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FDA Issues Fact Sheet On Tobacco Warnings

Six violations in 48 months could result in a $10,000 fine. The FDA has issued a one-page fact sheet titled “Overview:  Tobacco Retailer Warning Letters.” The fact sheet explains why warning letters are issued to tobacco retailers, what a retailer needs to do if a warning letter is received and what FDA tobacco regulations apply

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FDA Announces New Compliance Check Inspection Notice

If a minor succeeds in purchasing a regulated tobacco product during a compliance inspection, the FDA will now send the retailer a “Compliance Check Inspection Notice” after the inspection occurs. Last week, during an FDA-hosted compliance training Webinar for retailers, the FDA announced it plans to use a new Compliance Check Inspection Notice if a

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Maintaining Strong Cigar Sales

Despite a demand from adult consumers, retailers are continually forced to defend their right to sell flavored cigars responsibly. By Howard Riell, Associate Editor While tobacco has long been a bread-and-butter product for convenience stores, accounting for millions in individual unit sales and boosting the profits from the average smoker’s market basket, it remains a

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AWMA & Merchants Grocery Co. Host FDA Plant Tour

Merchants Grocery Co. plant tour aims to help FDA better understand the distributor’s role in the tobacco distribution process. A group of Food and Drug Administration (FDA) regulators visited AWMA member Merchants Grocery Co. in Culpeper, Va., on Wednesday, July 18, and viewed the company’s tobacco processing operation at the invitation of AWMA and Merchants. 

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Leveling The RYO Playing Field

In recent years, roll-your-own tobacco machines have surfaced at various retail locations putting convenience stores at a competitive disadvantage on price. By Howard Riell, Associate Editor America, and in particular its lawmakers, remains caught in a love-hate relationship with tobacco. That push-pull has resulted in very well-publicized attempts to dissuade Americans from using tobacco, or

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Decoding Haverstraw’s Questionable Tobacco Display Ban

With various federal laws banning or limiting certain cigarette product advertising, cigarette packaging itself has become a commercially accepted form of advertising. By John Lofstock, Editor. In early April, the Village of Haverstraw, N.Y., adopted a first-of-its-kind ordinance in the U.S. that requires retailers to keep tobacco out of public view. To learn more about

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FDA Announces Intent to Regulate OTP

FDA expects to issue a deeming regulation in summer 2012 to cover other tobacco products. Cigars, e-cigs and cigarillos are among tobacco products about to meet with U.S. Food and Drug Administration (FDA) scrutiny. The agency has announced its intent to issue a “deeming regulation” sometime during the summer of 2012 to cover other tobacco

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Dispelling the Myths of Tobacco Control

A response to the recent misleading “Deadly Alliance” report implicating convenience stores. By Seth A. Mailhot, Special Counsel, Sheppard Mullin Richter & Hampton LLP. This is the first of what will be a continuing series on the regulation of tobacco retailing. In future articles, I will address the U.S. Food and Drug Administration’s (FDA’s) regulation

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Battle Continues On Graphic Warning Labels

D.C. Circuit Court of Appeals hears arguments on FDA graphic warnings for cigarettes. On April 10, the U.S. Circuit Court of Appeals for the District of Columbia heard oral arguments regarding the constitutionality of the FDA’s graphic cigarette health warning labels. On Feb. 28, 2012, Federal District Court Judge Richard Leon issued a decision that

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FDA Rejects Petition On BPA

The FDA noted it requires more evidence of harm before banning BPA in food packaging. Late Friday afternoon, on the eve of its legal deadline, the U.S. Food and Drug Administration (FDA) announced it has rejected the 2008 Natural Resources Defense Council (NRDC) petition requesting that the toxic chemical bisphenol A, or BPA, be declared

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E-Cigarettes Are Here to Stay

Until recently, e-cigs have been sold through traditional tobacco stores that normally expect a keystone or 100% markup on items other than cigarettes. Though it is hard to determine the number of e-cig users in the U.S., the National Vapers Club estimated that about a million people used e-cigs last year, so it certainly is

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Cigarette Warning Labels Upheld By Appeals Court

Following a federal court decision that graphic warning labels were unconstitutional, an appellate court has ruled that requiring cigarette warning labels are not a violation of free speech, rather they fall under commercial speech disclosures, are disclosing the health risks of cigarettes and are reasonably related to the government’s interest of preventing the deception of

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FDA Issues Letter On Warning Labels

“At this time, FDA will not be soliciting or reviewing cigarette warning plans, the agency noted. Due to ongoing litigation, the implementation date for the Food and Drug Administration’s (FDA) final rule entitled “Required Warnings for Cigarette Packages and Advertisements” (“June 2011 Rule”) —which requires larger, more prominent health warnings on all cigarette packaging and

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FDA To Reveal Time of Inspection In Letters

Warning letters to note the time of day an inspection took place following NATO request. Going forward, the FDA plans to include the time a retail compliance inspection occurred in warning letters sent to retailers, National Association of Tobacco Outlets (NATO) reported. The FDA’s Center for Tobacco Products (CTP) sent a letter, dated Feb. 1,

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FDA’s CTP Announces Public Workshop

A Webcast of the workshop will be available, although preregistration is required. FDA’s Center for Tobacco Products has announced a Research Program Public Workshop: Expanding the Research Base for Tobacco Product Regulation. The purpose of the public workshop is to discuss FDA’s Center for Tobacco Products’ (CTP) research priorities across a broad array of disciplines;

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The Impact of Restrooms on Food Sales

Poor safety and sanitation practices will turn customers away. Going above and beyond what’s required is the key to a healthy program. By Howard Riell, Associate Editor. The numbers tell an interesting story: according to a recent research study by Cintas Corp., fully 95% of people avoid patronizing a business in which they have had

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Tobacco Retailers Get an “A” For FDA Compliance

NATO encourages FDA to issue letters of compliance to the tobacco retailers that pass compliance inspections, as positive reinforcement. More than 96% of tobacco retailers inspected by federal contractors in 38 states and the District of Columbia were found to be in compliance with new tobacco regulations designed to prevent the sale of tobacco products

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FDA Issues Warning Letters To Tobacco Retailers

More than 1,200 retailers that sell tobacco receive warnings about violations. The U.S. Food and Drug Administration (FDA) sent warning letters to more than 1,200 retailers, the majority of which respond to violations relating to selling tobacco to minors, as part of its ongoing effort to reduce tobacco use among children. While most retail establishments

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Center For Tobacco Products Postpones Meeting

New meeting date will be announced soon. FDA is postponing the Tobacco Product Scientific Advisory (TPSAC) meeting scheduled for Nov. 2-3, 2011. The meeting is being rescheduled because key participants were unavailable due to unforeseen scheduling conflicts. A new meeting date will be announced in the Federal Register. For more information:  <http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/ucm276969.htm

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FDA, NIH Announce Joint Tobacco Study

Tobacco use and risk perceptions will be reviewed during this collaboration—the first since the passing of the 2009 Tobacco Control Act.  The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced a joint, large-scale, national study of tobacco users to monitor and assess the behavioral and health impacts of

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Seizing Control of Smokeless Sales

Convenience store retailers are still concerned over the FDA’s involvement in smokeless tobacco, but many expressed optimism that the category can continue to thrive. By Howard Riell, Associate Editor. While taxes and regulations haven’t impacted sales of smokeless tobacco products as much as some had predicted, it remains up to retailers to continue aggressively marketing

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FDA Seeks Comments on Draft Guidance

FDA has posted a draft guidance to help persons submitting applications for new tobacco products understand the premarket tobacco product application process. The draft guidance addresses questions such as: •    Who may submit a new tobacco product application •    When to submit a new tobacco product application •    What information the FD&C Act requires you

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Tobacco Companies Fight Warning Labels

Hearing underway in U.S. Federal District Court on cigarette health warnings. Yesterday, Sept. 21, a hearing took place before U.S. Federal District Court Judge Richard Leon on a lawsuit filed by five tobacco manufacturers seeking a preliminary injunction against the implementation of the FDA’s new text and graphic picture warning labels for cigarette packages and

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FDA Seeks Comments On Draft Guidance

FDA Center for Tobacco Products posted two Draft Guidance documents and an Advance Notice of Proposed Rule-Making, and encourages retailers to review the documents and submit comments.  • Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. This draft guidance provides information in

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FDA Center for Tobacco Products Invites Retailer Comments

Retailers with comments on tobacco regulations, risk, etc., have a chance to present their views to the FDA’s Center for Tobacco (CTP) products: 1. Public Workshop on Modified Risk Tobacco Product Applications (MRTP) This workshop <http://www.fda.gov/TobaccoProducts/NewsEvents/ucm268472.htm> will provide an opportunity to discuss issues pertinent to the scientific evaluation of MRTP applications.  Aug. 25 – 26,

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