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The American Pain Association Applauds the Historic Passage of the Farm Bill and Launches Hotline for CBD Education

What the Farm Bill Means for Hemp

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds

Hemp Farming Legalized Across the United States by the 2018 Farm Bill




Released: 12/22/18


The American Pain Association Applauds the Historic Passage of the Farm Bill and Launches Hotline for CBD Education

Dr. Sanjay Gupta, President of the American Pain Association (APA) is leading the efforts to educate physicians, lawmakers and insurance companies about the significant health benefits of cannabidiol (CBD) products for the treatment and management of pain and Opioid Use Disorder.  The American Pain Association is hailing the passage of the Farm Bill as a breakthrough and major victory for patients and physicians seeking harmless therapeutic modalities to treat people suffering from various pain syndromes including spine, migraine, neuropathic, fibromyalgia and opioid use disorder.  The passage would remove CBD from the Controlled Substances Act and legalize CBD production.  

Speaking at the American Pain Association (APA) “Turn the Tide” symposium held at the Rutgers Robert Wood Johnson Medical School In New Jersey, Dr. Gupta applauded the passage of the Farm bill claiming that this historical step will make it easier for research and insurance coverage for HEMP CBD. Continued Dr. Gupta, “In spite of significant health benefits of CBD, there is a huge stigma and lack of education about CBD amongst physicians, patients and lawmakers.  There are patients and physicians who incredibly believe that CBD is more harmful than opioids. Our mission at the APA is to change that misperception through education.” On the eve of Farm Bill, APA has launched a SMS hotline where people can text word “CBD” to 345-345 to get further education and information about CBD. 

The keynote speaker, Dr. Shereef Elnahal, NJ Health Commissioner expressed his strong support for the Farm Bill as well as the mission of Dr. Gupta and the APA in education and research. He highlighted the work NJ State has done in expanding indications and improving access for medical marijuana. Pennsylvania State Senator Sharif Street and NJ Assemblyman Joe Danielsen joined the prestigious panel and expressed the need and support for the ongoing education and research. They are both pioneers in their respective states in increasing access to Marijuana to fight the opioid crisis.  Commented Bruce J. Schoengood, President of Medifirst Solutions (OTC/ MFST), “We are thrilled to partner with Dr. Gupta and the APA in this fight for all natural pain solutions and reduce to public dependence on opioids.” 

This symposium was part of the APA National Medical School Educational Tour Initiative started to educate, advocate and fight the deadly opioid epidemic that has been responsible for killing thousands and putting innocent youths and children at serious risk. Topics discussed included the challenges and strategies for Opioid Epidemic and exploring the role of CBD products in pain management and in stemming the deadly opioid epidemic. Previous symposiums were held at Temple University Medical School, PCOM Medical School and Rowan University Cooper Medical School. 

Stated Dr. Gupta, “CBD can help significantly in pain management as well as the opioid crisis the US is currently facing, however, given the cost and lack of insurance coverage, many patients are not able to afford it and therefore are more likely to choose the narcotics simply because they are covered by insurance companies. I believe insurance companies should be willing to pay for patients who are willing to not take opioids and use CBD as a replacement. It would be much cheaper for them to cover the cost of CBD compared to the cost of narcotic prescriptions and managing opioid side effects. There are not many good solutions for Opioid Use Disorders. Even medications like Saboxone, which were supposed to help in addiction, are being abused. So we are really glad that we have a harmless and natural solution in CBD for addiction and Opioid use Disorder."

“CBD is marijuana (or cannabis) without the THC, the psychoactive compound found in Cannabis plants. Unlike THC, CBD does not make patients high and Gupta believes, is proving to have many health benefits including pain relief, weight loss, sleep disturbances, ADD and Anxiety disorders, or smoking cessation. CBD is like a brain energy food or vitamin. Current energy foods are filled with caffeine and sugar causing damaging health effects. But CBD does not have any of that. Weight loss is a big area as the current weight loss medications are not safe but CBD is all natural weight loss solution,” stated Dr. Gupta. To further this movement, the APA has started a multi-institutional CBD research initiative and is partnering with faculty in seven medical schools and universities around the nation to obtain the research and data necessary to communicate the benefit of having insurance companies cover CBD products. Patients who would like to participate in studies are advised to email info@painassociation.org and will be provided CBD free of charge.  

Dr. Gupta currently serves as President of the American Pain Association, an organization with board members from Harvard Medical School, John Hopkins Hospital and Weill Cornell Medicine, among other prestigious universities and medical schools. The primary efforts of the American Pain Association are directed toward education, research and improving treatment of pain, the most common cause of disability in the United States. With a focus on education and research-backed data, Dr. Gupta and the American Pain Association are working to make CBD an accessible form of treatment to patients in US and worldwide.

Released: 12/20/18


What the Farm Bill Means for Hemp

Passage of the 2018 Farm Bill was a rare bipartisan affair—last week it passed the U.S. Senate, 87-13, and it passed the U.S. House, 369-47. President Trump signed the bill into law Thursday, Dec. 20. Already, there’s an estimated 750 brands in the hemp-derived CBD business with a market that is expected to be close to $600 million in 2018.

The industry is led by a handful of companies such as Charlotte’s Web, CV Sciences, Hemp Meds, and Elixinol. But the bulk of the sales come from small lesser known brands who have limited knowledge on how the natural products industry operates. Several mainstream supplement companies have entered the market and now with the risk of being shut down diminished you will expect to see a greater interest from many market leaders in the supplement marketplace.

“As part of the 2018 Farm Bill, the hemp provisions have cleared up a lot of confusion by naming it a legal agricultural commodity so it will no longer be mistaken for a controlled substance, like marijuana," said Joseph Dowling, CEO of CV Sciences, maker of PlusCBD Oil. "In addition to allowing farmers to grow hemp, the growth of the hemp-derived CBD industry will increase significantly, likely causing it to become the number one selling dietary supplement in the United States. The next step for the hemp CBD industry is that we need to self regulate CBD products to ensure they are safe, well tested, and properly labeled." 

This marks an exciting time for the CBD marketplace, we plan continued coverage of this fast paced industry.

Released: 12/20/18


Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds

Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.

Just as important for the FDA and our commitment to protect and promote the public health is what the law didn't change: Congress explicitly preserved the agency's current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency's important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.

We're aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD). This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products. In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products – meaning they're subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act. To help members of the public understand how the FDA's requirements apply to these products, the FDA has maintained a webpage with answers to frequently asked questions, which we intend to update moving forward to address questions regarding the Agriculture Improvement Act and regulation of these products generally.

In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area. We'll also continue to closely scrutinize products that could pose risks to consumers. Where we believe consumers are being put at risk, the FDA will warn consumers and take enforcement actions.

In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they're intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer's disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments raises significant public health concerns, as it may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

Additionally, it's unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it's illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.

We'll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA's authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food. 

While products containing cannabis and cannabis-derived compounds remain subject to the FDA's authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce. The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.

These pathways include ways for companies to seek approval from the FDA to market with therapeutic claims a human or animal drug that is derived from cannabis. For example, in June 2018, the FDA approved a drug, Epidiolex, that contains cannabis-derived CBD for the treatment of seizures associated with two rare and severe forms of epilepsy. That approval was based on adequate and well-controlled clinical studies, which gives prescribers confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.

It should also be noted that some foods are derived from parts of the hemp plant that may notcontain CBD or THC, meaning that their addition to foods might not raise the same issues as the addition of drug ingredients like CBD and THC. We are able to advance the lawful marketing of three such ingredients today. We are announcing that the agency has completed our evaluation of three Generally Recognized as Safe (GRAS) notices related to hulled hemp seeds, hemp seed protein and hemp seed oil and that the agency had no questions regarding the company's conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.

Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products. 

We'll use this meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We'll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers.

At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We're committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.

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.

 

SOURCE U.S. Food and Drug Administration

Released: 12/20/18


Hemp Farming Legalized Across the United States by the 2018 Farm Bill

Vote Hemp, the nation's leading grassroots hemp advocacy organization working to change state and federal laws to allow commercial hemp farming, is thrilled to announce the federal legalization of hemp farming in the U.S., after nearly 2 decades of the organization's advocacy and policy leadership on the issue. The 2018 Farm Bill, passed by Congress on December 12, 2018, and signed into law by the President on December 20, 2018, includes Section 10113 titled "Hemp Production," which removes hemp from the Controlled Substances Act, places full federal regulatory authority of hemp with USDA, and allows State departments of agriculture to file hemp programs plans and regulate hemp cultivation per their State specific programs.

"This bill constitutes a momentous victory for the movement in support of hemp farming, and will have far-reaching positive impacts on rural economies and farming communities, increase availability of sustainable products for American consumers, and create new businesses and jobs in the hemp industry," said Eric Steenstra, President of Vote Hemp. "Now that we have lifted federal prohibition on hemp farming, it's time to invest our energy in expanding hemp cultivation and the market for hemp products across the country so that all can reap the benefits of this of this versatile, historic American crop."

In addition to defining hemp as cannabis that contains no more than 0.3% THC by dry weight, the bill asserts a 'whole plant' definition of hemp, including plant extracts; and removes roadblocks to the rapidly growing hemp industry in the U.S., notably by authorizing and encouraging access to federal research funding for hemp, and removing restrictions on banking, water rights, and other regulatory roadblocks the hemp industry currently faces. The bill also explicitly authorizes crop insurance for hemp. The full text of the hemp provisions in the Farm Bill of 2018 may be found at: https://www.votehemp.com/2018farmbill. For more details on the specific hemp provisions in the 2018 Farm Bill, please check out Vote Hemp's blog post, "Hemp in the Farm Bill: What Does It Mean?" https://www.VoteHemp.com/hempinthefarmbill.

Furthermore, per Vote Hemp advocacy on the issue, Section 10113 "Hemp Production," expands federally legal commercial hemp cultivation to tribal lands, reservations and U.S. territories—lands that had previously been omitted in Sec. 7606 of the 2014 Farm Bill, which allowed only for hemp farming programs in 'States.' Vote Hemp is especially grateful for the support of Sen. Ron Wyden (D-OR), and Sen. Mitch McConnell (R-KY) for leading this effort in Congress, along with 27 Senators who joined in bi-partisan co-sponsorship of the Hemp Farming Act and for the support of Rep. James Comer (R-KY), Rep. Jared Polis (D-CO) and Rep. Thomas Massie (R-KY) who lead the effort in the in the House of Representatives. 

"For too long, the outrageous and outdated ban on growing hemp has hamstrung farmers in Oregonand across the country," Senator Ron Wyden said. "Hemp products are made in America, sold in America, and consumed in America. Now, hemp will be able to be legally grown in America, to the economic benefit of consumers and farmers in Oregon and nationwide."

Founded in May of 2000, Vote Hemp is the longest standing, leading national single-issue non-profit organization dedicated to the revival of a free market for commercial hemp farming and manufacturing of hemp products in the U.S. In its nearly two decades of advocacy, the organization has been pivotal in the creation of policy at both the state and federal levels, educating the public about the benefits of hemp through the creation of the Hemp History Week campaign, and engaging in numerous crucial legal battles to defend U.S. hemp businesses and the American hemp market. Notable victories for hemp that Vote Hemp played a key role in achieving in recent years include: The DEA Hemp Food Rules Challenge (2004); The North Dakota Hemp Controversy (2009); Inclusion of Sec. 7606 "The Legitimacy of Hemp Farming" in the 2013 Farm Bill; Legal Defense of Alex White Plume(2002 - 2016); and The DEA Marijuana Extracts Rule (2018). For more information about these landmark moments in the history of Vote Hemp's advocacy, please visit: https://www.votehemp.com/legal_cases.html. In addition, Vote Hemp worked with State legislators and advocates to help pass dozens of State hemp bills including current market leaders Kentucky, Colorado and Oregon. For more information about state hemp laws and legislation, please visit: 
https://www.votehemp.com/resources/state-hemp-law/.

"This monumental progress toward returning hemp to American farmlands is in large part the result of Vote Hemp's dedication and tenacious, strategic advocacy over the last 19 years," said David Bronner, Cosmic Engagement Officer (CEO) of Dr. Bronner's, the top-selling brand of natural soaps in North America, that uses hemp seed oil in its products. "Dr. Bronner's has advocated for the legalization of hemp farming since we added hemp seed oil to our products in 1999, and fought and beat the DEA during the Hemp Food Rules Challenge from 2001 to 2004. As a maker of hemp products, we are eager to source the 20 tons of hemp seed oil we use annually from American farmers. We applaud the leadership of Eric Steenstra, truly a hemp champion, whose leadership of Vote Hemp has united hemp companies, farmers, consumers, and lawmakers into a potent fighting force for the future of hemp in America."

Vote Hemp consulted with State agriculture officials and calculated that approximately 77,731 acres of hemp crops were planted across 23 states during 2018 in the U.S., 40 universities conducted research on hemp cultivation, and 3,544 State hemp licenses were issued across the country. Data from market research by Hemp Business Journal supports an estimate of total retail sales of hemp food, supplements and body care products in the United States at $553 million.  Sales of popular hemp items like non-dairy milk, shelled seed, soaps and lotions have continued to increase, complemented by successful hemp cultivation pilot programs in several states, and increasing grassroots pressure to allow hemp to be grown domestically on a commercial scale once again for U.S. processors and manufacturers. Hemp Business Journal has also reviewed sales of clothing, auto parts, building materials and various other products, and estimates the total retail value of hemp products sold in the U.S. in 2017 to be at least $820 million. The United States is the largest consumer market for hemp products in the world.

Vote Hemp is a national, single-issue, non-profit organization dedicated to the acceptance of and a free market for industrial hemp and to changes in current law to allow U.S. farmers to once again grow the agricultural crop.  More information about hemp legislation and the crop's many uses may be found at www.VoteHemp.com.

 

 

SOURCE Vote Hemp

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