Past News Items - April 2024

In the News

CRN Adopts New Guidelines for Melatonin Supplements to Promote Responsible Usage

CAMH develops first ever clinically validated natural supplement to prevent postpartum blues

Renowned Alzheimer's Neurologist Dale Bredesen, MD, Joins Pacific Neuroscience Institute

Dr. Paul Savage Unveils Pioneering Plasma Exchange Protocol: Reverses Toxins & Inflammation

Innocan Pharma Initiates FDA Approval Process for Liposome Injection Therapy for Chronic Pain

CRN Adopts New Guidelines for Melatonin Supplements to Promote Responsible Usage

The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, proudly announces the adoption of two sets of new voluntary guidelines: one focused on the formulation, labeling, and packaging of melatonin-containing dietary supplements marketed for sleep support, and another dedicated to the labeling of gummy dietary supplements. Adopted by CRN’s Board of Directors on March 28, 2024, these guidelines are a testament to CRN’s members’ commitment to establishing responsible marketing practices for the industry and ensuring the highest standards for consumer products.

The updated melatonin guidelines provide recommendations addressing intentional overages during manufacturing, child-deterrent packaging, and precautionary label statements for melatonin-containing products. These guidelines are designed to ensure that consumers have access to products that are responsibly formulated, labeled and packaged.

With the growing popularity of gummy dietary supplements among consumers of all ages, CRN’s new guidelines for gummy supplements specifically address the unique aspects of these products. The new recommendations focus on labeling clarity, reducing unsupervised access by children, addressing potential choking hazards for small children, and ensuring products are used as intended.

Key Updated Recommendations for Melatonin Supplements:

·       Labeling Instructions: The revised melatonin guidelines call for cautionary label statements alerting consumers that melatonin may cause drowsiness, not to take with alcohol, and that the products are intended for intermittent or occasional use only.

·       Overages During Manufacturing: While recognizing that federal regulations require dietary supplement to contain at least 100 percent of their labeled amounts throughout shelf life, the guidelines recommend that any overages of melatonin added during manufacturing be informed by data to support stability and safety.

·       Child deterrent packaging: While federal regulations do not require child deterrent closures for melatonin-containing products, CRN’s revised guidelines call for industry members to adopt child deterrent packaging for products containing melatonin that are in flavored chewable forms that could be especially attractive to children. This recommendation provides parents and caregivers with a tool to prevent unsupervised access to these products.

·       CRN members are being asked to adopt these guidelines for melatonin-containing supplements within 18 months.

Key Recommendations for Gummy Form Supplements:

·       Targeted Advisories: Detailed labeling advisories for products aimed at both adults and children include specific considerations for gummy supplements intended for young children and underscore the importance of using these products under appropriate conditions and guidance.

·       Avoiding Potential Choking Hazards: For products intended for children under 4 years of age, the guidelines recommend a precautionary statement that if not chewed properly, the product could present a potential choking hazard.

·       Packaging Considerations: The recommendations ask manufacturers to consider packaging gummy products in containers with child deterrent closures (e.g., by evaluating various product attributes like ingredient profiles, serving amounts, and total package contents, when making their packaging choices).

·       CRN members are being asked to adopt these guidelines for gummy supplements within 24 months.

“These are just the latest in a series of Voluntary Guidelines that CRN members have adopted that underscore CRN’s unwavering commitment to the well-being of consumers and the integrity of the dietary supplement market,” said CRN President and CEO, Steve Mister. “By setting these high standards, we help our members offer products that are responsibly manufactured and marketed, and widely trusted by consumers.”

CRN urges its members and the broader industry to adopt these guidelines as soon as practicable, with specific implementation timelines provided for each set of guidelines to facilitate a smooth transition.

The Council for Responsible Nutrition (CRN) has developed a collection of self-regulatory practices aimed at enhancing the safety, clarity, and efficacy of dietary supplements and functional foods across various categories. These include specific guidelines for caffeine-containing supplements, enzyme dietary products, and the provision of product information for e-commerce purchases. There are also guidelines to ensure the right iodine levels in supplements for pregnant and lactating women, as well as on the formulation, labeling, and packaging of probiotics. Other voluntary programs address the complex area of supplements containing proprietary blends, protein labeling, and a prohibition on SARMs-containing supplements. CRN members are also required to participate in the Supplement OWL, the industry’s voluntary label registry managed by CRN. This comprehensive framework is designed to uphold the highest standards of consumer safety and product transparency in the industry.

To view a complete list of CRN’s Voluntary Guidelines and Best Practices, visit: https://crnusa.org/self-regulation/voluntary-guidelines-best-practices

###

About CRN:

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. CRN is dedicated to advancing the science, safety, and regulation of its industry to promote the well-being of consumers worldwide.

CAMH develops first ever clinically validated natural supplement to prevent postpartum blues

A new study published in the Lancet discovery science journal eClinicalMedicine has confirmed that a novel natural supplement—invented, researched, developed and commercialized at the Centre for Addiction and Mental Health (CAMH)—prevents postpartum blues, and reduces symptoms of postpartum depression over the following six months after giving birth.

CAMH researcher Dr. Jeffrey Meyer provides details about his invention, the first ever clinically validated natural supplement to prevent postpartum blues.

CAMH researcher Dr. Jeffrey Meyer provides details about his invention, the first ever clinically validated natural supplement to prevent postpartum blues.

Centre for Addiction and Mental Health (CAMH) researcher Dr. Jeffrey Meyer stands with his invention, the first ever clinically validated natural supplement to prevent postpartum blues. Image courtesy of CAMH. All rights reserved. (CNW Group/Centre for Addiction and Mental Health)

Centre for Addiction and Mental Health (CAMH) researcher Dr. Jeffrey Meyer stands with his invention, the first ever clinically validated natural supplement to prevent postpartum blues. Image courtesy of CAMH. All rights reserved. (CNW Group/Centre for Addiction and Mental Health)

Up to 8 out of ten new mothers experience postpartum, or 'baby,' blues, characterized by mood swings, crying spells, anxiety and difficulty sleeping. The condition usually begins within the first few days after delivery and may last for up to two weeks. Postpartum blues strongly raises the risk of postpartum depression, a serious mental illness affecting 13 per cent of mothers. Postpartum depression has important health care consequences: impairing quality of life, increasing risk for future depressive episodes and suicide, and is associated with cognitive and emotional effects in children. Until now, options for widespread prevention have been lacking for either condition.

The study, entitled Dietary Supplement for Mood Symptoms in Early Postpartum: A Double-Blind Randomized Placebo Controlled Trial, involved more than 100 postpartum participants between January 2019 and December 2022 who either took four doses of the natural supplement several days after giving birth, or a matching placebo. Within the supplement group, two-thirds (66 per cent) experienced either no symptoms or only negligible symptoms of postpartum blues. Furthermore, in the following six months, participants who received the supplement experienced less symptoms of depression with none reaching the clinical threshold of postpartum depression six months after giving birth.

"Globally 140 million births take place every year. Most women then experience postpartum blues, which, when severe, increases the likelihood of getting full-blown postpartum depression at least fourfold. Our study showed that both postpartum blues and later symptoms of depression were lower in women who received the dietary supplement," said Dr. Jeffrey Meyer, inventor of the nutraceutical and study senior author. "Providing this specialized dietary support in the first few days after giving birth is a crucial window to avoid depressive symptoms which is tremendously important given there is considerable risk that they may recur and have lifelong impact."

Dr. Meyer has been investigating postpartum blues for more than 15 years. His previous imaging research found that a protein called MAO-A rises dramatically in the brains of postpartum women and this protein removes important brain chemicals—like serotonin and dopamine—that support normal mood. It also acts as an oxidant and is linked to the development and progression of certain mental illnesses. To combat this effect, the nutraceutical is made up of a patented unique combination of natural ingredients, including blueberry extract, which contain antioxidants, and amino acids that replenish essential neurochemicals in the brain to support healthy mood and the ability to concentrate under stress. The supplement was well tolerated and women who took it tended to report less symptoms, in part due to less drowsiness, headache and restlessness. The researchers previously showed that the amino acids in the supplement do not affect their total concentrations in breast milk, which was expected since these amino acids are already found in proteins in breast milk.

CAMH has partnered with international women's health supplement and pharmaceutical company Exeltis via a licensing agreement to bring the product to market under the name Blues Away®. Exeltis has maintained the natural health product approach in their preparations and manufacture for widespread distribution of the supplement. It is expected that the product will be available for sale in the U.S. beginning April 11, 2024. It is also in the process of being brought to other global markets—including Canada—with the pace of approvals being dependent on each country's regulatory requirements and reviews.

"We are thrilled to unveil the culmination of years of dedication and collaboration in the form of our groundbreaking nutraceutical for postpartum blues prevention. It is great that we are able to simultaneously share our clinical research around this product while also partnering with a global women's health industry leader to make it available to the new mothers who need it," said Klara Vichnevetski, Director of Industry Partnerships and Technology Transfer. CAMH has nurtured this innovation from its inception, guiding it from bench to bedside where it can make an immediate and profound difference in the lives of millions of women and their families."

A limitation of the study was that, of the several measures of depression in the study, the supplement did not demonstrate the expected protective effect in an experimental test that involves inducing low mood with sad stimuli, although it is possible that the stress of the COVID-19 pandemic and moving the setting of the study to participants' homes during the pandemic may have influenced the results of this particular test.

Aristotle Voineskos, Vice President of Research, added: "Two major pillars of our CAMH approach to research are the importance of integrating scientific findings into advancing mental health care and the value of early intervention. Through the perseverance and dedication of our researchers and technology transfer team, this novel preventative therapy may contribute to best practice when it comes to postpartum care and help women around the world avoid more serious and chronic mental illness."

This research was funded by CAMH, with some additional funding from Exeltis.

About the Centre for Addiction and Mental Health (CAMH)

CAMH is Canada's largest mental health and addiction teaching hospital and a world leading research centre in this field. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental illness and addiction. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please visit camh.ca or follow @CAMHnews on Twitter.

Renowned Alzheimer's Neurologist Dale Bredesen, MD, Joins Pacific Neuroscience Institute

Pacific Neuroscience Institute® (PNI) is thrilled to announce that Dale Bredesen, MD, has joined Pacific Neuroscience Institute®. Over the past four months, as the senior director of the nascent Precision Brain Health program, he and his colleagues have been intensely focused on developing what promises to be the world's first formalized system to comprehensively address neurodegenerative disease in the world. While not quite ready for primetime, the excitement around the clinical implications for patients is palpable.

"We are entering a new era in medicine," says Dr. Bredesen. "Younger generations should not have to live with the fear of Alzheimer's. At PNI, we will be implementing the methodologies that have arisen from my lab's three decades of fundamental research as well as our published success. Taking a personalized, biological systemwide approach and becoming proactive about interventions, represents the first steps towards stopping Alzheimer's in its tracks."

Cognitive decline is a complex and chronic process that requires a multimodal approach, he explains. "We recommend that everyone begin active prevention when they turn forty, and get a 'cognoscopy', to assess their cognitive health and risk factors. Our protocol recommends targeted, individualized treatments of specific chronic infections (which often go undiagnosed) and identifies cognition-compromising toxins (which are also often unrecognized). Along with implementing lifestyle adjustments, we see a lot of hope."

Dr. Bredesen, a trailblazer in cognitive decline research and author of the first published report of reversal of cognitive decline, is an internationally recognized neurologist with expertise in the mechanisms of neurodegenerative diseases. His years of clinical study and neurological research have opened the door to new approaches of treatment, leading to the ReCODE Protocol™. Also known as the Bredesen Protocol, this methodology has emerged as a viable attempt to prevent, arrest, and reverse symptoms of cognitive decline associated with conditions such as Alzheimer's disease, other dementias, and mild cognitive impairment.

"As a medical community, we have had very little to offer our patients living with diseases of cognitive decline. Hundreds of clinical trials have resulted in disappointment," comments David A. Merrill, MD, PhD, director of the Brain Health Center at PNI. "Dr. Bredesen's pioneering work over the last thirty years, along with over two hundred peer-reviewed publications, and more than thirty patents have pointed to tremendous promise. Now we are able to 'prescribe' lifestyle interventions such as exercise and nutrition recommendations, as well as other precision health interventions, that together can materially move people onto an alternate life trajectory – one that could circumvent cognitive decline."

PNI Foundation launched a separate Brain Wellness & Lifestyle educational program led by Karen Miller, PhD, and her team of expert brain health coaches in 2022. They are already helping hundreds of clients through customized courses that incorporate lifestyle recommendations along with both physical and cognitive training.

Dr. Bredesen is working closely with Dr. Merrill on the clinical side of brain health and Dr. Miller on the lifestyle intervention side. "The Precision Brain Health program will integrate both of these aspects of care along with complete cognitive testing, genetic analysis, phenomic (biochemical) analysis, long term action plans, and more," explains Dr. Bredesen. "I'm optimistic that outcomes will continue to improve—we are seeing that people with cognitive decline can, and do, get better. Pacific Neuroscience Institute has a history of innovation that fits perfectly with the development of this novel program."

More than six million Americans live with Alzheimer's disease—the most common type of dementia—suffering progressing symptoms of memory loss, confusion, behavioral change, and the loss of body control. It is unusual that deep scientific research comes to mainstream awareness, yet with a cure—or even an effective treatment—being frustratingly elusive, Dr. Bredesen's 2017 New York Times bestselling book, The End of Alzheimer's, captured the public's attention. The End of Alzheimer's Program and The First Survivors of Alzheimer's, further provide documentation of individuals who reversed their cognitive decline using the ReCODE Protocol.

"A multidisciplinary approach to complex problems of the brain and mind has been foundational to our success at PNI and specifically at the Pacific Brain Health Center since its inception in 2018. As we hone the Precision Brain Health program, our aspirational goal is to provide actionable and realistic options to improve brain health and overall quality of life," says PNI director and founder, Daniel F. Kelly, MD. "So far, results from clinical trials, and evidence-based lifestyle practices suggest that with Dr. Bredesen's vision and multipronged approach, we may begin to see substantial numbers of dementia patients achieve a slowing and, in some cases, even a sustained reversal of cognitive and memory decline."

Dr. Bredesen earned his medical degree from Duke University Medical Center and served as chief resident in neurology at the University of California, San Francisco, before joining Nobel laureate Stanley Prusiner's laboratory at UCSF as an NIH postdoctoral fellow. Prior to joining PNI, Dr. Bredesen held University of California faculty positions at UC San Francisco, UCLA, and UC San Diego. He directed the Program on Aging at the Burnham Institute and joined the Buck Institute as founding president and CEO. Currently, in addition to his role at PNI, he is chief scientific officer at Apollo Health.

About Pacific Neuroscience Institute

Pacific Neuroscience Institute® is devoted to the comprehensive care of patients with a wide spectrum of neurological and cranial disorders. Dedicated teams of specialists, state-of-the-art facilities, and the use of leading-edge treatment along with our collaborative approach ensure that each patient receives the attention they require for successful treatment and recovery. PNI's specialty clinics are located at award winning hospitals Providence Saint John's Health Center in Santa Monica, Providence Little Company of Mary Medical Center in Torrance, and Saint Joseph Medical Center in Burbank, California. PacificNeuro.org

Dr. Paul Savage Unveils Pioneering Plasma Exchange Protocol: Reverses Toxins & Inflammation

New research indicates plasma exchange therapy reverses toxins and increases lifespan. In a landmark presentation at the 2024 Age Management Medicine Group (AAMG) Conference in Miami, FL, MDLifespan's CEO, Dr. Paul Savage, will announce incredible data from a groundbreaking protocol that is set to revolutionize the medical industry. The research presents staggering statistics showing the potential to reduce all toxins from the body, with unprecedented results in improving inflammatory biomarkers.

The Toxic Reality: Stats That Startle

Living in today's world means grappling with an onslaught of toxins, from contaminated air and water to pesticide-laden food. According to recent World Health Organization data, toxins are now the leading cause of death, surpassing even heart disease at 25%. Dr. Savage's findings shed light on this crisis, revealing that toxins contribute to heart disease, cancer, Parkinson's, Alzheimer's Disease, and more.

Plasma Exchange: A Paradigm Shift

Therapeutic plasma exchange (TPE), the cornerstone of MDLifespan's patented protocol, offers a practical solution to mitigate the impact of over 144,000 toxins that affect the body. Like an oil change for the body, TPE systematically removes harmful substances from the bloodstream, replacing them with revitalizing fluids. The patented protocol not only reduces toxin levels but also rejuvenates the body's internal environment, tackling inflammation, oxidative stress, and bolstering the immune system.

TPE Key Data Highlights

Dr. Savage and his international team of scientists' protocol revealed remarkable improvements:

·         Heavy Metals decreased by an average of 80%, with Aluminum showing a remarkable 100% decrease

·         Phthalates decreased up to 97%

·         Environmental toxins decreased up to 95%

·         Health biomarkers improved up to 95%

·         Inflammation decreased up to 50%

·         Oxidative stress decreased up to 50%

·         Immune system improved up to 40%

Commitment to Accessibility and Further Research

Looking ahead, Dr. Savage and his team are writing and publishing articles on this protocol in various prestigious journals. MDLifespan is dedicated to refining and disseminating this protocol to ensure its accessibility to all who stand to benefit. Through continued research and collaboration, the company aims to unlock the full potential of plasma exchange in promoting vitality, health, and wellness.

"Our mission is to ensure that patients have the tools to take control of their health, now and in the future," said Dr. Savage. The convergence of 30 years of expertise in medical research and technological innovation has created a paradigm shift in our approach to the existential threat of environmental toxins, MDLifespan stands at the forefront of a transformative era.

About Paul Savage, M.D.

Dr. Paul Savage is a seasoned ER/trauma physician who transformed his career by embracing the health and wellness field of medicine. After struggling with personal health issues, he explored various healing modalities and adopted an evidence-based approach that combines traditional and innovative treatments. Today, Dr. Savage is a vibrant advocate for optimal health, dedicating his practice to helping others achieve wellness through a blend of various conventional therapies.

About MDLifespan

MDLifespan is at the forefront of precision medicine, spearheading research and innovation to redefine aging. Led by Dr. Paul Savage, MDLifespan's mission is to empower individuals to reclaim vitality and rid their bodies of dangerous toxins. For more information, visit www.mdlifespan.com.

Join the conversation: #ReverseAging #ReduceToxins #PlasmaExchange #HealthspanEqualsLifespan

SOURCE MDLifespan

Innocan Pharma Initiates FDA Approval Process for Liposome Injection Therapy for Chronic Pain

Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) ("Innocan" or the "Company"), is pleased to announce that is has reached a key milestone: the Company submitted its letter of application for a Pre-IND meeting, the first phase in the FDA approval process in the United States for Innocan's Liposome-Cannabidiol (LPT-CBD) injectable treatment of chronic pain.

With the global market for pain therapeutics widely expected to exceed US$100 billion by 2032[1], LPT therapy which requires only one single monthly subcutaneous injection, is positioned as a highly attractive alternative to opioid-based approaches. Opioids have and continue to take a significant human toll in recent years, with more than three-quarters of drug overdose deaths in the United States involving opioids, according to the United States Center for Disease Control and Prevention[2].

Innocan's therapy has shown consistent efficacy in multiple pre-clinical trials in recent years of it's LPT-CBD injectable treatment through prolonged and controlled release of CBD in animals with chronic pain conditions. Innocan's Pre-IND Meeting Request Letter to the FDA is a key milestone and important first step in seeking approval of its LPT-CBD therapy for use in humans. At the Pre-IND meeting, the objective will be to obtain guidance from the FDA on the preclinical and clinical development plan, enabling the initiation of an Investigational New Drug (IND) program in the United States.

Iris Bincovich, CEO of Innocan, commented: "We are extremely excited to embark on this next stage in the development of LPT-CBD injectables, this is a major Milestone for Innocan Pharma. We have invested significant effort and many thousands of person-hours in its research and development, accumulating a wealth of preclinical data that will serve as the foundation for our participation in the FDA process. This is a key milestone for Innocan and marks our first step towards the FDA's recognition of our technology. We see significant potential for our therapy, with an addressable market for pain management therapeutics expected to exceed US $100 billion by 2032, and we look forward to tapping that."

Dr. Joseph Pergolizzi, Innocan's FDA Advisory Board Member, added:

"We have worked hard to catalogue the data collected as part of our animal LPT therapy testing program and prepare it for the FDA. We look forward to working under FDA guidance, with the goal of completing the review process as quickly and efficiently as possible. We believe that Innocan's unique treatment method, if and when it should become FDA-approved has the potential of being a highly valuable non-opioid addition in the medical arsenal of the management of chronic pain."

About Innocan

Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies based on advanced cannabinoids science, to treat various conditions to improve patients' quality of life. This segment involves two drug delivery technologies: (i) LPT CBD- loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for: Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment, Innocan has established a joint venture by the name of BI Sky Global Ltd. that focuses on advanced targeted online sales. https://innocanpharma.com/

For further information, please contact:

For Innocan Pharma Corporation:

Iris Bincovich, CEO

[email protected]

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Cautionary note regarding forward-looking information

Certain information set forth in this news release, including, without limitation, information regarding research and development, collaborations, the filing of potential applications with the FDA and other regulatory authorities, the potential achievement of future regulatory milestones, the potential for treatment of conditions and other therapeutic effects resulting from research activities and/or the Company's products, requisite regulatory approvals and the timing for market entry, is forward-looking information within the meaning of applicable securities laws. By its nature, forward-looking information is subject to numerous risks and uncertainties, some of which are beyond Innocan's control. The forward-looking information contained in this news release is based on certain key expectations and assumptions made by Innocan, including expectations and assumptions concerning the anticipated benefits of the products, satisfaction of regulatory requirements in various jurisdictions and satisfactory completion of requisite production and distribution arrangements.

Forward-looking information is subject to various risks and uncertainties which could cause actual results and experience to differ materially from the anticipated results or expectations expressed in this news release. The key risks and uncertainties include but are not limited to: general global and local (national) economic, market and business conditions; governmental and regulatory requirements and actions by governmental authorities; and relationships with suppliers, manufacturers, customers, business partners and competitors. There are also risks that are inherent in the nature of product distribution, including import / export matters and the failure to obtain any required regulatory and other approvals (or to do so in a timely manner) and availability in each market of product inputs and finished products. The anticipated timeline for entry to markets may change for a number of reasons, including the inability to secure necessary regulatory requirements, or the need for additional time to conclude and/or satisfy the manufacturing and distribution arrangements. As a result of the foregoing, readers should not place undue reliance on the forward-looking information contained in this news release concerning the timing of launch of product distribution. A comprehensive discussion of other risks that impact Innocan can also be found in Innocan's public reports and filings which are available under Innocan's profile at www.sedar.com.

Readers are cautioned that undue reliance should not be placed on forward-looking information as actual results may vary materially from the forward-looking information. Innocan does not undertake to update, correct or revise any forward looking information as a result of any new information, future events or otherwise, except as may be required by applicable law.

[1] https://www.gminsights.com/industry-analysis/pain-management-drugs-market

[2] https://www.cdc.gov/opioids/data/index.html