Red Light Holland Applauds HHS Review of Psilocybin Rescheduling Petition, Expresses Optimism for Reversal of Schedule I Classification
Red Light Holland (OTCQB: TRUFF), a producer of functional mushrooms and magic truffles, has welcomed the DEA's historic decision to forward a psilocybin rescheduling petition to HHS for review. This marks the first-ever advancement of a petition to potentially reclassify psilocybin from Schedule I to Schedule II.
The company, through CEO Todd Shapiro, expressed optimism about the review, highlighting psilocybin's potential therapeutic benefits for anxiety, depression, and PTSD. The rescheduling could enable compassionate use programs, enhanced research development, and future FDA approvals.
Additionally, Red Light Holland reported successful validation of its natural psilocybin truffles through third-party testing at Irvine Labs, confirming their compatibility with potential medical grade manufacturing applications.
Red Light Holland (OTCQB: TRUFF), produttore di funghi funzionali e tartufi psichedelici, ha salutato la storica decisione della DEA di inviare una petizione per la riclassificazione della psilocibina al HHS per la valutazione. Si tratta della prima volta che una petizione viene avanzata per spostare la psilocibina da Schedule I a Schedule II.
Il CEO Todd Shapiro ha espresso ottimismo riguardo alla revisione, sottolineando il potenziale terapeutico della psilocibina per ansia, depressione e PTSD. La riclassificazione potrebbe aprire la strada a programmi di uso compassionevole, a un maggiore sviluppo della ricerca e a future approvazioni FDA.
Red Light Holland ha inoltre comunicato la convalida positiva dei propri tartufi naturali contenenti psilocibina, testati da terzi presso Irvine Labs, confermandone l’idoneità per potenziali applicazioni di produzione in ambito medico.
Red Light Holland (OTCQB: TRUFF), productor de hongos funcionales y trufas mágicas, ha acogido la histórica decisión de la DEA de remitir una petición de reclasificación de la psilocibina al HHS para su revisión. Es la primera vez que una petición avanza para reclasificar la psilocibina de Schedule I a Schedule II.
El CEO Todd Shapiro mostró optimismo sobre la revisión, destacando los posibles beneficios terapéuticos de la psilocibina para la ansiedad, la depresión y el TEPT. La reclasificación podría permitir programas de uso compasivo, un mayor desarrollo de la investigación y futuras aprobaciones de la FDA.
Además, Red Light Holland informó la validación exitosa de sus trufas naturales con psilocibina mediante pruebas de terceros en Irvine Labs, confirmando su compatibilidad con posibles aplicaciones de fabricación de grado médico.
Red Light Holland (OTCQB: TRUFF), 기능성 버섯과 매직 트러플을 생산하는 회사는 DEA가 실로시빈의 재분류 청원을 HHS로 이송하기로 한 역사적인 결정을 환영했습니다. 이는 실로시빈을 Schedule I에서 Schedule II로 재분류하는 청원이 최초로 진전된 사례입니다.
CEO 토드 샤피로는 불안, 우울증 및 PTSD에 대한 실로시빈의 잠재적 치료 효과를 강조하며 심사에 대해 낙관적인 입장을 보였습니다. 재분류는 동정적 사용 프로그램, 연구 개발 강화 및 향후 FDA 승인 가능성을 열어줄 수 있습니다.
또한 Red Light Holland는 Irvine Labs에서 제3자 검사를 통해 자사 천연 실로시빈 트러플의 유효성을 성공적으로 검증받았으며, 이는 의료 등급 제조 적용 가능성과의 적합성을 확인한 것이라고 보고했습니다.
Red Light Holland (OTCQB: TRUFF), producteur de champignons fonctionnels et de truffes psychoactives, a salué la décision historique de la DEA de transmettre une pétition de reclassification de la psilocybine au HHS pour examen. C’est la première fois qu’une pétition avance en vue de reclasser la psilocybine de Schedule I à Schedule II.
Le PDG Todd Shapiro s’est dit optimiste quant à l’examen, soulignant le potentiel thérapeutique de la psilocybine pour l’anxiété, la dépression et le SSPT. La reclassification pourrait permettre des programmes d’utilisation compassionnelle, un renforcement de la recherche et de futures autorisations de la FDA.
Par ailleurs, Red Light Holland a rapporté la validation réussie de ses truffes naturelles contenant de la psilocybine par des tests tiers réalisés chez Irvine Labs, confirmant leur compatibilité avec d’éventuelles applications de fabrication à usage médical.
Red Light Holland (OTCQB: TRUFF), ein Hersteller von funktionellen Pilzen und Magic Truffles, begrüßt die historische Entscheidung der DEA, eine Petition zur Umklassifizierung von Psilocybin an das HHS zur Prüfung weiterzuleiten. Dies ist das erste Mal, dass eine Petition zur möglichen Umstufung von Schedule I auf Schedule II vorangetrieben wird.
CEO Todd Shapiro äußerte sich optimistisch gegenüber der Überprüfung und hob die therapeutischen Möglichkeiten von Psilocybin bei Angstzuständen, Depressionen und PTBS hervor. Eine Umklassifizierung könnte Compassionate-Use-Programme, verstärkte Forschung und künftige FDA-Zulassungen ermöglichen.
Außerdem berichtete Red Light Holland von der erfolgreichen Validierung seiner natürlichen Psilocybin-Truffles durch Dritttests bei Irvine Labs, die deren Eignung für potenzielle medizinische Herstellungsanwendungen bestätigten.
- First-ever DEA advancement of psilocybin rescheduling petition for medical review
- Successful third-party testing validation of natural psilocybin truffles for medical grade applications
- Established partnership with FDA-compliant, DEA-registered Irvine Labs
- Successfully completed importation of psilocybin truffles from Netherlands to U.S.
- Current Schedule I classification still restricts medical use and research
- Rescheduling process outcome remains uncertain and timeline undefined
Toronto, Ontario--(Newsfile Corp. - August 20, 2025) - Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTCQB: TRUFF) ("Red Light Holland" or the "Company"), an Ontario-based corporation engaged in the production, growth, and sale of functional mushrooms and mushroom home grow kits in North America and Europe, and a premium brand of magic truffles to the legal, recreational market within the Netherlands, today welcomes the U.S. Drug Enforcement Administration's (DEA) decision to forward a psilocybin rescheduling petition to the Department of Health and Human Services (HHS) for medical and scientific review. This marks the first time the DEA has advanced such a petition for psilocybin's rescheduling from Schedule I to Schedule II.
The petition highlights compelling clinical evidence demonstrating psilocybin's potential to provide immediate, substantial, and sustained relief for individuals suffering from debilitating anxiety, depression, and PTSD (conditions that tragically contribute to high rates of suicide, particularly among veterans and those facing terminal illnesses).
"We are thrilled to see HHS taking this critical action to evaluate the medical and scientific merits of rescheduling psilocybin," said Todd Shapiro, CEO and Director of Red Light Holland. "This review represents a pivotal moment in recognizing the therapeutic potential of natural psychedelics, and we are hopeful that it will lead to a reversal of psilocybin's outdated Schedule I classification. Such a change would not only expand access to life-saving treatments under medical supervision but also pave the way for responsible innovation in the psychedelic sector. At Red Light Holland, we are committed to advancing this field through rigorous, compliant research and development and we remain vocal advocates for people's right to try psilocybin, especially for Veterans and first emergency responders."
The review follows years of legal advocacy by Dr. Sunil Aggarwal and represents a critical step toward recognizing psilocybin's therapeutic potential. Schedule I classification currently designates substances as having "no accepted medical use," while Schedule II acknowledges accepted medical applications under strict regulation.
If rescheduled to Schedule II, psilocybin would gain federal recognition of its medical value, creating clearer pathways for:
- Compassionate Use Programs: Physicians could request investigational psilocybin for seriously ill patients and those suffering from PTSD through FDA expanded access provisions
- Research Development: Enhanced ability for companies to conduct clinical trials and develop FDA-approved formulations
- Future FDA Approvals: Recognition of medical potential that could facilitate eventual prescription access if specific formulations gain FDA approval
Red Light Holland continues advancing psychedelic research through its partnership with Irvine Labs Inc., an FDA-compliant, DEA-registered California laboratory. The Company has successfully completed the importation of natural psilocybin truffles from its Netherlands facility to the U.S. and as announced earlier this week, August 18, 2025, Red Light Holland received initial third-party testing results confirming psilocybin potency and process validation for potential medical grade manufacturing applications. These results validate that the Company's naturally psilocybin truffles grown in the company's facility in the Netherlands are compatible with the manufacturing processes being developed by Irvine Labs for potential medical grade applications.
About Red Light Holland
Red Light Holland Corp. is an Ontario-based corporation engaged in the production, growth, and sale of functional mushrooms and mushroom home grow kits in North America and Europe, and a premium brand of magic truffles to the legal, recreational market within the Netherlands.
For additional information on the Company:
Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-TRIP (8747)
Email: todd@redlight.co
Website: www.RedLight.co
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking information" within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "hopeful", "potential", "would", "pave the way", "creates the foundation" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events.
The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the potential rescheduling of psilocybin from Schedule I to Schedule II; the anticipated outcomes and timing of the HHS medical and scientific review; the potential for psilocybin to gain federal recognition of its medical value; the potential creation of clearer pathways for compassionate use programs; the potential for physicians to request investigational psilocybin for seriously ill patients through FDA expanded access provisions; the potential for enhanced ability for companies to conduct clinical trials and develop FDA-approved formulations; the potential for recognition of medical potential that could facilitate eventual prescription access if specific formulations gain FDA approval; the potential for expanded access to life-saving treatments under medical supervision; the potential for responsible innovation in the psychedelic sector; the Company's commitment to advancing the psychedelic field through rigorous, compliant research and development; the Company's ability to continue advancing psychedelic research through its partnership with Irvine Labs Inc.; the Company's ability to continue importation of natural psilocybin truffles from its Netherlands facility to the U.S. for third-party testing and research development; the anticipated evaluation of psilocybin by HHS based on eight medical and scientific factors; the potential for this formal review to create the foundation for expanded legal access to psychedelic-assisted therapies; the Company's ability to maintain its partnership with Irvine Labs Inc.; the Company's ability to continue research and development activities; the potential therapeutic benefits of psilocybin; the potential for regulatory changes to impact the psychedelic sector; and the Company's ability to capitalize on potential regulatory changes.
Forward-looking information in this press release are based on certain assumptions and expected future events, namely: the Company's belief that the HHS review represents a positive development for the psychedelic sector; the Company's assumption that rescheduling would create clearer pathways for medical access; the Company's expectation that the review will be conducted fairly and based on scientific evidence; the Company's ability to maintain its partnership with Irvine Labs Inc.; the Company's ability to continue its research and development activities; the Company's ability to continue importing psilocybin truffles for research purposes; the assumption that regulatory changes could positively impact the psychedelic sector; the Company's ability to continue operations in compliance with applicable laws and regulations; the Company's ability to adapt to changing regulatory environments; and the Company's assumption that scientific evidence supports psilocybin's therapeutic potential.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the risk that psilocybin may not be rescheduled from Schedule I to Schedule II; the risk that the HHS review may result in an unfavorable outcome; the risk that even if rescheduled, anticipated pathways for medical access may not materialize as expected; the risk that compassionate use programs may not become available or accessible as anticipated; the risk that physicians may not be able to request investigational psilocybin as expected; the risk that companies may not have enhanced ability to conduct clinical trials as anticipated; the risk that FDA approvals may not be obtained for psilocybin formulations; the risk that expanded access to treatments may not occur as expected; the risk that innovation in the psychedelic sector may be limited by regulatory or other factors; the Company's inability to continue advancing research through its partnership with Irvine Labs Inc.; the Company's inability to continue importing psilocybin truffles for research purposes; potential changes in laws and regulations that could negatively impact the Company's operations; potential issues with the Company's research and development activities; the risk that the HHS evaluation may be delayed, suspended, or result in unfavorable findings; the risk that regulatory changes may not create the anticipated opportunities for expanded legal access; the Company's inability to maintain compliance with applicable laws and regulations; potential disruptions to the Company's partnership arrangements; and general risks associated with the psychedelic and pharmaceutical industries.
The Company cannot make medical claims and is purely in a research and development phase with its partners. The Company cannot guarantee that any regulatory changes will occur or that such changes will benefit the Company or the psychedelic sector generally.
Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Forward-looking statements contained in this press release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263210
FAQ
What is the significance of DEA forwarding TRUFF's psilocybin rescheduling petition to HHS?
What would rescheduling psilocybin to Schedule II mean for Red Light Holland?
What recent testing milestone did Red Light Holland achieve in August 2025?
How is Red Light Holland positioned in the U.S. psychedelic research market?
What medical conditions could potentially be treated with TRUFF's psilocybin products?
