Washington, D.C.--(Newsfile Corp. - August 18, 2023) - cbdMD, Inc. (NYSE American: YCBD) (NYSE American: YCBD-PA) (the "Company"), one of the nation's leading providers of premium cannabidiol (CBD) products, today announced its direct response to the Bicameral and Bipartisan Congressional RFI on FDA Regulation of CBD and urges FDA to provide regulatory clarity.
On Thursday, July 27th, following a historic hearing on hemp and CBD held by the House Oversight and Accountability Committee, a Request for Information (RFI) Regarding the Regulation of Cannabidiol Products was issued by bicameral health committee leaders in a bipartisan request for information regarding FDA regulation of CBD. In the request, House Energy & Commerce Committee Chair, Cathy McMorris Rogers (R-WA), and Ranking Member, Frank Pallone Jr. (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair, Bernie Sanders (I-VT) and Ranking Member, Bill Cassidy, M.D. (R-LA), asked subject matter experts and stakeholders for input on key areas pertaining to FDA regulation of CBD. Prior to the hearing, cbdMD's Chief Science Officer, Dr. Sibyl Swift, was asked to provide a written statement based on more than five years of sitting in a top position with the FDA's Office of Dietary Supplement Programs. In her written statement, Dr. Swift clearly outlined her belief that the FDA currently has all the required authorities to properly regulate hemp-derived dietary supplements, including CBD and Full Spectrum extracts containing low amounts of THC.
When asked her opinion on the FDA's position regarding CBD, Dr. Swift stated: "The FDA has spent more time plotting their public relations campaign to malign hemp-extracted cannabinoid ingredients than they have spent addressing any public health matter and reasonably regulating these ingredients under their current authorities provided in existing frameworks. The real issue is about the role of natural products and pharmaceutical IP in the marketplace and the FDA's historical refusal to properly recognize natural products in that ecosystem." Dr. Swift went on to state: "The Dietary Supplement Health and Education Act (DSHEA) was never intended to exclude these natural products, even when an approved drug exists, except in the rare cases where the drug and the dietary supplement are effectively the same thing, meaning the same dose marketed for the same purpose. That is just not the case for CBD products sold as dietary supplements, foods, and cosmetics. Congress's intent from the start was clear, that articles could exist at the same time as both a drug and a dietary supplement, and that such articles could continue to exist as a dietary supplement so long as it is properly labeled and marketed."
As a leader in the hemp-derived CBD industry, cbdMD knew it was critical to participate with other industry leaders to formulate a well-thought-out response and worked with several prominent hemp industry trade groups to draft it. Notably, the Company worked directly with the US Hemp Roundtable's (USHRT) General Counsel, Jonathan Miller. cbdMD also sits on the Board of the Natural Products Association (NPA), which will also submit a response to the RFI. Dr. Daniel Fabricant, NPA President & CEO, stated, "The existing FDA pathways are completely adequate to address any concerns about product safety/daily consumption limits, manufacturing quality, and labeling on CBD. The FDA has delayed matters indefinitely, and not due to any public health matter or bona fide safety concerns. We urge Congress to mandate that the FDA, with what's left of 2023, use its current authorities to stabilize the market by setting a daily consumption limit ensuring safety for all Americans and stabilizing the market for American Hemp Farmers, small businesses, brands, that make up the entire domestic supply chain."
This RFI is a critical opportunity for the Company to provide decision-makers in Congress with substantive information from a top CBD brand that has taken tremendous strides to be fully compliant with the Food, Drug & Cosmetic Act (FD&C Act), like any responsible dietary supplement company should do. Lance Blundell, cbdMD's General Counsel, stated, "It was important for the Company to take a leading role in this process by also submitting our own, separate response. This ensures there is no confusion on the correct path forward and so the bicameral, bipartisan Congressional committee receives the requisite information to cut through the rhetoric from the FDA and provide our industry and our customers with the regulatory clarity that they deserve. This is a key moment for the hemp and CBD industry to guarantee that its voice is heard by Congress. The FDA has been allowed to delay for far too long, causing the industry to languish."
cbdMD urges all CBD and hemp users to contact their Congresspersons to voice support for the taking of immediate action that provides regulatory clarity and gives the American people the freedom to choose CBD products for their personal health and welfare.
CLICK HERE to view cbdMD's RFI response and Dr. Swift's written statement to the House Oversight Committee. If you endorse our submission, or parts of it, please let Congress know.
We also encourage the review of the RFI and the Company's response as well as the submission of additional responses by today's August 18th deadline.
Your voices will be heard!
cbdMD, Inc. is one of the leading and most highly trusted and recognized hemp-derived cannabidiol (CBD) brands with a comprehensive line of U.S. produced, THC-free1 CBD products as well as Full Spectrum and Delta 9 THC products. The cbdMD brand currently includes high-quality, premium CBD products including tinctures, gummies, topicals, capsules, sleep aids and more. The Company's Paw CBD brand includes formulated pet products including tinctures, chews and topicals in varying strengths. To learn more about cbdMD and the complete line of products, please visit www.cbdmd.com, follow cbdMD on Instagram and Facebook or visit one of the thousands of retail outlets that carry cbdMD products.
This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified using words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.'' These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict. You are urged to carefully review and consider any cautionary statements, including but not limited to federal and state CBD regulation, and other disclosures, including the statements made under the heading "Risk Factors" in cbdMD, Inc.'s Annual Report on Form 10-K for the fiscal year ended September 30, 2022 as filed with the Securities and Exchange Commission (the "SEC") and our other filings with the SEC. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of cbdMD, Inc. and are difficult to predict. cbdMD, Inc. does not undertake any duty to update any forward-looking statements except as may be required by law. The information which appears on our websites and our social media platforms, including, but not limited to, Instagram and Facebook, is not part of this press release.
1 THC-free is defined as below the level of detection using validated scientific analytical tools.
Ronan Kennedy, Interim CEO & CFO
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