Although the production of Hemp has been legalized for some time now, the uses of CBD has still been limited by the FDA’s regulations. FDA will be holding a public hearing coming Friday, regarding its policies on CBD. Supporters are concerned about this hearing being a foundation to limit the use of CBD even further. Whatever ray of hope the supporters of Cannabis legalization saw after the Congresses’ vote to legalize it, might be at jeopardy.
Cannabidiol has become an increasingly popular compound in the wellness industry ever since hemp was legalized. Also known as CBD, it is already used in a vast array of products such as creams, medicines, supplements, sprays, lotions, and oils, etc. However, it’s still not to be added into food and drinks, since the substance hasn’t been approved by the FDA yet. Unlike THC, which is responsible for psychoactive effects, CBD does not make users feel high. A few restaurants have started selling CBD-containing foods already, such as Carl’s Jr burger chain. CBD has been known to help with insomnia, anxiety, inflammation and other ailments. Doctors have been known to prescribe CBD-infused oils to patients already. Despite these advancements, supporters are waiting for the FDA to speak up.
The Pressure is On
With a $20 Billion market on the horizon and 66% of the citizens pushing forward for the legalization of Cannabis, the pressure is really on for the FDA to take actions as soon as possible. However, the Food and Drug Administration responded to the call for the legalization of CBD in edible products by claiming that allowing it might reduce the pharmaceutical’s interest in researching the health benefits of this product.
According to the Scott Gottlieb, FDA’s Commissioner, the hearing will allow open questions to determine the allowed levels of CBD in Food and Beverages in a way that does not reduce the incentives of the pharmaceutical institutes to conduct further research on CBD and its benefits. This might be a potential indication of the FDA’s decisions to put a limit on CBD use in edible products.
The Speculations Continue
CBD companies are gearing up for the window of opportunity that they might get if FDA approves hemp-derived CBD, according to Robert DiPisa, the co-chair of cannabis law group in Cole Schotz law firm based in New Jersey. The firm has been trying hard to gather as much information as possible for the FDA, but the reality is that the legal restrictions and regulations are still either unknown or unclear to a lot of people. There have been reported arrests of people using CBD products despite medical approval.
He further reveals his suspicions that higher CBD content limits might be allowed for medicinal and research purposes than for the use of edible products. Whether or not these predictions come true or not, yet remains to be seen. But one thing is certain: CBD still has a long way to go before the world learns to let go of their tendencies to view this substance as taboo and openly legalize their use completely.
Kamala Harris Jokes About CBD to Make a Serious Point on Cannabis Reform
Senator Kamala Harris (D-CA) joked about how entrepreneurs are promoting cannabidiol or CBD lotion be rubbed on the skin as a cure-all at the same time that people of color struggle to enter the cannabis industry due to being targeted by the nation’s war on drugs.
Harris firmly pointed out social equity as a need in the growing marijuana industry.
Stance on cannabis
When she was still a prosecutor, Harris opposed reform efforts on the cannabis market. As a 2020 presidential candidate for the Democrats, she now recognizes the necessity of legislation that fully legalizes it. She said in her Cosmopolitan interview that those under prohibition enforcement should be allowed participation in the burgeoning market.
Harris stated that America’s mass incarceration system is a source of shame and is the reason for the incarceration, in particular, of brown and black men due to the failure of the war on drugs. She said that this is why she supports the legalization of marijuana and wants an equitable market when it happens.
However, Harris also talked about the cannabis industry, and how CBD is poised as a miracle remedy that can cure every problem by simply rubbing it all over the body. She noted how sellers are making a lot of money selling weed, calling the industry a massive cash cow.
She went on to mention brown and black men who are tagged as felons by selling the same. She called it unfair and wrong and a travesty.
A reform plan for marijuana
Harris further laid out her reform plans for the cannabis market, citing previously incarcerated folks who were convicted of a felony be considered for expungement. She also plans to prioritize them should they want to return to selling cannabis. She added that they should be first in line if marijuana legalization will be realized.
The candidate has sponsored a Senate bill that moves to de-schedule cannabis federally and offers reinvestments and expungements for people and communities affected by the drug war.
However, Harris received criticism for being previously opposed to the marijuana reform. In a skit last September, Saturday Night Live featured the US’ “cool aunt” who gives out weed but later on arrests those who were holding the substance in their possession.
Representative Tulsi Gabbard (D-HI) also slammed Harris during a Democratic debate for being instrumental to the incarceration of low-level cannabis felons during her stint as a prosecutor.
Another presidential candidate, Senator Cory Booker (D-NJ), scrutinized Harris, for taking a swipe at her being a past user of cannabis.
Cannabis sativa L., the source plant species for marijuana and hemp variety, is where cannabidiol or CBD is extracted from. This active component is said to have therapeutic benefits and is marketed as an infusion to many products, including skincare, makeup, pet items, and more. There is a serious lack of studies and clinical trials to support the claims, but users patronize CBD due to its alleged effectiveness.
NYS CBD Regulation in Limbo as People Wait for Governor’s Signature
The United States Department of Agriculture (USDA) finally released its regulations on CBD to give more explicit federal guidelines on hemp cultivation that produces CBD.
In New York, however, lines are still blurry as the bill approved by the State Legislature that aims to regulate CBD across the state is yet to be enacted upon by Gov. Andrew Cuomo.
Wild West in CBD Market
Jen Metzger, the Senate bill sponsor, expressed her hope that the NY Governor will sign the bill soon. She sponsored the proposed legislation to regulate cannabidiol, a compound derived from the hemp plant variety of Cannabis sativa L.
It’s the same source plant as marijuana, which has high amounts of tetrahydrocannabinol or THC, the chemical responsible for the psychoactive effects of the illegal substance.
According to Metzger, who is Hudson Valley Democrat, it’s the Wild West in the CBD market since there is no regulation of the said product.
The bill proposes routine testing for CBD products sold across New York and observance of proper labeling to prevent confusion and misunderstanding about the product’s ingredients and additives. It also includes guidelines for New York farmers regarding hemp cultivation and profit share.
Risks of unregulated CBD
CBD is currently in a legal gray area. The 2018 Farm Bill essentially legalized hemp-derived CBD with less than 0.3% of THC content and is also federally allowed for sale.
However, CBD-containing beverages and food are still illegal for the market. The New York City Health Department stopped restaurants and eateries in the state from selling CBD edibles and drinks since consumables with CBD have not yet been approved as a safe food additive.
Recently, a mysterious THC-related illness affected thousands across the country and claimed dozens of lives due to the use of a particular vape product. Metzger stated that CBD is not a common vaping ingredient. She relayed her concerns about the lack of regulation causing more illnesses since products may bear unfounded claims in the packaging.
Metzger pointed out that worrying about CBD might be necessary due to a lack of quality standards.
CBD is commonly used to relieve stress and help in insomnia and anxiety. It has more claimed therapeutic benefits, and the FDA has approved a CBD-containing drug used to treat seizure disorders in children.
Calls for more CBD studies
Metzger encourages more research on cannabidiol and its alleged effects, whether positive or negative.
Metzger and co-legislator Donna Lupardo presented the measure during a 2019 legislative session as soon as they realized that the comprehensive bill being worked on was not winning an approval. This bill was supposedly for the legalization of adult recreational marijuana use.
Metzger and Lupardo are the chairperson of their respective agricultural committees.
Gov. Cuomo has allied with three neighboring states to work on a comprehensive bill about vaping and cannabis use, which could be up for voting in 2020. However, Metzger said a concrete CBD regulation on or before the year ends still necessary.
Chuck Schumer Calls for FDA to Hasten CBD Rules Issuance
Chuck Schumer (D-NY), Senate minority leader, speaks about his request to the Food and Drug Administration or FDA to expedite the issuance of guidelines regarding hemp-derived CBD and its lawful marketing.
Schumer made a statement during a press call last Wednesday to call for regulatory clarity that is currently hampering the growth of the cannabidiol industry. He also mentioned the federal legalization of hemp and hemp-derived products in the 2018 Farm Bill.
However, the FDA is yet to publish official rules that allow sellers to market their products. In New York, most hemp cultivators also produce cannabidiol, according to Schumer.
Appealing to the FDA
Schumer cited a letter that he and colleagues in the Senate addressed to Ned Sharpless, an FDA acting commissioner. They collectively asked to show the agency’s outline regarding its plans for an official CBD regulatory framework and the timeline of finalization and implementation of enforcement policies concerning the substance. The group asked for an answer within 90 days.
According to Schumer, the CBD industry is a potential billion-dollar market in New York, which could bring in countless jobs and improved the economy along with its rise. However, he also stated that for these to be realized, critical players in the industry, such as the farmers, producers, consumers, and sellers should have a strict set of rules to follow.
He called on the FDA to perform its duty promptly and issue the guidance on CBD and its classification, quality, marketing, labeling, and sales.
Schumer believes that the FDA regulations on CBD are critical in the development of the industry and to protect consumers by setting stringent quality control benchmarks.
FDA stance on CBD
The FDA has expressed its awareness of the Congress’ request for CBD regulation amid the legalization of hemp. However, the agency points out that there are specific regulatory challenges they are still working to overcome.
The Cannabidiol or CBD-containing product that FDA recognizes is the approved Epidiolex medication. It is a prescription drug used to treat intractable epilepsy. CBD edibles, on the other hand, are yet to be FDA-approved and may need alternative pathways for regulation.
Scott Gottlieb, a former FDA commissioner, stated in an interview that the federal government should include themselves in state marijuana program regulation. He suggested that congressional involvement may be needed to make CBD marketing lawful if they want to hasten the process of developing rules.
It’s not only Schumer that reached out to the FDA. Mitch McConnell (R-KY), Senate majority leader, called on the FDA to release guidelines on enforcement discretion so producers, manufacturers, and owners in the CBD industry can do business without worrying about being penalized. McConnel led the inclusion of hemp legalization in the said agriculture legislation.
FDA stated that they are particular about CBD companies that make baseless claims about the therapeutic properties of CBD, which the agency considers to be highly inappropriate. The FDA, along with the Federal Trade Commission, issued a warning notice to a particular CBD business that violated the standard.
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