Food & Ag Policy Briefing: CBD rules still confusing, US adamant on ag in EU trade talks
Also, US ready for UK trade negotiations post-Brexit
The lack of clarity on rules concerning the production and marketing of food and drink products containing cannabidiol (CBD) was again highlighted in the United States last week.
The 2018 Farm Bill removed legal restrictions on CBD if it’s derived from hemp plants and has a THC level of lower than 0.3% - but shortly after the Bill went into law, FDA issued a statement clarifying that any hemp-based CBD product that is marketed as having therapeutic benefits or as a dietary supplement is illegal to sell unless the FDA has reviewed and approved it.
FDA has actively been trying to find a suitable regulatory pathway for CBD products to be made legal, such as holding an extremely popular public hearing on the subject in May, and it has also been issuing warning letters to companies who are selling unapproved products.
Massachusetts-based Curaleaf, the country’s largest cannabis company with operations in 19 states, recently received such a letter from FDA following a review of its marketing claims, which suggested its products could help treatment of serious illnesses and health conditions, including cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety.
Curaleaf immediately removed the statements and social media posts that came under scrutiny by FDA after investors expressed their concern – shares in the company fell 15% the day after the letter was published but have since rebounded, suggesting the industry and the market are closely attuned to the agency’s interest in CBD.
Two days after the letter was sent to Curaleaf, a top FDA official defended the agency’s position on CBD before a Senate panel and rebuffed suggestions that it should quickly clear a legal pathway for use of the non-psychoactive cannabis extract in foods and supplements.
The studies needed to show CBD is effective and safe “just haven’t been done,” FDA Principal Deputy Commissioner Amy Abernethy told the Senate Agriculture Committee on July 25. “We lack the information for science-based decision-making about CBD.”
Gottlieb identifies potential solution
Former FDA Commissioner Scott Gottlieb, who only stepped down from the role in April this year, thinks a balanced legal route to selling legal CBD foods can be achieved.
In an op-ed for the Washington Post last week, Gottlieb first pointed out that there are known risks from CBD, which can cause damage to the liver at high doses, and it may have a cumulative effect.
"If you eat CBD in your breakfast, lunch and dinner, you could get a toxic dose,” he explained. “Currently marketed products might also have undeclared ingredients and impurities, including the psychoactive compound found in marijuana, delta-9-tetrahydrocannabinol (THC).”
Current law would require a multi-year process to allow CBD uses in food and supplements, but "given the pressure on the FDA to create a more immediate path for CBD products, this route might simply take too long," Gottlieb wrote.
Despite the unknowns about CBD, “there is a way that the FDA can fulfill its public-health obligations and meet the political demand for these goods," he said. "It can approve the sale of some CBD products immediately, while effecting a framework for their safe and proper regulation and a pathway for an enforceable market for these goods.”
The delicate balance Gottlieb refers to involves putting “the onus on manufacturers” to petition FDA that CBD can be safely added to foods through the submission of dietary ingredient notifications or food additive petitions, which would include reviews of toxicity studies.
“These are the same standards any new food ingredients are held to," Gottlieb explained. "Congress can help by passing language saying that the FDA doesn’t need to issue a broad regulation on CBD and can instead rely on petitions filed by individual, prospective producers.”
In the interim, the FDA could exercise enforcement discretion to allow CBD to be marketed in food so long as the products meet certain conditions, Gottlieb suggested.
Agriculture in trade talks
Meanwhile, US Trade Representative Robert Lighthizer remains adamant that talks with the European Union on a trade agreement will not start until agriculture is put on the table.
Talks with the EU have not yet started, “because the EU has not agreed to negotiate reductions in tariffs on agricultural goods. It would not be acceptable to Congress, the Administration, or our stakeholders to conclude a tariff agreement limited to industrial trade”, Lighthizer said in written answers to questions released on July 29.
The EU system of geographical indications remains a “long standing” issue between the two sides, the trade official said. “This is an important concern, and USTR is pressing the EU both bilaterally and in multilateral fora to expand market access for US producers into the EU,” he stated.
“The EU’s actions are also concerning where there are existing international Codex Alimentarius standards, such as for certain cheeses. USTR is working to safeguard third country markets, including removing barriers such as over-broad GI protection for EU products that serve to block US producers and traders using common food names or who have prior trademark rights.”
This issue and more is discussed by former Director for Trade and Agriculture at the Organisation for Economic Co-operation and Development (OECD), Stefan Tangermann, in an article for IEG Policy available to read here.
Post-Brexit US-UK deal?
Lighthizer added that a “comprehensive agreement that provides a high level of access to the UK market and a level playing field for US exporters” remains a priority for the United States once the UK leaves the EU.
The UK is said to be considering breaking away from the European regulatory framework for areas such as food quality, animal welfare and the environment in future, which may eventually see it more aligned with the United States in areas such as biotechnology.
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Diary & updates
There will be no EU agri-food policy diary article for the next few weeks due to the lack of events taking place over the summer period.