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Draft Guidance on Medical Device Transition Period

In response to the COVID-19 Pandemic, the FDA took unprecedented action in transforming its enforcement because of the declaration of a Public Health Emergency while also issuing, and continuing, Emergency Use Authorizations. These governmental actions facilitated and increased the importation of necessary medical devices needed to combat the pandemic here in the United States. And now as the U.S. relaxes its pandemic protocol, the FDA is exploring the best way to have medical devices transition back to pre-pandemic regulations and protocol. On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. And to provide further assistance, the FDA hosted a webinar “Draft Guidances on Transition Plans for COVID-19 Related Medical Devices” providing further explanations to the trade community on what can be expected from the proposed transition plans.

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Essential Oils Company to Pay $760K for Lacey Act Violations

The Justice Department announced YOUNG LIVING ESSENTIAL OILS, L.C., (the Company), headquartered in Lehi, Utah, plead guilty in federal court to federal misdemeanor charges regarding its illegal trafficking of rosewood oil and spikenard oil in violation of the Lacey Act and the Endangered Species Act.

Despite the company voluntarily disclosing its violations and cooperating with government investigators, it entered into a plea agreement, and the Company was sentenced to a fine of $500,000, $135,000 in restitution, a community service payment of $125,000 for the conservation of protected species of plants used in essential oils, and a term of five years’ probation with special conditions. The conditions include the implementation of a corporate compliance plan, audits, and the publication of statements regarding its convictions.

“The importation of illegally harvested wood and timber products harms law-abiding American companies and workers and threatens forest resources around the world,” said Acting Assistant Attorney General Jeffrey H. Wood of the Environment and Natural Resources Division. “Our Division was proud to work alongside the U.S. Attorney’s Office in the District of Utah, the U.S. Department of Agriculture, the U.S. Fish and Wildlife Service, and the Department of Homeland Security to bring this case to a positive conclusion.”

“While the natural resource violations by certain employees of Young Living were intentional and substantial, the Company’s decision to conduct an internal investigation, voluntarily disclose the initial violations to government enforcement authorities, and cooperate throughout the ensuing investigation is to be […]

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