DOCKET for NICOPURE LABS v. FDA et al, Oct 17-26, 2016

October 26, 2016 9:16 pm by Gene Borio

EXCERPT:

MINUTE ORDER. By Tuesday, November 1, 2016, each side in this case shall file one supplemental memorandum . . . defendants’ memorandum must explain to the Court: what is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule (which is in effect, and assuming it is not invalidated by the Court) at this time? How would the FDA undertake its case-by-case analysis to determine if a liquid is subject to the Deeming Rule as a “tobacco product” under the statute without the information to be supplied in the pre-market review application, and why would a manufacturer be legally required to submit the application if the liquid was not a “tobacco product” in the first place? Given the two-year pre-market review compliance period, how would a challenge to the regulation of a nicotine-free e-liquid be adjudicated, if it is not ripe now? If a manufacturer waits to challenge the regulation until the time of enforcement, will it not be too late at that juncture, if a Court agrees with FDAs interpretation, for a nicotine-free e-liquid manufacturer to secure pre-market review? . . .

Finally, each side should address the impact of the rules concerning modified-risk tobacco products on these questions, including whether liquids marketed as “nicotine free” are modified risk products.

END EXCERPT

FULL TEXT:

NICOPURE LABS, LLC v. FOOD AND DRUG ADMINISTRATION et al
Assigned to: Judge Amy Berman Jackson
Case: 1:16-cv-01210-ABJ
Cause: 05:551 Administrative Procedure Act
Date Filed: 05/10/2016
Jury Demand: None
Nature of Suit: 899 Administrative Procedure Act/Review or Appeal of Agency Decision
Jurisdiction: U.S. Government Defendant

Date Filed # Docket Text

10/17/2016 50 TRANSCRIPT OF PROCEEDINGS before Judge Amy Berman Jackson held on October 11, 2016; Page Numbers: 1-130. Date of Issuance: October 13, 2016. Court Reporter/Transcriber Janice Dickman, Telephone number 202-354-3267, Transcripts may be ordered by submitting the Transcript Order Form

For the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purchased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter.

NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov.

Redaction Request due 11/7/2016. Redacted Transcript Deadline set for 11/17/2016. Release of Transcript Restriction set for 1/15/2017.(Dickman, Janice) (Entered: 10/17/2016)

Date Filed # Docket Text

10/26/2016 MINUTE ORDER. By Tuesday, November 1, 2016, each side in this case shall file one supplemental memorandum, not to exceed five pages, on the question of whether the portion of plaintiffs’ legal challenge to the Deeming Rule in Count 1 of the Nicopure complaint and Count 4 of the Right to be Smoke Free complaint that relates to the regulation of nicotine-free e-liquids is ripe for adjudication. (The question of standing requires no further briefing.) The Deeming Rule, 81 Fed. Reg. 28,974 (May 10, 2016), states that it covers such liquids if they are “intended or reasonably expected to be used with or for the human consumption of a tobacco product (e.g., with liquid nicotine).” Id. at 29,017. But the FDA goes on to explain that enforcement actions on nicotine-free e-liquids will be undertaken on a “case-by-case” basis, id. at 29,032, and will be based on a review of the “totality of the circumstances… such as circumstances surrounding the distribution of the product or the context in which it is sold,” id. at 29,015, to determine whether nicotine-free e-liquids are “intended or reasonably expected to be used with… a tobacco product.” Id. at 29,017. Under those circumstances, defendants’ memorandum must explain to the Court: what is it exactly that a manufacturer of a nicotine-free liquid is required to do to comply with the Rule (which is in effect, and assuming it is not invalidated by the Court) at this time? How would the FDA undertake its case-by-case analysis to determine if a liquid is subject to the Deeming Rule as a “tobacco product” under the statute without the information to be supplied in the pre-market review application, and why would a manufacturer be legally required to submit the application if the liquid was not a “tobacco product” in the first place? Given the two-year pre-market review compliance period, how would a challenge to the regulation of a nicotine-free e-liquid be adjudicated, if it is not ripe now? If a manufacturer waits to challenge the regulation until the time of enforcement, will it not be too late at that juncture, if a Court agrees with FDAs interpretation, for a nicotine-free e-liquid manufacturer to secure pre-market review? In their memorandum, plaintiffs shall specifically address the opinion in Sprint Corp. v. FCC, 331 F.3d 952, 956 (D.C. Cir. 2003) (explaining that “issues may not be fit for review where the agency retains considerable discretion to apply the new rule on a case-by-case basis, particularly where there is a complex statutory scheme or there are other difficult legal theories that are implicated by the agency action.”). Finally, each side should address the impact of the rules concerning modified-risk tobacco products on these questions, including whether liquids marketed as “nicotine free” are modified risk products. SO ORDERED. Signed by Judge Amy Berman Jackson on 10/26/2016. (lcabj3) (Entered: 10/26/2016)

Leave a Reply

The primary purpose of this site is to provide information in a timely manner. Postings should be informative. The usual rules apply: No libel, no profanity, no personal abuse, keep it on topic, and short.

If you are scheduled as a court witness, CHECK with your lawyer before posting anything here!