drugs, devices, combination products, and tobacco products
Today, the FDA pre-released another confusing missive, this time aimed at widening their determinations of evidence of medical claims; ENDS as a medical device.
Around page 26 is some telling verbage regarding theraputic claims- not just from marketing/manufacturers, but from anywhere they see fit.
Page 38: “The rule’s treatment of smoking cessation claims as generally suggestive of a therapeutic purpose means that products marketed with such claims would generally be regulated as medical products. Treating these products as medical products will help assure that such claims are supported by data demonstrating that a product is safe and effective for this intended use. Otherwise, consumers may attempt to quit smoking with unproven products, threatening both individual consumers’ health and the public health generally.”
What’s REALLY confusing the public is public health entities spreading lies about vaping!
Page 39: “A consumer might be confused about a product’s intended use, for example, if a “satisfying smoking alternative” claim is accompanied by other text or images indicating that the product can help smokers reduce withdrawal symptoms associated with quitting smoking. In that case, the product may be subject to regulation as a drug or device. ”
Referring a number of times to the open comment period and rejecting various arguments.
“(Comment 1) At least one comment stated that FDA is not permitted to regulate the nicotine in cigarettes as a drug and should not be permitted to regulate electronic nicotine delivery systems (ENDS) as medical products.
(Response) FDA disagrees. ”
“To establish a product’s intended use, FDA is not bound by the manufacturer or
distributor’s subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Thus, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold.”
Later on (p. 37 of 89), the FDA goes on to say:
“Manufacturers are free to decide how they would like to market their products, but must meet the appropriate statutory and regulatory standards governing the regulatory pathway they choose. ”
Yet, the high cost (upwards of $2M according to the guesstimate table in the beginning of the doc, unsettled MRTP (Modified Risk Tobacco Product) and PTMA (Preliminary Tobacco Manufacter Product) process makes this laughable.
I’ve only made to the halfway mark and need a break!
Oh, boy. Page 69: “A manufacturer’s making a modified risk claim for a specific tobacco product renders the product an MRTP, which can be marketed only after the manufacturer substantiates any modified risk claims in an MRTP application and after FDA determines that the product meets the statutory standard. Additionally, if a manufacturer intends that its product be used for cessation, it can submit an NDA, Abbreviated New Drug Application (ANDA), Premarket Approval Application (PMA), or premarket notification submission so that FDA can determine whether the product meets the statutory standard and can approve the application or clear the submission, if appropriate.”
For a better interpretation, please see: Michael Siegel – http://tobaccoanalysis.blogspot.com/