Federal regulators are warning electronic cigarette manufacturers that marketing claims that suggest the devices help people quit smoking are unfounded and illegal.
The FDA issued warning letters to five electronic cigarette (e-cigarette) makers on Thursday, in the latest move in an ongoing battle between FDA and the burgeoning industry regarding the agency’s right to regulate the devices. The letters were sent to E-CigaretteDirect LLC, Ruyan America Inc., Gamucci America (Smokey Bayou Inc.), E-Cig Technology Inc. and Johnson’s Creek Enterprises LLC. In some cases, the companies were also warned that they had poor manufacturing standards as well.
E-Cigarettes are battery-powered devices, usually shaped like a pen, cigarette or cigar, which heat up a flavored nicotine solution when the user inhales. The resulting vapors are inhaled in the same manner as smoking a cigarette.
The warning letters state that all five companies have run ads claiming that their products can be used to help quit smoking. The FDA has determined that the liquid in E-cigarettes is a drug and that the E-cigarettes themselves are drug-delivery devices, which the manufacturers dispute. The FDA says in its letters that it is illegal for the manufacturers to claim their drugs can be used as a smoking cessation treatment without FDA approval first. The agency says the companies have conducted no clinical trials or shown scientific evidence supporting their claims.
The FDA has said that it has not had the opportunity to evaluate e-cigarettes for safety or effectiveness, and that limited laboratory studies have raised concerns about the manufacturing process and quality control processes that the FDA says appears to be “substandard or non-existent.” The federal regulatory agency has also indicated that E-cigarettes contain toxins and carcinogens.
In addition to the warning regarding the claims that the devices can aid people to stop smoking, the FDA also warned Johnson Creek Enterprises that it found significant deficiencies in its manufacturing process, and that the company did not appear to have any quality control or testing procedures as required by the FDA. Johnson Creek makes Smoke Juice, a liquid used to refill E-cigarette cartridges.
The FDA also warned E-Cig Technology that it is marketing the erectile dysfunction drug, tadalafil, and the weight loss drug, rimonabant, illegally as refill cartridges for e-cigarettes. Rimonabant has not been approved for use in the U.S.
The FDA’s jurisdiction has been challenged in court by E-cigarette manufacturers. The agency has been stopping shipments of E-cigarettes, a Chinese invention, at the borders for examination, which has developed into an ongoing legal battle.
E-Cigarettes are sold mostly at mall kiosks and through the internet. The FDA is also concerned that the devices appear to be directly marketed to young people, do not contain any health warnings, and are currently virtually unregulated. They come in flavors such as bubblegum, chocolate, and mint.
Public health experts expressed concern that the cigarettes could increase nicotine addiction in young people, and that they are being marketed as being safer than they really are.