Steve Hoffman 7/29/21 Steve Hoffman 7/29/21

CBD: Consumers Crave Science, Information

This article originally appeared on https://www.letstalkhemp.com/

By Steven Hoffman

Based on a comprehensive consumer survey published in 2020 of 4,000 U.S. consumers plus another 1,000 consumers in Canada, healthy lifestyles research firm Natural Marketing Institute (NMI) found that people are eager and interested in exploring the medicinal value of CBD.

According to NMI’s 2020 North American Cannabis Market Opportunities and Challenges Report, 18% of the U.S. adult population (46 million consumers) say they have personally used CBD products in the past six months.

“Consumers don’t know a lot and they want to learn more,” said Diane Ray, NMI’s Vice President of Strategic Innovation. “Right now, they’re getting information from articles online and family and friends. It doesn’t appear that a lot of authoritative sources are connecting with consumers to provide them with reliable information. It could also be that resistance from social media companies may be a factor in limiting information,” Ray observed.

nmi-chart-consumer-familiarity-with-Cannabis-Terms-2020.jpg

“There’s an underlying desire to get healthier. People want to believe in the promise of CBD and they want to know how to tap into its benefits. However, the data indicates the industry isn’t educating enough. We see an influx of people experimenting and dabbling with CBD products – from dietary supplements and functional food and beverage to personal care – but that could flatten unless science comes into play more. The market is craving reliable science,” Ray said.

While an older generation in their 60s and 70s are turning to CBD products for pain management – in particular, CBD gummies are number one in terms of consumer choice, according to NMI data – Ray noted that a younger generation, including Millennials and the “i-gen” (the 18-25 age group) are among the most stressed, and they turn to CBD products for anxiety and relaxation.

“Consumers are slowly navigating the puzzle of dosage, quality, etc., to find out what products work for them and fit in their budget,” Ray said. “In the long term, they want to get it where they get everything else, but in the near term, they are looking for education and expertise, and for that they are going to specialty stores, including dedicated CBD stores, dispensaries, drugstores, the internet and natural food stores,” Ray noted.

Natural Marketing Institute identifies five consumer segments that are grouped along the lines of differentiated health attitudes, behavior and psychographics. They include:

Well Beings® – 26%
• Most health pro-active
• Leaders & influencers
• Most multi-cultural

Food Actives® – 14%
• Mainstream healthy
• Basics & balance

Magic Bullets® – 20%
• No healthy lifestyle commitment
• Managers vs. preventative

Fence Sitters® – 23%
• ‘Wannabe’ healthy
• Stressed, want control
• Multi-cultural segment

Eat, Drink & Be Merrys® – 17%
• Least health active
• Taste over health

For more information on the 2020 USA/Canada Whole Cannabis/Whole Health study, visit here.

Steve Hoffman 7/14/21 Steve Hoffman 7/14/21

Hemp-derived CBD Industry to Congress and FDA: “Regulate CBD as Dietary Supplements Now”

This article originally appeared in Presence Marketing’s July 2021 Industry Newsletter

By Steven Hoffman

The U.S. Hemp Roundtable (USHR) at a press conference on June 18th in Denver called on members of Congress in Colorado and in states across the country to support national legislation that would call on the FDA to regulate CBD like any other dietary supplement.

With approximately 100 people in attendance in person and online via Zoom at its spring 2021 membership meeting held at the Denver History Museum, USHR underscored its lobbying efforts by announcing the launch of Regulate CBD Now, an online campaign to encourage industry members and citizens to contact their representatives about important legislation impacting consumer access to hemp and CBD products in the U.S.

According to USHR General Counsel Jonathan Miller, the hemp industry is focused on two bills that Congress is currently considering – H.R. 841 in the U.S. House of Representatives, and S. 1698 in the U.S. Senate – that would call on the U.S. Food and Drug Administration (FDA) to regulate CBD as a dietary supplement or as a food additive.

“To have CBD regulated like dietary supplements would be a game changer for the hemp-derived CBD industry,” Miller told Let’s Talk Hemp. Miller noted that in addition to allowing CBD to be regulated like dietary supplements, the Senate bill also calls for CBD to be permitted as an ingredient in food and beverage products.

According to a statement by USHR, while the FDA has recognized the significant public interest in CBD, the agency has not yet established a legal pathway for its sale.

About the Bills:
H.R. 841 – Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021
Introduced by Rep. Kurt Schrader (D-OR), H.R. 841 allows the use of hemp, cannabidiol (CBD) derived from hemp, or any other ingredient derived from hemp in a dietary supplement, provided that the supplement meets other applicable requirements. Currently, FDA's position is that CBD products may not be sold as dietary supplements. (Source: congress.gov.)

S. 1698 – Hemp Access and Consumer Safety Act
Introduced by Sen. Ron Wyden (D-OR), S. 1698 would allow hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food and beverage products. (Source: congress.gov).

In addition to USHR, the Regulate CBD Now campaign is supported by organizations including the Alliance for Natural Health, American Herbal Products Association, Citizens for Health, Consumer Healthcare Products Association, Council for Responsible Nutrition, Friends of Hemp, Hemp Alliance of Tennessee, Hemp Industries Association, Midwest Hemp Council, National Grocers Association, Texas Hemp Coalition, United Natural Products Alliance, U.S. Hemp Authority, U.S. Hemp Building Association, Vote Hemp, We Are for Better Alternatives (WAFBA), and the Wisconsin Hemp Alliance.

The U.S. Hemp Roundtable is a national advocacy organization comprising a coalition of dozens of leading companies and organizations committed to safe hemp and CBD products. USHR works in partnership with national, regional, and state organizations, and helps lead the way forward for hemp and CBD products through education and action. For more information, visit www.regulateCBDnow.com and www.hempsupporter.com.

Steve Hoffman 6/21/21 Steve Hoffman 6/21/21

Hemp Industry to Congress and FDA: “Regulate CBD Now”

This article originally appeared on LetsTalkHemp.com

By Steven Hoffman

The U.S. Hemp Roundtable (USHR) at a press conference on June 18 in Denver called on members of Congress in Colorado and in states across the country to support national legislation that would call on the FDA to regulate CBD like any other dietary supplement.

With approximately 100 people in attendance in person and online via Zoom at its Spring 2021 membership meeting held at the Denver History Museum, USHR underscored its lobbying efforts by announcing the launch of Regulate CBD Now, an online campaign to encourage citizens to contact their representatives about important legislation impacting consumer access to hemp and CBD products in the U.S.

Members of the U.S. Hemp Roundtable announced on June 18 the launch of “Regulate CBD Now,” an online campaign to encourage passage of national legislation allowing access to CBD in dietary supplements and food and beverage products. Photo: Let’s Talk Hemp

According to a statement by USHR, while the FDA has recognized the significant public interest in CBD, the agency has not yet established a legal pathway for its sale.

“We wanted to raise awareness of this important legislation by hosting our Spring meeting in Colorado, an epicenter of the hemp industry,” said Miller. “We’re grateful to Colorado Representative Ed Perlmutter for co-sponsoring H.R. 841, and we hope that Congresswoman Diana DeGette (D-CO) will co-sponsor H.R. 841, as she serves on the committee of jurisdiction, Energy and Commerce. Also, we hope Senators Hickenlooper and Bennett will support the Senate bill, S. 1698.” Miller noted that in addition to allowing CBD to be regulated like dietary supplements, the Senate bill also calls for CBD to be permitted as an ingredient in food and beverage products.

“Colorado is a hemp state. We need Colorado’s elected officials to stand up and support legislation that gives consumers confidence in our products, protects small businesses and farmers, and allows this new industry to thrive,” said Steve Smith, co-founder of Pet Releaf, a family-owned company based in Littleton, CO. Smith noted that Colorado is home to many hemp and CBD companies. However, regulatory uncertainty has started to dismantle this up-and coming market, he said.

“The only way we’re going to see a regulated CBD market is if everyday citizens make their voices heard,” Miller emphasized. “Taken together, these two bills are a huge step forward in creating more certainty for farmers, greater protections for consumers, and more economic opportunity for…hemp companies,” he said.

About the Bills

H.R. 841 – Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021
Introduced by Rep. Kurt Schrader (D-OR), H.R. 841 allows the use of hemp, cannabidiol (CBD) derived from hemp, or any other ingredient derived from hemp in a dietary supplement, provided that the supplement meets other applicable requirements. Currently, FDA's position is that CBD products may not be sold as dietary supplements. (Source: congress.gov.)

S. 1698 – Hemp Access and Consumer Safety Act
Introduced by Sen. Ron Wyden (D-OR), S. 1698 would allow hemp-derived cannabidiol and hemp-derived cannabidiol containing substances in dietary supplements and food and beverage products. (Source: congress.gov).

“Regulate CBD Now” Endorsed by Leading Consumer Products Associations
The U.S. Hemp Roundtable is a national advocacy organization comprising a coalition of dozens of leading companies and organizations committed to safe hemp and CBD products. USHR works in partnership with national, regional and state organizations, and helps lead the way forward for hemp and CBD products through education and action.

For more information, visit www.regulateCBDnow.com and www.hempsupporter.com.

Supporting the Juneteenth Holiday, and Diversity and Inclusion in Hemp
In addition to covering a lengthy agenda, members of the U.S. Hemp Roundtable also wrapped up their Spring meeting by honoring Juneteenth – the new national holiday celebrating emancipation from slavery in the United States – with a number of USHR members volunteering to work at the Juneteenth Music Festival on June 19 in downtown Denver. The volunteer opportunity was organized by USHR’s Minority Empowerment Committee (MEC) to advance the association’s efforts to achieve equity, including, diversity and inclusion in the industry hemp and CBD industries.

*U.S. Hemp Roundtable members volunteered to work at the Juneteenth Music Festival on June 19 in Denver, CO – Photo: U.S. Hemp Roundtable Facebook Page*

Steve Hoffman 5/26/21 Steve Hoffman 5/26/21

U.S. Senators Introduce Bipartisan Bill to Legalize Sale of Hemp-derived CBD

This article originally appeared in the May 26, 2021 edition of the Let’s Talk Hemp Newsletter and Presence Marketing’s June 2021 Newsletter

By Steven Hoffman

In a bipartisan move, U.S. Senators Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR) on May 19 introduced S. 1698, the Hemp Access and Consumer Safety Act, in the U.S. Senate, a bill that would allow the sale of CBD and other hemp-derived ingredients in dietary supplements and in food and beverage products.

The Senate bill joins H.R. 841 a bill introduced in February 2021 in the U.S. House of Representatives to allow for the use of CBD in dietary supplements only. The Senate version also allows for hemp-derived CBD in food and beverage products.

According to a statement from Sen. Wyden’s office, currently, the Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition, however, the agency has yet to exempt hemp-derived CBD, despite Congressional action to legalize its production and sale.

By exempting hemp-derived CBD from the prohibition, the FDA can regulate hemp-derived CBD like all other new dietary ingredients, foods, and beverages, Sen. Wyden’s office said.

However, FDA, has stated that hemp-based CBD – or cannabidiol – cannot be lawfully marketed in dietary supplements or added to food and beverages because the compound was first studied as a drug and is currently the active ingredient in the GW Pharmaceuticals’ Epidiolex, approved by the FDA to treat certain forms of epilepsy.

According to a summary of S. 1698, the Hemp Access and Consumer Safety Act:

Gives hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act.
Prioritizes consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD.
Ensures that these products are properly labeled.
The Bill text can be found here.

The U.S. Hemp Roundtable encourages hemp industry members to urge their Senators to support S. 1698, the Hemp Access and Consumer Safety Act, and also to contact their Representatives to support H.R. 841, the Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act. For your convenience, you can use a pre-written letter here.

The Hemp Access and Consumer Safety Acthas support from the Consumer Brands Association, the Wine and Spirits Wholesalers of America, Hemp Roundtable, American Herbal Products Association, Oregon Farm Bureau, Vote Hemp, and the National Industrial Hemp Council. The following industry leaders submitted comments via press release, Sen. Wyden’s press announcement and direct submission:

Senator Ron Wyden (D-OR): “CBD products are legally being used and produced across the nation. Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone. It’s been more than two years since I worked with colleagues to have Congress legalize hemp and hemp-derived products. It’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”

Senator Rand Paul, (R-KY): “Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement. The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants.”

Sen. Jeff Merkley (D-OR): “Every day that the FDA drags its feet to update its CBD regulations, hemp farmers are left guessing about how their products will be regulated, and real economic gains for workers and business owners in Oregon and across the country are left on the table. Hemp-derived CBD products are already widely available, and we all need FDA to issue clear regulations for them just like they do for other foods, drinks, and dietary supplements.”

Jonathan Miller, General Counsel, U.S. Hemp Roundtable: “We could not be more excited about the successful, bipartisan rollout of S. 1698, which is simply critical for hemp farmers and businesses,” Miller told Let’s Talk Hemp. “The hemp and dietary supplement industries are united behind the bill and we’ve also secured the support of leading food and beverage companies and organizations. What we need now is the help of the grassroots to push this bill to final passage. We encourage all hemp supporters to go to www.hempsupporter.com to send emails to their Senators, urging them to co-sponsor this vital legislation.” In addition, Miller interviewed Sen. Wyden on May 24 on U.S. Hemp TV; you can watch the interview here.

Michael McGuffin, President, American Herbal Products Association: “The leadership of Senators Wyden, Paul, and Merkley in resolving this matter is greatly appreciated. Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated. AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market.”

Eric Steenstra, Executive Director, Vote Hemp: “It is critical that FDA begin regulating CBD products to ensure that consumers are protected and top quality compliant producers are the only ones on store shelves. Hemp derived CBD should be regulated the same as all other food and dietary supplements and we thank Senator Wyden, Senator Paul, and Senator Merkley for their leadership and support.”

Jason Miller, N.D., Cofounder and CEO, HempFusion, and Member of the Board of the U.S. Hemp Roundtable: “We proudly endorse and commend The Hemp Access and Consumer Safety Act and thank Senators Wyden, Paul and Merkley for their bipartisan support. A major component of our strategic business plan has been to prepare for this day and now we are finally at the door of what will open up the CBD industry for those brands that can properly adhere to FDA’s requirements.”

Ola Lessard, Chief Marketing Officer, HempFusion, and President of the U.S. Hemp Roundtable: “While the Senate bill is more comprehensive than the previously introduced House bill H.R. 841, passage of either will provide a vast and very important boost to the hemp industry, benefitting farmers, producers, manufacturers, small and large retailers and, most importantly, consumers. The lack of clear regulation for the past several years has had devastating economic impact across many sectors. It’s also allowed fly-by-night companies to thrive, selling products that don’t meet label claims, aren’t manufactured properly, and – in some cases – are actually dangerous to consumers.”

Patrick Atagi, Board Chair, National Industrial Hemp Council: “Last year, nearly $15 billion in economic benefits were left out of the economy because CBD wasn’t regulated appropriately. If the FDA can’t act, Congress should fulfill its oversight role and pass this legislation. NIHC supports Senators Wyden, Paul, and Merkley’s recognition of hemp and CBD as an ingredient in both food and supplements, and we applaud their legislative approach to ensure that it’s regulated accordingly. This bill will deliver safe products to the marketplace and create a hemp economy that works for everyone.”

Morris Beegle, Cofounder, We Are for Better Alternatives (WAFBA), Producer of NoCo Hemp Expo and Southern Hemp Expo, and Publisher of Let’s Talk Hemp: “As a producer of some of the largest industrial hemp trade shows in the world, we have to have a clear regulatory understanding of hemp-derived cannabinoids as ingredients for dietary supplements, foods and beverages. I have seen first hand over the last several years as this industry has started to take shape how the FDA’s lack of clarity and action has adversely affected the entire supply chain and created a vast amount of state-to-state patchwork regulations regarding CBD and hemp as a whole. The Hemp Access and Consumer Safety Act provides necessary relief to an industry that needs stability to mature. Here at WAFBA, we thank Senators Wyden, Paul and Merkley for championing the benefits of industrial hemp at the federal level, and we appreciate the broad industry support and collaboration around this proposed legislation. This cannot pass through congress and get signed by President Biden soon enough.”

Courtney N. Moran, LL.M., Oregon Industrial Hemp Farmers Association: “We are grateful for the continued leadership of Senators Ron Wyden (D-OR), Jeff Merkley (D-OR), and Rand Paul (R-KY) in advancing hemp policy, creating economic opportunities and broadening protections for our industry stakeholders. This bill is an important step forward not only for the cannabinoid sector, but for the grain and fiber sectors investing in infrastructure to open the food, animal feed, and supplements markets.”

Brian Furnish, Owner, Hempin’ Hill Farm: “I want to thank Senator Paul for being a co-sponsor of the Hemp Access and Consumer Safety Act. This is a much needed step in moving the hemp industry forward. This bill will clarify that hemp byproducts are treated as a food or dietary supplement. Senator Paul has been an advocate for hemp legalization since the very beginning.”

Katie Moyer, Owner, Kentucky Hemp Works: “I am so grateful for Senator Paul’s continued support of the U.S. hemp industry. This bill will take us one step further in ending the Drug War mentality and allow hemp farmers and processors to not only break even, but to flourish in their fields. Current regulations pit state and federal bureaucracies against our farmers, and I’ve never been prouder of my Senator for consistently looking for ways to get government off the farm.”

Derek Selznick, Executive Director, Kentucky Guild of Brewers: “The Kentucky Guild of Brewers would like to thank Senator Paul and all of the other sponsors of this bill. Allowing breweries to use safe products like CBD in beer allows us to continue to innovate and respond to consumer demand by offering new and unique beers. Innovation is at the core of our industry and this is one more way we can further diversify our product portfolio.”

Scott Melville, President & CEO, Consumer Healthcare Products Association: “We strongly commend Senators Wyden, Paul and Merkley for their bipartisan bill which will provide a pathway for CBD to be legally marketed as a dietary supplement. A lawful regulatory pathway will provide long-term certainty in the hemp-derived CBD market and protect consumers from potentially unsafe products.”

Angi Bailey, President, Oregon Farm Bureau: “We are so thankful to both Senator Merkley and Senator Wyden for their steadfast support for one of Oregon’s fastest growing agricultural crops. This important legislation will ensure consumers have access to non-intoxicating hemp and hemp derived ingredients in both food products and dietary supplements. Providing consumers with the assurance that the CBD products they are purchasing are safe and property labeled is of utmost importance to the industry.”

Dawson Hobbs, EVP, Wine and Spirits Wholesalers of America: “The lack of clarity on the legality of hemp-derived CBD products used in foods and beverages has been a significant source of confusion in the marketplace. America’s family-owned wholesalers are federally permitted and regulated businesses that need clarity from federal regulators regarding the legal status of CBD products. We applaud this action directing the Food and Drug Administration to affirm that CBD is legal in dietary supplements, including food and beverages. It will allow America’s wholesalers to continue providing U.S. consumers with the most diverse product selection in the world.”

Jen Daulby, SVP, Government Affairs, Consumer Brands Association: “The Consumer Brands Association commends Senators Wyden, Paul and Merkley for shining a spotlight on a product that has been a catalyst for a conflicting patchwork of state laws and regulations. Consumer Brands has long advocated for a national regulatory framework for CBD that empowers FDA to establish smart, consistent regulations and gives them the resources they need. Today’s action is a first step in delivering these much-needed regulations for American consumers.”

Photo courtesy of Let’s Talk Hemp

Steve Hoffman 3/31/21 Steve Hoffman 3/31/21

Large-scale Study Finds No Evidence of Liver Toxicity from Oral CBD Products

This article originally appeared in Presence Marketing’s April 2021 Industry Newsletter

By Steven Hoffman

CBD products do not cause liver damage when taken orally, according to preliminary results of a seven-month clinical investigation conducted by Validcare in response to the FDA’s request to help inform the agency’s regulatory approach regarding products containing hemp-derived CBD. Twelve companies, including CBD market leader Charlotte’s Web, helped support the study. Preliminary findings showed no evidence of liver disease in the 839 participants in the study, and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions. The Validcare study’s findings were shared with the FDA when researchers met with the agency on March 15 to review preliminary liver safety results in the form of an abstract, reported Nutra Ingredients-USA. “We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” said Keith Aqua, M.D., co-principal investigator of the study.

Steve Hoffman 11/18/20 Steve Hoffman 11/18/20

UN Vote on Cannabis Could Impact THC and CBD Products Worldwide

This article originally appeared in the November 18, 2020 edition of the Let’s Talk Hemp Newsletter

By Steven Hoffman

The United Nations (UN) Commission on Narcotic Drugs (CND) is scheduled to vote on December 2 on the fate of cannabis recommendations made by the World Health Organization (WHO). The vote, reports Green Entrepreneur, will affect a series of recommendations for THC and CBD products, including pharmaceutical cannabis products such as Marinol, Syndros and Sativex.

“Among its recommendations, the WHO calls for all forms of THC to be removed from the drug convention of 1961, placing it with cannabis in Schedule I, the least restrictive classification by UN standards. Meanwhile, pharmaceutical cannabis medications would be placed in Schedule III,” Green Entrepreneur reported.

“In addition to the WHO’s recommendation on rescheduling cannabis and cannabis resins, another significant recommendation relates to ‘cannabidiol preparations,’ or CBD, Nushin Rashidian reported in Cannabis Wire. “The WHO already took a position in 2018 that pure CBD doesn’t warrant regulation. This latest recommendation is to put that position into effect by adding a note under the cannabis and cannabis resin entry under Schedule I that ‘preparations containing predominantly cannabidiol and not more than 0.2% of delta-9-tetrahydrocannabinol are not under international control,’” Rashidian wrote.

It should be noted that while Schedule I in the U.S. means the most stringent of regulated categories under the Controlled Substances Act (CSA), under the UN 1961 Single Convention on Narcotic Drugs, Schedule IV is the most restrictive and includes substances considered dangerous with limited or no medical value. “In removing cannabis and cannabis resin from Schedule IV, the WHO is effectively acknowledging its medical utility, Cannabis Wire reported.

Writing in Forbes, leading cannabis attorney Bob Hoban said, “The Single Convention on Narcotic Drugs of 1961 is an international treaty prohibiting production and supply of specific drugs and of drugs with similar effects — except under governmental license for specific purposes, such as medical treatment and research. Under the Single Convention, Cannabis (not ‘marihuana’ or ‘marijuana’) is categorized alongside cocaine and heroin as a dangerous substance with no medicinal benefit and a high potential for abuse,” he wrote.

“The UN Convention doesn’t distinguish between marijuana or hemp or make other legal distinctions that exist in the United States, but defines the substance as ‘cannabis’ and generally comments on the legality of its various uses. This excludes most ‘industrial’ uses of cannabis, or what we think of as non-psychoactive hemp in the United States, from UN control. These industrial uses can include applications for textiles, bioplastics, pulp for paper, and biofuels, just to name a few” Hoban reported.

No Changes Anticipated in the Near Future
Hoban noted that even if the UN votes to approve WHO’s cannabis recommendations, the legality of cannabis won’t change in the near future.

“Here’s an example: if the UN were to adopt these changes, or even if the Single Convention were abolished in its entirety (highly unlikely), its tenets continue to be ingrained in the United States’ CSA and the domestic laws of its numerous signatories. Until those laws are also repealed, amended, altered or otherwise modified, nothing will change overnight because of the political will and conflict in signatory countries” he wrote in Forbes.

Representatives of the U.S. said the country will not support recommendations regarding CBD as a medical preparation, Hemp Today reported. “The U.S. representative said the WHO proposal to remove CBD medicine from international drug controls could ‘introduce legal ambiguities and contradictions that would undermine effective drug control.’ Instead, she reaffirmed that medical CBD is not scheduled in the Conventions, and therefore not subject to drug controls, reminding as well that CBD which may be present in industrial hemp products are similarly exempt,” Hemp Today reported.

In addition to the U.S., not all member states, including Russia, are on board with WHO’s cannabis recommendations or any changes to international drug rules. However, a group of international NGOs (non-governmental organizations) signed on the support approving WHO’s recommendations, according to activist and organizer Kenzi Riboulet-Zemouli, based in Barcelona, Spain.

NGOs Encouraged to Sign On to Support WHO’s Cannabis Recommendations
“As you may know, the United Nations will make a historic decision on medical cannabis in early December 2020,” Riboulet-Zemouli said in an email communication. “Together with ECOSOC-accredited organizations [referring to the UN Economic and Social Council], we have created a statement to be submitted to the Commission on Narcotic Drugs member states for consideration. We are calling on global drug policy reformers, patients, advocacy, and health organizations to sign-on,” he said.

“This statement will be submitted to the proper authority at the Commission of Narcotic Drugs for inclusion during the proceedings and in the official records, showing that NGOs care about the issue at stake. We would like for your organization to be included,” Roboulet-Zemouli added.

Steve Hoffman 11/4/20 Steve Hoffman 11/4/20

Bipartisan Support Builds for Legislation to Legalize the Sale of Hemp-derived CBD in Dietary Supplements

This article originally appeared in Presence Marketing’s November 2020 Newsletter

By Steven Hoffman

Legislation is advancing that potentially bodes well for sellers of dietary supplements made with hemp-derived CBD.

According to reports from the U.S. Hemp Roundtable, 18 members of Congress have signed on in support of a bill introduced in September in the U.S. House of Representatives that would “make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the Federal Food, Drug and Cosmetic Act as a dietary ingredient in a dietary supplement, and for other purposes.”

The Bill, H.R. 8179, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020, enjoys bipartisan support. If passed, it would allow hemp-derived CBD and other hemp-derived ingredients to be legally marketed as an ingredient in dietary supplements, as long as the products comply with current legal requirements for new dietary ingredients, as well as other requirements pertaining to dietary supplements under federal law.

“In a year when Congress is bitterly divided and has been unable to find agreement on key issues such as pandemic response and aid relief, there is unusual and exciting agreement around a potential bill to allow hemp CBD to be marketed as a dietary supplement, with 18 members from both parties supporting the bill,” said the U.S. Hemp Roundtable in a statement.

“H.R. 8179 … is more than hemp and supplements, however. It represents an opportunity to provide consumers greater product safety and confidence due to regulations, hemp farmers an economic lifeline, and states struggling from reduced revenues a new source of profitable opportunity,” said the U.S. Hemp Roundtable. “Failing to establish a regulatory pathway for legalizing hemp-derived CBD will continue to reduce economic opportunity for U.S. hemp farmers and deny consumers access to safe, quality products. H.R. 8179 would help stabilize the hemp markets, open up a promising economic opportunity for U.S. agriculture and honor the commitment made to growers in the 2018 Farm Bill,” the organization added.

Hemp Can Provide an Economic Stimulus
“Once FDA does legally recognize and regulate CBD products, the hemp industry can provide a needed financial jolt to a nation emerging through economic recovery. Regulatory relief for the hemp-derived CBD industry constitutes an economic stimulus package for the nation’s farmers and small businesses without requiring one dime from the American taxpayer,” the U.S. Hemp Roundtable stated.

“Independent surveys predict that with a regulatory pathway, sales of CBD products would grow from approximately $1.2 billion in 2019 to anywhere from $10.3 billion to $16.8 billion by 2025,” U.S. Hemp Roundtable concluded.

The bipartisan legislation, introduced by Rep. Kurt Schrader (D-OR) and Rep. Morgan Griffith (R-VA), would direct the U.S. Food and Drug Administration (FDA) to use its authority and resources to set a clear regulatory framework for hemp and hemp-derived CBD and assure consumer protection for these products, reported the American Herbal Products Association (AHPA) in a release. For marketers of hemp-based CBD in dietary supplements, the bill would eliminate regulatory hurdles and uncertainty that have hampered the category’s growth.

The bill’s lead co-sponsor, Rep. Morgan Griffith, added, “Hemp was historically an important crop for Virginia farmers, and dietary supplements made from it do not possess dangerous addictive qualities. Nevertheless, the current state of regulation creates confusion about its legal uses. I joined this bipartisan bill to provide certainty for hemp farmers that their crop may find legal uses,” said Rep. Griffith in a statement.

Other sponsors of the bill include Representatives Tulsi Gabbard (D-HI), James Comer (R-KY), Peter DeFazio (D-OR), Don Bacon (R-NE), Ron Kind (D-WI), Mike Rogers (R-AL), and more. In total, nine Republicans and nine Democrats signed on to sponsor the bill.

In response to the proposed legislation, leading dietary supplement industry associations, including AHPA, the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), Citizens for Health, and the United Natural Products Alliance (UNPA), have endorsed H.R. 8179. The National Grocers Association and the National Association of State Departments of Agriculture, along with the U.S. Hemp Roundtable and other hemp industry leaders, also have endorsed H.R. 8179.

Hemp Industry Pushes Back on the DEA; Gains Congressional Support
In related news, U.S. Senators Ron Wyden (D-OR) and Jeff Merkley (D-OR) joined others in championing the potential of hemp CBD by sending a letter on October 22, 2020, to U.S. Drug Enforcement Administration (DEA) Acting Administrator Timothy Shea to make clear that the DEA’s Interim Final Rule (IFR) regarding hemp is in opposition to federal law and derails the intent of the 2018 Farm Bill.

"We are grateful for Senator Wyden and Merkley’s leadership and are hopeful that the DEA will listen and take necessary steps to withdraw its misguided rule. We will continue to pursue our efforts to fix this problem in Congress and/or the courts," said Jonathan Miller, General Counsel for the U.S. Hemp Roundtable.

DEA's Interim Final Rule (IFR) drew strong objections from the hemp industry overall as it potentially criminalizes the hemp extraction process, undermining the industry and U.S. hemp farmers.

In mid-October, the Hemp Industries Association (HIA) along with South Carolina-based CBD maker RE Botanicals filed a federal lawsuit claiming that the DEA is unlawfully attempting to regulate certain products derived from lawful hemp by misinterpreting the 2018 Farm Bill.

Specifically, said the plaintiffs, the DEA classifies intermediary hemp material (IHM) and waste hemp material (WHM), two necessary and inevitable byproducts of hemp processing, as Schedule I controlled substances. The plaintiffs argue that Congress deliberately removed such commercial hemp activity from the DEA's jurisdiction when it legalized hemp production, including hemp processing, via the 2018 Farm Bill.

The filing is the second such federal action is as many months taken by the plaintiffs on behalf of the hemp industry. In September, HIA and RE Botanicals filed an initial federal lawsuit challenging DEA’s rule and perceived interference in the industrial hemp market.

Resources
H.R. 8179 Bill
H.R. 8179 Fact Sheet
H.R. 8179 White Paper
H.R. 8179 Two-pager with Bill Sponsors
Legislation Would Legalize Sale of Hemp-derived CBD in Dietary Supplements
It’s Hemp vs. the DEA … Again!
CBD Industry Takes the Fight to the DEA

Steve Hoffman 10/21/20 Steve Hoffman 10/21/20

Italy Classifies CBD as Narcotic; Orders Products Off Retail Shelves

This article originally appeared in the October 21, 2020 edition of the Let’s Talk Hemp Newsletter.

While the EU is the world’s second largest market for hemp-derived CBD products, Italy’s Ministry of Health this week decreed CBD is a drug, and retailers were warned not to sell hemp extract products, in conflict with the country’s Agriculture Ministry, which listed hemp flowers for “extraction uses” as an agricultural product, and not a drug.

By Steven Hoffman

With the CBD-based pharmaceutical, Epidiolex, manufactured by the UK’s GW Pharmaceuticals, poised to enter the Italian market, hemp-derived CBD was classified this week as a narcotic in Italy by the country’s Ministry of Health. According to a HempToday report on October 20, CBD was officially added to Italy’s list of medicines.

In addition to the ruling, Italy’s Customs and Monopoly Agency immediately followed up with a warning to retailers, advising them “not to hold and sell … inflorescences (flowers), oils, resins or other products containing substances derived from hemp sativa,” HempToday reported.

The move comes in conflict with the country’s Agriculture Ministry, which published an official decree in August 2020 that listed hemp flower, or “canapa infiorescenza,” for extraction uses as an agricultural product.

According to the Cannabis Law Report, the decree was approved by Italy’s Agriculture Minister Teresa Bellanova, adding hemp flower under “medicinal plants” in a list of approved agricultural products. HempToday reported that Italy’s Agriculture Ministry “listed hemp flowers for ‘extraction uses’ as an agricultural product, and not a drug.”

Concerns Over Proposed EU CBD Regulation
Italy’s decision contributes to the hemp industry’s concern that the EU market overall is becoming less friendly to hemp-derived CBD products. According to Better Retailing, retailers in Europe could see up to half of existing CBD brands disappear due to upcoming cost-prohibitive regulation.

“From 31 March 2021, CBD food, drink, oil and supplement brands must be able to prove that products released to [the EU] market before 13 February 2021 have a validated novel foods application to be legally allowed to sold in stores. It applies only to ingested goods, meaning CBD vaping lines are exempt,” Better Retailing reported. According to Better Retailing, it could cost more than $500,000 to have each product line submitted for EU regulatory approval.

Then, in July 2020, news reports shared that the European Commission was suspending applications for CBD to be included as a novel food. Instead, it was learned the commission is reviewing whether CBD and other extracts derived from hemp flowers would be better regulated as narcotics. The reasoning behind the suspension was based on a reference in the United Nations Single Convention on Narcotic Drugs in 1961, which states that “’extracts and tinctures’” of the flowering tops of the hemp plant (cannabis sativa) should be classed as a narcotic,” reported New Food Magazine.

While it is still only a proposal, the ramifications of such a ruling has the European hemp industry quite concerned. Responding to the proposal to rule CBD as a narcotic in the EU, the European Industrial Hemp Association (EIHA) accused the European Commission of being “poised to kill the EU’s hemp sector,” Hemp Gazette reported.

“If confirmed, this position is likely to strike the final blow to the sector and deprive farmers from a low maintenance and profitable rotation crop with the potential to bringing environmental benefits,” the EIHA said in a July 2020 statement. “Cannabidiol would stay on the market but only in synthetic form, produced via polluting chemical manufacturing.”

According to EIHA’s view, “Industrial hemp and its downstream products are not narcotic or psychotropic drugs.” Further, EIHA stated that “hemp is exempted from the scope of the United Nations Single Convention of 1961, whose authors made a clear distinction between cannabis varieties grown for the production of drugs (falling under the scope of the treaties) and exempting those grown for any other purpose (i.e., low-THC varieties). On top of that, EIHA states clearly that not all hemp extracts shall be considered novel but only the enriched and isolated ones,” the organization stated.

“EIHA collected many evidences which clearly demonstrate that traditional hemp extracts were widely used as food for centuries. Traditional hemp extracts, which have been consumed for centuries in Europe and worldwide, should therefore be considered as traditional food according to food regulations. Hemp extracts processed by new extraction methods should be subject to the respective legal frameworks of the Novel Food Regulation (EU) 2015/2283,” EIHA asserted.

Meanwhile, in Italy, hemp industry observers expressed concern that GW Pharmaceuticals’ desire to enter EU markets – and its recent request to begin marketing in the Italian market – may have prompted the Italian Ministry of Health’s decree establishing narcotics status for CBD, reported HempToday.

According to HempToday, “It remains to be seen what will happen in Italy with smokable hemp, which is based on hemp flowers (“inflorescenses”) and therefore not extracted, under the Customs and Monopoly Agency’s stop-sell order.” Sold as pre-rolled cigarettes and loose in pouches, smokable hemp has grown in popularity in Italy, Switzerland and elsewhere in the EU over the past few years, HempToday reported.

Also, HempToday pointed out that hemp flowers can also contain hemp seeds, “which are technically legal in Italy, raising still further potential confusion.” Approximately 80% of Italy’s agricultural hemp production is in food seed, according to a report published in February 2020 by the Foreign Agricultural Service of the U.S. Department of Agriculture.

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Steve Hoffman 10/2/20 Steve Hoffman 10/2/20

Life After Manitoba Harvest: Mike Fata Celebrates 25 Years of a Personal and Entrepreneurial Journey to Health

This article originally appeared on LetsTalkHemp.com

By Steven Hoffman

Mike Fata, founder and former Chair and CEO of Manitoba Harvest – and one of the original founders of the hemp food industry – is celebrating the 25th anniversary this month marking the beginning of his personal journey to health.

In 1995, Mike was, as he said, “an unhealthy and unhappy 18 year old who weighed 300 pounds. I became sick and tired of being sick and tired, and decided to do something about it.”

Along the way, Mike learned a lot about nutrition, a healthy diet and an active lifestyle. He lost 125 pounds, regained his health, and … “the journey to health got me to see the value of hemp seed,” he said.

Inspired by the superfood potential hidden in the hemp seed, Fata in 1998 founded Manitoba Harvest. Today, the award-winning company is a widely recognized global hemp food leader, with lifetime sales in 2020 surpassing $500 million.

After successfully selling Manitoba Harvest in 2019 to Tilray (NASDAQ:TLRY), a publicly traded, vertically integrated cannabis company based in Canada, for US$318 million, Mike is no longer involved on a day to day basis with the company. “It came to the point where the business was going that it was best to have a classically trained CEO leading the company,” he observed.

Yet, having carved out a significant entrepreneurial legacy in hemp and the natural and organic foods industry, Mike has future plans to mentor and invest in companies and brands that are committed to improving health, the environment and the quality of people’s lives.

“My passion is health and my purpose is to share it with the world,” Fata said. “I’m starting to diversify and help other founders fulfill their mission in the natural products space. I’ve made a couple of investments and got involved on the board level, and am involved actively in a couple of businesses.” Mike cites, for example that he’s become involved with Om Organic Mushrooms, an emerging natural supplements brand.

Mike also is committed to helping the hemp industry and natural products industry grow in Canada. “Giving back has been a big part of my work for my whole career; I’ve done 25 years of nonprofit board work,” he shared. Currently, Fata serves as Chair of the Canadian Health Food Association (CHFA), and during his tenure, the organization has been supportive of removing restrictions on CBD sales in Canada.

Currently, there are no legal means to bring non-prescription CBD health products to the Canadian marketplace, said CHFA in a statement. However, the association this past month released a report identifying CBD products as an opportunity for economic recovery in Canada that could create a niche market valued at more than C$1 billion.

“CHFA has been very outspoken in favor of hemp and CBD in the last couple of years,” said Fata. “Currently, to buy CBD in Canada you have to go to a licensed dispensary. We’re trying to change it so natural food retailers in Canada can sell these products.”

In applying what he’s learned leading the growth of Manitoba Harvest, Fata said, “At the end of the day, if you have a great product and you put the right capital and great people together, good things can happen. However, he noted, “The hemp industry is missing strong strategy and planning because it’s still a new industry. Also, more innovation has to happen,” he advised.

Fata also believes that “extracts aren’t the cure all and end all for the hemp industry. People rushed in; it will take years to work out.”

However, Mike notes that there is huge potential for hemp food and hemp fiber. “There is tremendous value in the seed and the fiber 10 to 20 times over where the industry is now,” he said. “For now, we have hemp hearts, but we need more innovation. Look at the advancements in soy protein, pea protein, for example. “Hemp is just scratching the surface. We’re just getting started on being a superfood.”

While Mike admits he is currently under a noncompete agreement in the hemp market as a result of the sale of Manitoba Harvest to Tilray, “I am a super hemp consumer and am super passionate about it, from genetics to market. So, stay tuned.”

The best way to reach out to Mike Fata is via LinkedIn.

Steve Hoffman 9/23/20 Steve Hoffman 9/23/20

CBD Industry Takes the Fight to the DEA

Harmony, RE: Botanicals CEO Janel Ralph Leads Industry Lawsuit Challenging DEA’s Proposed Rules on Hemp

By Steven Hoffman

The U.S. Drug Enforcement Administration (DEA) just made the wrong person mad.

By issuing in late August an interim final rule to regulate hemp that is separate from USDA’s, many hemp business leaders feel DEA’s IFR could seriously threaten the hemp extracts market.

Enough so that Janel Ralph, CEO of two leading hemp extract brands including Harmony (aka Palmetto Harmony) and RE: Botanicals, has taken the initiative to file a federal lawsuit challenging DEA’s rule and perceived interference in the industrial hemp market.

In particular, manufacturers are challenging DEA’s rule stating that any hemp product exceeding the federal limit of 0.3% THC during manufacturing is considered a Schedule I controlled substance, even if the final product contains less than the 0.3% limit.

The petition was filed on September 18, 2020, in the U.S. Court of Appeals for the District of Columbia Circuit by RE Botanicals, Inc. in partnership with the Hemp Industries Association. A leading hemp extract manufacturer based in South Carolina, RE Botanicals in 2019 acquired Palmetto Synergistic Research (dba Harmony), which was founded in 2015 by Janel Ralph, inspired to develop products to serve her special needs daughter Harmony.

“We are a small, woman-operated company,” said Ralph. “The DEA’s new rule could put us out of business overnight.”

The lawsuit claims DEA’s interim final rule is unlawful because it exceeds the DEA's legal authority and violates the Agriculture Improvement Act of 2018, also known as the Farm Bill.

The DEA’s rule clarifies the agency’s position that all hemp derivatives or extracts exceeding 0.3% THC shall remain Schedule I controlled substances. According to the petitioners, this requirement could be interpreted to include intermediate hemp derivatives that temporarily exceed 0.3% during processing, but contain less than 0.3% in final products.

As such, it improperly establishes the DEA’s authority over legal hemp activities, which is contrary to the plain language and intent of the 2018 Farm Bill, the petitioners claim.

The petitioners also argue that acting DEA administrator Timothy Shea, who is individually named as a respondent along with the agency, issued the interim final rule without observing procedures required by law.

Attorneys for the petitioners include Vicente Sederberg LLP, Yetter Coleman LLP, Hoban Law Group and Kight Law Office PC.

"The DEA implemented this rule without following proper rule-making procedures, such as providing the public with notice and the opportunity to comment," said Shawn Hauser, a partner at Vicente Sederberg and chair of the firm's hemp and cannabinoids practice. "The petitioners believe legal action is necessary to protect the lawful U.S. hemp industry that Congress intended to establish when it enacted the 2018 Farm Bill.”

Hemp industry members, business owners and advocates are encouraged to provide comments to the DEA before the October 20, 2020 deadline. Comments can be submitted here.

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