Admin
Sibyl Swift, PhD, is the chief science officer and vice president of regulatory affairs for cbdMD and the co-chair of cbdMD Therapeutics. She also serves as a member of the Board of Directors for cbdMD. As CSO for cbdMD, she directs the company’s research partnerships and clinical trials, advises on regulatory matters, guides new product development and R&D, and provides guidance on good manufacturing practices. Prior to joining cbdMD, Swift was the senior vice president for scientific & regulatory affairs at the Natural Products Association (NPA). She represented the association on Codex Alimentarius (an international standards organization) and provided guidance on claims reviews, substantiation and regulatory policy. Before joining NPA, she was the associate director for research and strategy within the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs.
Question: Please discuss the latest updates on FDA news or legislation regarding CBD.
Answer: There have been two notable updates in the last few months. First, House Committee on Oversight and Accountability Chairman Rep. James Comer (R-KY) and Subcommittee on Healthcare and Financial Services Chairwoman Lisa McClain held a hearing on July 27, 2023 with industry stakeholders to gather information about the regulation of cannabinoids following the FDA’s announcement in January of 2023 regarding its authority to regulate CBD products as dietary supplements. The announcement stated the FDA did not believe the current regulatory framework allowed it to regulate cannabidiol and it needed additional authorities to be granted by Congress. In response, Chairman Comer and Chairwoman McClain held a hearing which resulted in Chairwoman McClain urging the FDA “to use its existing authority to do its job to regulate hemp-derived products so that Americans can be confident in the safety and efficacy of products they purchase. The FDA must do better and use their already existing authorities to regulate.” “It is imperative that the FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to the American people about the safety of CBD products.” Because of my experience while at the FDA and our brand’s expertise and advocacy efforts in this space, cbdMD was asked by Chairman Comer’s office to provide a written statement on the record for the hearing.
The second notable update on the regulatory front was a bicameral request for information on the regulation of hemp-derived products by House Energy & Commerce Committee Chair Cathy McMorris Rogers and Ranking Member Frank Pallone, Jr., along with Senate Health, Education, Labor and Pensions Committee Chair Bernie Sanders and Ranking Member Bill Cassidy, MD. The request was released the same day as the Comer/McClain Oversight Committee meeting (July 27, 2023) with a deadline for response on Aug. 18, 2023. The committee made the following statement as part of the RFI: “Since hemp was descheduled five years ago, consumers, manufacturers and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. Questions remain about the best way to provide a legal pathway to market for CBD products.” cbdMD worked closely with the US Hemp Roundtable, the leading hemp trade association to submit a response, but also felt as though it was important to submit our response to ensure our specific areas of concern (and expertise) were represented.
Question: How should retailers read CBD product labels?
Answer: For purposes of this answer, I will refer specifically to ingestible dietary supplement labels (food and supplement are different). If you are selling products in all 50 states, then you should ensure that the labels for CBD products that you are selling are compliant in each state in which you sell. Some companies, like cbdMD, make labels that are 50 state compliant, which means an excess of individual state warnings that may even conflict at times. Labels should also reflect all of the requirements for dietary supplements found in the FDC&A (Food, Drug and Cosmetic Act), including a Supplement Facts panel. Although not required under any current federal law related to dietary supplements, many states also require a label to contain cannabinoid content displayed as the total amount in the container and/or total amount per serving. States also require a QR code to be present on outer packaging that links to the certificate of analysis (COA) specific to the lot or batch of product indicated on the package. Retailers should read labels to ensure that they are compliant with the dietary supplement regulations pertaining to claims and efficacy. They cannot make statements about disease endpoints.
Question: What should retailers look for in a CBD supplement?
Answer: Supplier verification will filter out a lot of the disreputable companies who are interested in selling into retail. Retailers should look at labeling as I described above, particularly the labeling information. Does the product comply with applicable regulations from 21 CFR? Does the label comply with dietary supplement rules? Does the product contain THC? Ensure that the response to that question aligns with your brand’s philosophy. Does the product contain additional ingredients? If so, are they labeled appropriately? Does the supplier have the current documentation to support your sale of the products?
Retailers should implement “know your customer” rules which require any CBD brand to provide supporting documentation validating their supply chain source of hemp extract and lab results for each lot/batch before buying any CBD products.
Sibyl Swift, PhD, is the chief science officer and vice president of regulatory affairs for cbdMD and the co-chair of cbdMD Therapeutics. She also serves as a member of the Board of Directors for cbdMD. As CSO for cbdMD, she directs the company’s research partnerships and clinical trials, advises on regulatory matters, guides new product development and R&D, and provides guidance on good manufacturing practices. Prior to joining cbdMD, Swift was the senior vice president for scientific & regulatory affairs at the Natural Products Association (NPA). She represented the association on Codex Alimentarius (an international standards organization) and provided guidance on claims reviews, substantiation and regulatory policy. Before joining NPA, she was the associate director for research and strategy within the U.S. Food and Drug Administration’s (FDA) Office of Dietary Supplement Programs.
Question: Please discuss the latest updates on FDA news or legislation regarding CBD.
Answer: There have been two notable updates in the last few months. First, House Committee on Oversight and Accountability Chairman Rep. James Comer (R-KY) and Subcommittee on Healthcare and Financial Services Chairwoman Lisa McClain held a hearing on July 27, 2023 with industry stakeholders to gather information about the regulation of cannabinoids following the FDA’s announcement in January of 2023 regarding its authority to regulate CBD products as dietary supplements. The announcement stated the FDA did not believe the current regulatory framework allowed it to regulate cannabidiol and it needed additional authorities to be granted by Congress. In response, Chairman Comer and Chairwoman McClain held a hearing which resulted in Chairwoman McClain urging the FDA “to use its existing authority to do its job to regulate hemp-derived products so that Americans can be confident in the safety and efficacy of products they purchase. The FDA must do better and use their already existing authorities to regulate.” “It is imperative that the FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to the American people about the safety of CBD products.” Because of my experience while at the FDA and our brand’s expertise and advocacy efforts in this space, cbdMD was asked by Chairman Comer’s office to provide a written statement on the record for the hearing.
The second notable update on the regulatory front was a bicameral request for information on the regulation of hemp-derived products by House Energy & Commerce Committee Chair Cathy McMorris Rogers and Ranking Member Frank Pallone, Jr., along with Senate Health, Education, Labor and Pensions Committee Chair Bernie Sanders and Ranking Member Bill Cassidy, MD. The request was released the same day as the Comer/McClain Oversight Committee meeting (July 27, 2023) with a deadline for response on Aug. 18, 2023. The committee made the following statement as part of the RFI: “Since hemp was descheduled five years ago, consumers, manufacturers and policymakers have sought clarity regarding the legal status of CBD. Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. Questions remain about the best way to provide a legal pathway to market for CBD products.” cbdMD worked closely with the US Hemp Roundtable, the leading hemp trade association to submit a response, but also felt as though it was important to submit our response to ensure our specific areas of concern (and expertise) were represented.
Question: How should retailers read CBD product labels?
Answer: For purposes of this answer, I will refer specifically to ingestible dietary supplement labels (food and supplement are different). If you are selling products in all 50 states, then you should ensure that the labels for CBD products that you are selling are compliant in each state in which you sell. Some companies, like cbdMD, make labels that are 50 state compliant, which means an excess of individual state warnings that may even conflict at times. Labels should also reflect all of the requirements for dietary supplements found in the FDC&A (Food, Drug and Cosmetic Act), including a Supplement Facts panel. Although not required under any current federal law related to dietary supplements, many states also require a label to contain cannabinoid content displayed as the total amount in the container and/or total amount per serving. States also require a QR code to be present on outer packaging that links to the certificate of analysis (COA) specific to the lot or batch of product indicated on the package. Retailers should read labels to ensure that they are compliant with the dietary supplement regulations pertaining to claims and efficacy. They cannot make statements about disease endpoints.
Question: What should retailers look for in a CBD supplement?
Answer: Supplier verification will filter out a lot of the disreputable companies who are interested in selling into retail. Retailers should look at labeling as I described above, particularly the labeling information. Does the product comply with applicable regulations from 21 CFR? Does the label comply with dietary supplement rules? Does the product contain THC? Ensure that the response to that question aligns with your brand’s philosophy. Does the product contain additional ingredients? If so, are they labeled appropriately? Does the supplier have the current documentation to support your sale of the products?
Retailers should implement “know your customer” rules which require any CBD brand to provide supporting documentation validating their supply chain source of hemp extract and lab results for each lot/batch before buying any CBD products.
