How CBD Can Help with Skin Problems

Anyone who’s suffered throughout their life with uncooperative skin has probably looked at many solutions to their troubles. Once they’ve exhausted other more obvious solutions, they may then cast a jaded eye towards skin cream that includes CBD as a significant ingredient.

What they may not understand clearly is whether a cream containing CBD will be helpful to them or not. Therefore, this article is aimed at providing some clarity on this issue.

One Itch or Three?

While it’s natural for the skin to itch when it is healing, it’s not as common or comfortable when that’s not the root cause. In which case, you’re trying to not scratch the area, but the itching is driving you’re a bit nutty!

If you’ve already tried antihistamine tablets and it didn’t do anything for you, then perhaps a cream with CBD will be worth trying now?

How will CBD help in this situation? Good question. What it does is disable the signal that’s communicating from the brain to your skin to create the itchy sensation. As a result, it’s felt less or removed entirely.

Protect the Skin from Damage

When out and about in the spring and summer months, being exposed to sunlight is almost inevitable. UV rays can cause cellular damage to the skin that’s irreversible and will eventually catch up with you. This is why sunbathing is detrimental, no matter how attractive a tan is.

The use of CBD cream can assist in preventing free radicals from UV rays that cause damage to the skin. When there’s no sun cream to hand, this alternative is great.

Remedy for Skin Breakouts

Chronic skin problems including minor to major breakouts are a real bugbear. Even if you’re a woman and able to cover over them with makeup, it’s still far from perfect. It’s also possible that the makeup will cause further skin irritation that won’t help either.

CBD cream helps with skin issues because it can reduce the build-up of oils on or below the surface that cause blocked pores in the first place. For people who suffer from an excess of oil on the skin that frequently creates fresh skin dilemmas, the use of CBD creams can reduce the frequency and severity of skin problems.

Avoid Aging as Rapidly

Avoiding aging is important to all of us. While we cannot stop the passage of time, we can at least try to stop our skin from looking significantly older.

CBD contains many antioxidants that shield the skin from harm including environmental-related damage. UV rays and air pollution are prevented from prematurely aging the skin when the cream is applied. Dark areas, fine lines, and pronounced wrinkles may be delayed as a result.

While no treatment is a cure-all for the way that the environment, pollution, and UV rays can ravage the skin, CBD cream provides added defense against them. Along with an effective cleaning and cleansing regimen, it can prove effective in keeping the skin looking its best.

 

 

Jazz Pharmaceuticals To Acquire GW Pharmaceuticals, Creating An Innovative, High-Growth, Global Biopharma Leader

UNITED KINGDOM: Jazz Pharmaceuticals plc and GW Pharmaceuticals announced the companies have entered into a definitive agreement for Jazz to acquire GW for $220.00 per American Depositary Share (ADS), in the form of $200.00 in cash and $20.00 in Jazz ordinary shares, for a total consideration of $7.2 billion, or $6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

Upon close of the transaction, the combined company will be a leader in neuroscience with a global commercial and operational footprint well positioned to maximize the value of its diversified portfolio.

GW is a global leader in discovering, developing, manufacturing and commercializing novel, regulatory approved therapeutics from its proprietary cannabinoid product platform to address a broad range of diseases. The company’s lead product, Epidiolex® (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. Epidiolex was the first plant-derived cannabinoid medicine ever approved by the U.S. Food and Drug Administration (FDA). This product has also been approved, under the tradename Epidyolex®, by the European Medicines Agency (EMA) in patients two years of age and older for the adjunctive treatment of seizures associated with LGS and Dravet syndrome in conjunction with clobazam and is under EMA review for the treatment of seizures associated with TSC. In addition to the approved indications for Epidiolex, there are considerable opportunities to pursue other indications within the epilepsy field, including other treatment-resistant epilepsies where significant unmet needs of patients exist.

Beyond Epidiolex, GW has a scientific platform and deep innovative pipeline of cannabinoid product candidates, as well as highly specialized manufacturing expertise, developed over two decades of pioneering and building leadership in cannabinoid science. This pipeline includes nabiximols, for which the company is in Phase 3 trials to seek FDA approval for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.

“Jazz is proud of our leadership position in sleep medicines and rapidly growing oncology business. We are excited to add GW’s industry-leading cannabinoid platform, innovative pipeline and products, which will strengthen and broaden our neuroscience portfolio, further diversify our revenue and drive sustainable, long-term value creation opportunities,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. “We are joining two teams that share a passion for, and track record of, developing differentiated therapies that advance science and transform the lives of patients. This will help facilitate a successful integration and bring added capabilities to Jazz. Given the strength of our balance sheet and the meaningful financial drivers of the transaction, we are confident in the value we can deliver to both companies’ shareholders and patients. We look forward to welcoming the GW team to Jazz to build an even stronger company.”

“Over the last two decades, GW has built an unparalleled global leadership position in cannabinoid science, including the successful launch of Epidiolex, a breakthrough product within the field of epilepsy, and a diverse and robust neuroscience pipeline. We believe that Jazz is an ideal growth partner that is committed to supporting our commercial efforts, as well as ongoing clinical and research programs,” said Justin Gover, CEO of GW Pharmaceuticals. “We have a shared vision of developing and commercializing innovative medicines that address significant unmet needs in neuroscience and an approach of putting patients first. Together, we will have an opportunity to reach and impact more patients through a broader portfolio of neuroscience-focused therapies than ever before.”

FDA Warns Companies Illegally Selling CBD Products

DISTRICT OF COLUMBIA:  The U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.

“The FDA’s first priority is to protect the health and safety of Americans. Many questions remain regarding the science, safety, effectiveness and quality of products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose the greatest risk of harm to the public.”

The warning letters were issued to:

The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food, and some of the products were impermissibly marketed as “dietary supplements.”

The products that are the subject of the letters issued today have not gone through the FDA drug approval process and therefore are considered unapproved new drugs. It is not known whether they are effective for the uses claimed in labeling, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products or whether they have dangerous side effects or other safety concerns. In addition, the manufacturing process of these unapproved CBD-containing drug products has not been subject to FDA review as part of the human or animal drug approval processes, so it is not known what the manufacturing conditions of, or contaminant levels in these products may be.

Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. New human and animal drugs must be approved by the FDA or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review, before they can be legally marketed as drugs. CBD was not an ingredient considered under the OTC Drug Review.

The FDA has not approved any CBD products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) in human patients. CBD has not been approved as a food additive and does not meet the statutory definition of a dietary supplement.

The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FTC Announces Crackdown On Deceptively Marketed CBD Products

Companies made unsupported claims that their oils, balms, gummies, coffee, and other goods could treat serious diseases such as cancer and diabetes

DISTRICT OF COLUMBIA: The Federal Trade Commission today announced the first law enforcement crackdown on deceptive claims in the growing market for cannabidiol (CBD) products. The FTC is taking action against six sellers of CBD-containing products for allegedly making a wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.

The FTC is requiring each of the companies, and individuals behind them, to stop making such unsupported health claims immediately, and several will pay monetary judgments to the agency. The orders settling the FTC’s complaints also bar the respondents from similar deceptive advertising in the future, and require that they have scientific evidence to support any health claims they make for CBD and other products.

“The six settlements announced today send a clear message to the burgeoning CBD industry: Don’t make spurious health claims that are unsupported by medical science,” said Andrew Smith, Director of the FTC’s Bureau of Consumer Protection. “Otherwise, don’t be surprised if you hear from the FTC.”

The crackdown, Operation CBDeceit, is part of the Commission’s ongoing effort to protect consumers from false, deceptive, and misleading health claims made in advertisements on websites and through social media companies such as Twitter.

Each case the FTC is announcing today is described below:

Bionatrol Health, LLC

According to the FTC’s complaint against Utah-based companies Bionatrol Health, LLC and Isle Revive, LLC, and two former managers and owners, since at least December 2019 the respondents sold a CBD oil to consumers on two websites. Among other things, the respondents allegedly claimed without substantiation that their CBD product is safe for all users, treats pain better than prescription medications like OxyContin, and prevents and treats age-related cognitive decline and chronic pain. The respondents also claimed, without scientific evidence, that CBD oil is “medically proven” to improve a variety of conditions, according to the FTC’s complaint. In addition, the FTC alleges the respondents deceived consumers who ordered one bottle of their CBD oil by changing the order to five bottles without consumers’ consent.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs without human clinical testing to substantiate the claims. It also requires competent and reliable scientific evidence for other health-related product claims, and prohibits the respondents from misrepresenting the cost of any good or service and from charging consumers without their express, informed consent. Finally, it requires the corporate respondents and individual respondent Marcello Torre to pay $20,000 to the FTC and to notify consumers of the Commission’s order.

Epichouse LLC (First Class Herbalist CBD)

According to the FTC’s complaint against Utah corporation Epichouse, LLC, which operated under several names, including First Class Herbalist, and the company’s founder and owner, John Le, since at least September 2019 the respondents sold several CBD products on their website, including oils, a pain-relief cream, coffee, and gummies.

Among other alleged unsupported claims, Epichouse and Le promoted CBD as safe for all users, able to treat pain better than prescription medications such as OxyContin, and able to prevent a wide range of serious conditions, including cancer, diabetes, and heart disease. In their advertising, they also falsely claimed that CBD is scientifically proven to improve many serious health conditions—including chronic pain and hypertension—and provide neurological benefit—such as preventing age-related cognitive decline—according to the FTC’s complaint.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. It requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, the order requires the respondents to pay $30,000 to the FTC and notify consumers of the Commission’s order.

CBD Meds, Inc.

According to the FTC’s complaint against CBD Meds, Inc.; G2 Hemp, Inc.; and Lawrence Moses, a/k/a Lawrence D. Moses, Jr., individually and as an officer of the corporate entities, the two companies advertised CBD oil on their website and on YouTube. In their ads, the FTC contends, the Winchester, California-based firms made a number of false or unsubstantiated claims, including that CBD effectively treats, prevents, or mitigates serious diseases and conditions like artery blockage, cancer, glaucoma, autism, and schizophrenia, among many others. The respondents also falsely represented that some of the efficacy claims were scientifically proven or that the U.S. government has confirmed the health benefits of CBD.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. More broadly, it requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, the order requires the respondents to notify consumers of the Commission’s order.

HempmeCBD

According to the FTC’s complaint against EasyButter, LLC, also d/b/a HempmeCBD, and its owner and officer Michael Solomon, since at least January 2018, the respondents have sold CBD products on their website, including CBD-infused shea butter, gummies, lozenges, honey sticks, vape pens, and oils. The complaint alleges that HempmeCBD claimed its CBD products could treat or cure serious ailments like cancer-related symptoms, substance abuse, and AIDS. The complaint alleges HempmeCBD lacked the scientific substantiation for such health claims and falsely claimed to have studies showing CBD is effective at treating autism.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. It also requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, it requires the respondents to pay the FTC $36,254 and to notify consumers of the Commission’s order.

Reef Industries, Inc.

According to the FTC’s complaint against California-based Reef Industries, Inc.; Cannatera, Inc.; AndHemp, Ltd., and the companies’ three principals, the respondents have sold a variety of CBD products directly to consumers on their website and Twitter accounts since at least January 2019 and misrepresented the health benefits of CBD. The FTC alleges that the respondents made unsubstantiated claims that CBD can prevent, cure, mitigate, or treat diseases and serious health conditions, including Alzheimer’s disease, arthritis, autoimmune disease, and irritable bowel syndrome. The complaint also alleges the respondents falsely claimed that studies or scientific research prove that CBD is effective at treating, curing, or mitigating these diseases and conditions.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. More broadly, it requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, it requires them to pay the FTC $85,000 and notify consumers of the Commission’s order.

Steves Distributing, LLC

According to the FTC’s complaint against Steves Distributing, LLC, d/b/a Steve’s Goods; and the company’s CEO Steven Taylor Schultheis, since beginning operations in 2018, the respondents have sold a variety of products containing both CBD and cannabigerol (CBG), which, like CBD, is a non-psychoactive compound derived from hemp. The company advertises its CBD and CBG products, including tinctures, gummies, capsules, topical balms, suppositories, bath balms, and coffee, on its website and through social media companies like Twitter.

The FTC alleges that the respondents claimed, without adequate substantiation, that their CBD and CBG products are effective alternatives to prescription medications and treat a wide range of diseases and serious health conditions, including Alzheimer’s disease, cancer, and diabetes. The complaint also alleges the respondents falsely claimed that their CBD and CBG products have antibacterial properties, prevent or reduce the risk of heart attacks, strokes, and other diseases, and that certain of these claims were supported by scientific evidence.

The proposed administrative order settling the FTC’s charges prohibits the respondents from making certain prevention, treatment, or safety claims about dietary supplements, foods, and drugs, unless they have the human clinical testing to substantiate the claims. More broadly, it requires them to have competent and reliable scientific evidence when making any other health-related product claims. Finally, it requires the respondents to pay the FTC $75,000 and notify consumers of the Commission’s order.

The Commission votes approving each of the six administrative complaints and proposed consent orders were 5-0, with Commissioner Rohit Chopra and Commissioner Christine S. Wilson issuing separate, concurring statements. A complete list of respondents can be found in the complaint for each respective case.

The FTC will publish a description of the consent agreement package in the Federal Register soon. The agreement will be subject to public comment for 30 days after publication in the Federal Register after which the Commission will decide whether to make the proposed consent order final. Instructions for filing comments will appear in the published notice. Once processed, comments will be posted on Regulations.gov.

NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $43,280.

Kristen Bell Launches Happy Dance CBD Brand

CANADA: Cronos Group Inc. announced the launch of Happy Dance™, a new, clean, simple CBD skincare brand, co-founded with actress and New York Times best-selling author Kristen Bell. Happy Dance launches with a trio of high-quality, cruelty-free and vegan bath and body care products.

The new Happy Dance collection features a body butter, a coconut melt and a bath bomb, all formulated with Kristen Bell’s favorite clean ingredients and high-quality CBD from full-spectrum hemp extract. These multi-purpose products are infused with delightful blends of plant-based oils and butters in enjoyable textures that are effortlessly easy-to-use. The ultimate head-to-toe body treats, Happy Dance products are perfectly suited for the CBD enthusiast or for someone experiencing CBD for the first time.

“I discovered CBD through the Lord Jones™ brand in 2017 and was blown away by its quality, integrity and consistency. As a working mom, I turned to CBD skincare as a way to turn down the volume of my life and CBD products have since become an essential part of my self-care routine,” said Kristen Bell. “I was inspired to create a line of high-quality, affordable CBD bath and body care products that would reach a wide audience. Having been involved in all aspects of bringing this new brand to life, from the formulations to the packaging, I couldn’t be happier to launch Happy Dance today.”

“After years as a working actress, Kristen Bell understands the importance of taking care of your skin,” said Summer Frein, U.S. General Manager, Cronos Group. “Her passion for the category started with her personal and professional experience as a skincare ambassador and she has since become someone who people look to for personal care advice and expertise.”

The Happy Dance brand is the epitome of good, clean, fun. The full-spectrum hemp-derived CBD product collection launching today features:

  • Happy Dance Whipped Body Butter (200mg CBD) – $30
  • Happy Dance Head-to-Toe Coconut Melt (225mg CBD) – $25
  • Happy Dance Stress Away Bath Bomb (60mg CBD) – $15

“We feel fortunate to be working with someone as authentic, caring and kind as Kristen,” said Kurt Schmidt, President and Chief Executive Officer, Cronos Group. “We have always been committed to improving people’s lives with breakthrough cannabinoid products, which is why we’re incredibly excited to launch an accessible, purpose-driven brand with Kristen Bell, someone we know consumers trust for her integrity and relatability.”

Happy Dance’s commitment to self-care extends not only to its products, but to the community it serves. One percent of profits from sales on the Happy Dance website will benefit A New Way of Life Re-Entry Project, a Black-owned LA-based organization that provides housing, case management, pro bono legal services, advocacy and leadership development for women rebuilding their lives after prison.

“It was essential to me that Happy Dance be a purpose-driven brand that challenged the traditional notion of self-care,” said Kristen Bell. “And when I care for myself, I can better care for others. Happy Dance’s commitment to care extends to those who need it most, which is why we are honored to be partnering with A New Way of Life Re-Entry Project.”

Happy Dance products undergo extensive third-party testing, are vegan and cruelty-free and tested for heavy metals, microbiological contaminants, residual solvents and pesticides. Each product formula is evaluated through clinical testing according to cosmetic industry standards. Every product also features traceable lot codes allowing customers to review product Certificates of Analysis (COA).

For more information, or to purchase Happy Dance products, visit www.doahappydance.com or @happydance.

Anavii Market Offers Brand New Line Of Martha Stewart CBD Products

​Anavii Market, a premier online retailer of verified CBD oil, today announced the unveiling of a much-anticipated brand of Martha Stewart CBD. The new collection consists of six unique hemp products, including CBD tinctures, gummies and softgels, all developed and curated by Martha Stewart herself in partnership with Canopy Growth Corporation.

This is the first-ever CBD product launch by the lifestyle enthusiast in collaboration with Canopy Growth, which is a world-renowned CBD company.

Anavii Market is thrilled to team up with Canopy Growth in selling Martha Stewart’s brand new collection of CBD oil.

“Bringing quality and pure hemp wellness products to America is our mission at Anavii Market, and we are happy to partner with Martha and Canopy to help spread the good news about CBD to their networks,” said Jason Amatucci, co-founder of Anavii Market.

Starting today, customers are able to enjoy the exciting new flavors that Martha Stewart specially designed herself. This new range of products incorporates the most flavorful side of CBD, as well as Martha’s drive to create only the best quality products made from the purest hemp.

Buyers are welcomed to try Martha Stewart CBD Tincture, which is a concentrated blend of CBD oil extracted from the highest quality hemp. CBD tinctures are easy to use and designed to distribute a specific amount of CBD per serving. Each serving contains 25 mL of two exciting, citrusy flavors. These include blood orange and Meyer lemon.

Anavii Market is also offering a delicious assortment of Martha Stewart CBD Gummies. Infused with 99% pure CBD isolate per gummy, these tasty, chewable treats come in two fruit medleys of berry and citrus, and are the perfect size to carry anywhere you go.

Made with only the finest ingredients, Martha Stewart CBD Softgels offer the best quality and consistency of CBD oil on the market. Each softgel contains 25mg of CBD and is made with non-GMO, coconut-derived MCT oil and pure-hemp derived CBD isolate.

All Martha Stewart CBD products have been rigorously lab-tested to ensure that the products contain zero heavy metals, pesticides, solvents and other toxins.

Consumers can purchase each Martha Stewart CBD product through Anavii Market’s online store and get a 20% off discount for a limited time. For more information and updates about the Martha Stewart CBD product launch, follow the Anavii Market blog today.

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FDA Advances Work Related To Cannabidiol Products With Focus On Protecting Public Health, Providing Market Clarity

DISTRICT OF COLUMBIA: Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

Today, we are providing updates on our efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.

Educating the Public About Potential Risks of Using CBD

We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons.

But as the agency has stated before, we are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.

We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.

In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.

We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.

Closing Knowledge Gaps in Both Safety and Potential Benefits

The marketplace for CBD-containing products is quickly evolving and it is critical that we work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.

To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data. This includes data on, among other things: the sedative effects of CBD; the impacts of long-term sustained or cumulative exposure to CBD; transdermal penetration and pharmacokinetics of CBD; the effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile; the safety of CBD for use in pets and food-producing animals; and the processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products.

Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.

Importantly, the Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very low levels of the psychoactive intoxicating component of cannabis, delta-9 tetrahydrocannabinol (THC) are no longer controlled substances – has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and we are working to support drug development as much as possible.

First, given all the research and activity in this space, we are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available. To this end, in the coming days we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.

This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.

We also are working to generate data to help inform our work in this area. For example, the FDA’s Office of the Chief Scientist recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.

As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.

Monitoring the Marketplace with a Focus on Greatest Risk to Public Harm

As we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.

We have seen many CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.

We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.

As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.

Conclusion

Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Asheville Hemp Project Launches CBD Infused Gum

First Product from Asheville Hemp Project Brand Highly Efficiency Delivery Method

NORTH CAROLINA: Asheville Hemp Project (AHP), an Asheville, NC-based hemp cultivator, is unveiling its new CBD Mint Gum. The launch marks the first consumer product for the brand, with other SKU’s in the pipeline. Asheville Hemp Project aims to connect consumers to the source of the natural plant, and their own inner nature.

The brand reminds us of the calming effect that nature provides, with a view through an open-slatted tobacco barn imprint. AHP selected gum as the first product to introduce because of its super-efficient delivery of CBD. Each piece of AHP’s CBD Mint Gum contains 10 milligrams of CBD and comes in a convenient foil pack that maximizes freshness and improves product protection and dispensing. AHP Gum is available for sale in the U.S. via the Company’s online store and at retailers including boutique food markets, CBD dispensaries, gas stations and smoke shops, and soon in sports emporiums and golf pro shops. A single pack containing 8 pieces sells for $19.90 online.

Leslie Hoffman, co-founder of AHP, stated, “This is our first consumer product, and we are excited about its potential. It delivers hemp-derived cannabinoids most efficiently through mucosa glands being activated by the chewing of the gum. Our gum enhances wellness for anyone who can benefit from CBD – and delivers it in a refreshing ‘normal’ format that is as discreet as it gets.”

CBD Mint Gum

Users include those with busy modern (and sometimes stressful) lives or those who need to lessen arthritis and joint pain or need better sleep. Sports aficionados might find that they can focus more intently or diminish the inflammation that sometimes follows a strenuous workout.”

Hoffman continued, “We intend to follow up with the launch of our CBD premium pre-rolls which will be unfiltered to ensure the consumer ingests the cannabinoids. Further, we have plans for releasing a CBD tincture. The number of potential products is enormous.”

Transitioning to the 21st Century Economy

Hoffman, whose pedigree in the cannabis industry includes farming, a hemp fashion business, and work in medical cannabis, formed Asheville Hemp Project in 2017 with co-founder, Scott Brinkley, a scientist and grower. Hoffman was a pioneer in sustainability and was previously a designer and builder of green construction projects.

The two saw an opportunity in North Carolina where tobacco had once been king. The agricultural and processing infrastructure for tobacco is well-suited to the cultivation and production of hemp.

Hoffman said, “The equipment and buildings needed to grow and dry the leaves, and the factories for rolling cigarettes already exist and are under-utilized. The workforce has the requisite skills to produce high quality products. The difference is the plant. Hemp is vastly more useful than tobacco. We aim to share a point of view, a connection to nature, and our understanding of the plant and its many uses. And so, we expanded our activities beyond the farm.”

She added, “Asheville has a reputation as an epicenter for craft cuisine and breweries. The region’s old tobacco farms are benefitting as they are revitalized by a thriving hemp farming community. Our brand’s tagline is Look Homeward, a reference to Thomas Wolfe’s famous book written in Asheville and set there, called Look Homeward, Angel. We believe this is the right business, with the right values, operating in the right place at the right time.”

Asheville Hemp Project’s base is a 23-acre hemp farm outside of the small city of Asheville, North Carolina nestled between the Blue Ridge and Great Smoky Mountains.

“This is where our experience grows, thoughts and ideas turn into new product innovations,” Brinkley states. “We work with other local farmers and processors in developing new products and establishing new markets. The vacuum tobacco left behind provides an atmosphere for us to all work together to build the hemp industry. As a community, we can do more and do it better.”

FDA Warning Letters And Test Results For Cannabidiol-Related Products

MJLegal

DISTRICT OF COLUMBIA: Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD).

As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.

FDA WARNING LETTTERS