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.
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.
Borderland Businesses Experience the CBD Wellness Boom
Nanette Lattimer-Gamboa relayed to KVIA TV how her job as a licensed massage therapist was at risk after sustaining rheumatoid arthritis, which has affected her hands. She told the news outlet how her condition has almost prompted her to quit her work due to intense pain.
Lattimer-Gamboa opted for a natural cure and ventured on CBD or cannabidiol for her arthritis. Later on, the pain she felt every after massages have considerably lessened and the inflammation more bearable after using CBD.
Starting a CBD business
After her remarkable pain relief, Lattimer-Gamboa got the idea to incorporate CBD with her products. CBD has made its way to the wellness market in the form of lotions and creams, and the most popular cannabidiol product that is the CBD oil.
Nanette Lattimer-Gamboa, with her partner and Co-Owner Anthony Rincon of Infused Massage & Wellness, decided to infuse CBD oil into their massage and facial. Rincon stated that there is a special feeling in receiving a CBD-infused massage as opposed to rubbing it into oneself.
CBD is a derivative compound industrial hemp, a cousin plant of marijuana. Both plant varieties have the same source plant species, which is the Cannabis sativa L. that most people only associate with the illegal substance. However, CBD does not cause a high, unlike tetrahydrocannabinol or THC, the active compound in cannabis with psychotropic effects.
In Texas, CBD is legal and may contain THC as long as it does not go over the limit of 0.3% THC content.
The Federal Drug Administration (FDA) approved only one CBD-containing drug as of writing. Epidiolex, the medication used to treat intractable epilepsy, is the only cannabidiol drug that can be prescribed by a doctor. This means that CBD products in stores still have questionable legality at the federal level, especially those that are ingested.
Calls for more CBD research
José Rivera, UTEP School of Pharmacy founding dean, said that more CBD research should be done. He stated that products, especially those from the internet, are not equally made. Many of such items have various claims about ingredients and therapeutic effect.
Rivera further said that what’s on a product’s label does not necessarily include what is actually in the product. Minimal studies on CBD may confuse many consumers.
Anthony Rincon noted that their town, El Paso, is small and still holds a lot of stigma regarding CBD and its related products.
For other users, CBD is allegedly life-changing for them. Ciara Horton, a CBD user, claims to go for two CBD-infused massages per month to manage her anxiety and relieve pain. She stated that she is happy to have discovered such massages that give her both relief and enjoyment.
For Lattimer-Gamboa, being able to aid people like Horton makes her feel good and gives an avenue to inform more people about CBD. She is delighted to change people’s perspective of the said substance.
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