FDA Fighting for Authority to Regulate Electronic Cigarettes
Appeals Court Order Stays Lower Court Ruling in Favor of e-Cigarette Distributors
By News Staff
3/2/2010
District Court Judge Richard Leon said in the Jan. 14 ruling that the Family Smoking Prevention and Tobacco Control Act passed last year does give the agency the authority to regulate "any product made or derived from tobacco that is intended for human consumption." That could include e-cigarettes, which contain nicotine extracted from tobacco.
FDA officials, however, say they would prefer to regulate e-cigarettes as drug delivery devices rather than as tobacco products because treating e-cigarettes as the former would give the agency far broader control, including the ability to block importation of the devices and their components.
The agency said in its appeal that it has regulated nicotine products, including nicotine patches, for years under the drug and device provisions of the Food, Drug and Cosmetic Act, or FDCA. The agency argued that tobacco legislation enacted last year "expressly excludes from the definition of 'tobacco product' any article that is a drug, device or combination product under the FDCA, and provides that such articles shall be subject to regulation under the pre-existing FDCA provisions."
An agency spokesperson declined to comment on the case, which is ongoing.
According to court records, the dispute between the FDA and e-cigarette distributors started in September 2008 -- before the tobacco legislation passed -- when the agency put a hold on two shipments of e-cigarettes at Los Angeles International Airport. A month later, FDA officials issued notices of detention on the grounds that shipments belonging to Smoking Everywhere Inc. -- one of the companies that later sued the FDA -- appeared to be "adulterated, misbranded or otherwise in violation" of the FDCA.
In July 2009, the FDA issued a warning about e-cigarettes to consumers and physicians after the Division of Pharmaceutical Analysis in the agency's Center for Drug Evaluation and Research said samples from the products had detectable levels of known carcinogens and toxic chemicals.
Manufacturers have touted the smokeless products, which are battery-operated devices that turn nicotine and other chemicals into a vapor that is inhaled by the user, as safer than conventional cigarettes. However, public health officials have countered that the products have not been adequately tested and should not be marketed to young people.
Misuse of Fingerstick, Similar Devices Linked to Bloodborne Infections
HHS Expands Medicare Coverage of Tobacco Cessation Counseling
More Than 500 Million Eggs Recalled as Investigation Continues
AAFP Joins Court Brief Supporting Vaccine Injury Compensation Program
GAO Report Critical of Genetic Tests Marketed to Consumers
Advisory Panel Rejects FDA Plan for Controlling Opioid Use
FDA Warns Docs, Patients About Unapproved IUDs
Studies Link Vitamin D, Cognitive Ability in Seniors
NFID Initiative Aims to S.T.O.P. Meningitis!
FDA Expert Panel Members Split on Avandia Question
FDA Adds to Leflunomide's Boxed Warning
McNeil Expands Recall List Again
FDA Warns Against Off-Label Use of Malaria Drug
Dietary Guidelines Report Focuses on Obesity
Pertussis Activity Spikes in Several States
AAFP Wants Medicaid Coverage for Quitlines
HHS Launches Multifaceted Health Literacy Plan
FDA to Report on Safety Monitoring Activities
AAFP Recruiting Practices for Smoking Cessation Pilot
Hypertension Well-controlled in Half of U.S. Adults
AMA Delegates Tackle Various Public Health Issues
CDC: One in Five Teens Has Abused Prescription Meds
Report: FDA Needs Overhaul of Food Safety System
IOM Calls for More Scrutiny of Food, Supplement Health Claims
FDA Proposals Would Shed Light on Drug Approval Process
IV Antibiotics, Antiemetic Recalled After Mold Detected
More Children's Medications From Shuttered McNeil Plant Recalled
Severe Liver Injury Tied to Orlistat Prompts Label Revisions
AAFP, Others Urge Ratification of Tobacco Treaty
AAFP Defends USPSTF, Breast Cancer Screening Recs
FDA Investigating McNeil Consumer Healthcare
Encouraging Healthy Lifestyles: A Special Report on Overweight and Obesity
FDA Campaign Cracks Down on Misleading Drug Ads
FDA Forces Device Maker to Recall Infusion Pumps
McNeil Recalls Multiple OTC Infants', Children's Products
FDA Conducting Safety Review of Prostate Cancer Drugs
FDA Offers Guidance on Rosiglitazone Use as Safety Review Continues
Warning to Consumers
FDA Analysis Finds Toxins, Carcinogens in Electronic Cigarettes
(7/28/2009)
More From AAFP
Ask and Act Tobacco Cessation Program
Additional Resource
FDA: Electronic Cigarettes
