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Thuy Vu
Director of Operations, Regulatory Affairs, & Business Development at Hammer Enterprises Integrated Solutions
+ 5 speakers
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CBD Expo MOUNTAIN 2019
October 12, 2019, Denver, USA
CBD Expo MOUNTAIN 2019
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CBD Expo MOUNTAIN 2019
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CBD Expo MOUNTAIN 2019
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Understand “The Man”: Food & Drug Compliance And Federal Enforcement
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About the talk

Fighting the authorities can be a struggle. Although long held rules and regulations on CBD and other cannabinoids are rapidly changing, it still pays to pick your battles and know your rights. One wrong move in your CBD companies manufacturing process or production line can have the authorities breathing down your back, imposing huge fines at best and shutting your business down altogether in a worst case scenario. Don’t let this happen to you. Understand “The Man” and why it pays to follow the rules with this panel aimed at taking the crosshairs off of your business with a look at the requirements, processes and protocols to stay in good standing with the FDA and other federal enforcement.

00:20 Introduction

02:47 What is “The Man”?

12:05 Dangerous claims in cultivation and manufacturing

27:45 A piece of advice on how to be successful in the industry

38:32 Q&A

About speakers

Thuy Vu
Director of Operations, Regulatory Affairs, & Business Development at Hammer Enterprises Integrated Solutions
Jennifer Lott
Technical Director Pharmaceuticals, Cosmetics, and Personal Care at SGS North America
Dylan Sheji
Legal Team Manager at CannaRegs
Jonathan Havens
Partner and Co-Chair at Cannabis Law Practice
Julie Herzog
Managing Partner at Fortis Law Partners
Neil Butterfield
President and Founder at Mineralife Nutraceuticals LLC

Thuy serves as the Director of Operations and Regulatory Affairs for Hammer Enterprises LLC, one of the largest vertically integrated, ISO 9001:2015 accredited, USDA Organic Certified industrial hemp companies in Colorado and is the first and only cannabis company to be awarded the Colorado Department of Public Health and Environment’s (CDPHE) Environmental Leadership Program (ELP) Achievement Award since 2018. Hammer Enterprises is a custom white label manufacturer offering full-spectrum hemp oil, CBD isolate, concentrates, vapes, tinctures, soft gels, topicals, and edibles. Hammer Enterprises is committed to strict quality control guidelines, ethical standards, and high integrity to deliver pesticide-free, chemical-free, and preservative-free products. Hammer Enterprises is devoted to setting the standard in the industry, promoting public health, public safety, and environmental stewardship.

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Jennifer Lott is the Technical Manager at SGS North America supporting the quality, integrity and efficacy of cannabis, cosmetic, personal care, pharmaceutical and food products and its supply chain. Her expertise includes Regulatory Requirements GMP, GDP, ISO 22716, ISO 9001, GFSI. As an accredited Lead Auditor and Trainer with over 25 years’ experience in quality and safety management system development, consulting, packaging and laboratory management, Her passion for cosmetics, pharma and food industries drives her commitment to excellence and attention to detail.

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As the Legal Team Manager at CannaRegs, Dylan Sheji, Esq. manages the full team of legal research attorneys and analysts responsible for the constantly-updated content in the CannaRegs platform. After attaining his undergraduate degree at Georgetown University, he attended law school at the University of Colorado, Boulder, where he focused on topics related to cannabis law and interned with several cannabis law firms. Upon earning his JD and passing the Bar Exam, Dylan immediately joined the CannaRegs team as a legal research analyst in 2017, where he quickly emerged as a leader and was promoted to Legal Team Manager. Dylan has hosted several webinars on topics related to cannabis and hemp, from in-depth looks at state-specific systems to general issues and concerns that affect the hemp industry.

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Jonathan Havens’s practice focuses primarily on regulatory, compliance, enforcement, and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), and myriad state and local agencies. He counsels state cannabis and hemp license applicants and awardees, ancillary service and product providers, investors, management companies, and various other entities that are affected by federal and state marijuana laws, such as long-term care facilities and higher education institutions. Jonathan is co-chair of the Cannabis Law Practice at Saul Ewing Arnstein & Lehr LLP. He also serves as vice chair of the firm’s Food and Beverage Practice and is a member of the firm’s Life Sciences Practice. Jonathan’s unique perspective on cannabis regulation is informed by his congressional, federal agency, and national and international law firm experience. Prior to entering private practice, Jonathan served as a regulatory counsel with FDA, where he focused on compliance and enforcement related to promotion, advertising, and labeling. Prior to law school, Jonathan was a legislative aide in both the U.S. Senate and U.S. House of Representatives.

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As head of the corporate/securities practice, Julie Herzog handles a wide variety of corporate, securities and merger and acquisition transactions. She has handled transactions valued at over $4 billion for major public companies and investment banks and enjoys working with a diverse clientele ranging from Fortune 100 corporations to startups, family offices, and venture capital and private equity funds. In the last six years, Julie negotiated and closed over 75 transactions valued at over $1.5 billion on behalf of our clients. Her clients represent a variety of industry sectors, including hemp/cannabis, energy, health care, technology, manufacturing, real estate, food and beverage, business consulting and other services. She has counseled several hundred companies from inception through initial public offerings or successful sales.

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Today, Mineralife Nutraceuticals into a full service cGMP manufacturer offering custom dietary supplement and topical product manufacturing, white label and private label products, copackaging, and a retail product portfolio of liquid ionic mineral supplements, at-home mineral hair analysis test kits, immune enhancing capsules, and CBD based products available in 36 countries.

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Started with Jonathan Havens, I'm a Food and Drug Attorney head up the Cannabis Law Practice We are a 400-person 16 office firm in the country been practicing in space for quite a bit of time before Private Practice. I was Regulatory Attorney at the US Food and Drug Administration. Good morning. Everybody will get off to noon. I'm Neil Butterfield. I'm the Owner and Founder of a company called Mineralife Nutraceuticals here in Colorado Springs. I am a nutraceutical company that manufactures vitamins and minerals. But

now we're also in the CBD space operating their we are in an FDA order to facility and you know, I'm a brand company that started in the basement. I'm about to short 15 years ago. So I really have a pretty broad understanding of what it takes to bootstrap a company from concept to a full manufacturing facility that I have right now. So text me. Good afternoon. My name is Thuy Vu and I am the Director of Operations and Regulatory Affairs for Hammer Enterprises. We are a vertically integrated Industrial Hemp company located

here in Colorado. And we specialize in custom white label products as well as being a raw ingredients manufacturer prior to my stents in hemp. I worked in the marijuana space for a few years and prior to that. I was the Lead foodborne illness an outbreak investigator for the City and County of Denver as well as the first marijuana investigator for the City and County of Denver and the Beast on my experience. I

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Thuy Vu
Jennifer Lott
Dylan Sheji
Jonathan Havens
Julie Herzog
Neil Butterfield