Regal 2 has helped him transition from tobacco smoking to electronic.

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