What general rules apply to food products in the US and what agency is in charge of their regulation?
At the federal level, foods are regulated by two authorities: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). The FDA regulates all food products except meat, poultry and certain processed eggs, which are regulated by the USDA. However, it is important to note that local rules and regulations apply—so if you plan on manufacturing foods, always check with your local food health and sanitation authorities.
The Food Safety and Inspection Service, an agency within the USDA, is tasked with ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labelled and packaged.
Generally speaking, inspectors from the FDA’s Office of Regulatory Affairs carry out inspections on behalf of the FDA.
Can I sell CBD-containing food products? What does the FDA think about it?
It is illegal to sell food products which contain an active ingredient in a drug product approved by the FDA—and that includes CBD. The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD, stating: “The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.”
Additionally, the 2018 Farm Bill gave the USDA authority to regulate hemp cultivation at the federal level, and it has thus implemented its US Domestic Hemp Production Program through an interim final rule (84 FR 58522).
What about hemp-containing foods—which products are legal?
It depends. The 2018 Farm Bill removed industrial hemp (products with a THC concentration of no more than 0.3% on a dry weight basis) from the list of substances regulated under the Controlled Substances Act.
Therefore, hemp is no longer regulated federally. However, the 2018 Farm Bill left the FDA’s authority to regulate some hemp products—as it does any other product—intact. So, if your hemp food product contains CBD, then it would be regulated by the FDA like any other CBD-containing product.
Is it possible to use the buds/flowers, and resins of hemp in food products?
Again, it depends. Theoretically, if the buds/flowers or resins (or derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not as stated in the 2018 Farm Bill) contain less than 0.3% THC on a dry weight basis and no other cannabinoids, then it could be legal federally. However, flowers and resins are high in cannabinoid content, so in practice only products such as hemp seed oil are otherwise free of regulatory oversight.
Can a food product contain THC traces (i.e. up to 0.3%)?
According to the 2018 Farm Bill, products that contain “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis” are no longer regulated as controlled substances.
However, the FDA reserves the right to regulate these products like all other food products. In practice, the FDA does not regulate products that contain “only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant.”
What is the process to authorise a new food product in the US?
Unlike tobacco, medical devices and human and animal drugs, the FDA does not have a premarket authorisation process for foods generally regarded as safe (GRAS).
As the FDA states that: "Any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.”
So there is a premarket review process for foods not GRAS. Furthermore, the FDA has a robust regulatory and inspection programme intended to keep food products safe.
When will we know if CBD/hemp can be included in food products?
Technically speaking, we already do know. Food products that contain CBD are illegal under federal law. However, the FDA has stated that it is continuing to evaluate the “regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.”
Are individual states allowing the sale of hemp or CBD foods?
Yes. There are a number of states that allow CBD in foods, while others have outlawed such products. However, regardless of the state law, these products are still illegal at the federal level.
Can I import CBD food products from other countries?
No. CBD-containing food products being imported into the US may be refused admission.
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