FDA Matters

From hemp seed or propagules, Robison Law hemps its clients comply with consistently evolving policies regulations, laws and enforcement practices at the local, state, U.S. federal and international levels. Food and dietary supplement law is a passion. What humans and animals consume and how we regulate it defines who we are. The Food and Drug administration has a history based on preventing the introduction of misbranded and adulterated food and dietary supplements into U.S. commerce.

Our clients are diverse in terms of location, both geographical and on the supply chain. We advise many of the most well known and recognized food, beverage and dietary supplement producers, manufacturers, and retailers, as well as first time entrepreneurs, start-ups, trade associations, and charitable organizations. Because we counsel many different cannabis (hemp and marijuana) stakeholders, we understand the issues and legal concerns facing this nascent industry. To be sure, the hemp industry is not ending neither is marijuana. They are just beginning. We are not cannabis lawyers, but are lawyers that know hemp and marijuana the how the legal evolution of these amazing plants fits into routine and complex commercial and corporate deals.

Legal issues with a nexus to the Food and Drug Administration and the Food Drug and Cosmetic Act are omnipresent, in both hemp and marijuana, and will continue to be unless there is an unprecedented legal and policy shift. Call Robison Law, a firm that works with the FDA regarding U.S. and international matters.

Our services regarding FDA Matters include:

  • Clinical Trial Agreements
  • ClinicalTrials.gov
  • Institutional Review Boards (IRBs)
  • Label Reviews
  • FDA Corrective Actions
  • Respond to Warning Letters
  • Observational Research with Cannabis (hemp and marijuana)
  • Sponsored Research Agreements


TRANSACTIONS

We have deep experience counseling on sophisticated transactional matters. Drawing on our expert knowledge of the cannabis industry, we advise clients from deal initiation through contract negotiation, review and drafting. Our core experience includes a wealth of work product on intellectual property and corporate deals.


COMPLIANCE

Cannabis is a highly regulated industry, with rapidly evolving federal and state rules touching every aspect of our clients’ business. We offer up-to-the-minute knowledge of those regulations and we provide legally sound and practical advice on how to ensure compliance. With the enactment of the 2018 Farm Bill, compliance related to hemp, CBD and other cannabinoids remains nuanced and critical to your success.


INVESTMENTS

Marijuana and hemp are growth industries that have attracted sophisticated investors, who require a detailed understanding of the field’s evolving legal framework before they commit financing. We counsel investors and prospective investors on the unique legal, financial, and tax issues that face cannabis businesses.