Another challenge from the cigar industry has been filed against the FDA’s Deeming Regulations. Among the plaintiffs are a premium cigar retailer/lounge, a premium cigar manufacturer, and a non-profit association comprised of premium cigar manufacturers and retailers. The case is En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Administration, et al., No. 4:18-cv-00028 (E.D. Tex.). Continue Reading Deeming Regulations Litigation Update–New Challenge Filed on Behalf of Premium Cigar Plaintiffs

A series of challenges to the Deeming Regulations has recently been filed by several vapor-product manufacturers, retailers, and a non-profit supporting the industry. These are constitutional challenges, advanced with representation from the Pacific Legal Foundation (“PLF”). The cases are Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.); Hoban, et al. v. Food & Drug Administration, et al., No. 0:18-cv-269 (D. Minn.); Moose Jooce, et al. v. Food & Drug Administration, et al., No. 1:18-cv-203 (D.D.C.). Continue Reading Deeming Regulations Litigation Update–New Challenges Filed on Behalf of Vapor Plaintiffs

Coming under scrutiny in the 2017-18 session of the New York State Legislature, electronic cigarettes and other vapor products have been the subject of various proposed bills. Pending legislation could affect excise taxation, discounts, and warning labels. Some bills would even prohibit certain types of vapor products. Continue Reading E-Cigarette Bills Pending in New York State Legislature

A bill was introduced in the New Hampshire legislature on January 3, 2018 regarding the regulation of e-liquids. The bill, NH18-H.1812, specifically addresses labeling requirements for e-liquid products. Distributors and manufacturers of e-liquid products to be sold in New Hampshire would be required to add a product label which includes a list of ingredients in the product in accordance with the FDA’s food guidelines. Also, e-liquids could not contain diacetyl, acetyl propionyl, or acetoin or “any substance known to be hazardous when inhaled in accordance with federal Food and Drug Administration guidelines.” If passed, this bill would be in effect as of January 1, 2019.

On November 8, 2017, Congresswoman Diana DeGette (D-Colo.) introduced H.R. 4273. The next day, Senator Brian Schatz (D-Hawaii) introduced S. 2100. If passed, either bill would enact the “Tobacco to 21 Act.” The bills have been referred, respectively, to the House Committee on Energy and Commerce and the Senate Committee on Commerce, Science, and Transportation. Continue Reading Renewed Effort to Push “Tobacco to 21” Bills Through Congress

Troutman Sanders Partner Bryan Haynes will attend the Food and Drug Law Institute Conference on Enforcement, Litigation, and Compliance held December 6-7, 2017 in Washington, DC. Bryan will moderate a session on the FDA’s enforcement of age verification and other requirements for tobacco products.

Click here to learn more about the conference.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.

 

Further briefing and deliberation are expected on a Motion to Intervene filed by several anti-tobacco advocacy and health groups in Nicopure Labs, LLC, v. FDA, No. 17-5196 (D.C. Cir.). The would-be intervenors include the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative. Continue Reading Deeming Regulations Litigation Update — Merits Panel to Take Up Intervention Question in D.C. Circuit Appeal, Further Briefing Expected

In the cigar industry’s challenge to the FDA’s Deeming Regulations, there has been a flurry of activity in anticipation of oral argument on the parties’ cross- motions. The case is Cigar Association of America, et al. v. FDA, et al., No. 1:16-cv-01460 (D.D.C.). Continue Reading Deeming Regulations Litigation Update — Recent Filings in Run-Up to December 14 Oral Argument on Cigar Industry’s Challenge

Recent filings in the cigar industry’s challenge to the FDA’s Deeming Regulations involve outside support and opposition. The case is Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.).

After Plaintiffs in the cigar-industry challenge to the Deeming Regulations filed a Motion for Preliminary Injunction and a Motion for Partial Summary Judgment on October 3, 2017, filings of amici curiae have come on their side. Meanwhile, the Court has denied a Motion to Intervene filed by several anti-tobacco advocacy and public-health groups. Continue Reading Deeming Regulations Litigation Update — State and Nonprofit Amici Support Cigar Challenge, Anti-Tobacco Intervention Disallowed

The U.S. Food and Drug Administration recently finalized is industry guidance on the prohibition of distributing free tobacco product samples. This guidance is intended to assist tobacco product retailers, manufacturers, and distributors in interpreting the requirements related to the distribution of tobacco products through non-monetary exchanges, membership and rewards programs, contests and games of chance, and business-to-business exchanges, among others. Continue Reading FDA Finalizes Guidance on the Prohibition of Free Tobacco Product Samples