2009-07-23 06:44:47 - The Food and Drug Administration [FDA] today finally agreed to regulate e-cigarettes - and presumably also e-pipes and e-cigars - apparently as a result of pressure from an NBC-TV Nightly News piece which appeared tonight, and which would have featured an interview with public interest law professor John Banzhaf about a legal petition he and his organization filed which could have compelled the FDA's action if the agency continued to drag its feet.

Instead, NBC-TV announced that the FDA found toxic chemicals, including known carcinogens, in the e-cigarettes, presumably inhaled by users and those around them, and that it would be taking "additional activities to address its concerns about these products." It now classifies e-cigarettes as a "drug device combinations . . . subject to regulation and enforcement." http://www.msnbc.msn.com/id/3032619/ns/nightly_news_with_brian_williams#32091534

Thus the FDA is finally asserting that it does have jurisdiction over e-cigarettes which administer nicotine - just as the agency has asserted jurisdiction over gum, patches, inhalers and sprays which likewise administer nicotine, and as they did over a prior version of so-called smokeless cigarettes which also emitted nicotine - and that it apparently will allow the products to be sold only if they

meet FDA standards and include any FDA-required warnings.

Apparently in response to a legal petition by Action on Smoking and Health (ASH) seeking to require the FDA to regulate this new product, the agency had begun taking preliminary steps towards this end. For example, the FDA has begun listing the product on its "Import Alert" as "misbranding" and as an "unapproved new drug" - "Product appears to be a combination drug-device product that requires pre-approval, registration and listing with FDA." This has prevented shipments from being imported into the U.S., and triggered a new legal action.

However, despite a number of public statements by the agency expressing alarm about e-cigarettes and many possible dangers, the FDA had so far hesitated to formally announce that it would begin regulatory proceedings. In the meantime, the number of sales and sales outlets for the product has exploded, and e-pipes and even e-cigars are now being marketed - all without any regulatory oversight.

Banzhaf, who got antismoking messages on the air, drove cigarette commercials off radio and television, started the movement to ban smoking in indoor areas as well as outdoors and in some homes, and helped pressure the FDA into regulating tobacco cigarettes, was vehement about the need for FDA action.

"In summary, it is illegal and wrong for manufacturers to foist on the public a new product containing a deadly and addictive substance without any independent and impartial determinations as to its safety," says Banzhaf, noting that very safe products like aspirin require FDA approval, that many other very safe drugs like birth control pills even require prescriptions, and that all other nicotine replacement products likewise required FDA approval.

"Smokers desperate to quit should not serve as guinea pigs to test a new product which may be neither safe nor effective, especially since it contains a known addictive and deadly drug, and many well contain other toxins. It is the FDA - and not the Chinese manufactures nor American importers - which should evaluate safety and adopt whatever restrictions might be appropriate," argues Banzhaf.

THE FOLLOWING LINKS PROVIDE ADDITIONAL BACKGROUND INFORMATION IF DESIRED:

SUMMARY OF FDA ANALYSIS OF E-CIGARETTES:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm

COMPLETE FDA ANALYSIS OF E-CIGARETTES:
http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

E-CIGARETTE CRITICS ACCUSED OF "LIBEL" AND "SLANDER" // BUT FDA IS ALREADY ASSERTING JURISDICTION OVER PRODUCT
http://www.pr-inside.com/e-cigarette-critics-accused-of-libel-and-r1402964.htm

ASH'S LEAD FOLLOWED; BILL BANS E-CIG USE IN NO-SMOKING SECTIONS
http://www.legislatorcooper.com/pressrelease_259.html

FDA BEGINS REGULATING E-CIGARETTES AS DRUG-DELIVERY DEVICES // ASH'S LEGAL PETITION SPURS/EXPLAINS ACTION
http://www.pr-inside.com/fda-begins-regulating-e-cigarettes-as-r1262323.htm

ASH SEEKS REGULATION OF E-CIGARETTES - COPY OF PETITION
http://ash.org/ecigpetition

FOUR NEW DANGERS TO NONSMOKERS - INCLUDING E-CIGARETTES
http://ash.org/4dangers.html

PROFESSOR JOHN F. BANZHAF III
Professor of Public Interest Law and Executive Director
Action on Smoking and Health (ASH)
2013 H Street, NW, Washington, DC 20006, USA
(202) 659-4310 // (703) 527-8418 // ash.org/