CRN: Thought Leader on CBD
States continue to address regulatory gap with CBD proposals
(Daily Supplement, Feb. 16, 2022)
CRN's Steve Mister: Don't Sell Out DSHEA for CBD
We all want an expedient solution to the stalemate with FDA over the legal status of cannabidiol (CBD), but the call to allow FDA to set a maximum safe level for CBD is antithetical to the law governing dietary supplements, DSHEA.
- CRN submits comments on Cannabis Administration and Opportunity Act Discussion Draft Section 505 relating to the regulation of hemp-derived cannabidiol (CBD)
Steve appears with Charlotte's Web CEO Deanie Elsner responding to FDA's response to the company's NDI submission
FDA’s response to Charlotte's Web's new dietary ingredient (NDI) notification highlights the scope of regulatory hurdles facing the CBD industry, and according to many, the need for a legislative solution.
Statements and press:
- CRN Denounces FDA Rejection of New Dietary Ingredient Notifications for Hemp Extract Containing CBD, Urges Congress to Act
- CRN President & CEO speaks to Bloomberg: FDA Objects to CBD as Diet Supplement, Extending Uncertainty
- CRN President & CEO speaks to POLITICO Pro: Dietary Supplement Trade Group Bemoans Lack of CBD Clarity
CRN has publicly called for FDA to act on CBD for more than two years:
- CRN officially opened membership to CBD companies in April of 2019.
- CRN participated in FDA's public meeting in May of 2019.
- CRN submitted comments to FDA on June 21, 2019.
- CRN filed a Citizen Petition June 16, 2020 (FDA has responded that it needs more time to assess the complex issues presented).
Following CRN's Citizen Petition filing, Steven Tave, former head of FDA's Office of Dietary Supplement Programs spoke on behalf of the agency at a legal, regulatory and compliance conference indicating that companies may be able to successfully argue that full spectrum hemp extract is not the same article as CBD isolate—indicating companies should bring forward arguments for FDA to evaluate. CRN President & CEO Steve Mister highlighted Tave’s statements a NutraIngredients-USA article.
CRN works to promote legislation directing FDA to provide a legal pathway to market for dietary supplements containing hemp-derived CBD
CRN has been vocal in its support of HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, which creates an important exception to the drug preclusion rule of the the Food, Drug, and Cosmetic (FD&C) Act, allowing hemp-derived CBD to coexist in both the drug and dietary supplement spaces. Prior to the passage of the 2018 Farm Bill, the FD&C Act created a race to market in which, as CRN President & CEO notes, "the dietary supplement industry had its shoelaces tied together because we couldn’t get to market, but the drug side of the industry was certainly free to investigate and commercialize CBD and other cannabinoids."
HR 841 continues to gain additional cosponsors on a bipartisan basis. CRN, along with other supporters of the legislation, have had numerous discussions with the staff of the Energy & Commerce Committee that has jurisdiction for the bill, who have indicated that a hearing on the bill could occur as soon as this summer. CRN continues to build support for HR 841 and to address objections that have been raised about the legislation.
By directing FDA to establish a federal regulatory framework for hemp-derived CBD to be lawfully marketed as dietary supplements, the recently-introduced Senate's Cannabis Administration & Opportunity Act "promotes consumer safety while providing an economic boost to struggling farmers," as CRN's VP of Government Relations Julia Gustafson noted HBW Insight. The Senate bill, released by Majority Leader Chuck Schumer (D-NY), Finance Committee Chair Ron Wyden (D-OR), and Sen. Cory Booker (D-NJ) proposes decriminalizing marijuana and includes provisions relevant to CBD in dietary supplements.
In addition, the Senate discussion draft proposes implementing a set level of CBD per recommended serving. CRN has voiced opposition to this, with President & CEO Steve Mister noting in NutraIngredients-USA, "We absolutely believe FDA should not be setting a safe level up front. If a level is mandated we won't be able to go back and change it as safety data evolves." CRN is engaging with the Senate contacts to share industry insights and assist in the development of a final proposal.
Get "Frequently Asked Questions" answered about hemp-derived CBD.
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February 4, 2021: CRN Commends Bipartisan CBD Legislation that Protects Consumer Safety
January 8, 2021: New FDA Announcement on CBD Signals Continued Agency Inaction
Published articles by CRN experts
If you repeat something often enough…even with CBD
by Steve Mister in Natural Products Insider, April 2021
As More Consumers Seek Supplements to Support Health During COVID-19 Pandemic, CBD Regulation Is More Critical Than Ever – Brian Wommack in Nutrition Industry Executive, May 2020
FDA’s Ongoing Review of CBD and its Impact on Class Action Litigation – Megan Olsen with Amin Talati Wasserman's Rend Al-Mondhiry in the Washington Legal Foundation's Legal Backgrounder, May 2020
Hey FDA, can you show a little CBD discretion – Steve Mister in Natural Product Insider's "Hemp/CBD Market Evolution" edition, February 2020
5 (actually, 10) things that should concern us about CBD – Steve Mister in Nutrition Business Journal's recently published "Hemp & CBD Guide 2.0," December 2019
CBD and the 2018 Farm Bill–the legal status of CBD supplements – Megan Olsen in Natural Products Insider, February 2019
Science, CBD and the prisoner's dilemma – Steve Mister in Natural Products Insider, February 2019
Will CBD Become a Shakespearean Tragedy? – Steve Mister in Nutrition Industry Executive, February 2019
Position Paper on Hemp/CBD State Legislation
Council for Responsible Nutrition Hemp-Derived CBD Dietary Supplement Position – Hemp-derived cannabidiol (CBD) regulations, even in the current absence of federal direction, should establish or maintain a regulatory framework consistent with the federal approach for dietary supplements. CRN members include manufacturers and suppliers that sell hemp-derived CBD dietary supplements around the country and therefore have a vested interest in having hemp-derived CBD dietary supplements consistently regulated by existing federal standards for dietary supplements. Particularly concerning is the possibility of inconsistent and perhaps conflicting state requirements on the regulation of hemp-derived CBD products, including dietary supplements, that contribute to a patchwork of state laws that make simultaneous compliance with anticipated federal regulations difficult if not impossible. Read our Position Paper to learn more.