Month: June 2024

The US Food and Drug Administration announced Thursday it had rescinded marketing denial orders for vaping products from Juul Labs Inc., stating it has not yet decided whether the products will ultimately stay on the market. The FDA action focuses on importation, distribution and sales, not individual use, and it “cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.” Juul said Thursday its products will remain on the market during scientific review.

The FDA issued a marketing ban on Juul products back in 2022, including devices and tobacco and menthol-flavored pods. The marketing denial order was stayed weeks later as “scientific issues warranted additional review,” but had not been rescinded. The FDA added that it reviewed the company’s premarket tobacco product applications and determined some of Juul Labs’ study findings had “insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed.”

US Health and Human Services Secretary Xavier Becerra said in a statement Thursday: “This action by FDA reflects the agency’s steadfast commitment to carefully evaluating the science to ensure that only those products meeting its rigorous public health standards are granted marketing authorization. FDA has taken the proper steps to protect the health of all Americans.”

Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in the agency’s news release: “The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company. As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

The FDA said court decisions since then “establish new case law and inform the FDA’s approach to product review to maintain the agency’s commitment to issuing final decisions that are appropriate on both the scientific merits and the law,” adding that rescission of the marketing ban “is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied .. The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed.”

In a statement, Juul said it looks forward to “re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”

Editorial credit: rblfmr / Shutterstock.com

Accused Gilgo Beach serial killer suspect Rex Heuermann was charged on Thursday with the murder of two additional women 10 years apart on Long Island. Heuermann, 60, was indicted on murder charges in the 1993 killing of Sandra Costilla and the 2003 killing of Jessica Taylor; the New York City architect pleaded not guilty to the new murder charges.  Heuermann now faces charges in the deaths of six women spanning three decades and multiple Long Island communities after he was indicted on the two new murder charges Thursday.

Costilla’s death was not previously tied to the Gilgo case; body was discovered in a wooded area of North Sea, a hamlet in Southampton. Prosecutors initially suspected Manorville carpenter, John Bittrolff, in her death, and he was later convicted of killing two other women. The Suffolk County district attorney’s office says DNA from hair found near Costilla and Taylor’s remains connect Heuermann to their killings; with ivestigators also stating that evidence showed Heuermann had his Massapequa Park house to himself at the time of their deaths, leaving him with “unfettered time” to carry out the crimes. Prosecutors believe Costilla was killed sometime between Nov. 19 and 20 in 1993, and Taylor was killed between July 21 and July 26 in 2003. The Manorville Pine Barrens are roughly 25 miles west of North Sea, which is on the South Fork on Long Island.

Heuermann was charged in July 2023 with killing four women. The remains of Maureen Brainard-Barnes, Amber Lynn Costello, Melissa Barthelemy and Megan Waterman were found in burlap bags along Gilgo Beach’s Ocean Parkway in 2010. The new charges on Thursday comce after two recent searches, including a return to Heuermann’s home in Massapequa Park last month; with prosecutors released disturbing new details into the ongoing investigation. Suffolk County District Attorney Ray Tierney said Thursday: “It is alleged that the pornographic images that were accessed by Heuermann are consistent with the crime scenes of both Sandra Costilla and Jessica Taylor. The indictment also includes a photo of a document, which investigators say Heuermann used as a “blueprint” to “plan out his kills with excruciating detail. We allege that this document evinces the defendant’s intent in committing the charged crimes, that his intent was, specifically, to locate these victims, to hunt them down and to bring them under his control and to kill them.”

Heuermann’s defense attorneys have asked for more time to review the new evidence and say he maintains his innocence.

Editorial credit: WoodysPhotos / Shutterstock.com

Hunter Biden’s ex-wife Kathleen Buhle and former girlfriend Zoe Kestan both testified Wednesday on Day 3 of his federal gun trial. The case marks the first time the child of a sitting president was ever put on trial during their father’s presidency.

The trial proceeded with cross-examination of an FBI witness concerning Biden’s laptop and a discussion of a timeline of his addiction with Buhle, who was married to Hunter Biden for 20 years and shares three daughters with him; and Kestan, who was involved with Biden around 2017-2018. A third woman romantically linked to Hunter Biden — Hallie Biden, the widow of Hunter Biden’s brother Beau — is expected to to take the stand on Thursday. Hallie Biden found and discarded the gun at the center of the case.

Biden’s defense attorney Abbe Lowell resumed his cross-examination Wednesday morning of FBI agent Erika Jensen in front of U.S. District Judge Maryellen Noreika. Jensen was the first witness under cross-examination to discuss the well-publicized laptop, which was subpoenaed in 2019 and entered into evidence Tuesday. They went over the timeline of Biden’s past drug use and how he allegedly lied on a federal form that asks about addiction in relation to gun ownership. Jensen said under cross-examination that Biden might not have been using drugs continuously from 2015-2019.

Biden’s ex-wife Kathleen Buhle took the stand after Jensen as the prosecutor’s first witness, testifying that her 25-year marriage to Hunter Biden deteriorated due to his past drug and alcohol use, but that she never personally saw him consume drugs. Buhle said that she would often find drug remnants in his car and that she saw him frequently work and interact with friends or family while she believed he was under the influence of crack cocaine, but he would try to hide it from people close to him.

Biden’s ex-girlfriend Kestan also took the stand, saying she met Biden in December 2017 at a Manhattan strip club and dated him for several months, testifying that he would smoke crack very often in private and admitting at times she would help him buy drugs at his request by using his mobile banking app at an ATM. She said at times she would see Biden smoke crack “every 20 minutes or so,” but that he remained “cognizant and coherent,” and would often drink alcohol while on drugs.

Also on the stand on Wednesday was Gordon Cleveland, the man who sold Hunter Biden the firearm. Cleveland testified that Hunter Biden did not seem confused by the form, while defense attorney Abbe Lowell tried to show how Biden was not addicted at the time to drugs, but rather alcohol.

And the end of proceedings on Wednesday, the prosecution said they have six witnesses remaining, and it is “possible” they will rest their case on Thursday; with Biden’s lawyer sharing that the first witness for the defense could potentially come Friday morning.

If convicted on all counts, Hunter Biden could face up 25 years in prison and $750,000 in fines, according to court filings. However, because Biden does not have a violent past and is an alleged first-time offender, it is possible he could get a lighter sentence.

Editorial credit: Andrew Leyden / Shutterstock.com

Amanda Knox was re-convicted of slander by an Italian court on Wednesday, upholding the only conviction still standing in association with the brutal murder of her roommate Meredith Kercher in 2007. Knox was an American student living in Italy at the time of the murder of Kercher. She spent nearly four years in an Italian prison after she and then-boyfriend, Raffaele Sollecito, were initially convicted of murder in 2009, a ruling that was overturned in 2011. She was again convicted of murder in 2014, after which the country’s highest court definitively acquitted her and Sollecito of murder in 2015. Rudy Hermann Guede was convicted and served 13 years for the murder; he was released in 2021.

Knox was re-convicted in Florence for wrongly accusing Patrick Lumumba, a Congolese bar owner she had been working for part-time in Perugia at the time of Kercher’s killing; however, she will not serve more jail time in Italy as her new three-year sentence has already been satisfied by time she served on the reversed murder conviction.

The European Court of Human Rights had ruled in 2019 that Italian law enforcement violated Knox’s rights during questioning, which led to Italy throwing out her slander conviction. The country’s supreme court then asked the Florence court to begin a new trial to decide whether there had been slander in the note.

Knox was accompanied by her husband, Christopher Robinson, with whom she shares two children, in court. The court said Knox would have to pay the legal fees of and damages to Lumumba, the sum of which is said to still to be determined.  Knox’s lawyers said she would appeal Wednesday’s ruling, and they have 45 days to file their appeal with Italy’s highest court, the Court of Cassation in Rome. That court only rules on whether a lower court’s ruling has been reached in line with legal procedures, however, not on the merits of any particular case. The Florence court was to publish the reasoning for its decision within 60 days.

Editorial credit: Alessia Pierdomenico / Shutterstock.com