The Food and Drug Administration seeks more comments on a final rule that clarifies when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said (here). Under the final rule, issued Jan. 9, a product made or derived from tobacco is regulated as a drug, device or combination product: “(1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000" (see 1701060011). Originally effective March 21, 2017, FDA recently delayed the effective date until March 19, 2018 (see 1703170030). Comments on the final rule, as well as a request FDA has received to reconsider the new regulation, are now due July 18.

On May 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

A 2017 update to the mutual recognition arrangement (MRA) on pharmaceuticals between the U.S. and the European Union will allow the Food and Drug Administration to dramatically increase inspections of drug facilities in China and India, said Dara Corrigan, FDA’s acting deputy commissioner for Global Regulatory Operations and Policy, in recent remarks (here) at the Food and Drug Law Institute’s annual conference. The agreement, which provides for recognition of EU inspections of its own drug facilities, means FDA can instead allocate its inspectors elsewhere. In 2016, for example, FDA would have been able to nearly double its inspections in China and India had the amended MRA with the EU already been in place, it said. FDA also posted the presentation that accompanied Corrigan’s remarks (here).

On May 12 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 11 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for May 10 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

The Food and Drug Administration issued a guidance (here) on the agency's three-month extension of compliance deadlines for e-cigarettes, cigars and pipe tobacco (see 1705050045). The FDA in a May 2016 final rule placed new restrictions on cigars, electronic cigarettes, pipe tobacco and other tobacco products, bringing them under the scope of its tobacco regulations alongside cigarettes and smokeless tobacco (see 1605050011). The guidance includes a table of compliance dates, among other things. Starting with the May 10, 2017, deadline, compliance dates are delayed three months.

The Food and Drug Administration updated its website to include more information on the Foreign Supplier Verification Program ahead of the regulation’s first compliance date on May 30, it said (here). New materials include updates to FDA’s fact sheet on FSVP (here), as well as a recent guidance document on how to file entries newly subject to FSVP on May 30 that allows the transmission of “unknown” for the FSVP importer’s unique identifier (see 1705100028), FDA said.

On May 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On May 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: