Shawn Hauser
Partner and Chair, Hemp & Cannabinoid Practice Group
Vicente Sederberg LLP
What does the FDA’s submission of draft guidance on CBD Enforcement Policy to the White House OMB mean for the sector?
It means the sector gets some kind of enforcement policy for CBD products under which certain hemp CBD companies would operate (still in violation of federal law in certain circumstances), while the FDA continues to consider a change in the law that ‘ t possible CBD products regulate as ingredients in food and dietary supplements.
While what the sector needs is a clear regulatory structure, a risk-based enforcement policy can provide companies with at least some necessary clarity in manufacturing and retail standards and additional enforcement by FDA that will help eliminate bad actors who benefit from it. current lack of enforcement.
This may be similar in form to the risk-based enforcement policy that the cannabis industry operates under (the 2013 Department of Justice Directive for Marijuana Enforcement aka “Cole Memo”) which in practice regulated state legal cannabis business (even after his dismissal) by former Attorney General Jeff Sessions) in that a federal agency would identify its enforcement priorities that would trigger its enforcement of federal law.
Based on FDA rulings, it is possible that this guidance could only be limited to certain product types and be quite restrictive, although leaving the sector in a very difficult position.
It is also possible that this enforcement manual affects the FDA’s ultimate approach to regulating CBD as an ingredient in consumer products.
What do you expect this to include and how long will it take for the sector to review the document?
I expect that we will see the document first as the fall, but it is certainly possible that the guidance will be delayed until next year, especially since we are at the presidential election.
The details and final release date for the guidance are unknown, but based on the FDA’s progress reports and explanations related to its ongoing CBD safety evaluation, I think we can expect the guidance to be in line with the agency’s primary safety concerns. and product quality standards, such as labeling, unlawful claims, high levels of THC, pesticides, and contaminants such as heavy metals.
It is also possible that FDA is treating standards for measuring THC content in various types of finished products, something the agency has addressed in its recent guidance on drugs on cannabis.
Given the FDA’s clear statements and concerns regarding the safety of CBD in food, it is possible that this guidance does not cover food or simply confirms its current ban.
Given the FDA statements so far, the sector has no reason to be optimistic about this guidance and should continue to concentrate on reforming the Food, Drug and Cosmetics Act.
What should the sector see from FDA? What will be in the perfect world in politics?
The sector needs a regulatory structure that regulates hemp CBD like other ingredients (that is, subject to the existing regulatory framework for food and dietary supplements), and enforces against bad actors.
A viable regime that protects consumer safety would require hemp ingredients to comply with existing FDCA regulations for dietary supplements and in food, where they can be used as ingredients if they meet safety standards for such use.
These standards would include requirements such as registration of food supply, compliance with current regulations for good manufacturing practices, labeling requirements (including food labeling, disclosure of allergens, contact information, etc.), reporting requirements for unusual events, and new provisions for dietary ingredients and dietary ingredients. where applicable.
The FDA would ideally also set a clear, achievable standard for measuring THC content in end products, and establish protections for intermediate hemp products.
The FDA would also address certain safety concerns with warning label requirements, as it does with other products, such as warnings related to use by pregnant or nursing women and by children (except with parental supervision or health care).
What will happen if the sector does not soon see some guidance on CBD? How has a lack of FDA action affected the sector?
The entire supply chain of hemp (including consumers) will continue to suffer, which is particularly challenging in a pandemic / recession, and the US will further hinder the real hemp economy that it intended with the passage of Farm Farm 2018.
We will probably also see a proliferation of the “state patchwork” of regulation, which is unsustainable.
Without some federal guidance, I think we will see states go even further in developing state-level regulations that conflict with federal law and are impossible for states to enforce and enforce.
The FDA’s failure to regulate consumption of hemp products, long after the legalization of hemp has forced states to regulate to protect consumer safety, which has created a patchwork of inconsistent state regulations that make it incredibly difficult for companies in the practice.
The situation is becoming unbearable for both companies and regulators, and is incredibly confusing for consumers.
The lack of regulation has been devastating for many companies, affecting the entire hemp supply chain. In addition to the state’s dysfunctional patchwork, CBD companies are experiencing massive delays in executing their business plans, challenges in obtaining investments and traditional access to capital, as well as extreme costs and resources having to be allocated to compliance.
It is important not to forget that consumers are particularly affected, as the lack of regulation or enforcement by the FDA endangers consumer safety. The lack of regulation has opened the door for “bad actors” who ignore safety standards and sell faulty / misleading products, who are on an equal playing field with responsible companies that meet quality and safety standards.
