#NO GRAVITY SMOKE SHOP MANUAL#

Respondent indicated that it had not reviewed the witness declarations, but wanted to cross-examine both of CTP's witnesses. As Respondent did not object to CTP's proposed exhibits, I admitted them into the record. During the prehearing conference, we discussed CTP's proposed witnesses and exhibits. On August 14, 2019, I held a prehearing conference call. CTP did not object, and I granted Respondent's motion. On June 25, 2019, Respondent requested a continuance due to a family member's medical emergency and the need to obtain legal counsel. On May 30, 2019, I issued an Order scheduling a prehearing conference for June 27, 2019. Respondent did not file a prehearing exchange. 3) and Inspector Felicia Fairfield (CTP Ex. 1-21), including the written direct testimony of two proposed witnesses, CTP's Senior Regulatory Counsel Laurie Sternberg (CTP Ex. 4.ĬTP timely filed its prehearing exchange, consisting of a prehearing brief, list of proposed witnesses and exhibits, and 21 exhibits (CTP Exs. On January 3, 2019, I issued an Acknowledgment and Pre-Hearing Order (APHO) acknowledging receipt of Respondent's Answer and establishing procedural deadlines for this case.

#NO GRAVITY SMOKE SHOP MANUAL#

In its Answer, Respondent denied the allegations, raised defenses, and submitted the following documents in its defense: a December 4, 2018, letter an employee time card a payroll register review an undated POS statement and a POS register manual instructions. Respondent timely filed its Answer, which the Civil Remedies Division (CRD) received on December 27, 2018. As detailed below, I find, based on the evidence of record, that it is more probable than not that Respondent sold the alleged tobacco product to a minor and utilized a vending machine in a non-exempt facility in violation of 21 C.F.R. Specifically, Respondent sold a covered tobacco product to a minor on September 4, 2018, at approximately 5:24 PM, and Respondent utilized a vending machine in a non-exempt facility on September 14, 2018. CTP also asserts that Respondent subsequently committed two additional violations of the Act. Specifically, CTP asserts that Respondent previously admitted to three violations of the Act and implementing regulations. CTP's Complaint alleges that Respondent committed five violations of the Act and its implementing regulations over a 36-month period. §§ 17.5 and 17.7, CTP served a Complaint on Respondent Famous Smoke Shop, located at 1213 East Brady Street, Milwaukee, Wisconsin 53202, by United Parcel Service, on November 23, 2018. Background and Procedural HistoryĪs provided in 21 C.F.R. For the reasons discussed below, I find Respondent liable for the violations alleged in the Complaint and conclude that a CMP of $5,591 is appropriate. Respondent also contends that it cannot afford the proposed CMP and requests reduction of the penalty based on the cost of a new Point-of-Sale (POS) system. Several remedial measures to prevent sales to minors in the future, and it is an exempt facility. Specifically, Respondent states that it has taken Respondent denies the most recent violations, raises defenses to liability, and argues that the proposed penalty amount is too high.

CTP further alleges that Respondent subsequently committed two additional violations of the Act when it sold a covered tobacco product to a minor and utilized a vending machine in a non-exempt facility. Specifically, Respondent admitted that it sold covered tobacco products to minors on two occasions and failed to verify, by means of photo identification containing a date of birth, that the purchaser was 18 years of age or older during one of the sales.

CTP alleges that Respondent previously admitted to three violations of the Act. § 301 et seq., and its implementing regulations, 21 C.F.R. The Center for Tobacco Products (CTP) of the United States Food and Drug Administration (FDA) seeks a civil money penalty (CMP) of $5,591 against Respondent, Famous Cigar, LLC d/b/a Famous Smoke Shop, for at least five violations of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.

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