Today, the Trump Administration announced that it is instructing the Food and Drug Administration to “finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products.”  Continue Reading Trump Administration Instructs FDA to “Clear Market” of Flavored ENDS Products (including Menthol and Mint)

In a press release dated September 3, 2019, Michigan Governor Gretchen Whitmer announced her administration would be introducing emergency rules to ban the sale of “flavored vaping products” in retail stores and online, and ban “misleading” marketing of vaping products, including the use of terms like “clean,” “safe,” and “healthy.” Continue Reading Michigan Moves to Crack Down on the Sale and Advertising of Vapor Products

On August 22, 2019, Troutman Sanders will host the Tobacco Merchants Association “(TMA”) / Vapor Voice conference entitled “Finding Direction – Navigating PMTAs.”  The conference will address the FDA premarket tobacco application process for electronic nicotine delivery systems (ENDS).  The conference will be held in our Richmond office and Bryan Haynes will be one of the panelists.

We look forward to seeing clients and friends at the conference.  For more information, please see below.

Workshop Event Details

On Thursday, August 15, 2019, the Food & Drug Administration published for public comment a new proposed rule covering cigarette labeling and advertising. The proposed rule, Required Warnings for Cigarette Packages and Advertisements, would require, once finalized, new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. The FDA is proposing 13 warnings featuring text statements accompanied by photo-realistic color images depicting humans suffering certain health risks attributed to cigarette smoking.

This is FDA’s second attempt at issuing requirements that cigarette companies include graphic warnings in their labeling and advertising.

For further information, please contact us.

The U.S. Food and Drug Administration continues to be concerned about the proliferation of products containing CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA.  On Tuesday, July 23, 2019, FDA issued a press release announcing it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, alleging the company illegally sold unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. Continue Reading U.S. Food and Drug Administration Expresses Concerns About Therapeutically Marketed CBD Products

On the heels of a Maryland federal judge’s order advancing to May 2020 the deadline for premarket review submissions (discussed here), a group of public health advocates (led by Iowa Attorney General Tom Miller) has petitioned the Secretary of Health and Human Services to appeal the court’s decision and to revamp the premarket review process for electronic nicotine delivery systems (ENDS). Continue Reading Public Health Advocates Urge FDA to Revamp ENDS Premarket Review Process and Appeal Maryland Ruling

Last Thursday, July 18, 2019, Mark Herring, Virginia’s Attorney General, called again for marijuana regulatory reform in light of new data showing arrests rose in the Commonwealth last year. The Attorney General noted that in 2018 marijuana arrests accounted for 59 percent of all drug arrests in Virginia.  Herring favors the decriminalization of possession of small amounts of marijuana, action to address past convictions for simple possession and a move towards legal and regulated adult use in Virginia.  The Attorney General’s press release was followed the next day by a tweet from Virginia Governor Ralph Northam also urging the decriminalization of marijuana. Continue Reading VIRGINIA’S GOVERNOR AND ATTORNEY GENERAL REITERATE CALL FOR MARIJUANA REFORM AS ARRESTS CONTINUE TO RISE

On July 11, a federal judge issued an important ruling that dramatically advances submission deadlines for premarket review of tobacco products.  As a function of that ruling, the deadline for applications for FDA premarket review of “deemed” tobacco products (including cigars, pipe tobacco and electronic nicotine delivery systems (ENDS)) is now May 11, 2020. Continue Reading Court Ruling Advances FDA Premarket Review Deadline for Deemed Tobacco Products

In the June 2019 edition of SMOKESHOP Magazine, Troutman Sanders attorney Bryan Haynes discusses “The FDA’s New Catch-22.”  Haynes outlines the FDA’s threat to step up enforcement of premarket review requirements for “new tobacco products” while stalling on long-awaited guidance and regulations establishing the boundaries for industry submissions.

Read the article here.

 

The Federal Trade Commission (FTC) and the U.S. Food and Drug Administration (FDA) recently sent warning letters to four firms that manufacture and market flavored e-liquid products [Letters 1, 2, 3, 4]. According to the letters, the companies used social media “influencers” (individuals who promote a company’s product on social media websites in exchange for compensation) to promote their products.  Those promotional tweets and other postings on sites including Facebook, Instagram, and Twitter failed to include the requisite FDA warnings, prompting the FDA to declare the promoted products misbranded. Continue Reading Warn or Be Warned