FDA Urged To Include CBD In Foods And Supplements
FDA (Food and Drug Administration) recently called for responses from concerned stakeholders on how best to regulate hemp extracts like CBD. The public response period ended on July 16, 2019 with more than 4,000 responses. The FDA intends to use the comments from stakeholders as a basis for their rule making process for CBD products.
FDA called for the responses on April and was followed by a public hearing on CBD, which involved testimonies from reform advocates and industry stakeholders. This was the first-ever FDA hearing on CBD-infused products and CBD oils.
The deadline for comments from concerned individuals was initially set for July 2, but had to be extended by two weeks as a result of strong public interest on the issues raised by the FDA, which encompasses benefits, risks, product quality, and production processes for the non-intoxicating cannabis compound.
In the responses, many people shared how CBD has helped them wean off other dangerous drugs, and others on how the hemp-extract had helped treat symptoms of various ailments such as pain and anxiety.
Various medical associations and health professionals suggested that CBD is a health supplement and as a result should be regulated as such. According to Dravet Syndrome Foundation, “Our patient community has used non-FDA approved CBD and other cannabis-based products when other options have failed to provide seizure control for their family member with Dravet syndrome… due to reports of extreme variations in product consistency and frequent label misrepresentation, we would welcome standardizing labeling for cannabis based dietary supplements and foods including concentration, ingredients, and stability”
Also, the National Association of State Departments of Agriculture (NASDA), U.S. Hemp Roundtable, Center for Science in the Public Interest (CSPI), Vote Hemp, and Cannabis Industry Association were among the many groups that responded to the request of the FDA.
Other organizations, including law firms and advocacy groups also responded with details on how best they think CBD should be regulated, best practices that should be adhered to for testing and labeling, and its impact on safety.
A group of 37 state attorneys also responded thus, “… although products containing cannabis or cannabis-derived compounds may well offer real benefits to consumers, it is important that consumers have reliable risk and benefit information to make informed choices about initiating and continuing the use of these products.”
The Attorney Generals want the FDA to investigate CBD testing and marketing best practices, so that consumers are not misled by media advertising or exposed to any harm that could be as a result of undisclosed risk from using CBD-infused products.
More so, the Center for Science in the Public Interest (CSI) wrote that it’s “critical that FDA assert its authority on behalf of consumers to ensure that products are safe, accurately labeled, and free of adulterants and contaminants, and that consumers are aware of relevant risks… to do so will require that the agency articulate a long-term program to gradually align the state laws that legalize these products with applicable federal health and safety protections, as we propose.”
Furthermore, according to the U.S. Hemp Roundtable, “FDA has all the tools necessary to expeditiously issue a rule allowing CBD in foods and dietary supplements… we believe that a federal regulatory framework, rather than a patchwork of state and local laws, provides the best means for ensuring consumers receive accurate, consistent information about hemp-derived products.”
The Hemp Vote group also responded that, “FDA should recognize that whole-plant hemp extracts are distinct from any substance that has been submitted to FDA for approval as a pharmaceutical drug, and that “whole-plant hemp extracts can be part of a healthy diet, are beneficial to consumers, and are not pharmaceutical drugs, especially when they are not marketed to have a therapeutic effect on consumers.”
Consequently, an official of the FDA said that the agency will be fast tracking the rule making process for CBD and other hemp extracts, which is something that industry stakeholders and lawmakers have been pressing on the FDA to do since the signing of the 2018 Farm Bill.