All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field. But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates …
On October 12, 2021, FDA authorized the marketing of R.J. Reynolds (RJR) Vapor Company’s Vuse Solo electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2. …
It seems that although FDA giveth, the ITC taketh away. IQOS is a tobacco heating system in which “heatsticks” (reconstituted tobacco blended with glycerin) are electrically heated to release nicotine-containing aerosol, but the tobacco is not combusted. Because IQOS was classified as a cigarette by FDA, …
The Food & Drug Administration (FDA) announced on April 29, 2021 that it is working towards banning menthol flavored cigarettes, committing itself to issuing a proposed product standard to prohibit menthol as a characterizing flavor in cigarettes “within the next year.” In the same announcement, …
On July 7, 2020, a unanimous panel of the D.C. Circuit held that FDA violated the Tobacco Control Act (TCA) and the Administrative Procedure Act by failing to study whether the extensive health warnings required on cigars would actually lower the number of smokers in …
For those following the war between the Food and Drug Administration (“FDA”) and industry over the regulation of vaping products, last week’s opinion by the United States Court of Appeals for the District of Columbia Circuit upholding FDA’s so-called Deeming Rule is yet another battle …
Companies challenging FDA in court typically face a steep uphill battle given the long-standing doctrine known as Auer deference, which (in simplified terms) requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. The recent Supreme Court ruling in Kisor …
Historically, the Food and Drug Administration has called its decisions not to pursue enforcement against or prosecution of legal violations an exercise of “enforcement discretion,” which is a misnomer. In reality, such decisions are an exercise of “nonenforcement discretion.” But, whatever it is called, rarely …
A few months ago we reported on FDA’s recent enforcement efforts targeting electronic nicotine delivery systems (ENDS), such as e-cigarettes, and warned that the Agency is watching retailers and manufacturers closely (see here and here). In a September 12, 2018 announcement, FDA summarized its enforcement efforts …
A district court in Massachusetts scolded FDA for failing to meet a two-year deadline for issuing a final rule mandating color graphic warnings on cigarettes. This decision is important for the public health interests associated with the graphic warnings, but interesting for the loss dealt …
FDA is continuing the crackdown on the sale of tobacco products to minors (see our post here regarding recent FDA actions). On May 1, 2018, FDA and FTC issued 13 joint warning letters to manufacturers, distributors, and retailers for misleadingly labeling or advertising nicotine-containing e-liquids …
On April 24, 2018, FDA released a statement regarding new enforcement actions and a Youth Tobacco Prevention Plan aimed to help stop minors from using e-cigarette products. Under the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), a “tobacco product” is defined as “any …
Vape shops in several states have banded together in litigation challenging the constitutionality of FDA’s Deeming Rule (for background information on that regulation, see our prior posting here). Plaintiffs are pursuing the litigation simultaneously in several federal district courts – perhaps with the objective of …
In 2015, FDA proposed to revise the intended use regulations, which describe how the agency determines the intended use of a drug or device, including the types of evidence that may be considered. FDA’s proposed rule would have deleted the infamous “knowledge” sentence, which could …
In a stunning development, newly appointed FDA Commissioner Scott Gottlieb, M.D. held a briefing last Friday to announce a multi-year plan for tobacco and nicotine regulation. The Commissioner’s remarks are available here, and a press release announcing the policy is available here. The Agency’s new approach …
