WASHINGTON -- The U.S. Food and Drug Administration (FDA) kicked off 2016 with a flurry of activity. Though the agency still hasn’t announced the long-awaited final deeming regulations, which will grant the FDA authority over a number of currently undeemed tobacco products, there’s been no shortage of FDA-related news in recent days.
Three major announcements include:
Senate Panel Approves New FDA Commissioner
Technically, the agency has been without a commissioner since Margaret Hamburg early last year. ABC News reports that Dr. Robert Califf, the current No. 2 at the FDA, is one step closer to taking the job after the Senate Health Committee approved President Obama’s nominee this Tuesday.
Chairman Lamar Alexander (R-Tenn.) voiced his support, stating Califf has been thoroughly vetted and he is confident the former cardiologist and medical researcher at Duke University can lead the agency “fairly and impartially.”
First-Ever No-Tobacco-Sale Orders Go Into Effect
Last October, the FDA’s Center for Tobacco Products (CTP) issued its first-ever No-Tobacco-Sale Orders (NTSO) to eight retailers who had repeatedly failed compliance inspections; this week, the CTP announced it has reached settlements with four of the eight retailers, resulting in the first NTSOs going into effect.
Retailers who settled included:
- C & C Supermarket LLC, Irvington, N.J.
- Family Food Market Inc., Detroit.
- MFA Petroleum Co., doing business as Break Time 3028, Columbia, Mo.
- Mon-Jan Corp., doing business as Monaghan’s Pub, Baltimore.
“As a result, these retailers are prohibited from selling tobacco products at their establishments for the dates listed (on the CTP’s website),” the CTP announcement reads. “The cases filed against the remaining retailers are still pending.”
Online Retailer Issued Warning Letter
The CTP and Center for Drug Evaluation and Research (CDER) issued a joint warning letter to an online retailer that’s selling products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), marking the first time the CTP has issued a warning in conjunction with another FDA Center.
“This warning letter is issued jointly by CTP and CDER because the website illegally sells and markets both violative tobacco products and an unapproved drug/device combination product,” reads a CTP statement. “The company has 15 working days to submit a written response to the FDA describing the corrective actions. Failure to ensure full compliance may result in the FDA initiating further action against the company without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.”
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