The recent policy announcements and the FDA’s sturdy position regarding the legality of CBD products have put hemp farmers in a difficult situation. Massachusetts hemp farmers are now supporting a recent bill regarding the clarification of CBD products sales. They want the state to understand and protect the hemp businesses from falling. CBD stands for cannabidiol, which is extracted from hemp plants. CBD has been labeled as non-psychoactive and is thought to deliver some benefits without causing serious side effects in some patients. CBD containing products are not regulated directly, and they are largely sold online. Retailers carrying these products do not usually get in trouble with local health or police departments.
MDAR on Hemp Regulations
The Massachusetts Department of Agricultural Resources regulates hemp growth throughout the state. They issued guidance which stated that the sale of CBD containing food products, animal feed, and dietary supplements or any products making false therapeutic claims are considered illegal. Mark Cusack, former Marijuana Policy Committee chairman representative issued a bill that declared that CBD containing products should not be considered as adulterants and controlled substances, and should be considered as foods. The bill (HD 4339) would allow CBD products derived from hemp to be sold and also made in Massachusetts. The bill was referred to the House Committee on Rules on Monday.
Policy director of Northeast Organic Farming Association Marty Dagoberto mentioned that this bill is a great starting point to address the issues associated with the guidance published by MDAR. Massachusetts stakeholders, MASS Hemp Coalition and NOFA/Mass chapter could consult together and contribute strong recommendations to support the bill, so that the hemp economy can be protected, thus ensuring the protection of hemp farmers.
Growing Support of The Mass Hemp Coalition
More than 100 farmers are licensed to grow hemp in the state, but only one is responsible for hemp-derived CBD production according to the coalition. Non-profit organizations such as the US Hemp Roundtable support hemp industry at the federal level. They said that Cusack’s bill could provide strong hemp and CBD protection, as it reflects some important concepts discussed in the Roundtable’s Model State Bill. MASS Hemp Coalition wants to share recommendations with the Cannabis Policy Committee and Cusack directly, but they also aim to seek further protection for small businesses, who largely rely on uncontrolled competition of online sellers and local boards of health.
The aim is to seek stronger protection for state-wide business and retail quickly without damaging the current progress, and the Bill HD 4339 just might be the answer, according to Laura Boehner, co-founder of a CBD company, The Healing Rose in Newburyport. A few of the coalition members are already affected by the laws, thus a community-wide approach is immediately needed to protect local retailers and small businesses.
State Board of Pharmacy Speaks Up
The MDAR guidance originated after the FDA stated that CBD cannot be used in the food and dietary supplements, which was backed by the state Department of Public Health. The Department prohibited sales of CBD oils derived from hemp. However, the coalition is united against the guidance. The Massachusetts Board of Pharmacy issued notes to license holders, advising them to review MDAR and FDA statements and to question agencies about CBD product sales. Hemp seeds, proteins, hemp fiber derived clothing are currently approved for sale throughout the state.
3 Developments in CBD for the Food and Beverage Industry in 2020
In 2019, the cannabidiol industry saw considerable growth, with the upward trend set to continue in 2020.
Despite the absence of federal guidelines, many CBD retailers delving into the food and beverage industry need to know about the three development points that may affect the sale of CBD products and the sector as a whole.
Clarification from the FDA
The Food and Drug Administration or FDA handed out several warning letters to CBD sellers, and as well as acknowledged the data gap and unanswered questions regarding CBD toxicity back in November 2019. Based on the Consumer Update published by the FDA, CBD incorporated into food or marketing as a dietary supplement is still illegal.
The FDA has included in its announcement the agency’s plan to explore other pathways that other CBD products can potentially be marketed with legal consent. It also looks forward to providing updates on the agency’s progress with the approach to be used on such products in the next few weeks.
Following this November announcement and the warning letters, CBD food, and beverage sellers need to be aware of the FDA’s next advisory regarding the products and how they could be lawfully marketed in 2020.
State and local response
The lack of federal guidance has prompted states to take matters in their own hands and craft a regulatory patchwork. However, these rules come in conflict with other established regulations across the US. In Maryland and New York, CBD-infused drinks and food are illegal. In the latter, city officials have sanctioned five restaurants that sell CBD edibles. The penalties range from $200-$650.
Industry players should watch out for the actions respective states will take amid the scarce federal regulation. New York has already passed a new law to take effect in March 2020, establishing the regulatory framework for CBD sale. New rules are bound to be issued by officials in the coming weeks.
Class action litigation in the CBD industry is expected to rise in number this year, especially in cases concerning the food and beverage companies that sell CBD-infused products. Several lawsuits on the federal level have been filed against CBD manufacturers that allegedly violate the consumer protection laws of a state.
Industry experts predict that an avalanche of CBD-related complaints and lawsuits is imminent in 2020.
State and federal officials are set on determining the right course of action to take regarding CBD. Several private plaintiffs are also waiting for the developments in the food and beverage sector of the CBD industry. The high availability of CBD and CBD-containing products and the FDA’s latest pronouncement can stir a commotion in the private sector.
Cannabidiol manufacturers should, therefore, be on the lookout for any new changes or regulations in the industry to avoid legal complications and ensure that the CBD items they produce are lawfully allowed for sale.
CBD Industry Goes Local, citing ‘Wild Wild West’
CBD is being hyped up across states, but the budding industry in Michigan is still navigating through the unclear regulatory landscape. CBD or cannabidiol was initially dismissed as a marijuana relative, but its alleged health and wellness benefits make it an early crowd favorite.
Today, CBD is everywhere in Michigan and is touted as a wellness product that doesn’t give the users a high, unlike its cousin marijuana. It’s found in shelves of Kroger and Family Video, and are sold as oils, bath products, and lotions. Some people feed it to their pet horses or infused them in ice cream.
Banking on CBD
Mother Earth Natural Health sibling owners Arianna and Tory Welsh started in 2016 when their father wanted a pain reliever that does not have psychoactive effects like medical marijuana. Today, they have three store branches and two more in the works for next year. They expect a 300-400% growth in sales for 2019.
The local market is now filled with the first harvest of industrial hemp since World War II. Michigan’s pilot program prompted Gov. Gretchen Whitmer to view the hemp industry as a potential enterprise creator. In early November, Michigan issued 572 licenses for growers and 433 permits for processor-handlers.
Welsh believes that Michigan-made CBD oil will be made available in as early as December or in January.
Urban Roots CBD LLC, a Monroe-based manufacturer, produces CBD tinctures, gummies, pet oil, topical creams, and more using out-of-state sourced hemp. However, the company’s co-founders Alex Kolpacke and Brandon Koz are hoping to become entirely Michigan-sourced.
All about hemp
Hemp is a variety of Cannabis sativa L. that does not contain more than 0.3% tetrahydrocannabinol (THC) content, the active component responsible for the high in marijuana. CBD is the non-psychotropic compound that can be extracted from the hemp and marijuana variety, but the federal law based on the 2018 Farm Bill specifies hemp-derived CBD as legal.
Last March, the Michigan DA and Bureau of Marijuana Regulation released CBD guidelines, although rules are still shifting due to the new interim rules issued by the USDA regarding industrial hemp. However, not one agency claims to govern sales for CBD in Michigan, adding to the confusion and murky regulation on the substance.
CBD has gotten famous over the years due to its alleged health and wellness benefits, alleviating conditions like pain, anxiety, stress, and even sleep deprivation. There has been strong clinical evidence for CBD’s effectiveness in helping with epilepsy in children, but experts believe that more research should be done to prove the other therapeutic claims of CBD.
Trey Malone, assistant professor, an economist at Michigan State University expresses his uncertainty on where the CBD market is headed. There is a lot of confusion, especially considering that the substance was included as a Schedule 1 in the Controlled Substances Act not long ago.
The CBD industry is dubbed by many as the “Wild Wild West” due to the inconsistency of quality, regulations, and health benefits. Malone cites the lack of data for consumer trends on CBD.
Growth and uncertainty
CBD’s lack of clarity in regulations was evident when the Detroit Health Department cracked down the sale of CBD-infused drinks, which are currently still not FDA-approved for purchase and consumption.
However, known retailers like Family Video now sell gummies, edibles, and CBD water in Michigan. Several others are doing the same amid the FDA’s lack of approval on CBD food intake.
CBD as food additives is still not federally legal, according to Detroit-based lawyer and owner of a law firm, Atty. Scott Roberts. He also notes that the rule is not actively enforced due to the current period of uncertainty in the CBD market today.
Based on a report by The Nielsen Co., the cannabis market can grow to a $6B industry in 2025. Brightfield Group also predicts the market to grow to $5B by the end of this year, with a foreseeable growth of up to $23.7B by 2023.
Senator Relays Personal Experience with Cannabidiol
A confirmation hearing for the Food and Drug Administration commissioner by the Senate veered towards the discussion of cannabidiol or CBD, as senators asked about the federal regulation circling the substance.
Lawmaker Pat Roberts recounted during the discussion his personal experience with the use of CBD oil, for which he expressed particular interest in the agency’s take on the said product.
Roberts Points Out Issues on CBD
Pat Roberts, a Kansas Republican lawmaker, recalls his wife encouraging him to try applying topical CBD oil on his bad “football” knees. However, the substance failed to bring pain relief, which also prompted him to discuss the lack of regulation regarding the product.
The Trump nominee for FDA commissioner being questioned at the confirmation hearing was Dr. Stephen Hahn. Roberts pointed out to him that there have been several reports and studies that show labeling inaccuracy on CBD products. He also voiced concern on the unregulated market, saying that there are many questions about the safety of these hemp-derived products.
Roberts also mentioned how CBD is now being used for everything, jokingly adding hair growth as an example. He went on to say that farmers are also pushing for a robust framework for such products since it is an expanding market, and growers want in on it.
Hahn answered by agreeing that CBD is now widely accessible and needs more data, research, and science to prove its efficacy and safety for consumers. He also stated that the FDA is in the process of creating a transparent and precise framework for CBD from a medical perspective.
Roberts is currently the Agriculture Committee chairman of the Senate.
CBD’s lack of federal regulation
Several industry critics call out the FDA for dragging the rulemaking process so that issues can be addressed with official rules. As of writing, the agency is yet to release federal guidelines on CBD use, which also frustrates industry players like growers, manufacturers, and sellers.
Hemp-derived products like CBD have been federally legalized since December 2018, when the Farm Bill was successfully passed into law. However, the market is still mostly unregulated since the FDA has not issued an approval for many CBD products that are circulating the industry today.
There is only one CBD-infused medication that the FDA recognizes, which is the Epidiolex. This drug is used to treat intractable epilepsy.
The agency is struggling to hand out regulations, and it may partly be due to the lack of quantifiable scientific research discussing this hemp derivative. There is a significant lack of evidence when it comes to proving therapeutic claims involving CBD.
Although lacking proof, cannabidiol is widely popular for its non-psychoactive properties since it does not have tetrahydrocannabinol or THC, the cannabis component responsible for the high that users experience in marijuana.
CBD is believed to be a natural cure-all for many health conditions, including anxiety, insomnia, cancer, Parkinson’s disease, several types of pain, and more.
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