On March 17, 2023, two U.S. legislators reintroduced two bipartisan bills. They aim to create regulations for the use of beverage and food products infused with CBD and the use of CBD products as supplements in diets. The legislators considered reintroducing the bills as the FDA called on Congress to provide further guidance on CBD regulations. The bills were reintroduced by Reps. Angie Craig from Ohio and Morgan Griffith from Virginia will direct the FDA to take action on CBD regulations based on the current regulatory frameworks.
The Food and Drug Administration agency is dragging its feet
The two legislators said the FDA had dragged its feet and failed to give proper CBD regulations, including products produced from hemp. Due to the FDA CBD regulation failure, there has been confusion in the market concerning its legal uses. In his statement, Griffith said it is time that Americans get better guidance which is the reason he reintroduced the two bills.
He expects the bills will provide a clear way for FDA CBD regulation on the use of the chemical in food and dietary supplements. The first bill is named Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023. It aims to legalize the use of Hemp and CBD extracted from hemp, including products infused with hemp to be used as dietary supplements unless the FDA directs otherwise.
The second CBD regulations bill is named CBD Product Safety and Standardization Act. It aims to instruct the FDA to create guidelines for CBD use the same way the organization does for food ingredients in other types of products. The guidelines should include CBD packaging labeling. FDA has taken a long time since CBD was legalized in the U.S. in 2018.
FDA requested guidance from the Congress
Although it was legalized in 2018, the public and other parties have been asking is CBD regulated or not. The buck stops with the FDA, but in January, they asked for legislative action by Congress to guide on the issue. The federal government agency had cited there was too much unpredictability concerning CBD safety. The agency had said the uncertainty made it harder for them to regulate CBD based on the current framework.
The USHR general counsel Jonathan Miller said FDA’s failure to act had affected hemp cultivators negatively. Additionally, it opened loopholes for thousands of unregulated products to find their way into the market. Miller said USHR was happy because the bills introduced by Craig and Griffin would provide a solution. He said his team would work closely with the two legislators, including the co-sponsors of the bills.
CBD is available in a variety of consumer goods, such as vapes, topicals, and tinctures. It is packaged in packaging such as tincture bottles, bags, tins, and jars.
In their request for guidance by Congress, FDA had further cited their concerns about the impacts of CBD on health due to prolonged use. They argued that there were suggestions cannabinoids could potentially damage the liver. According to FDA, CBD could also negatively affect expectant mothers, children, and the male reproductive system. Before implementing FDA CBD regulation, the agency needed guidance on such matters.
According to Dr. Janet Woodcock, FDA’s Deputy Commissioner, the agency is yet to find sufficient proof to decide the quantity of CBD users can consume. The DC said the agency felt a fresh CBD pathway is necessary to help balance the desire for users to access CBD products and the need for the agency to manage the risks.
Different regulation aspects suggested by FDA
Based on FDA suggestions, Congress needs to consider several regulatory aspects.
- What regulatory aspects need to be followed for CBD packaging and labeling
- Set limitations on CBD percentages in products
- Set limitations for CBD testing for product safety and potency
- Guidance of the negative effects of CBD on livestock and pets
The public may not understand is CBD regulated or not since the law says it is legal. However, there is a difference between legalization and regulation. The purpose of regulation is to ensure the products are safe, in the right amounts and tested. FDA says CBD carries different risks to animals. If animals accidentally consume CBD, people might consume CBD unknowingly through animal products such as milk, meat, and eggs.
According to Woodcock, it is not yet clear how CBD-infused products would achieve the right safety benchmarks for ingredients in animal feeds. FDA does not intend to develop guidelines that would allow CBD to be infused in animal food. Woodcock said it is necessary to have a new regulatory avenue that will give oversight and access to some CBD-infused products for animals.
The new bills from Craig and Griffith have massive support
After Craig and Griffin reintroduced the two bills, they received massive support from different stakeholders. They have support from activists, for-profit and nonprofit organizations, and cannabis organizations. Support from the cannabis sector includes:
- National Cannabis Industry Association
- Americans for Safe Access
- Indigenous Cannabis Industry Association
- National Association of State Departments of Agriculture
From the statement by the FDA, it is understandable that Congress needs to take legislative action to help solve the regulatory problem. It creates a platform for setting FDA CBD regulation guidelines. Jonathan Miller from US Hemp Roundtable said the bills by the legislators provide critical legislation important for hemp cultivators, CBD manufacturers, and consumers. Once FDA acts, there will be no complex questions about is CBD regulated or who is responsible for CBD regulations. Miller said circulation of unregulated CBD products has made consumers and health professionals concerned about their health and safety.
Bills introduced earlier failed to kick off
The earlier versions of the reintroduced bills failed to advance after they were introduced to Congress. However, stakeholders in the sector feel the remarks by FDA will help put pressure on lawmakers to hasten and take the right actions. For many days, there have been repeated appeals for legislators, stakeholders, and advocators to take administrative action. In January, James Comer had said he was getting ready to challenge the FDA for failing to enact CBD regulations. James is the chairperson of the House Oversight and Accountability Committee.