Legal Blogs

Right To Be Smoke Free Coalition Takes on FDA

 Right to Be Smoke-Free Coalition, et al v. Food and Drug Administration, et al (Case No. 1:16-cv-01210)

On June 20, 2016, ten (10) national and state advocacy and trade associations representing the ENDS industry, including manufacturers, distributors and retailers, filed a lawsuit against the Food and Drug Administration (FDA), Robert Califf, MD (Commissioner of the FDA), and Sylvia Mathews Burwell (Secretary of Health and Human Services) in U.S. District Court for the District of Columbia. [Exhibit “1.”]

E Cig Industry Challenges FDA's New "Deeming Regulations" of the industry.

E Cig Industry Challenges FDA’s New “Deeming Regulations” of the industry.

Plaintiffs state the FDA adopted a “one-size-fits-all” approach, even though Congress was clear in the Tobacco Control Act that the FDA should use its regulatory authority in a flexible manner that recognizes the continuum of risk presented by different tobacco products. They state FDA acknowledges that there are an increasing number of studies that have shown a distinct harm-reduction role for e-cigs and vaporizers. They allege the “one size fits all” approach requires ENDS manufacturers to follow the pre-market tobacco application (PMTA) pathway, which will result in the vast majority of such products being forced to exit the market over the next two years. They also challenge the broad definition of “tobacco product” as interpreted by the FDA and the state the cost/benefit analysis was inadequate. They seek to enjoin the FDA from implementing portions of the Deeming Rule, and orders declaring that portions of the Deeming Rule are unlawful on constitutional and administrative grounds.

The complaint contains eight (8) counts (or claims) alleging different violations of laws, as follows:

  1. Violation of the Administrative Procedure Act (APA) – Grandfather Date: Plaintiffs allege Congress did not intend FDA to implement the TCA in a manner that would exclude ENDS manufacturers from using the Substantial Equivalent (SE) pathway. Therefore it had a duty to establish a new Grandfather Date, but failed to do so in violation of the APA. (¶¶ 71-75)
  2. Violation of the APA – Pre-Market Authorization Process: FDA had an obligation to exercise flexible enforcement authority, but instead applied a “one size fits all” regime, despite acknowledging that ENDS products have lower risk profile than traditional cigarettes . By subjecting all tobacco products to the same requirements, FDA will all but ban e-liquid and device categories in violation of the regulatory scheme under the TCA. (¶¶ 76-82)
  3. Violation of Due Process and Equal Protection Clauses – TCA: FDA insists that the TCA requires it to employ a “one size fits all” scheme on tobacco products, but the TCA permits it to exercise flexible enforcement authority because different tobacco products present different risks. If the TCA in fact requires a “one size fits all” approach, then Congress has treated differently situated products in a similar manner without any rational relationship between the similar treatment. (¶¶ 83-89)
  4. Violation of First Amendment and APA – Ban on Free Samples: Distributing free samples is integral to marketing e-liquids and is a form of non-misleading speech protected by the First Amendment. FDA has no interest in a total ban on free samples and any concern about youth access can be resolved by subjecting access to free samples to age verification requirements. (¶¶ 90-100)
  5. Violation of First Amendment and APA – Modified Risk Tobacco Products (MRTP): The MRTP requires manufacturers of tobacco products to obtain FDA approval before making certain truthful non-misleading claims about their products. As to ENDS, the following claims would require approval: “smokefree,” contains reduced levels of or does not contain a certain substance, or presents a reduced level of risk when compared to traditional tobacco products. However, ENDS do not produce smoke, combust or contain tar or other substances in traditional tobacco. This process fails to advance any government interest and improperly prevents commercial speech that is not misleading. FDA has other options such as disclaimers and verifying tests. (¶¶ 101-110)
  6. Violation of APA – Definition of “Tobacco Product” and Application to ENDS: FDA considers a broad range of ENDS products to be regulated as “tobacco products,” despite the fact they do not contain tobacco, are not derived from tobacco and are not components or parts of an actual tobacco product. There is no rational for this extensive definition and it is unreasonable. (¶¶ 111-117)
  7. Violation of Regulatory Flexibility Act – Unlawful Cost/Benefit Analysis: The Regulatory Flexibility Act requires administrative agencies to consider the effects of their actions on small business entities. A small entity tobacco manufacturer is less than 1,500 employees and a small entity tobacco retailer has less than $7.5 million in receipts. The vast majority of ENDS manufacturers and retailers qualify as small businesses. Despite this, FDA failed to consider the impact of the compliance period when there is no long term clinical study available, underestimated the number of small entities and ENDS products subject to the Deeming Rule and overestimated the number of PMTA that would be submitted. It overestimates the benefits and underestimates the costs of the Deeming Rule. (¶¶ 118-127)
  8. Violation of the APA – Unlawful Cost/Benefit Analysis: The APA also requires consideration of all relevant factors and consideration of costs and benefits of Deeming Rule, but FDA failed to do so. (¶¶ 128-133)

This is the largest lawsuit against the FDA regarding the Deeming Rule to date.[1]

Plaintiffs allege they are “fully committed to the safety of ENDS products, from manufacturing through distribution and sale, and recognize the need for reasonable regulation at the federal level.” (Complaint, ¶ 1.) They state, however, that the Deeming Rule “sets forth obligations that reach far beyond any reasonable level of regulatory oversight and imposes requirements that are unlawful in their nature and scope.” (Id.) As such, they are only challenging portions of the Deeming Rule and TCA

The complaint states, “the [FDA] adopted a ‘one-size-fits-all’ approach even though Congress was clear in the [Tobacco Control Act] that the agency should use its regulatory authority in a flexible manner that recognizes the continuum of risk presented by different tobacco products.” (Id. at ¶ 2.)

 

This lawsuit is still in the preliminary stage. We keep you updated as this challenge to the Deeming Rule continues to develop. Should you have any questions or comments in the meantime, please call or email. 

[1] Other lawsuits include: Nicopure Labs LLC v. FDA, Case No. 1:16-cv-878 (challenging definition of “tobacco product” and pre-market authorization process); Lost Art Liquids, LLC v. FDA, Case No. 2:16-cv-3468 (cost/benefit analysis supporting Deeming Rule is not adequate and restraints on commercial speech); John Middleton Co. LLC v. FDA, Case No. 16-cv-996 (subsidiary of Altria Group Inc. wants to stop the FDA from banning its “Black & Mild” brand name for cigars and pipe tobacco because mild is in the name); Enrique Fernando Sanchez Icaza and Global Premium Cigars LLC v. FDA, Case No. 1:16-cv-21967 (Miami cigar maker wants to prevent the FDA from requiring labels that could comprise up to 30 percent of its cigar box and objects to how the FDA rules affect trademarked and copyrighted artwork); Larry W. Faircloth v. FDA, Case No. 2:16-cv-5267 (user of e-cigarette devices challenges “tobacco product” definition, states FDA regulations will drive up costs for consumers and consumers will be unable to receive truthful and non-misleading statements regarding products).

#pmta, #fda, #e-liquid