Editors Note: We aplogize for not responding to the many emails we receive. But our readers must understand we have a very select audience of experts in science, law, public affairs and politics. Consequently any response requires a very well reasoned response, not necessarily in length but in content. The following post is made in response to inquiries regarding a likely regulatory scenario for tobacco regulation by the FDA. Nonetheless we encourage you to continue to express your opinions either by posting on this website or sending us an email through the link provided to the right of this article under “Important Sites”.
See the article in TPSAC News entitled New Tobacco Review Process [Inside Health Policy] in which the author states:
“A new tobacco approval process that mimics device 510(k) clearance procedures could also require that industry supply clinical trial data and other information as the agency implements a mandate from the 2009 law that brought tobacco regulation under FDA’s purview”
“Companies will have until March 11 to submit information comparing their products to a predicate product grandfathered into the system before February 2007 to prove that they are as safe or safer than tobacco products already on the market.”
The determination regarding “safe or safer” is a scientific decision. It is likely that TPSAC will be involved in reviewing a number of these determinations.
The menthol review will establish the precedent for the role scientific data will play in the regulation of the tobacco industry and its attendant products, whether or not they are regulated under a section that mimics Section 510(k) clearances.
The menthol review has already established one important precedent–the TPSAC is writing its own reports in lieu of editing drafts prepared for them by the FDA. The menthol review is about to establish another precedent–how the Center for Tobacco Products addresses petitions filed under the Data Quality Act, in particuar the petition filed by CRE at http://www.thecre.com/tpsac/?p=541
To give our readers and idea of what the likely regulatory scenario for tobacco products will look like, we are reproducing from the FDA website its statement on “510(k) clearances.
510(k) Clearances
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use
While the SE rules for tobacco sound like they came from the 510(k) regulations, the FDA apparently intends to make life difficult, especially for the smaller manufacturers. They appear to be insisting that you must reference any new or changed product back to a specific commercial product that was on the market on 2/15/2007. If you don’t have a product from 2/15/2007 to analyze and use as a predicate product, what are you supposed to do?