To CBD or not To CBD? Questions Remain

To CBD

or not

TO CBD?

QUESTIONS REMAIN

20 | CALIFORNIA GROCER

By Jason Dumont

Products with cannabidioil (CBD) derived from hemp are in high demand from consumers across the country as expectations and demands have shifted rapidly in recent years.

According to a recent Consumer Reports survey, more than one-quarter of Americans say they have tried CBD and one out of seven of those people have used products with CBD every day.

A Nielsen report showed that one-third of American adults (age 21 and older) are interested in consuming legal cannabis products, and the top reasons for the interest are tied to ailment treatment, prevention and general wellness.

Consumers are looking to their local grocery stores for general health and wellness products and many are asking grocers to carry CBD products.

Many independent food retailers have responded to this demand and are experiencing growing sales, but others are deterred because of the lack of legal clarity surrounding CBD products.

Safety, quality and marketing are other considerations grocers should consider before devoting resources including valuable store space to CBD.

What is legal CBD?

Typically, CBD from hemp has less than 0.3 percent of tetrahydrocannabinol (THC), which is the chemical responsible for most of the psychological effects from cannabis.

The Hemp Farming Act of 2018 (H.R. 5485) was introduced with the intention of removing hemp from Schedule I controlled substances and making it an ordinary agricultural commodity.

On December 20, 2018, President Trump signed the Agricultural Improvement Act of 2018 (also known as the Farm Bill), which included the Hemp Farming Act of 2018, into law with several provisions that changed the regulatory framework for the cultivation and production of hemp in the U.S., in addition to the commercialization of hemp-derived ingredients and products.

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“The potential benefits of CBD range from relieving pain including from cancer, reducing anxiety, lessening spasms, improving heart health and treating substance abuse.”

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What are some of the CBD products in the market?

CBD products range from beverages and dietary supplements to topical creams and lotions. The potential benefits of CBD range from relieving pain including from cancer, reducing anxiety and depression (in humans and animals), lessening spasms for people with epilepsy and multiple sclerosis, improving heart health and treating substance abuse.

Taylor Leevers, Special Projects Manager at Leevers Supermarkets in Colorado, presented during a National Grocers Association (NGA) webinar on July 10 called, “CBD: The Next Health Food?”

During the webinar, Leevers said, “In my opinion, CBD seems to be sort of the snake oil of the 21st century, and while many of the purported uses may be valid, I think just as many probably are not.”

Leevers said while his company does not yet carry CBD products, it will in a new Denver store opening soon. He mentioned a handful of products including coffee, Keurig cups, lotions, drinks including those that are similar to “energy shots,” capsules, food, tinctures or liquid extracts, chewing gum, and oils and treats for pets.

Who is in the market for CBD products?

Companies producing CBD products are targeting consumers in ways that range from broad to specific. While Trace Minerals, CV Sciences and Receptra Naturals aim for people, especially women, with a healthy lifestyle who buy natural products, GW Pharmaceuticals has a drug called Epidiolex that is intended for the treatment of seizures in patients age 2 and older (in clinical trials, Epidiolex caused liver damage).

In preparation for the webinar, Leevers visited multiple stores in Colorado, contacted the stores and manufacturers for pricing details and saw differences in the display, pricing and availability of products.

In one store, there was a small display with $800 of product including 10 units of balm near the wellness section. A second store had twice the inventory of the first store. Both stores sold products for about 30 percent of the gross price compared to the 40 percent manufacturer’s suggested gross retail price (MSRP).

A third store, had a large supplement section and a locked glass case for CBD products even though they were not more expensive than other offerings in the store. Leevers said those products were priced at 40 percent gross MSRP.

Leevers said he saw a 30-pack of chewing gum for $70 retail, a shot of CBD drink was $8 and pet products were between $75 and $80. He said there is a problem with products having different standards for CBD extraction, which makes for different levels of quality.

According to his research, Leevers said tinctures, capsules and sprays are the most popular products and the best value per milligram for consumers and some of the top companies producing CBD products such as Hemp Meds, Charlotte’s Web, CV Sciences and Kannaway are doing more quality control testing.

What have federal and state regulators done?

Even with the legalization of growing and producing hemp in the Farm Bill, there is a patchwork approach to CBD products in the states amid the absence of rules from the U.S. Food and Drug Administration (FDA).

FDA policy says that under the Federal Food, Drug and Cosmetic Act, CBD cannot be marketed as a food or dietary ingredient. The law also prohibits the marketing of a substance as a dietary supplement or food if the substance is the subject of an investigational new drug application.

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“NGA urges FDA to create a legal pathway for retailers to carry CBD products on their store shelves.”

The FDA has made it clear that it views CBD as a drug, because CBD is the main ingredient in the only approved cannabisbased drug, Epidiolex (made by GW Pharmaceuticals), which is a treatment for severe childhood epilepsy.

The FDA has told companies that they cannot add CBD to food or beverages, although it appears willing to tolerate it in topical products – as long as companies don’t make serious health claims.

Since 2015, the FDA has issued about 50 warning letters to firms for marketing unapproved drugs that allegedly contain CBD. As part of those actions, the FDA tested the chemical content of cannabinoid compounds in some of the products, and many did not contain the claimed levels of CBD.

None of the products were approved by the FDA for the diagnosis, cure, mitigation, treatment or prevention of any disease. The FDA notes that consumers should beware purchasing and using any such products.

In the case of Curaleaf, the FDA said the company was “illegally selling unapproved products containing [CBD] online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” Following the FDA’s warning, Curaleaf removed its blog

and articles on its website and deleted social media content that said its products could treat various medical conditions.

What are industry leaders saying?

To meet growing consumer demand for CBD products, the NGA urges FDA to take quick and decisive regulatory action to clarify the federal rules surrounding the sale of CBD.

“NGA urges FDA to create a legal pathway for retailers to carry CBD products on their store shelves,” said Laura Strange, senior vice president of communications. “We suggest that FDA clearly distinguish CBD as a dietary supplement and food additive rather than a human drug under regulations that require clinical trials before going to market.”

Strange said the NGA also urges the FDA to quickly establish a pathway for the marketing and sales of safe CBD products on grocery store shelves.

Like the state AGs, the NGA said the FDA should also clarify what, if any, health risks are posed to consumers by the consumption of CBD products.

“We suggest FDA provide guidance to product makers and manufacturers about how to display the health risks of CBD products on its packaging and whether to recommend specific dosing levels for its safe consumption,” said Strange.

The NGA would support a regulatory framework for CBD similar to that of folic acid, where lower dosed products may be obtained over the counter, while higher dosage products must be prescribed by medical professionals.

Peter Matz, director of food and health policy at the Food Marketing Institute (FMI), testified before the FDA in May 31. Matz said, “I am here to convey the seriousness of the regulatory ambiguity facing our member companies and their customers each day as consumer demand for products containing hemp and hemp-derivatives continues to grow, as does the commercial availability of such products – especially those which count CBD as an ingredient.”

24 | CALIFORNIA GROCER

Matz said FMI is fielding more and more questions from companies that are seeking clarity about the current regulatory framework for the sale and labeling of products containing CBD.

Noting that FMI and its member companies want to be in full compliance with all FDA requirements, Matz said he also wants to ensure members have appropriate assurances that the products they sell are both safe and appropriately sold.

“Given the prevalence of these products in the marketplace, we respectfully urge FDA to move swiftly to provide additional clarity and establish a pathway forward,” said. Matz. “The safety concerns and marketplace confusion surrounding hemp and hemp-derived products will continue until FDA provides guidance governing the production, sale, quality and marketing of these products.”

Betsy Booren, senior vice president of science and technology at the Grocery Manufacturers Association (GMA), applauded the FDA at the public hearing for taking the first step in stakeholder engagement.

“As consumer interest for food, beverage, personal care and household products containing cannabis and cannabis derivatives continues to grow,” said Booren, “The necessity for national uniform regulatory frameworks that protect public health is of critical importance.”

Booren and the GMA declined a request for further comments on FDA regulations for CBD products.

As the FDA determines standards for CBD and monitors marketing by companies, states can regulate hemp cultivation if there is federally-approved agricultural plan.

Which states are taking action on cannabis and CBD?

More than 30 states and the District of Columbia (DC) have legalized cannabis in some form. Eleven states including Alaska, California, Colorado, Illinois, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont and Washington permit

recreational use. However, the regulation of hemp and CBD products differs in those 11 states.

According to the National Organization for the Reform of Marijuana Laws, 14 states legalized CBD for medical use. Those states include Alabama, Georgia, Indiana, Iowa, Kansas, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Virginia, Wisconsin and Wyoming. Many of those states allow for CBD use if a person has epilepsy or other conditions that cause seizures.

In mid-July, attorneys general (AG) from 34 states plus DC, Guam and the Northern Mariana Islands submitted a letter in response to the FDA’s request for comments on the safety, manufacturing and sale of products containing cannabis or cannabisderived compounds.

Among other things, the AGs asked the FDA to explore the creation of best practices for manufacturing, testing and marketing products so consumers are not susceptible to confusion based on false advertising claims or harm from dangerous additives or undisclosed risks of use. This includes how products interact with other dietary or pharmaceutical products.

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“I think it’s a great opportunity to provide access to a nonintoxicating, alternative product that many people believe helps improve their lives.”

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“the hemp industry is booming industry and it will contribute to California’s economy, as a more environmentally-friendly crop, while creating jobs and opportunities for farmers.”

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Colorado recently amended food and drug laws to clarify that food containing CBD is not adulterated and permitted for sale.

What is happening in California?

However, California’s Department of Public Health (CDPH) last summer issued guidance saying that until the FDA changes its position, or the state receives information changing its position, the state does not view CBD as a lawful food or dietary ingredient.

California allows the sale of non-food items such as CBD-infused lotions and allows the manufacturing and sale of cannabis products including edibles. State legislation (Assembly Bill 228) that would allow for the retail sale of CBD in food.

California Grocer asked California State Assemblymember Cecilia Aguiar-Curry (D-Winters), the author of Assembly Bill 228, why she is excited about the inclusion of hemp and CBD in a variety of products. (At the time of writing this article, AB 228 had passed the State Assembly and multiple State Senate committees.)

“I think it’s a great opportunity to provide access to a non-intoxicating, alternative product that many people believe helps improve their lives,” said Aguiar-Curry. “AB 228 is important because not only does it allow hemp-derived CBD to be manufactured and sold, it also puts some parameters around how this can be done safely and with state oversight.

The alternative is unregulated product from outside the state, or even outside the country.”

Aguiar-Curry echoed the state AGs and industry members in saying that it is important to her that consumers are not misled by labels or packaging. She included language in AB 228 that prohibits false health claims or advertising that presents a misleading impression as to the health effects of CBD products.

“There is some research on CBD, but it is not comprehensive, which is why I want our state’s health regulators to be on top of the products being used by Californians,” said Aguiar-Curry. “That’s our job, not creating a situation where the demand is filled by outsiders who don’t care about Californians’ health.”

When asked about the marketing and use of products, Aguiar-Curry said regulation is needed because CBD products are already on the market for purchase in stores and online. Without AB 228, she said the CBD marketplace is completely unregulated, and there is no standard for health.

“Businesses and consumers will suffer if CBD is removed from the retail space,” said Aguiar-Curry. “Ironically, CBD made from cannabis is currently legally available in California inside dispensaries. For those who want CBD that is made without the psychoactive effects that come from THC, the law currently says no.”

The assemblywoman has met with Governor Gavin Newsom’s office multiple times. She plans to continue to work with CDPH and Governor Newsom’s office to make sure that consumers can access CBD in a safe way.

“It is critical to me that consumers are protected and informed,” said Aguiar-Curry. “I am hopeful that the administration will recognize that it’s illogical to say, ‘It’s not ok with the federal government’ in a state where cannabis-based products are allowed.”

Aguiar-Curry would like to see California join more than 20 other states that passed legislation to authorize the sale of CBD.

She said the hemp industry is booming industry and it will contribute to California’s economy, as a more environmentally-friendly crop, while creating jobs and opportunities for farmers.

Aguiar-Curry referred to the juxtaposition of reduced federal barriers to using hempderived products and prohibition in California as an “Alice in Wonderland world in which adult consumers can walk into a licensed [cannabis] dispensary and purchase all manner of recreational products, but they cannot legally purchase non-intoxicating hemp products that they believe can bring them calm or ease their pain.”

Until the FDA issues rules and California legalizes the cultivation, production and sale of CBD products, consumers in the Golden State may have to wait to legally use CBD at their tea parties. ■

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