FDA Moving Forward on a Regulatory Pathway for CBD and Seeking Guidance from Industry

Apr 15, 2019

Opportunity for Greenspoon Marder Clients to Testify at FDA Hearing or Submit Written Comments to Inform FDA on Key Issues for Establishing CBD Regulations

FDA has been moving, since the December 20, 2018 passage of the 2018 Farm Bill, toward the full legal recognition of hemp-derived CBD as a food additive and dietary supplement and recently announced that it will be holding a public hearing on products, such as hemp derived CBD, on May 31, 2019, from 8 a.m. to 6 p.m. FDA is currently accepting requests for presentations during the public hearing and is accepting written comments through July 2, 2019.

This is a critical opportunity to inform FDA before it issues regulations or moves forward to regulate CBD. The hearing will be a major gathering of CBD companies in the Washington DC area to testify for a full day at FDA headquarters before a panel of high-level FDA officials.

The public hearing will give stakeholders an opportunity to provide the agency with additional input relevant to its regulatory strategy related to existing products, as well as the lawful pathways by which products can be marketed, and how FDA can make these legal pathways more predictable and efficient.

This hearing and comment period provide you the opportunity to present information and explain why FDA should move forward to allow CBD products to exist in the marketplace as food and supplements alongside CBD drugs such as Epidiolex. FDA must be convinced that responsible manufacturers are ready to work with FDA to allow this innovative industry to flourish while producing a safe product.

FDA has requested information relating to the safety, manufacture, and marketing/labeling of product including hemp-derived CBD:

How are such products manufactured; and are standards, processes, validation and testing needed to address safety and quality issues involved in manufacturing and processing such products?
Are there standardized definitions used for ingredients in such products and would standardized definitions be helpful?
What are the functional purposes of adding hemp-derived compounds, such as CBD, to foods (e.g., nutritive value; technical effect) both in terms of manufacturer intent and consumer perceptions?
What risks should consumers be informed about, and how should consumers be informed of such risks?
What other information should FDA consider in the labeling of specific product categories?

For further information or to discuss your comments or testimony, contact Jessica Wasserman at [email protected], or your Greenspoon Marder attorney.

About Greenspoon Marder

Greenspoon Marder LLP is a full-service law firm with over 225 attorneys and more than 20 office locations across the United States. With operations from Miami to New York and from Denver to Los Angeles, our firm attracts some of the nation’s top talent in key markets and innovation hubs. Our core practice areas include Real Estate, Litigation, and Transactional Services, complemented by the capabilities of a full-service firm. Greenspoon Marder has maintained a spot on The American Lawyer’s Am Law 200 as one of the top law firms in the U.S. since 2015, and our goal is to provide exceptional client service by developing a thorough understanding of each client’s business needs and objectives in order to provide strategic, cost-effective solutions.

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This Greenspoon Marder LLP Client Alert is issued for informational purposes only and is not intended to be construed or used as general legal advice nor a solicitation of any type. Please contact the author(s) or your Greenspoon Marder LLP contact if you have any questions regarding the currency of this information. The hiring of a lawyer is an important decision. Before you decide, ask for written information about the lawyer’s legal qualifications and experience.

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FDA Moving Forward on a Regulatory Pathway for CBD and Seeking Guidance from Industry

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