smartfixx excerpt from website

[Flitzanu]

not really news, but i was looking at the site based on another post, and saw this in the FAQ and thought it was interesting:

Is Smart Fixx approved by the FDA or the ATF?

The Alcohol and tobacco Trade Bureau (TTB) formerly the (ATF) and the Food and Drug Administration (FDA) have formally stated that Smart Fixx is not a product that warrants the involvement or oversight of either government entity. The FDA (which protects public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation) notes that Smart Fixx and its benefits do not fit the classification of products that it governs. The TTB (which exists to administer laws and regulations that protect consumers) tested the ingredients of Smart Fixx and formally determined that the TTB has no regulatory interest in Smart Fixx because it does not contain tobacco.

 

[Kate]

It looks to me like they are not claiming approval and are saying it's not required.

 

[TropicalBob]

I've seen that wording before .. and it is now outdated, replaced by the new edicts from the FDA, which now says it does have authority to regulate the "new drug" and "drug delivery devices." The quote is simply no longer valid.

 

[yvilla]

Or, is it only no longer valid as applied to those marketing ecigs as NRT or smoking cessation devices? And conceivably still valid as applied to those who are very careful in their marketing?

Edit: This quote from another FDA representative is what I'm referring to:

"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising."

eCig sales soar online: Sci-Tech: News: News24