FDA

Hemp Market Takes Off at Expo West

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For Presence Marketing Newsletter, April 2019
By Steven Hoffman

Anyone attending Natural Products Expo West, the world’s largest natural products trade show, held this past March, couldn’t help but notice that 2019 has emerged as “The Year of Hemp” in the natural and organic products market.

Indeed, the legalization of industrial hemp under the 2018 Farm Bill has been a boon for independent natural foods retailers, said Loren Israelsen, president of the United Natural Products Alliance. “For smaller stores, this category has been a lifeline for them as they battle to maintain foot traffic in the stores as online sales continue to grow.”  

Larger stores, too, are eyeing the hemp market: Boulder-based Lucky’s Market has taken the lead in hemp and CBD product sales in its stores nationwide, with full shelf sets in the natural living department. Ohio-based Mustard Seed Market’s supplement sales are being driven by its commitment to CBD products, says Nutrition Director Abraham Nabors. Whole Foods Market’s trend spotters identified hemp as a “top 10 food trend for 2019,” and recently, Whole Foods CEO John Mackey indicated the possibility of Whole Foods selling cannabis products should they become legal in the future.

According to Hemp Business Journal’s new report, The Global State of Hemp: 2019 Industry Outlook, U.S. sales of hemp products – from full-spectrum hemp extract and CBD products to hemp foods, textiles, building materials, bioplastics and more – estimated at $1 billion in 2018, are projected to grow 27% annually to reach $2.6 billion by 2022. Global hemp retail sales totaled $3.7 billion in 2018 and are projected to grow to $5.7 billion by 2020.

The passage of the Agriculture Improvement Act of 2018, commonly known as the Farm Bill, in late December was nothing less than historic, legalizing for the first time in more than 80 years the commercial cultivation and sale of industrial hemp. “Most importantly, noted journalist Chris Chafin in Rolling Stone, “it removes hemp and any hemp derivative from the Controlled Substances Act, legally separating it from marijuana and putting its supervision under the Department of Agriculture. In the most basic sense, these plants serve three primary uses: fiber (paper and cloth), seeds (for hemp oil and food), and cannabinoid oils. It’s this last category that’s the most profitable and has the biggest potential for growth. The [Farm Bill] defines hemp as any part or derivative of cannabis with a THC level below 0.3 percent on a dry-weight basis,” Chafin reported.

Hemp Steals the Show at Expo West
Interest in the category was so strong at 2019 Natural Products Expo West that a full-day Hemp & CBD Summit held at the show spilled out beyond a 500-person ballroom into two other rooms where a similar-sized audience watched by live video feed. Also, during a panel discussion hosted by Presence Marketing and NCG at Expo West for over 150 retailers, CBD and hemp supply chain (e.g., ensuring that the full spectrum hemp extract products you carry are sourced from certified organic producers, etc.) dominated the discussion.

Full spectrum hemp and CBD products from new and national brands alike were introduced everywhere at the trade show: carob snacks with hemp extract from Missy J’s; CBD sparkling water from Weller; hemp-infused honey from Colorado Hemp Honey; CBD wellness shooters introduced by Navitas; organic full-spectrum hemp extract from Gaia Herbs, Charlotte’s Web, CV Sciences and others; hemp supplements by Leaf Therapeutics, a new brand launched by legacy brand Solaray; hemp gummies and caramels from Boulder-based Restorative Botanicals; CBD sports nutrition, hemp balms, hemp infused body care products and more. Honestly, what didn’t have CBD hemp extract at Expo West?

And that’s not to mention hemp foods derived from hemp seed – high in plant-based protein and omega-3 essential fatty acids, but with no CBD or cannabinoid compounds. Sold for over 20 years in natural foods stores, hemp seed-derived products are now widely regarded as superfoods. Brands such as Tempt, Manitoba Harvest, Evo Hemp and others presented new hemp food offerings at Expo West, capitalizing on heightened interest in all things hemp.

CBD or Hemp Extract?
The FDA may yet come out against use of the term “CBD.” While the agency is expected to review CBD and hemp extracts in food and supplements in the near future, according to outgoing FDA Commissioner Scott Gottlieb, CBD isolate was approved as a drug by the agency after granting license for Epidiolex, the first pharmaceutical derived from cannabidiol (CBD), manufactured by the company GW Pharmaceuticals. The commissioner had recently spoken of a “pathway” to acceptance of hemp CBD as a dietary ingredient. However, with Gottlieb announcing his resignation in early March, many in the natural products industry are uncertain whether progress on FDA regulatory policy regarding hemp and CBD will be made.

However, judging from exhibit after exhibit on the trade show floor, you wouldn’t know the regulatory waters around the use of the term “CBD” are murky. For many exhibitors at Expo West, “CBD” was the go-to phrase on product packaging, literature and exhibit signage, while others more conservatively stuck to the phrase “full-spectrum hemp extract.” 

Despite FDA’s lack of a decision to date in this regard, manufacturers, retailers and consumers alike are responding positively to the use of CBD on the product label, and are not waiting for FDA to decide. This could be an issue down the road for many manufacturers, should the FDA decide to crack down on use of CBD on labels. The key, advised a number of speakers at the show, is avoid the use of CBD isolate in products and stick with full-spectrum hemp extract to avoid unwanted attention from the FDA. 

While "it’s still unclear how different federal agencies will interpret the new [Farm Bill] rules...it doesn’t matter — people in the CBD industry are calling the new legislation a game changer," observed Chafin in Rolling Stone.

Transparency and Testing Are Crucial
A major theme at Expo West’s Hemp & CBD Summit focused on manufacturers operating with safety and integrity, noted CBD Insider in a March 9, 2019, report. “To preserve integrity, businesses must always test their products, especially in these six areas: cannabinoid potency, residual solvents, heavy metals, pesticides, microbes, and terpenes. After this testing is complete and the products are verifiably ready for consumption, companies should be transparent with their testing and provide documentation of third-party lab results. Companies — and consumers — must do their homework and ask questions. If a laboratory, farmer, brand, or any other entity in the supply chain is not willing to be transparent, it’s a sign that you should do business elsewhere. Many of the speakers discussed how they personally vet businesses before working with them, such as requiring documentation or personally visiting the company’s facility,” reported CBD Insider.

In addition, and importantly, retailers and consumers should seek out hemp products that are grown in accordance with certified organic and preferably climate friendly regenerative practices, emphasized John Roulac, founder of Nutiva and RE: Botanicals, a new hemp “apothecary,” which debuted at Expo West. Beware of low-cost hemp extract products that may have been produced with industrial agriculture practices including toxic, synthetic pesticides and synthetic nitrogen fertilizers derived from natural gas and fracking – contributors to global warming – and extracted with toxic organic solvents, he cautioned.

U.S. Hemp Acreage – 80,000 Acres and Growing
Although hemp is now legal across the U.S., the message seems to be getting out slowly, and state and local authorities are still seizing hemp crops and truckers are being arrested for crossing state lines with container loads of harvested industrial hemp for processing, tying up individuals in jail and leaving valuable inventory in limbo.

Currently, nine states – Idaho, Louisiana, Mississippi, Georgia, Ohio, South Dakota, Iowa, Texas, and Connecticut – still prohibit hemp production under any circumstances. And four states – Idaho, South Dakota, Nebraska, and Kansas – still prohibit hemp-derived CBD. “For now, transporting hemp across these state lines may still be as dangerous as it’s ever been,” reported science writer Leo Bear-McGuiness in Analytical Cannabis.  

Yet, “damn the torpedoes,” U.S. farmers are saying, as they respond to soaring demand by dedicating farmland to hemp cultivation, seeing it as a potential cash crop and an alternative to growing GMO corn, soy, tobacco and other commodity crops. 

According to hemp advocacy group Vote Hemp, the U.S. hemp crop tripled in 2018 to 78,176 acres, up from 25,713 acres in hemp cultivation in 2017. That figure is expected to grow now that the Farm Bill has opened the door nationwide to hemp production, says Vote Hemp. Montana emerged as the top hemp growing state in 2018, followed by Colorado, Oregon, Kentucky, Tennessee, North Carolina and North Dakota, respectively, according to Vote Hemp.

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FDA Announces Plans to Tighten Oversight of Dietary Supplements; Issues Warnings to 17 Companies

Photo: Pixabay

Photo: Pixabay

For Presence Marketing Newsletter, March 2019
By Steven Hoffman

In what Food and Drug Administration (FDA) Commissioner Scott Gottlieb called “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” FDA on February 11 announces plans to strengthen its oversight of the dietary supplements market.  

“In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers,” Gottlieb said in a statement.

According to FDA, the use of dietary supplements, such as vitamins, minerals or herbs, “has become a routine part of the American lifestyle.” Three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. And one in three children take supplements, either given to them by their parents or, commonly as teenagers, taking them on their own, the agency said. 

Commissioner Gottlieb’s statement acknowledged the widespread use of supplements and also that “most players in this industry act responsibly” under the regulatory framework that exists under current law. He also said, however, that “bad actors” have been able to “exploit the halo” created by good companies, and so have been able to distribute and sell potentially dangerous products that put consumers at risk.

“As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver,” Gottlieb said. 

Under the new policy, FDA is developing a “rapid-response tool” to alert the public to avoid buying products that may contain unlawful or potentially dangerous ingredients. The agency also is looking to update its compliance policies with new dietary ingredient notifications (NDIs), which requires manufacturers to alert the FDA of any ingredients that weren’t sold in the U.S. before 1994.

“An effective NDI notification process represents the FDA’s only opportunity to evaluate the safety of a new ingredient before it becomes available to consumers and helps promote transparency and risk-based allocation of resources,” Gottlieb said.

FDA also is creating the Botanical Safety Consortium, a partnership between the public and private sectors, to evaluate the safety of botanical ingredients and mixtures in supplements.

“As we celebrate in 2019 the 25th anniversary of the passage of DSHEA, AHPA shares Commissioner Gottlieb’s vision…of finding the right balance between preserving consumers’ access to lawful supplements, while also protecting the public from unsafe and unlawful products and holding accountable companies that are not in compliance with the law,” Michael McGuffin, President of the American Herbal Products Association (AHPA), said in a statement. “AHPA has previously communicated specific suggestions for regulatory improvements to FDA and we look forward to a robust and transparent discussion on how best to serve Americans who include supplement products in their families’ health care choices,” he said.

Regarding NDIs, McGuffin added, “AHPA has invested significant resources to assist industry in submitting NDI notifications that meet the statutory requirements to bring a new ingredient to market. We have also submitted thoughtful comments to FDA’s prior draft NDI guidance documents and will continue to provide input so that any eventual guidance is both useful to the trade and does not stray from FDA’s statutory authority.” 

Under its tightened regulations, FDA also is hoping to make enforcement processes easier, which allows employees to issue warnings to companies and consumers. The agency on February 11 rolled out part of its plan when it sent warning letters to 17 companies for “illegally selling” products that it said claim to treat Alzheimer’s disease.

“I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as a part of a comprehensive care plan,” Commissioner Gottlieb said. “It’s clear to me that dietary supplements play an important role in our lives as we strive to stay healthy. It’s also clear that the U.S. Food and Drug Administration plays an important role in helping consumers make use of safe, high-quality dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for marketing.”

GreenMoney Journal: GMOs in Our Food: Do We Have a Right to Know?

Test your knowledge on GMOs in food! Compass Natural's Steve Hoffman and Nikki McCord of McCord Consulting co-authored an article in the Fall 2013 edition of GreenMoney Journal: "If you’re anything like us, you’re probably enjoying a snack while checking your email and catching up on your blogs. If you’re eating a conventionally produced snack – that is, one that is not Certified Organic or Non-GMO Verified – chances are it could be full of GMOs. Check your packaging. Did you see the label informing you of this fact? Most likely you didn’t because companies are not required to tell you whether or not GMOs are in your foods. And yet, GMOs are in about 80% of commonly processed foods. So what are GMOs and what is their impact on human and animal health and the environment? . . ."