dylanramsey – Page 5

Court sides with Brazilian patient over import of CBD product

Posted on June 23, 2021February 21, 2022 by dylanramsey

Source: HempToday.net | Author: HempToday | June 22, 2021

A Brazilian medical CBD patient has received a reward of R$10,000 (~$2,000) for distress suffered when the government refused to import a specific CBD product upon request.

The unnamed patient received the favorable judgment on appeal after a lower court had refused his request to import CBD from NuLeaf, a U.S. based producer of hemp-derived cannabinoid products.

While an original civil filing won a judgment that health insurance cooperative Unimed indemnify the patient after refusing to import the CBD product, a second court dismissed the request before it was reinstated in a final ruling.

Health risks

The patient claims he has generalized anxiety and needs the NuLeaf product, which was recommended to him by a medical doctor. He claimed psychological distress and cited risks to his health in seeking redress in the case.

In its original dismissal of the request, the lower court said even though CBD-based medicines are importable with special authorization from the Brazilian Health Regulatory Agency (ANVISA), NuLeaf is not specifically authorized by the agency.

But the magistrate in the final appeals case said a government resolution on the import and use of CBD-based medicines de facto means products that meet certain criteria are eligible for import into Brazil.

Clinical Study Reports No Evidence of Liver Toxicity in CBD

Posted on March 24, 2021February 21, 2022 by dylanramsey

Source: Hemp Supporter | Author: Hemp Supporter | Mar 24, 2021

We’re excited to announce the results of an important clinical study conducted by ValidCare on CBD: Preliminary results reveal no evidence of liver toxicity.

Since passage of the 2018 Farm Bill, the FDA has been investigating a pathway to regulate the sale of ingestible hemp-derived CBD products. Unfortunately, the agency has not taken any concrete steps, claiming that it needs more real-world data on CBD’s safety profile.

As part of the hemp industry’s continuing effort to provide FDA data, ValidCare commissioned a study and concluded that “preliminary findings show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions.”

Major kudos to ValidCare, as well as to the US Hemp Roundtable members who funded and participated in the study: American Shaman, CBD Distillery, Charlotte’s Web, Hemp Fusion, Kannaway and Medterra.

Evidence like this confirms that it is high time for FDA to legally recognize and regulate ingestible hemp-derived CBD products. That’s why it’s so important that Congress pass HR 841, which would establish a legal pathway for the sale of hemp-derived extracts as dietary supplements.

Please use our online portal to email your U.S. Representative today, urging him or her to co-sponsor HR 841.

U.S. Hemp Roundtable States Opposition to “Legal” Hemp-Derived THC

Posted on March 10, 2021April 30, 2021 by dylanramsey

Source: Whole Foods Magazine | Author: Whole Foods Magazine Staff | Mar 9, 2021

The U.S. Hemp Roundtable has released a statement against the marketing of products for their intoxicating or euphoric effects under the guise of hemp, which has made headlines in New York Times and Rolling Stone.

The Times pointed to Hometown Hero CBD, a company based in Austin, Texas, which sells joints, blunts, gummy bears, and more that can get people high—they contain Delta-8-THC, which can be extracted from hemp. Delta-9-THC is explicitly outlawed under federal law, the Times explains, but Delta-8-THC from hemp is not, allowing companies to market drug products as hemp, legally.

Rolling Stone explains that Delta-8 isn’t as psychoactive as Delta-9, offering a high that is “less sedative and more functional than Delta-9.”

However, while Delta-8-THC is technically legal when derived from hemp, Joseph Hoelscher, Founding Member of the Texas Association of Cannabis Lawyers, told Rolling Stone that “the process most commonly used to produce Delta-8—synthetically altering CBD into Delta-8-THC—probably isn’t legal.” Delta-8 only exists in tiny amounts in hemp, so it is far more cost-effective to alter CBD in a process that is, in fact, federally banned.

The Hemp Roundtable is categorically against this, according to their statement. “Unlike marijuana, hemp is, by definition, not intoxicating,” the statement says. “Rather hemp products like CBD are popularly used by consumers to benefit their general health and wellness, not to get them high. Adult-use cannabis products, which feature concentrated THC and are intended for intoxication, should not be marketed as dietary supplements, and should be subject to a distinct regulatory pathway. We look forward to working with Congress and federal agencies to develop responsible laws and regulations to provide separate pathways and proper guardrails to distinguish these products.”

A first step, according to the statement: HR 841, which would establish a regulatory pathway for the sale of hemp-derived extracts. “This bill will help stabilize hemp markets, open a promising economic opportunity for U.S. farmers, and protect consumers by requiring hemp extract product manufacturers to comply with the entire existing comprehensive regulatory framework for dietary supplements.”

Cannabis & COVID19 Patients: New Insights from Israel

Posted on February 28, 2021April 30, 2021 by dylanramsey

STERO Biotechs, headquartered in Israel, provides insight into the use of cannabis and CBD as potential treatment for COVID-19 and other conditions

Source: Health Europa | Author: Dr Sari Prutchi Sagiv, Chief Science Officer | Jan 29, 2021

Thanks to universal access to a well-organised healthcare system and constant scientific advances, Israel has had relatively fewer severe cases and deaths in the COVID-19 pandemic.

For decades, Israel has also been a pioneer in investigating the potential mechanisms of action and uses of cannabis and its derivatives for a wide range of medical conditions. STERO Biotechs, a research and development start-up, is committed to the research and development of novel cannabidiol (CBD)-based treatment solutions which will potentially benefit millions of patients. STERO works to achieve further knowhow in its quest for more effective treatments for COVID-19 patients, among other conditions.

Cannabis and COVID-19: friends or foes?

An array of literature has been written on CBD and cannabis as potential treatments for COVID-19. It is important to understand that, depending on the stage of the disease, cannabinoids could either help or harm a patient; as each phase of the disease is likely to require very different treatments. In the early stages, patients must mount an immune response to combat the virus so their immune system must be at its best. In the later stages, however, if a patient with a severe case of COVID-19 develops a cytokine storm, the immunosuppressive function of cannabinoids might be used to fight off its harmful, often fatal effects. Evaluating the safety and efficacy of isolated cannabinoids or Cannabis in general, at various stages of COVID-19 infection in clinical settings, is key.

STERO Biotechs is supporting a clinical study to evaluate the safety and efficacy of STERO’s CBD solution for treating patient cytokine storms in severe stages of COVID-19. STERO has extensive experience working with CBD-based drug development from previous trials performed in over 150 patients with Graft Versus Host Disease (GVHD), Steroid-Dependent Crohn’s Disease, Chronic Urticaria, and more; searching for effective ways of reducing or eliminating patients’ dependence on steroids, as well as helping patients who are refractory to steroids to respond to them.

Cannabis in the early stages of COVID-19

Under normal circumstances, whenever the immune system senses an infection or inflammation, the body releases cytokines into the bloodstream. Cytokines are – proteins, peptides, or glycoproteins secreted by specific cells of the immune system which mediate and regulate immunity, inflammation, and haematopoiesis – by rushing to the site and communicating to white blood cells which virus or cell to attack. Once the infected or damaged cell is destroyed, the cytokines disperse; and the destroyed cells are carried away as waste.

As cytokines play a crucial role in fighting off infections, reducing them as a preventative measure or in early stages of the infection may be a bad idea. Many authorities caution against using cannabis agents in early stages of infection because cannabis and specific cannabinoids such as CBD and THC suppress immune responses.

Patients with weakened immune systems are at higher risk of getting gravely sick or remaining infectious for a longer period of time than others with COVID-19. There are many reasons a person may be immunocompromised or have a weakened immune system, including a solid organ, blood, or bone marrow transplant; immune deficiencies; and prolonged use of corticosteroids or treatments with other immune weakening medicines.¹

However, some evidence does indicate that several high-CBD extracts can inhibit viral cell entry and spread by decreasing angiotensin-converting enzyme 2 (ACE2) receptor levels, a receptor expressed in lung tissue and the oral and nasal mucosa that SARS-CoV-2 uses for entry into a human host.² As this data is from in vitro studies only, it is not conclusive and requires further large-scale validation and clinical studies.

Furthermore, observation in patients being treated with other immunosuppressants or anti-tumour necrosis factor (TNF) alpha biologics for inflammatory bowel disease (IBD) or rheumatoid arthritis, indicates they seem to fare better than the general population, needing less hospitalisation, and not reaching the most severe stages of COVID-19.³ Trials are still ongoing using various anti-TNF alpha treatments.

Cannabinoids and cytokine storms in patients with severe COVID-19 infection

Various studies have shown that cytokine storms, resulting in acute respiratory distress syndrome (ARDS), are a leading cause of death in severe COVID-19 cases. In some cases where cytokine release is necessary, the immune system overreacts, releasing too many proinflammatory cytokines like interleukins IL-6 and IL-1β, as well as immune cells like neutrophils and monocytes. This hyperinflammation is called a cytokine storm; and can become dangerous to patients’ health as the immune system attacks the body’s own cells instead of the virus, meaning patients may experience high fever, inflammation, severe fatigue, and nausea. In extreme cases, known as hypercytokinaemia, a cytokine storm can become life-threatening and even cause organ failure.

In these cases, the lungs fail to remove harmful gases like carbon dioxide and are unable to efficiently provide oxygen to the body. This helps the virus multiply rapidly in the lungs, resulting in respiratory conditions such as ARDS.

Endocannabinoids produced in the respiratory system and cannabinoid-induced bronchial dilation suggest a significant therapeutic potential for cannabinoids in the treatment of respiratory diseases, including COVID-19-induced ARDS. Several studies mimicking lung damage caused by ARDS in mice show that CBD improved clinical symptoms, significantly improved the levels of oxygen, and reduced the levels of inflammation-promoting cytokines caused by COVID-19 induced ARDS.⁴ Detailed examination showed that CBD partially or totally reversed the damage caused to the lungs, such as tissue overgrowth, scarring and swelling. A study showed the reason for this is a significant increase in the levels of apelin, a peptide made by cells of the heart, lung, brain, fat tissue and blood that works in reducing inflammation. In the ARDS model, apelin levels dropped close to zero in the lungs and blood, but when scientists gave the mice CBD, apelin levels increased by 20 times.⁵

Whole plant cannabis extracts have also been shown to reduce blood coagulation in animal models.⁶ It is known that many of the negative systemic effects of COVID-19 appear to be related to altered coagulation, so it is possible that cannabis may be useful in managing these sequelae too.

However, despite all the observations above together with less grounded rumours and promises, there remains little clear evidence regarding the effect of cannabis on the course of COVID-19.

Exercising caution

A survey of over 1,500 cannabis users in the Netherlands ⁷ showed that during the lockdown, habitual users increased rather than decreased cannabis consumption regarding both frequency and quantity: 41.3% of all respondents reported they had increased their cannabis use since the lockdown measures and 49.4% used it as often as before. Only 2.8% stopped temporarily. One third of those who were not daily users before the lockdown began to use cannabis daily or close to daily.

In the US, cannabis use increased among seniors between 2015 and 2018.⁸ This is of concern because the most serious complications and highest mortality rates from COVID-19 infection occur in older people.⁹Weakly or unsupported claims on the internet that cannabis use can prevent COVID-19 may have encouraged its use.

Risk may become heightened for regular cannabis smokers: as COVID-19 predominantly kills people by harming their lungs, it seems logical to think that patients whose lungs are irritated and inflamed have a higher risk of lung damage and complications from COVID-19.

Both the FDA and the WHO advise against smoking cannabis to treat COVID-19

Several CBD producers and vendors claiming their products can be used to mitigate the symptoms of or treat COVID-19 have been issued warnings by the US Food and Drug Administration (FDA), which considers the sale and promotion of products with unsubstantiated claims of treating COVID-19 to be a threat to public health. Dubious products promising to cure, treat, or prevent COVID-19 have not been properly evaluated for safety and effectiveness. The main concern is that people may be given the false perception that they are protected from contracting the virus, in the best case; or in the worst, cause them to delay or avoid appropriate medical treatment altogether, leading to serious and potentially fatal outcomes.

The STERO Biotechs contribution to COVID-19 research

STERO Biotechs will supply and support a clinical trial, covered by its IP for Cannabidiol Treatment of Severe and Critical COVID-19 Pulmonary Infection, at Rabin Medical Center (RMC) in Israel, as part of the global effort to fight COVID-19.

The investigator-initiated clinical study running in cooperation with STERO and Mor Research Applications, the TTO arm of Clalit, commenced with the onset of the ‘second wave’ rise in the number of COVID-19 patients in Israel. The trial has already received Helsinki Committee approval and plans to include 20 patients as a Proof of Concept (POC), using STERO’s CBD-based treatment. It will be conducted by Dr Ilya Kagan from the Intensive Care department at RMC.

The study aims to help severely affected COVID-19 patients with respiratory failure stemming from ARDS. The treatment cycle will be 14 to 28 days with a subsequent follow-up period of the same length. Pending the success of this POC, STERO plans to expand and scale to a Phase 2a multicentre study with 40 additional patients, under FDA clinical trial guidelines and regulations.

Founded in 2017 and headquartered in Israel, STERO Biotechs is a clinical-stage company committed to research and development of novel cannabidiol (CBD)-based treatment solutions that will potentially benefit millions of patients by enhancing the therapeutic effect of steroid treatments; lowering the dosage of steroids needed in such treatments, thus reducing their terrible side effects; and allowing refractory patients to begin responding to the steroid treatments they need, all by using STERO’s CBD-based treatment. STERO’s patent was issued in the US and covers over 130 indications by name, CBD from any source (botanical or synthetic), any dosage, in any combination and any delivery system. The company currently has two ongoing Phase 2a clinical trials and is planning to commence more clinical trials in 2020-2021 for various indications.

One of STERO’s main partners and shareholders is MOR Research Applications, the technology-transfer arm of the Clalit Health Services, a 360° HMO, the largest in Israel and second largest in the world. Clalit owns 14 hospitals and around 2,000 clinics, employs 9,000 physicians who provide care for over five million patients. MOR manages the process of finding new indications and commercialising the ideas and inventions conceived at Clalit, so everybody wins: researchers, industry partners, and the public at large.

The concepts of Talent Biotechs and STERO were conceived by one of these physicians and all resources of this gigantic, well-oiled HMO mechanism are available for the continuation of our research and trial work.

References

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html#immunocompromised-state
Wang, B et al. Aging (Albany NY); 2020 Nov 22;12(22):22425-22444.
Robinson et al. The Lancet, Vol. 2, Issue 11, E653-E655, November 01, 2020
Khodadadi, H et al. Cannabis Cannabinoid Res. 2020; 5(3): 197–201
Salles, E et al. Journal of Cellular and Molecular Medicine. 15 October, 2020
Coetzee, C et al. Phytomedicine 2007 May;14(5):333-7
Van Laar, M et al. Front. Psychiatry, 21 December 2020
Han, BH et al. JAMA Intern Med. (2020) 180:609–11
Onder, G et al. JAMA. (2020) 323:1775–6

Health Benefits of CBD

Posted on February 28, 2021April 30, 2021 by dylanramsey

The list of health benefits below may be applicable. Always consult your medical professional before taking any cannabinoid product.

A Closer Look at CBD & Skincare

Posted on February 27, 2021April 30, 2021 by dylanramsey

Source: Aesthetic Authority | Author: Katie Hobbins | Sep 17, 2020

CBD is said to hold anti-inflammatory and analgesic properties, and may help to treat dry skin, psoriasis, eczema, and acne.

Seen everywhere from Sephora and Target to the local supermarket and gas station, cannabidiol (CBD) has the potential to be the next blockbuster ingredient in supplements and skincare.

And if your patients haven’t asked about it yet, they will soon.

While more information is needed to truly understand its potential benefits, the general public is driving significant growth of the global CBD skincare market—predicted to grow by nearly 25% over a six-year period.¹

“The global CBD skin care market size was valued at $633.6 million in 2018 and is anticipated to reach $3,484.00 million by 2026, with a CAGR of 24.80% during the forecast period,” according to Allied Market Research. “The CBD skin care market exhibits an incremental revenue opportunity of $2,747.4 million from 2019 to 2026.”¹

The normalization and popularity of CBD in recent years is in part due to loosening laws surrounding cannabis, but its suggested wellness benefits have given the notorious plant legitimacy.

According to Matthew Zirwas, MD, FAAD, who spoke at last year’s Cosmetic Surgery Forum in Nashville, Tenn., CBD products can be made from hemp or marijuana, both of which are derived from the same plant family, Cannabis. Tetrahydrocannabinol (THC) is the principal psychoactive, or high-inducing, constituent. The plant can be bred with high levels of THC, which is classified as marijuana, or to have little to no THC, thereby classified as hemp.²

CBD is one of more than 80 cannabinoids taken from the flowers, stems, and leaves of the cannabis sativa plant. If CBD is extracted from the hemp plant, it has little to no THC. For areas where THC-containing products are still prohibited, CBD derived from hemp is considered legal.²

“There’s no official cutoff [for THC in CBD],” Dr. Zirwas says. “The closest thing to an official cutoff is 0.3%. If it has 0.3% or less of THC, it is considered hemp, but if it has 0.3% or more THC, the plant is considered marijuana.”

Marijuana meant to induce a high has a THC content of around 20%, he says.

CBD may be legal, but it is not regulated, and as a result, Dr. Zirwas says, almost all CBD products can be contaminated with enough THC to cause positive drug tests.

Also problematic, he says, is that some commercially available supplements and ingestables marketed as CBD actually contain hemp seed oil, which contains no CBD.²

Oral vs Topical CBD

Extracted in the form of a powder, CBD is usually mixed with various types of oils, including olive oil, coconut oil, or hemp oil, to work as a carrier to dissolve the compounds of the hemp plant. According to the CBD industry, CBD is a fat-soluble substance and the carrier oil signals the rest of the body to prepare for fat absorption. This increases the amount of CBD the body can absorb.³

While evidence says that it is theoretically possible for CBD products to offer benefits topically, Dr. Zirwas says that this information is often based on reasoning that there are cannabinoid receptors in the skin.

“Let’s clear the air,” says Dr. Zirwas. “There are cannabinoid receptors in the skin, and it has been proven that cannabidiol does not activate them.”

However, other non-cannabinoid receptor mechanisms have been proposed in a study in the Molecule journal by MDPI.

“… receptor mechanisms of CBD have been proposed, among them its agonism at serotonin 1A receptor (or 5-TH1A), vanilloid receptor 1 (TRPV1) and adenosine A2A receptors,” study authors write. “These data may help explain some of the observed CBD effects including analgesic, anti-inflammatory, anti-anxiety and anti-psychotic activity.”⁴

According to the same MDPI study, in vitro studies of topical CBD suggest sebostatic and anti-inflammatory effects. When applied topically, “It’s high lipophilicity means that CBD is expected to preferentially enter the skin via the transfollicular route and to accumulate in the sebaceous gland.”⁴

CBD shows promise, and may offer skin benefits, but scientific evidence is needed.

Examining CBD Skin Benefits

Before the legalization of cannabis in most of the United States, studies researching related skin benefits were almost nonexistent.

Now, its newfound mainstream popularity boasts anti-inflammatory and analgesic properties. In addition, scientists are finding more evidence for its use in treating dry skin, psoriasis, eczema, and acne.⁵

In a recent 2019 study, “A therapeutic effect of cbd-enriched ointment in inflammatory skin diseases and cutaneous scars,” researchers examined 20 patients suffering from psoriasis (n=5), atopic dermatitis (n=5), and resulting outcome scars (n=10) to whom they administered topical CBD-enriched ointment to lesioned skin twice daily for three months.⁵

After three months, researchers saw improved skin and inflammatory symptoms in study participants.

“Based on skin evaluations (hydration, TEWL, elasticity), clinical questionnaires (SCORAD, ADI, PASI), and supported by photographic data and investigators’ clinical assessment, the results showed that topical treatment with CBD-enriched ointment significantly improved the skin parameters, the symptoms and also the PASI index score,” according to the study. “No irritant or allergic reactions were documented during the period treatment.”

A 2014 study in the Journal of Drugs in Dermatology also found that CBD could help to suppress acne breakouts by regulating oil production of the sebaceous glands.⁶

Still, while Dr. Zirwas says CBD shows promise, nothing has been scientifically proven. CBD products may very well work, he says, but he emphasizes that there is no evidence that they do.

Even so, not all CBD is considered equal.

When discussing CBD with patients, Dr. Zirwas explains that while there is no scientific evidence that CBD works, topical CBD is unlikely to cause problems. Furthermore, it’s hard to know which products have quality CBD.

He suggests referencing ConsumerLab.com for insightful reviews of CBD supplements.

As for the need for concrete evidence in this area, Dr. Zirwas says, “A small, double-blinded study would be needed at minimum to establish the credibility of CBD products. Nothing anecdotal, no case report, no case series, nor any open label study could make it credible.”

References:

Bhandalkar, S., & Deshmukh, R. (2020, January). CBD Skin Care Market Size, Share & Trends | Research Report by 2026. Allied Market Research. https://www.alliedmarketresearch.com/cbd-skin-care-market
Zirwas, M. (2020, August 3). CBD and Cosmetics: Does CBD really work? Cosmetic Surgery Forum. https://www.cosmeticsurgeryforum.com/is-cbd-oil-in-beauty-products-worth-the-hype/
Oleinik, G. (2020, August 9). What’s in Your CBD Oil? Why Carrier Oil Matters. Daily CBD. https://dailycbd.com/en/carrier-oils/
Bruni N, Della pepa C, Oliaro-bosso S, Pessione E, Gastaldi D, Dosio F. Cannabinoid Delivery Systems for Pain and Inflammation Treatment. Molecules. 2018;23(10)
Palmieri B, Laurino C, Vadalà M. A therapeutic effect of cbd-enriched ointment in inflammatory skin diseases and cutaneous scars. Clin Ter. 2019;170(2):e93-e99.
Barbieri JS, Choi JK, Mitra N, Margolis DJ. Frequency of Treatment Switching for Spironolactone Compared to Oral Tetracycline-Class Antibiotics for Women With Acne: A Retrospective Cohort Study 2010-2016. J Drugs Dermatol. 2018;17(6):632-638.

Artificial sweeteners may promote antibiotic resistance

Posted on February 26, 2021April 30, 2021 by dylanramsey

Source: The University of Queensland Australia | Author: Associate Professor Jianhua Guo, Sharon James | Feb 26, 2021

Common artificial sweeteners such as saccharine and aspartame could speed up the spread of antibiotic resistance, according to University of Queensland research.

More than 117,000 tonnes of artificial sweeteners are consumed across the world each year and are accepted as safe food additives, but their effects on antibiotic resistance had been unknown.

Associate Professor Jianhua Guo, from UQ’s Advanced Water Management Centre, said scientists investigated if artificial sweeteners would encourage the transfer of antibiotic resistance genes between bacteria.

“Our previous studies have reported many common household items promote antibiotic resistance, so recently we started wondering if artificial sweeteners may also play a role,” Dr Guo said.

The research team tested four commonly consumed artificial sweeteners, including saccharine, sucralose, aspartame, and acesulfame potassium.

Green Sugr uses Allulose which does not cause this type of inhibiting behavior of the above sweeteners.

UQ PhD student Zhigang Yu said the sweeteners significantly accelerated the exchange of bacteria through a process known as conjugation.

“This process is regarded as the bacterial equivalent of sexual reproduction or mating and occurs when two bacteria come into direct contact,” Mr Yu said.

“The resistance genes are transferred from the donor to the recipient, and as a consequence, the recipient might become a multi-drug resistant strain of bacteria.

“Given the high consumption of non-antibiotic pharmaceuticals, our findings highlight the potential risk associated with the presence of artificial sweeteners in our food and drinks.”

Antimicrobial resistance has become a major threat to public health globally.

Dr Guo said further animal or in vivo research was needed to test whether long-term use of artificial sweeteners was able to promote antimicrobial resistance in human urinary and gut systems.

“It is becoming clear that we need to be very careful in our use of these common products, as overuse can rapidly increase the problems brought on by antimicrobial resistance,” Dr Guo said.

The study has been published in the ISME journal (DOI: 10.1038/s41396-021-00909-x).

The research was undertaken by a UQ team which also included Dr Yue Wang, Dr Ji Lu and Dr Philip Bond, and was funded by the Australian Research Council Future Fellowship.

Congress introduces bill to legalize hemp CBD supplements

Posted on February 7, 2021April 30, 2021 by dylanramsey

H.R. 841 would make hemp and all its cannabinoids (except THC) subject to all the other FDA regulations as for any other dietary supplement.

Source: Natural Product Insider | Author: Todd Runestad | Feb 07, 2021

Impatient with foot-dragging by the U.S. Food and Drug Administration, Congress has re-introduced legislation to compel the regulatory agency to approve CBD—as well as all the other cannabinoids and terpenes within hemp (sans THC)—for use in dietary supplements.

The bill, H.R. 841, is called the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021. It is identical to H.R. 8179, introduced in the last Congress.

Introduced by Oregon Democrat Kurt Schrader and Virginia Republican Morgan Griffith, with five Republican and 12 Democratic co-sponsors, the bill would simply make hemp subject to all the other regulations as for any other dietary supplement, subject to new dietary ingredient (NDI) filings, Good Manufacturing Practices (GMP), and labeling and marketing provisions.

It would maintain hemp’s definition as a cannabis plant with less than 0.3% THC—the euphoria-inducing cannabinoid in the plant, which is solely responsible for the difference between hemp and marijuana.

The NDI aspect is a heavy lift, one that could be counted on to radically shrink the number of brands on the market. But the certainty would be a boon for companies that have the wherewithal to produce quality hemp or spend a high six figures to conduct toxicology testing. For growers who have done the tox work, the riches could be legion.

“It provides the category and all of us that play in that field a legitimate entry point into the mainstream marketplaces that have kept us at bay for years now,” said Josh Hendrix, chief growth officer at Driftless Extracts and Workman’s Relief. “This is a step in the right direction for sure. It’s certainly not the final piece of the puzzle but a very important first step for those that are making quality products.

That sentiment is echoed by a longtime supplements trade group, the Council for Responsible Nutrition, which represents large supplements companies that offer guardrails and boundaries circumscribing the “responsible” supplements space.

Julia Gustafson, vice president of government relations for CRN, expressed frustration with the FDA, and hopes that this bill would shift the agency’s thinking around hemp and hemp CBD.

“Due to continued FDA inaction,” said Gustafson, “more consumers are at risk every day of unsafe or illegal products that are poorly manufactured, incorrectly labeled, or illegally deliver THC or other adulterants. Concurrently, responsible CBD companies that adhere to federal regulations and product and market safe and beneficial CBD dietary supplements are forced to share the shelf with disreputable companies that compromise public safety for profit.”

Will the bill compel the FDA to act?

Concern remains for the bill’s fate, as some members of Congress are seen as preferring to let the FDA take the lead. However, impatience with the FDA’s position has directly led to this Congressional action.

“Reps. Schrader and Griffith have shown true leadership on this issue, and we anticipate support continuing to build as it progresses through Congress,” said Jonathan Miller, General Counsel for the U.S. Hemp Roundtable, and spokesperson for a coalition of 19 groups representing hemp and supplements concerns. “The organizations working collectively to establish a trusted marketplace for ingestible hemp-derived ingredients applaud the bipartisan approach on this legislation.”

The coalition, in a press release, lamented the “regulatory uncertainty” that remains about the inclusion of hemp and hemp-derived CBD into ingestible products.

CBD commerce and investment, asserted the coalition, “have resultingly been chilled, impairing job creation and economic opportunity for farmers and small businesses.”

Michael McGuffin, president of the American Herbal Products Association and a coalition partner, provided clarity around the intense desire in the industry for Congress to step in now. He has long maintained that hemp and hemp CBD should simply be treated as any other botanical supplement on the market.

“There remains an absence of substantive progress on FDA’s reported attention to creating a lawful pathway for CBD, and a similar lack of clarification from the agency that simple hemp products, such as tinctures and extracts, should be regulated the same as other herbal supplements,” said McGuffin. “This legislation will fill those gaps, and we see it as important for ensuring that consumers will be able to find hemp and CBD products that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal supplements.”

CRN’s Gustafson hopes this bill will jump-start the FDA’s efforts, focusing its attention on the goal of expanding consumer access to hemp CBD and other cannabinoids and terpenes.

“We call on FDA to constructively engage with the bill sponsors and other stakeholders to address any reservations it may have and to help craft legislation that protects public health while fostering a new category of supplements.”

The U.S. Hemp Roundtable has built a portal where interested parties can contact their Congressional representatives and encourage them to co-sponsor and otherwise support the bill’s passage.

The coalition of 18 groups supporting this bill includes the U.S. Hemp Roundtable, American Herbal Products Association (AHPA), Alliance for Natural Health, Citizens for United Health, Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), Hemp Alliance of Tennessee, Hemp Industries Association (HIA), Midwest Hemp Council, National Cannabis Industry Association (NCIA), National Association of State Departments of Agriculture (NASDA), National Grocers Association, Texas Hemp Coalition, United Natural Products Alliance (UNPA), U.S. Hemp Authority, U.S. Hemp Building Association, Wisconsin Hemp Alliance, and We Are For Better Alternatives (WAFBA).

Does CBD benefit the skin?

Posted on February 1, 2021April 30, 2021 by dylanramsey

Source: Dermatology Times | Author: Morgan Petronelli, Associate Editor | Oct 08, 2020

The use of CBD skincare products is recently on the rise, but do these products really possess the skin benefits companies claim they do?

Cannabidiol (CBD), one of two active ingredients in cannabis, has recently come to the forefront of the beauty industry, with companies rushing to put the substance into products such as moisturizers and face masks, among others. However, these companies are hurrying to implement CBD into skincare without fully knowing its effect on the skin.

In 2018 Farm Bill, the United States Federal government legalized the regulated production of hemp, a cannabis sativa plant containing CBD and less than 0.3% tetrahydrocannabinol (THC).¹ This change in policy caused a sudden increase in products containing CBD, with companies claiming its many health benefits without the clinical data to support those very claims.

MORE: Are CBD skincare products effective?

However, some recently conducted studies have found that CBD does have the potential to benefit the skin.

According to the 2019 study, “A therapeutic effect of CBD-enriched ointment in inflammatory skin diseases and cutaneous scars,” researchers administered topical CBD-enriched ointment to lesioned skin twice daily for three months on 20 patients with psoriasis (n=5), atopic dermatitis (n=5) and resulting outcome scars (n=10).²The study goes on to report that following three months, researchers saw improvement in inflammatory and skin symptoms.

Another study from the Journal of Drug in Dermatology published in 2014 found CBD has the potential to aid in suppression of acne breakouts by regulating oil production within the sebaceous glands.³

Despite all of these findings, there is still a need for further research to identify and investigate CBD’s benefits for the skin.

In this two-part series, Aesthetic Authority takes a closer look at CBD skincare market and examines its possible skin benefits.

References:

2018 Farm Bill. (n.d.). Retrieved October 08, 2020, from https://www.agriculture.senate.gov/2018-farm-bill
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U.N. Reclassifies Cannabis as a Less Dangerous Drug

Posted on December 1, 2020April 30, 2021 by dylanramsey

A United Nations commission voted on Wednesday to remove cannabis for medicinal purposes from a category of the world’s most dangerous drugs, a highly anticipated and long-delayed decision that could clear the way for an expansion of marijuana research and medical use.

Source: NY Times | Author: Isabella Kwai | Dec 2, 2020

The vote by the Commission for Narcotic Drugs, which is based in Vienna and includes 53 member states, considered a series of recommendations from the World Health Organization on reclassifying cannabis and its derivatives. But attention centered on a key recommendation to remove cannabis from Schedule IV of the 1961 Single Convention on Narcotic Drugs — where it was listed alongside dangerous and highly addictive opioids like heroin.

Experts say that the vote will have no immediate impact on loosening international controls because governments will still have jurisdiction over how to classify cannabis. But many countries look to global conventions for guidance, and United Nations recognition is a symbolic win for advocates of drug policy change who say that international law is out of date.

“This is a huge, historic victory for us, we couldn’t hope for more,” said Kenzi Riboulet-Zemouli, an independent researcher for drug policy who has closely monitored the vote and the position of member states. He said that cannabis had been used throughout history for medicinal purposes and that the decision on Wednesday reinstated that status.

The change will most likely bolster medical research and legalization efforts around the world.

The vote was a “big step forward,” recognizing the positive impact of cannabis on patients, said Dirk Heitepriem, a vice president at Canopy Growth, a Canadian cannabis company. “We hope this will empower more countries to create frameworks which allow patients in need to get access to treatment.”

Marijuana for medical use has exploded in recent years and products containing cannabis derivatives like cannabidiol or CBD, a nonintoxicating compound, have flooded the wellness industry. Cowen, an investment and financial services company, estimates that the CBD industry in the United States will be worth $16 billion by 2025.

Some research has suggested that CBD can protect the nervous system and provide relief from seizures, pain, anxiety and inflammation. The list of CBD-infused products — including creams, serums, soda water and juice — is also expanding rapidly.

The recommendations for changing the classification of marijuana were first made by the World Health Organization in 2019. But they were politically divisive, which led to unusual delays in the United Nations commission’s vote.

The reclassification passed 27 to 25, with an abstention from Ukraine. The United States and European nations were among those who voted in favor, while the likes of China, Egypt, Nigeria, Pakistan and Russia were opposed.

China’s delegate said that, despite the United Nations move, the country would strictly control cannabis “to protect from the harm and abuse.”

Britain’s delegate said that the reclassification was “in line with the scientific evidence of its therapeutic benefits” but that the country still strongly supported international controls for cannabis, adding that marijuana presented “serious public health risks.”

The differing messages underline the complexities behind the decision. “It’s been a diplomatic circus,” said Mr. Riboulet-Zemouli, who added that some countries initially opposed to the change, like France, had since switched their position.

Michael Krawitz, executive director for Veterans for Medical Cannabis Access, an advocacy group in the United States, said the change in international law would “help reduce the suffering millions of people” and could help mitigate reliance on opiates, noting that cannabis was an important medication that could provide unique pain relief.

Also on Wednesday, the commission rejected a proposal to include the cannabis derivative THC in the 1961 convention, which would have tightened some controls.

The overhaul of cannabis policy, particularly around legalization for medical use, has moved at a rapid pace over the last few years, said Jessica Steinberg, managing director at the Global C, an international cannabis consulting group. Industry insiders have expressed hope that the vote will open the field for more research into the therapeutic benefits of the drug.

But the impact on the American and European markets was driving the issue, Ms. Steinberg noted. In the United States, where more states legalized the use of medical and recreational marijuana in the recent election, the market for both of those is expected to expand to more than $34 billion by 2025, according to Cowen.

Before the vote this week and other decriminalization efforts, share prices of some cannabis companies jumped.

But aside from the financial boon it could provide for American and European marijuana markets, downgrading the dangers of cannabis may have the biggest impact on countries that have more conservative policies, such as many Caribbean and Asian nations.

“Something like this does not mean that legalization is just going to happen around the world,” Ms. Steinberg said. But “it could be a watershed moment.”