Food & Drug Law Access
Insights and Analysis from Kelley Drye's International Food and Drug Law Practice
Senator Wyden Again Urges FDA to Clarify CBD Pathway; Agency Extends Comment Deadline and Issues New Communications
By Kristi Wolff & Lee Baumgardner on July 8, 2019
Posted in Cannabis, FDA
On June 25, 2019, Senator Ron Wyden (D-OR) issued a letter urging Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless to take action by addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Specifically, Senator Wyden requested that FDA issue guidance announcing a formal enforcement discretion policy by August 1, 2019 and, pending publication of a permanent final rule, issue an interim final rule that ensures a regulatory pathway for lawful use of CBD as a food additive and as a dietary ingredient in dietary supplements.
This is not the first time that Senator Wyden has urged FDA to move quickly on clarifying a non-drug pathway for CBD. Earlier this year, he co-authored a letter with fellow Democratic Oregon Senator Merkley that urged then-Commissioner Scott Gottlieb to "immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption, and sale of hemp products."
Senator Wyden's position focuses to a greater degree on the economic opportunity associated with CBD than the public health focus discussed in a recent House Appropriations Committee report. The Committee, charged with review of funding for FDA, emphasized public health and commitment to science, as follows:
"The Committee recognizes the FDA is considering a public regulatory process to evaluate the appropriateness, and possible parameters, of a regulatory pathway that would permit CBD in certain foods and dietary supplements. The Committee expects the FDA to assert its commitment to identifying lawful federal regulatory pathways for CBD foods and dietary supplements if such pathways are consistent with protection of the public health. . . . The Committee also expects the FDA to preserve the integrity of its drug development and approval processes, which ensures that products marketed for drug uses have undergone a rigorous scientific validation process demonstrating quality, safety and efficacy."
Although Senator Wyden stated that he "fully embrace[s] FDA's commitment to the promotion and protection of public health and understand[s] that, with respect to hemp-derived CBD, the agency will be examining a number of health and safety considerations," he made clear that "FDA's indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements [is] fully unacceptable."
Just a few days prior to publication of Sen. Wyden's letter, FDA announced that it was extending the public comment period regarding CBD issues to July 16 and issued two new communications (here and here) reiterating the agency's positions on CBD and highlighting areas of inquiry relative to a possible non-drug pathway. These include the following:
How much CBD is safe to consume in a day? How does it vary depending on what form it's taken?
Are there drug interactions that need to be monitored?
What are the impacts to special populations, like children, the elderly, and pregnant or lactating women?
What are the risks of long-term exposure?
In this same announcement, FDA emphasized that it is working in an "efficient and science-based" way and expressed a commitment to preserve incentives for drug-level research.
While FDA's course of action regarding CBD is uncertain, it seems clear that many in Congress will maintain pressure on the agency to provide the certainty that industry seeks to support the burgeoning hemp industry.
Kristi Wolff
Read more about Kristi Wolff
Lee Baumgardner
Read more about Lee Baumgardner
Podcast: CBD Warning Letters, FDA Commissioner Confirmation Hearing and Preview of Upcoming Webinar
FTC Issues Warning Letters to Companies Advertising Their CBD-Infused Products as Treatments for Serious Diseases
NY and Ohio: Recent Legal Changes Diverge on Whether CBD Can Be Added to Food
Court Requires Drug Enforcement Administration To Explain Why Only One US University Can Currently Source Cannabis
FDA Responds To Congressional Pressure To Speed Up CBD Review
RSS LinkedIn Twitter
Key Authors Show/Hide
Sarah Roller
Kelley Drye
Dana B. Rosenfeld
John E. Villafranco
Donnelly L. McDowell
Katie Townley
Carmen Hinebaugh
NMFS
Opioid Litigation
Product Labeling & Marketing
Archives Select Month December 2019 September 2019 August 2019 July 2019 June 2019 May 2019 April 2019 March 2019 February 2019 December 2018 October 2018 July 2018 June 2018 May 2018 April 2018 March 2018 February 2018 January 2018 December 2017 November 2017 October 2017 August 2017 July 2017 June 2017 May 2017 April 2017 March 2017 February 2017 December 2016 September 2016 August 2016 July 2016 June 2016 May 2016 March 2016 February 2016 December 2015 November 2015 August 2015 July 2015 June 2015 February 2015 January 2015 December 2014 October 2014 August 2014 July 2014 April 2014 March 2014 February 2014 January 2014 December 2013 November 2013 October 2013 September 2013 August 2013 July 2013 June 2013 May 2013 April 2013 March 2013 February 2013 January 2013 December 2012 November 2012 October 2012 September 2012 August 2012 July 2012 June 2012 May 2012 April 2012 March 2012 February 2012 January 2012 December 2011 November 2011 October 2011 August 2011 July 2011 June 2011 May 2011 March 2011 February 2011 November 2010 October 2010 September 2010 August 2010 July 2010 June 2010 May 2010 April 2010 March 2010
Follow Kelley Drye
Privacy PolicyDisclaimerTerms of UseAttorney Advertising
About Our Practice Group
Kelley Drye's food and drug team is experienced in the full spectrum of regulatory and legal risk management issues that food and drug companies must navigate to comply with Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Federal Trade Commission (FTC) requirements, and be successful in the U.S. marketplace.
Kelley Drye Blogs
Kelley Green Law
Labor Days
On Competition Law & Economics
Trade and Manufacturing Monitor
Ad Law Access
Bankruptcy Law Insights
Cannabis Law Update
CommLaw Monitor
Food and Drug Law Access
Copyright © 2020, Kelley Drye & Warren LLP. This website contains attorney advertising. Prior results do not guarantee a similar outcome.