Advocacy / FDA

FDA Final Deeming Regulations

The FDA final (as of 5/10/16) regulations “deem” all vaping / electronic cigarettes as tobacco products so that they fall under their jurisdiction. These regulations to not seem too big of a burden on the surface: labeling, marketing restrictions, no sales to minors etc.

The main obstacle is what they consider FDA “approval” of all “tobacco products”. This is a costly procedure that will be imposed on every application, whether it is a single flavor in a single nic level (each nic level is a new product), a wick or coil, a complete system such as Blu.

Initial estimates are in the multiple 100,000.00 for each application and potential millions for clinical trials. This is obviously prohibitive for any business other than the tobacco companies.

The compliance period for these applications is up to two years after the effective date, after which all products not in FDA review will need to be removed from the marketplace. This means that most businesses will end on 8/8/18.

Suggested reading: Deeming Regulation

The Food and Drug Administration (FDA) has the authority to regulate the distribution, manufacture, and marketing of tobacco products to “protect public health” through the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA). The FSPTCA has defined the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product.

Between 2008 and 2010, the FDA detained and/or refused admission of electronic cigarettes. Companies sued the FDA to stop it from detaining their products and were upheld, though 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,” “drugs,” “devices” and combination products. The court held that products made or derived from tobacco can be regulated as “tobacco products” (including e-cigarettes) under the FDCA.

The FDA has issued a ruling that will “deem” (ie. consider) e-cigarettes and other new products not already specified in the FSPTCA to also be “tobacco products”. This would include liquid and devices, all of which would need to go through an expensive approval process estimated in the millions per device or liquid.

Suggested reading: Deeming Regulation

Consumer Advocacy developed at this time to advocate for consumers of all tobacco harm reduction products especially e-cigarettes. The deeming regulations of the FDA rule are on course to require such extreme approval processes that few other than perhaps tobacco companies could afford the millions it would take to get a product available. Time frames are unsure at this point for the impact of these regulations however as they stand the impact will be devastating to vapers and the industry as a whole.

State, county and city ordinances are becoming an increasing threat as they ban, restrict and tax local products and businesses. Many groups and organizations have developed to advocate for vaping rights, some oriented on consumers, some on businesses and some unfortunately just for their own profit.

Moving the Grandfather Date – HR2058 and the Cole amendment

A group of US Congressional Representatives have offered HR2058 as a way for the FDA to be curbed from decimating the present industry though it still needs more support to be of any hope. If it were to pass then the industry  has a viable chance of surviving in a similar capacity to what it presently is.
The Cole amendment (to appropriations) is a separate attempt at a similar solution with some less desirable additions than the HR2058. Still worth consideration by your representatives.

FDA Deeming Authority Clarification Act of 2015

Casaa’s portal to contact your Representative about HR2058