Hemp, Hemp-Derived Cannabinoids and Other Natural Products

Hemp businesses encounter a distinct set of challenges and opportunities within the greater cannabis industry. The 2018 Farm Bill’s provisions have stimulated significant growth in the hemp industry, yet the regulatory environment remains complex and challenging. Our holistic approach addresses both immediate regulatory and compliance issues while also focusing on long-term strategies. We are committed to understanding our clients’ products and business objectives, allowing us to provide tailored solutions that foster success and growth in a regulatory environment that continues to evolve.

CBD, the prominent non-psychoactive cannabinoid found in hemp, has gained significant commercial and medical interest. Despite its popularity, it is subject to rigorous regulation, with the FDA maintaining strict control over its use in food and dietary supplements. The legal landscape is further complicated by the emergence of other cannabinoids such as delta-8-THC, hemp-derived delta-9 THC, and THCa, all of which possess psychoactive properties. With regulatory agencies, state legislatures, and the U.S. Congress moving to address regulatory loopholes on hemp-derived cannabinoids, businesses must stay informed and adaptive to remain compliant and competitive.

Additionally, numerous less common or “exotic” natural products have found their way into the food, beverage, and dietary supplement markets. These include Kava, Kratom, and exotic, non-hallucinogenic mushrooms such as Lion’s Mane, Chaga, and Amanita Muscaria. We help clients navigate with federal and state laws regulating the use of these exotic natural products in the stream of commerce.

At Asebey Life Science Law, our experience and expertise in handling these complexities ensures that our clients are well-prepared to meet all relevant laws and maximize their business opportunities in this evolving sector. We provide comprehensive legal support, helping our clients understand and meet regulatory requirements while positioning themselves for long-term success in the dynamic hemp, hemp-derived cannabinoid, and exotic natural product market.

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Services Provided

  • Regulatory opinions regarding state compliance for cannabinoid-containing products
  • Business transactional support including buy / sell, licensing, contract manufacturing / tolling, and distribution agreements
  • Label, website, and advertising reviews for state and federal compliance
  • FDA Warning Letter, Form 482, and state enforcement defense
  • FDA, FTC, DEA, and CBP enforcement defense
  • Regulatory compliance support for import of hemp and products containing hemp-derived cannabinoids
  • State and federal GMP compliance
  • Prepare clients for financing and M&A events

Representative Matters

  • Advised various hemp / CBD / hemp-derived cannabinoid companies on regulatory matters associated with the manufacturing / marketing of Delta-8 THC and THCa-containing products
  • Negotiated and drafted transactional documentation for various multimillion-dollar hemp biomass acquisitions
  • Defended a Kava-infused beverage company in a Prop 65 action
  • Guided CBD companies on state and federal regulatory compliance in the areas of agricultural production, grower’s state license, transportation, tolling, sale, and product / label claims of hemp and hemp-containing products
  • Assisted two CBD ventures in acquiring related companies to pursue vertical integration
  • Represented a South American cannabis / hemp company in acquiring extraction / distillation equipment from a distressed U.S. hemp / CBD venture
  • Represented a Kratom product / manufacturer in FDA and state of Florida enforcement action
  • Assisted a Chilean hemp company with federal and state regulatory compliance and CBP import compliance
  • Represented a hemp-derived cannabinoid beverage company with federal and state label and marketing compliance
  • Represented a manufacturer / marketer of Kava- and Kratom-infused beverages with state and federal label and advertising compliance

Tell us more about your regulatory needs so we can help you succeed.

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