August 26, 2016

R2B Smoke Free-Nicopure v FDA Joint Petition

This legal brief contains the subject matter below to address the August 8th, 2016 Deeming Reg.s
The gist:
“the TCA’s text, context, and history unambiguously show that FDA may “deem” a product only if that product—not a hypothetical combination of goods assembled by a consumer at some later juncture—contains or is derived from tobacco.”

From the Table Of Contents:

  • FDA Lacks Authority to Regulate Products Not Made or Derived from Tobacco
    Products neither made nor derived from tobacco are not “tobacco products”
    Nicopure has standing to bring its ripe challenge to FDA’s authority over non-nicotine-containing e-liquids
    Sottera did not and could not address whether FDA had authority under the TCA to “deem” non-tobacco and non-nicotine-containing products
  • The Deeming Rule’s Regulation of Vaping Devices and E-Liquids Fails “Hard Look” APA Review
    The Deeming Rule is not exempt from judicial review, but rather is subject to “hard look” scrutiny under the APA
    The Deeming Rule fails APA review because it is internally inconsistent
    and contrary to the public health
    FDA failed to consider reasonable alternatives
    FDA failed to reconcile the Deeming Rule with the TCA’s structure
  • The Deeming Rule Is Invalid Because It Is Premised on an Arbitrary and Capricious Cost-Benefit Analysis
    FDA’s arguments regarding Executive Orders are irrelevant
    FDA must consider costs and benefits when regulating under the TCA
    FDA’s cost-benefit analysis is unreasonable and inadequately explained
    FDA violated the Regulatory Flexibility Act
    The Deeming Rule Violates the First Amendment
    The Deeming Rule’s regulation of vaping device and e-liquid samples violates the First Amendment
    The sampling ban regulates speech
    The sampling ban fails scrutiny under Sorrell and Central Hudson
    The Deeming Rule’s Restrictions on Truthful, Nonmisleading Speech Violate the First Amendment
    The modified risk restrictions do not escape First Amendment review
    The modified risk restrictions are invalid under Sorrell and Central Hudson

You can read the whole thing or skip to the Conclusion on page 53 of the above document.

Case 1:16-cv-0878-ABJ  8/26/16 U. S. District Court of Columbia

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