NY and Ohio: Recent Legal Changes Diverge on Whether CBD Can Be Added to Food

We’ve written a lot about FDA’s current position on CBD in food and the ongoing process to evaluate a potential non-drug pathway for the ingredient that emerged seemingly out of nowhere to capture the attention of consumers, legislators, and regulators alike.  While we all wait for FDA to announce an update to its review, states continue to push forward… in seemingly divergent directions.

On July 19, 2019, New York State’s Department of Agriculture and Markets (the “Department”) issued a letter clarifying its position on the inclusion of cannabidiol (CBD) in food products.  The Department plainly stated, “No food or beverage product may be made or sold in New York State if it contains CBD as a food, a food additive or an ingredient.”  The Department also warned that any food or beverage products found to contain CBD are considered adulterated and subject to enforcement actions that may include (1) voluntary removal of products, (2) seizure and/or destruction of products, or (3) issuance of a fine and/or a failing sanitary inspection.   The letter is apparently intended to clarify whether New York City’s ban on CBD in foods applies to the rest of the state.  The question now is to what degree the Department’s position will be enforced.

Conversely, on July 30, 2019, Ohio Governor Mike DeWine signed into law Senate Bill 57 to legalize hemp and hemp-derived CBD oil.  Under the new law, individuals in Ohio may possess, buy, or sell “hemp” or a “hemp product” without a license.  A “hemp product” includes dietary supplements or food intended for animal or human consumption, among other items.  The law also clarifies that the “addition of hemp or a hemp product to any other product does not adulterate that other product.”  While Ohio’s position is in contrast with FDA’s (and that of other states), a number of states expressly allow CBD in foods and in dietary supplements per their state laws.

For companies marketing or selling CBD in any product, the lesson is this:  While there is continuing uncertainty regarding CBD’s non-drug pathway at the federal level, the states (and even some cities) remain an evolving patchwork.  Prior to marketing, state by state and product by product analysis may be necessary to fully understand the risks.

Court Requires Drug Enforcement Administration To Explain Why Only One US University Can Currently Source Cannabis

As readers of this blog already may know, the Drug Enforcement Administration (DEA) currently allows cannabis – consisting of the marijuana plant, with greater than 0.3% THC content – to be grown for research purposes at only one location: The University of Mississippi. This past June, the Scottsdale Research Institute (SRI) challenged this federally-imposed limitation in court.  SRI filed a Petition with the D.C. Circuit – the appellate court often charged with reviewing federal agency policies – arguing that the DEA’s limitations are arbitrary and capricious, and that additional facilities and universities should be allowed to grow the cannabis plant for study.

The D.C. Circuit had the authority to deny SRI’s Petition outright.  Instead, on July 29, the D.C. Circuit Court issued an Order requiring the DEA to file a response to SRI’s Petition.  The DEA must respond to the Petition by August 29. The D.C. Circuit’s Order highlights that the Court likely thinks the DEA’s position, limiting cannabis research to a single university, is at least arguably arbitrary and capricious.

If the D.C. Circuit does in fact require the DEA to broaden the sourcing of cannabis for research purposes in the United States, the effects of such a ruling would be vast.  At this time, because cannabis for all intents and purposes cannot be legally grown in the United States (at least on the federal level), much of the hype around the health benefits and liabilities of cannabis is either anecdotal or comes from abroad.  Administrative agencies such as the Food and Drug Administration often cite the lack of peer-reviewed studies as a reason to prevent cannabis – and related products which are currently legal to produce federally, such as hemp-derived CBD – from being more widely used and ingested.  Allowing more comprehensive sourcing of the cannabis plant to move forward would likely do much to remove this administrative hurdle.

 

FDA Responds To Congressional Pressure To Speed Up CBD Review

Last week, FDA Principal Deputy Commissioner and Acting Chief Information Officer Dr. Amy Abernethy released a series of tweets indicating that the agency is “expediting” its work towards addressing the confusion and uncertainty surrounding the regulation of hemp-derived CBD. Dr. Abernethy also stated that FDA plans to report on the agency’s progress around the end of summer or early fall.

As we have discussed before, FDA has been receiving pressure from Senator Ron Wyden (D-OR), among other members of Congress, to clarify a regulatory pathway for CBD.  Senator Wyden’s position focuses  on the economic opportunity associated with CBD, stating 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.”

Senate Majority Leader Mitch McConnell (R-KY) has also exerted pressure on FDA to move quickly. “Congress’s intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement,” McConnell said in a statement.

On the House side, the House Appropriations Committee passed a measure that allocates $100,000 to FDA to evaluate and set a safe level for conventional foods and dietary supplements containing CBD.

And finally, today is the deadline to submit comments to FDA’s public docket on CBD.  With over 3800 comments received thus far and stakeholder pressure mounting, one thing appears certain:  FDA is facing a hot – and busy – rest of the summer.

 

Senator Wyden Again Urges FDA to Clarify CBD Pathway; Agency Extends Comment Deadline and Issues New Communications

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.

Court Rules Indian Tribe Cannot Regulate Hemp Production (Yet)

As we’ve written about several times, the 2018 Farm Bill legalized hemp but specified that it must be done pursuant to a state or tribal plan, known as a 279B plan. Such a plan is not effective until approved by the Secretary of Agriculture. The USDA has not yet issued its own hemp plan, and has stated that it will not approve any state or Indian tribe’s plan until after it issues its own. This conundrum places states and Indian tribes who currently wish to allow the production of hemp (but who have not established a plan per the 2014 Farm Bill) in a precarious position.

The tension between participating in the rapidly-growing hemp marketplace and the slow pace of the administrative rulemaking process was brought to the fore in a recent case filed by the Flandreau Santee Sioux Tribe (the “Tribe”) in United States District Court in South Dakota, Flandreau Santee Sioux Tribe v. United States Dep’t of Agric., Case No. 19-cv-04094. In that case, the Tribe argued that the USDA was preventing the lawful production of hemp on the Tribe’s lands. The Tribe had submitted a plan for approval to the USDA on February 29, 2019. In response, on March 19 USDA Secretary Purdue wrote that he would neither approve or deny the plan until after the USDA issued its own hemp regulations – which could be a matter of months, or even years. The Tribe sued, arguing that the USDA should be enjoined from preventing it from lawfully producing hemp. The Tribe requested that the Court issue a preliminary injunction, forcing Secretary Purdue to accept or deny the Tribe’s hemp plan.

On June 6, 2019, the Federal District Court denied the Tribe’s request. In doing so, the Court concluded that the Farm Bill…

“provides exclusive authority to the Secretary to issue rules and regulations that relate to the implementation of 7 U.S.C. § 1639p, the same section under which the Tribe seeks to produce hemp. A harmonious reading of the statute lends to the likelihood that the 60 day window to approve or deny a plan does not begin until regulations are promulgated by the USDA.”

While the Court also found that the Tribe would suffer irreparable harm if it were not allowed to produce hemp under its own plan, the Court concluded that this result was outweighed by the fact that – in the Court’s opinion – the Tribe would not likely succeed on the merits.

Why does this matter? The USDA’s decision not to approve or deny the Tribe’s plan and the Court’s denial of the request for preliminary injunction underscores the uncertainty prevalent relative to the practical application of the 2018 Farm Bill. It also amplifies questions about the degree to which other states or tribes seeking to harmonize their laws with federal policy may face obstacles that limit their participation in this rapidly-expanding marketplace, at least in the short term.

USDA Legal Opinion Seeks To Clarify Interstate Transport of Hemp

On May 28, 2019, the United States Department of Agriculture’s (“USDA”) Office of the General Counsel issued a Legal Opinion, which attempts to address open questions relating to interstate transport of hemp. While the 2018 Farm Bill legalized hemp production, the current state of the law as to whether it is legal to transport hemp through states that do not currently allow the production or sale of hemp is unclear. We recently published an article describing this very issue and analyzing the conflicting case law stemming from the 2018 Farm Bill.

The USDA’s Legal Opinion made the following three pertinent conclusions:

1. As of the enactment of the 2018 Farm Bill, hemp is no longer a schedule 1 drug under schedule I of the Controlled Substances Act. Hemp and is therefore no longer a controlled substance.

2. After USDA publishes regulations implementing the new hemp production provisions of the 2018 Farm Bill, states and Indian tribes may no longer prohibit the interstate transport of hemp lawfully produced under a state or tribal plan or under a license issued under the USDA’s plans.

3. Currently, states and Indian tribes may not prohibit the interstate transport or shipment of hemp lawfully produced under the 2014 Farm Bill.

USDA’s opinion that de-scheduling is self-executing is notable and the agency goes to some length to ensure its position is clear and explain its rationale. The Legal Opinion states, in part:

“It is important to note that this decontrolling of hemp (and THC in hemp) is self-executing. Although the CSA implementing regulations must be updated to reflect the 2018 Farm Bill amendments to the CSA, neither the publication of those updated regulations nor any other action is necessary to execute this removal.”

USDA then goes through the primary objections to this position and explains why they are invalid. The first objection is that rulemaking is required to modify the CSA. To that, USDA responds that rulemaking is not required. Congress has authority to amend the CSA and has done so several times. The second objection is that because the change is not yet reflected in the regulations, 21 C.F.R. § 1308.11, the change is not effective. USDA argues that where Congress amends the schedules to add or remove a controlled substance, that change is effective immediately upon enactment.

Regarding transport specifically, as discussed in our article, there is conflicting case law regarding whether hemp produced pursuant to the 2014 Farm Bill provides an adequate safe harbor allowing the interstate transport of that hemp, notwithstanding any state law prohibiting hemp’s transport or sale. It has been addressed by district courts in California and West Virginia, both of which held that the transport in question was allowed. The issue is before the Ninth Circuit currently and is likely to be decided this Fall.

In the meantime, the USDA’s Legal Opinion provides some much needed clarity as to the agency’s position, allowing the interstate transport of hemp produced pursuant to the 2014 Farm Bill. The Legal Opinion confirms the USDA’s position that while states and Indian tribes will still be able to regulate the production of hemp in their jurisdictions, they are preempted from regulating the interstate transport of hemp produced in accordance with either the 2014 Farm Bill or the 2018 Farm Bill. While courts will not necessarily follow the USDA’s Legal Opinion – and are not beholden to it – it is certainly important dicta that courts should and likely will pay attention to when dealing with the issue of the interstate transport of hemp in the coming months.

Five Key Takeaways From FDA’s CBD Public Meeting

With CBD projected to be a $450 Million industry in the coming year, FDA hosted a packed house of industry stakeholders last week in a day-long public meeting that was the kickoff of a discussion to determine whether there is a pathway for CBD in ingestible products such as foods and dietary supplements.  See our summary of key themes here and check out this podcast episode to hear five key takeaways. 

House Appropriations Committee Cautions FDA To Focus on Public Health and Preserve Clinical Study Incentives As It Examines CBD Pathways

Earlier this week, the House Appropriations Committee approved the fiscal year 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies bill by a vote of 29 to 21. The committee report accompanying the bill included notable language on CBD.  Specifically, it expressed concern regarding potential safety issues such as drug interactions, somnolence, liver toxicity, the presence of THC or other compounds, and aggressive health benefit claims.  These were among the many issues discussed at FDA’s May 31 public meeting.

The report urges the agency to focus on public health and, should there be a non-drug pathway for CBD, to preserve the incentives to invest in drug-level research. It states in part:

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. Such pathways may include necessary public health and safety parameters that will protect the public health, such as labeling requirements and limits on CBD or other cannabis-derived ingredients in products, based upon anticipated total exposure levels. 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. It is also imperative that any FDA regulation of foods and dietary supplements containing CBD or other cannabis-derived ingredients preserve incentives to invest in robust clinical study of cannabis, so its therapeutic value can be more fully understood.

This position from the House Appropriations Committee stands in contrast to other Congressional pressure on FDA regarding CBD. Specifically in a January 2019 letter, Sens. Wyden and Merkley, both Democrats from Oregon, 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.”  The letter demanded that FDA answer questions regarding whether food and dietary supplement pathways were available for hemp products, even though FDA had recently announced three GRAS affirmations on hemp ingredients and re-stated its public position regarding CBD.

What’s the takeaway? The House Appropriations Committee, charged with review of funding for FDA, wants public health and rigorous clinical evaluation to be the top priorities.  Meanwhile, as evidenced by Sens. Wyden and Merkley (among many others), consumers are clamoring for CBD and U.S. businesses are fearful of losing opportunity.  Given that FDA has acknowledged that the administrative notice and comment process may not be the most efficient way to address CBD pathways, we shall see whether the agency can strike a balance between the call for regulation that protects and informs consumers and the business community’s fear of missing out.

FDA CBD Public Meeting Features Overwhelming Calls For Robust Regulation and Enforcement; Relaxation of Obstacles to Research

FDA’s CBD Public Meeting featured a full house of manufacturers, researchers, health professionals, trade association representatives, and other stakeholders.  Each speaker was given a few minutes to offer their input in response to FDA’s call for submissions relating to health and safety risks; manufacturing and product quality; and  marketing, labeling, and sales.  Here are key themes and highlights:

  • Opening Remarks:  Acting FDA Commissioner Ned Sharpless opened the meeting by acknowledging the “explosion” of consumer interest and the complexity of the task that FDA faces given hemp’s long prohibition:  “When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety,” he noted.  He also responded to Congressional and stakeholder pressure to explore a pathway for CBD in foods and dietary supplements by noting that the agency has a high-level working group focused on the issue.
  • Regulatory Structure:  Per the Natural Products Association, approximately 1500 new CBD products have been introduced over the last three years.  Overwhelmingly, manufacturers and trade association representatives called on FDA to provide a predictable pathway to market, in large part by enforcing existing laws relating to product categories, such as DSHEA.  Multiple speakers discussed the history of hemp in the diet as the basis for treatment of hemp extracts as a safe dietary ingredient, with some acknowledging that CBD isolate could be continued to be regulated as a drug.  In addition, there were many calls to enforce quality standards such as GMPs, identity testing, product testing for contaminants, labeling requirements, and adverse event reporting.

The three to five year timeframe that FDA previously referenced for a potential new regulation was a significant concern to many stakeholders.  Several speakers called on FDA to issue guidance as it explores a potential pathway for CBD in foods.  One speaker, Douglas MacKay of CV Sciences, encouraged FDA to create a “lane” for different product categories, i.e., drugs, foods, dietary supplements, based on dosages and intended use, using omega-3s as an example of an ingredient that currently exists in similar “lanes.”

  • Consumer Use and Understanding:  Lisa Gill from Consumer Reports presented consumer survey data with several interesting findings, including the following:  26% of U.S. consumers have used CBD.  Of these, edibles are the most commonly used.

Consumers are most likely to obtain CBD from a cannabis dispensary.

And – perhaps most interesting from a public health perspective – many consumers replace OTC or Rx medications with CBD and are strongly of the opinion that it is effective.

  • Marketing and Labeling:  Many speakers expressed concern over aggressive product claims, questionable manufacturing and testing practices, and adulteration with not just THC but other contaminants.  Several speakers presented data based on product sampling and testing of CBD content, THC content, contaminants such as lead, pesticides, etc.  Generally speaking, the takeaway was that CBD products feature highly variable potency and contamination levels.  Two speakers who had conducted separate product surveys each found just one product that featured 100% of the amount of CBD listed on the label.  Others contained no CBD and some contained multiples of the label claim.  In addition, in one survey, 45% of products tested contained THC, although amounts detected were not indicated in the results presented.

  • Health and Safety Risks:  The World Health Organization report regarding CBD was cited by several speakers as support for the general safety and lack of evidence of addictive properties.  However, key concerns noted included limited understanding of potential drug interactions between CBD and other medications and, in particular, the dose/effect relationship between such interactions.  GW Pharmaceuticals and academic researchers acknowledged the potential for CBD-associated liver damage discovered during the Epidiolex trials and other studies.  Other speakers encouraged FDA to review data gathered from state medical marijuana programs (some of which include CBD products) relating to adverse events and drug interactions.  The effect of cumulative exposure from several product types was also cited as an area requiring further research.
  • Research Restrictions:  Researchers from several universities throughout the countries as well as practitioners of several specialties presented findings based on clinical studies and patient treatment with CBD and medical marijuana.  While their interests varied, they universally supported more research into the safety and efficacy of CBD and expressed concern about their ability to access market-grade product for research.  In particular, they cited restrictions relating to DEA scheduling, DEA’s delay in issuing cannabis permits, the inferior quality of cannabis (marijuana) that is obtainable from the U of Mississippi (the only federally-sanctioned site for cultivation), the IRB process, and related gating steps that are required for clinical studies as barriers to pursuing research.

*                            *                            *

Throughout the day, FDA panelists asked a variety of questions such as what the speakers believed are the health benefits of CBD, what support they have for that conclusion, the number of new manufacturers who have entered the CBD market over the last few years and the degree to which they are following GMPs, and the body of evidence relating to food producing animals and pet products generally.

As expected, the meeting was largely a listening exercise and the first step in a deliberative process.  Comments can be filed until July 2.

California Bill to Allow Hemp-Derived CBD in Foods, Beverages, and Cosmetics

Assembly Bill 228 is a promising piece of legislation that could soon bring an end to California’s prohibition on adding hemp-derived CBD to foods, beverages, and cosmetics.  The bill, in its current form, would add two provisions to the California Health and Safety Code clarifying that food, beverages, and cosmetics are “not adulterated by the inclusion of industrial hemp, as defined in Section 11018.5, or cannabinoids, extracts, or derivatives from industrial hemp.”  The provisions would further provide that such items “that include industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp shall not be restricted or prohibited based solely on the inclusion of industrial hemp or cannabinoids, extracts, or derivatives from industrial hemp.”

AB 228 stands in direct contrast to the California Department of Public Health’s (“CDPH”) current policies.  As we wrote about here, in July 2018, CDPH released a set of FAQs that included a summary of the agency’s position on CBD being added to foods:

Until [1] the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or [2] California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.

Neither of these thresholds have been met: The FDA’s position is still that hemp-derived CBD cannot be used as a food, and AB 228, as amended, does not explicitly state that hemp-derived CBD products are safe to use for human and animal consumption.  Further, the CA bill does not list dosage thresholds for use in any product.

Despite this official position, CDPH’s FAQ is not law, and it has not been systematically enforced.  While hemp CBD products are widely available in California, passage of AB 228 seems likely to expand that state’s market even further by clarifying and sanctioning a pathway to market.  While FDA retains jurisdiction over foods transported in interstate commerce, the size of California’s economy and the number of states that currently allow CBD in foods is pushing toward critical mass and geographic distribution, potentially making FDA’s role in regulating this issue even more complex.

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