United States: FDA Considering Changes To Regulation Of CBD Products

Michael J. Werner is a Partner and Sara M. Klock is an Associate in our Washington, D.C. office.

Highlights

  • With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed.
  • The FDA held a public hearing on May 31, 2019, to gather scientific data and information from various industry stakeholders and consumers about the safety, manufacturing, quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds.
  • FDA has made clear that it is considering how to appropriately regulate CBD products.

The U.S. Food and Drug Administration (FDA) held a nine-hour public hearing on May 31, 2019, to gather scientific data and information from approximately 140 stakeholders representing various industries as well as consumers about the safety, manufacturing, quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds. FDA has signaled it is considering modifications to its regulation of these products.

Representing FDA at the hearing were key FDA officials, including Deputy Commissioner Amy Abernethy and Lowell Schiller, who co-chair the FDA's CBD Working Group,1 as well as Sharon Mayl and Douglas Throckmorton, who sit on FDA's Marijuana Working Group. FDA Acting Commissioner Ned Sharpless opened the meeting and described the agency's commitment to moving quickly to develop a comprehensive regulatory framework to protect the public health.

As Holland & Knight has discussed previously, FDA has made clear that food and dietary supplements containing CBD, derived from any source, cannot be lawfully sold in the U.S. (See Holland & Knight Healthcare Blogs, " Hemp Is Now Legal, But What Does That Actually Mean?," Jan. 4, 2019, and " FDA Issues Statement on Cannabis Regulation and Announces Public Hearing," April 2, 2019.) FDA has particularly warned that it will institute enforcement proceedings against manufacturers making "egregious" claims about the health and disease treatment effects of such products. The FDA has taken recent enforcement against companies making disease claims selling food, supplements, oil and salve containing CBD.

Regulatory changes are likely. With the dramatic expansion of CBD products in the market, the FDA is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed. FDA is clearly considering what and how to appropriately and safely move forward, and FDA's questions to stakeholders at the public hearing offer insight into the agency's thinking. Four key issues discussed at the hearing were:

1. Unpredictability and nonuniformity of dosages and routes of administration raise safety concerns for FDA

FDA continually expressed concerns about the various routes of administration and unpredictable dosages of CBD in products. FDA asked questions regarding full spectrum, broad spectrum and isolate products, and what this labeling means. This concern was supported by toxicologists who pointed out that each route of administration (vape, oral, cream, etc.) has different effects on the body, and dosage among and between products –even those within the same product category – often vary. Exacerbating this problem, it was clear based on several studies presented that the labeling and public information about consumer products containing CBD is often inaccurate.

2. Potential harm to vulnerable populations (children, pregnant women, the elderly)

FDA is concerned about how vulnerable populations could be affected by CBD, and what it can do to prevent some vulnerable populations from being exposed to CBD (such as minor children) while reducing risks to other vulnerable populations taking CBD products.

3. Dietary supplements curbing drug development

FDA expressed its concerns with enacting a regulatory scheme that ensures the development and availability of safe dietary supplements containing CBD (with proper labeling, etc.) to meet the public demand, without stifling the development of prescription drug products containing CBD – that are already regulated to address many of FDA's concerns.

4. FDA wants to review more data on the safety and efficacy of CBD

Several stakeholders said that CBD has been "proven" to be safe. FDA consistently asked for the sources of that data. This is clearly of interest to FDA; the agency asked for all safety data to be submitted to the public docket for its review. Numerous stakeholders pledged to do so. Moreover, FDA asked dietary supplement manufacturers and distributors of CBD products what standard these stakeholders were using to test for heavy metals and pesticides in their products. FDA offered no guidance on what standards should be used.

While FDA has previously said it would provide guidance to the public on a new regulatory framework this summer, based on the hearing, this seems unlikely. Instead, FDA's views on how to regulate CBD in food, drugs and dietary supplements are likely to emerge in late summer or fall.

Companies interested in participating in the FDA's regulatory process or that may have questions, should feel free to contact the authors.


Footnotes

1 The CBD Working Group focuses on CBD from all sources, including from hemp


The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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