The DEA announced last week that it is placing certain drug products that have been approved by the FDA and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act. The action places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in Schedule V.

Schedule V

FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that sponsors of new drug applications may wish to consider to demonstrate the safety and effectiveness of nonprescription drugs.  In announcing the draft guidance, FDA Commissioner Scott Gottlieb explained that the agency sees an opportunity to “foster

Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of marijuana. Specifically, the Marijuana Freedom and Opportunity Act removes marijuana from the list of scheduled substances under the Controlled Substances Act, effectively decriminalizing it at the federal level.  Under the bill, states would continue to have individual authority to regulate marijuana but federal authorities would be able to prevent trafficking between states where the substance is legal to where it is not and to oversee advertising to the extent necessary to prevent targeting ads to children.  Co-sponsors include Senators Bernie Sanders (I-VT), Tim Kaine (D-VA) and Tammy Duckworth (D-IL).

Highlights of the proposed legislation, per the Fact Sheet, include the following:

  • Decriminalize Marijuana: The legislation would decriminalize marijuana at the federal level by descheduling it, which means removing marijuana from the list of scheduled substances under the U.S. Controlled Substances Act of 1970;
  • Respect States’ Rights: The legislation would maintain federal law enforcement’s authority to prevent marijuana trafficking from states that have legalized marijuana to those that have not;
  • Level The Economic Playing Field: The legislation would establish dedicated funding streams to be administered by the Small Business Administration (SBA) for women and minority-owned marijuana businesses that would be determinant on a reasonable estimate of the total amount of revenue generated by the marijuana industry;
  • Ensure Public Safety: The legislation would authorize $250 million over five years for targeted investments in highway safety research to ensure federal agencies have the resources they need to assess the pitfalls of driving under the influence of THC and develop technology to reliably measure impairment;
  • Invest In Public Health: The legislation would invest $500 million across five years for the Secretary of Health and Human Services to work in close coordination with the Director of National Institutes of Health (NIH) and the Commissioner of Food and Drug Administration (FDA) in order to better understand the impact of marijuana, including the effects of THC on the human brain and the efficacy of marijuana as a treatment for specific ailments;
  • Protect Children: The legislation would maintain the Department of Treasury’s authority to regulate marijuana advertising in the same way it does tobacco advertising to ensure the marijuana businesses aren’t allowed to target children in their advertisements. The bill also allows the agency to impose penalties in the case of violations;
  • Incentive sealing and Expungement programs: The legislation authorizes grant programs to encourage state and local governments to administer, adopt, or enhance expungement or sealing programs for marijuana possession convictions. The bill provides $100 million over five years to the DOJ to carry out this purpose.


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On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention.  The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals.  The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found in cannabis that is not considered psychoactive.  If approved, Epidiolex would have orphan drug status, meaning that it is marketed to treat rare diseases or conditions, in this instance rare forms of epilepsy.  FDA is not bound by the advisory committee recommendations, but often follows them.

With Epidiolex’s approval likely looming, one question is what the impact will be on the CBD dietary supplements currently on the market. FDA has made clear that it does not believe that CBD can be legally marketed as a dietary supplement because of GW Pharmaceuticals’ initiation of investigational new drug applications for its products prior to CBD being marketed as a supplement.  Further, FDA has issued numerous warning letters relative to CBD labeled as dietary supplements but that contain little or no actual CBD as well as those that feature express disease treatment claims.  Will the approval of Epidiolex impact those CBD products currently sold as supplements?
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As the gravitational pull toward marijuana legalization continues, new sources of revenue continue to emerge. Former Republican House Speaker John Boehner (and former opponent of legalization) recently announced that he joined the board of directors for a cannabis company, and sales of cannabis in California are expected to exceed $3.5 billion in 2018 and to surpass the $5 billion mark in 2019.  As a result, media outlets stand to gain substantial sums in advertising revenue for all the newly-licensed state legal businesses.  But before placing any advertisement, companies need to consider the rarely-used but newly-relevant provision of federal criminal law that addresses advertising.

Although seldom used in federal criminal prosecutions, a provision of the Controlled Substances Act prohibits placing advertisements for marijuana and other Schedule I substances. 21 U.S.C. § 843(c)(1).  Specifically, this provision makes it “unlawful for any person to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or distribute a Schedule I controlled substance.” 21 U.S.C. § 843(c)(1).  So does that mean no one can run advertisements?  No, but it means that advertisements need to be approached with caution. 
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On Monday, President Trump delivered an opioid speech in New Hampshire in which he promised to get tough on opioid investigation and enforcement. This follows on the Department of Justice’s (“DOJ”) prior assertion that it will strengthen its efforts against pharmaceutical industry members.

On February 27, 2018, the DOJ announced the creation of a

Ohio Judge Dan A. Polster, who is handling the multi-district opioid litigation proceedings, is taking a very active hand in the management of the proceedings before him, the New York Times reports.  His methods are unorthodox: calling for minimal discovery, rapid settlement (if possible), and real-world solutions to “clean up this mess.”  Judge Polster’s

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug Marketing Act. As prescription drug companies have increased their direct-to-consumer outreach through social media, native advertising, and health information platforms, questions have arisen as to the role that the NAD might play in regulating these advertisements.  For those who are unfamiliar, the NAD is the National Advertising Division of the Better Business Bureau.  It is an industry self-regulatory body that is charged with hearing and rendering decisions in advertising disputes, typically among competitors.  It is commonly used amongst advertisers of consumer-directed products and services.  It is not commonly used amongst prescription drug advertisers and, until recently, many likely assumed that NAD did not have jurisdiction to hear prescription drug advertising challenges.

A relatively recent NAD decision makes clear that that body believes that it has jurisdiction over prescription product advertising, however. Late last year, the NAD evaluated advertising by Synergy Pharmaceuticals for its Trulance product, which is prescribed for chronic idiopathic constipation.  Allergan, maker of a competing product, challenged the advertising on the basis that it included false implied superiority claims, expressly false superiority claims, and undisclosed native advertising in the form of a waiting room pamphlet that allegedly was positioned as independent and impartial patient education material. 
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The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act.  In addition to the 11 joint warning letters

Timed almost to the day that California legalized recreational marijuana, Attorney General Jeff Sessions announced on Thursday, January 4, that the Department of Justice has rescinded the Obama-era guidance (the Cole Memo) issued to federal prosecutors relative to marijuana enforcement. The announcement characterizes the move as an effort to restore prosecutorial discretion, noting that the