Texas THC Lawyer

House Bill 63, authored by Speaker Pro Tempore Joe Moody with bipartisan support, would eliminate the arrest, jail time, and criminal record associated with low-level marijuana possession. The bill will be considered by the Criminal Jurisprudence Committee on Monday, March 4th.

As discussed earlier this week, Food and Drug Administration (FDA) Commissioner Scott Gottlieb offered new hope for a path towards the full acceptance of hemp-derived cannabidiol (CBD) as a food additive and/or nutritional supplement.  Yesterday, he told a Congressional committee that he has heard the people's voice: 

"We heard Congress loud and clear...Congress wants there to be a pathway for CBD to be available."

Commissioner Gottlieb followed that up with a pledge that the FDA will hold a public meeting in April to initiate a rulemaking procedure for CBD.  His goal is to create "an appropriately efficient and predictable regulatory framework for regulating CBD products." Read more about Gottlieb's testimony here.

Meanwhile, the US Department of Agriculture released its first comprehensive guidance about hemp production under the 2018 Farm Bill. It is USDA’s intention to issue regulations in the Fall of 2019 to accommodate the 2020 planting season. The rulemaking will provide for the publishing of a proposed rule, comment period, and a final rule.  Read the agency's guidance here, and view answers to some commonly asked questions here.

A letter is being circulated to CBD and Hemp retailers in the City of Tyler. These enforcement measures have been implemented despite the fact that proposed legislation is now pending in the Texas State House to legalize hemp and CBD products. HB 1325 would bring Texas into full compliance with the Federal 2018 Farm Bill, and clarify beyond any doubt that hemp products such as CBD can legally be sold at retail. Unfortunately, until that Bill passes and becomes law, Texas still remains in a gray area in which law enforcement can elect to prosecute indivudals who possess CBD derived hemp products.

In a shocking turn of events, millions of Texans were sent into a fury by a television news report that suggested that the Tarrant County District Attorney’s office in Ft. Worth was preparing to arrest individuals for the simple possession of hemp-derived cannabidiol (CBD).  Many argue that this would be a miscarriage of justice, and well as a misappropriation of scarce resources needed to fight real criminals. After passage of the 2018 Farm Bill (which declasified hemp as a controlled substance under federal law), many in Texas were hopeful that the State would decline to enforce current Texas law which still regards hemp as being the equivalent of marijuana.

Thankfully a bill was introduced in the Texas Legislature by State Rep. Stacy King (House Bill 1325) that would solve the issue and establish a full hemp program in the Lone Star State. Rep. King’s bill would allow Texas to join 41 other states in hemp cultivation, bring the state into full compliance with the 2018 Farm Bill, and clarify beyond any doubt that hemp products such as CBD could be sold at retail. Unfortunately, until that Bill passes and becomes law, Texas still remains in a gray area in which prosecutors can elect to prosecute indivudals who possess CBD derived hemp products. Although, many DA's across the State have decided to take a wait and see approach on CBD and hemp, the DA in Fort Worth has elected to enforce a law which is likely slated to change in the very near future. 

Here is a great summary of the current legal status of CBD under federal law written by Jonathan Miller, General Counsel to the U.S. Hemp Roundtable, Frost Brown Todd, Lexington, KY and Rend Al-Mondhiry, FDA Counsel to the U.S. Hemp Roundtable, Amin Talati Upadhye, Washington, DC

Upon the December 20, 2018 signing of the 2018 Farm Bill, the era of hemp prohibition is over. Questions continue to be raised, however, about the legality of one of the country’s most popular hemp products, hemp-derived cannabidiol (CBD).  The U.S. Hemp Roundtable, the industry’s leading business advocate for the full and permanent legalization of hemp and hemp products, strongly believes that U.S. federal law protects the retail sale of hemp-derived CBD.  Our analysis follows:

Hemp-derived CBD is no longer a controlled substance under federal law.

As a consequence of the 2018 Farm Bill, hemp is now permanently removed from the Controlled Substances Act (CSA).  It is now deemed an agricultural commodity, no longer able to be classified as a controlled substance, like marijuana.

Furthermore, by redefining hemp to include its “extracts, cannabinoids and derivatives,” Congress explicitly removed popular hemp products – such as hemp-derived CBD -- from the purview of the CSA.  Accordingly, the Drug Enforcement Administration (DEA) no longer has any claim to interfere with the interstate commerce of hemp products, so as long as the THC level is at or below 0.3%. This should give comfort to federally regulated institutions – pharmacies, banks, merchant services, credit card companies, e-commerce sites and advertising platforms -- to conduct commerce with the hemp and hemp CBD industry. 

State and Tribal governments may impose separate restrictions or requirements on hemp growth and the sale of hemp products – however, they cannot interfere with the interstate transport of hemp or hemp products.  

The FDA’s position on CBD is unsettled and unsupported by law.

While the DEA is now officially out of the hemp regulation business, the U.S. Food and Drug Administration (FDA) retains its authority to regulate ingestible and topical products, including those that contain hemp and hemp extracts such as CBD.  Much public attention has focused on a non-binding Q&A posted on the FDA web site starting about three years ago[1] -- reiterated in a December 20, 2018 statement by the FDA Commissioner[2]-- which suggests that CBD products cannot be marketed as foods or dietary supplements.
 
This position, however, is unsettled and rests on questionable legal grounds.  More importantly, the agency’s current position is nota final determination and should not be interpreted as the law.
 
As background, the Food, Drug & Cosmetics Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA),[3]defines a “dietary supplement” as a product intended to supplement the diet that contains one or more of the following: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a) through (e).[4]

Thus, the law permits a wide range of dietary ingredients in dietary supplements, including CBDwhich is an extract of a botanical (Cannabis sativa L.plant). CBD also falls under clause (e) as it is a dietary substance for use by man to supplement the diet by increasing the total dietary intake.

The FDA has taken the position – via Warning Letters sent to hemp-CBD companies,[5]as well as the FDA Q&A posting – that because a product containing CBD was approved as a drug and substantial clinical trials studying CBD as a new drug were made public prior to the marketing of any food or dietary supplements containing CBD, dietary supplements or food are therefore precluded from containing this ingredient ( referred to as the “IND Preclusion”).[6]

However, we firmly disagree that the referenced clinical trials are in fact “substantial,” as the trials were extremely limited in scope, and funding and the publication of these trials were limited. The FDA also seems to misinterpret the IND Preclusion in that it believes the preclusion date is simply the date in which it authorized CBD as an IND, without giving deference to the remaining portion of the statute, which requires that substantial clinical investigation be commenced and that such substantial clinical investigation be made public. In addition, the FDA Q&A document does not have the effect of law but instead reflects FDA’s opinion, which the agency suggests may change as evidenced from the FDA’s own request for further input on the topic. 

Rather, we believe that hemp-CBD products were marketed as dietary supplements and/or foods prior to any substantial drug investigations being undertaken, or made public, and that based on the definition of “dietary supplement” under DSHEA, CBD is in fact a permissible dietary ingredient. Moreover, Warning Letters and agency Q&A documentsare by no means final agency determinations.
 
It is of significant import that, to date, the FDA has not prohibited the sale of hemp-derived CBD products or ordered a product recall. Further, the primary motivation for the Warning Letters issued in 2015, 2016, and 2017 concerned the improper use of disease-remediation claims by supplement/food companies. No Warning Letter has been issued to a company that merely sold legitimate hemp-derived CBD products without making inappropriate disease-remediation claims.

Scientists, even FDA’s own, have concluded that CBD is safe as an ingestible product.

Current scientific research confirms that hemp-derived CBD is safe in food, supplements, and beverages and has provided general health and wellness benefits to millions of Americans. Because hemp contains only a negligible amount of tetrahydrocannabinol (THC), the psychoactive component of cannabis, hemp-derived CBD products are non-psychoactive and do not cause a “high” in users. Further, hemp-derived CBD does not have the potential for abuse or addiction, and there is no potential for diversion. 

Food and supplements that contain hemp-derived CBD are subject to a comprehensive regulatory framework that addresses both the safety and quality of these products. In fact, the current Good Manufacturing Practices for food and supplements (21 CFR Part 117 and Part 111, respectively) are equally if not more robust than the regulations governing the manufacture and production of cannabis products in most states. 

Indeed, the World Health Organization (WHO)Expert Committee on Drug Dependence recommended in August 2018 that “preparations considered to be pure CBD should not be scheduled within the International Drug Control Conventions.” Some key findings from the WHO:

  • “There are no case reports of abuse or dependence relating to the use of pure CBD.”
  • “No public health problems have been associated with CBD use.”
  • “CBD has been found to be generally well tolerated with a good safety profile.”
  • “There is no evidence that CBD is liable to similar abuse and similar ill-effects as substances…such as cannabis or THC.”[7]

Perhaps more significantly, a May 2018 memorandum from FDA Assistant Secretary Brett Giroir concludes that “CBD and its salts…could be removed from control under the CSA.” After a thorough scientific review and analysis, the FDA opined:

  • “There is little indication that CBD has abuse potential or presents a significant risk to the public health.”
  • “No evidence for a classic drug withdrawal syndrome for CBD, and no evidence that CBD causes physical or psychic dependence.”
  • “CBD does not appear to have abuse potential under the CSA.”
  • “There is no signal for the development of substance use disorder in individuals consuming CBD-containing products.”
  • “It is unlikely that CBD would act as an immediate precursor to THC for abuse purposes.”[8]

The FDA foresees a path toward full recognition of hemp-derived CBD as a dietary supplement and food additive.

Shortly after the Farm Bill signing, a letter was released by FDA Commissioner Scott Gottlieb that restated FDA’s current position, opining that it’s a violation of federal law to introduce CBD ingredients “into the food supply or market them as dietary supplements.”[9] While that portion of the statement provoked a few breathless media reports, it was old news.

The real news provided by the Gottlieb letter was that it also contained, for the very first time, a clear new path toward FDA’s permanent and formal acceptance of hemp-derived CBD as a food additive or nutritional supplement.  For the very first time, the FDA is seriously considering using its authority to issue a regulation that will specifically allow hemp-derived ingredients in foods and supplements:

[P]athways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. 

This is unprecedented; the FDA has never used this authority for any ingredient determined to only be permissible in pharmaceutical drugs per the IND Preclusion. As it makes this decision, the FDA is reaching out to the industry and the public:

Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products. We’ll use this meeting to gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers. At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.

We can assure that the Roundtable will be in the room where it happens.  With the partnership of other industry organizations such as the American Herbal Products Association and the Hemp Industries Association, the pursuit of this approval path will be one of our top priorities for 2019.

There was also more good news from the FDA on December 20.  That same day, FDA issued a statement opining that the “agency has no questions” about the conclusion that hulled hemp seed, hemp seed protein powder and hemp seed oil are generally recognized as safe (GRAS) under their intended conditions of use.[10]  While the GRAS evaluation was made at the request of a specific company, Fresh Hemp Foods, “the GRAS conclusions can apply to ingredients from other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars.”

===

There is still work to be done. But incautious media reports that broadly suggest that hemp-derived CBD is now federally illegal must be rejected.  With the backing of consensus scientific research, and the evolving viewpoints of the FDA, the clear and permanent recognition of the legality of hemp-derived CBD as a food and dietary supplement ingredient is within our sites.
 
Sincerely,
 
Jonathan Miller, General Counsel to the U.S. Hemp Roundtable, Frost Brown Todd, Lexington, KY

Rend Al-Mondhiry, FDA Counsel to the U.S. Hemp Roundtable, Amin Talati Upadhye, Washington, DC

Legislation has been filed HB 989, to establish a state-licensed industrial hemp research program by Representative Ryan Guillen.

Federal law explicitly authorizes states to engage in the state-authorized cultivation of hemp for research purposes. Over two dozen states have enacted legislation permitting licensed hemp cultivation in a manner that is compliant with federal law.

Many ask, is CBD Oil legal in Texas? Here's a great article in the latest Statesman.com that breatks it down. Bottomline, it's a gray area.

 

 

Despite legal uncertainty, sales of cannabis extract booming in Texas

By Bob Sechler

Posted Oct 12, 2018 at 4:46 PM Updated at 3:50 PM

Stores selling CBD – a nonpsychoactive component of marijuana and hemp – have been popping up statewide, almost as if Texas recently enacted a sweeping medical cannabis program.

It hasn’t.

The boom in retail sales of products containing CBD, or cannabidiol, has instead been taking place in a legal gray zone, with law enforcement agencies, prosecutors and some pro-cannabis activists disagreeing among themselves as to whether it is lawful in Texas.

The uncertainty stems largely from vaguely worded state marijuana prohibitions, as well as from evolving cannabis policies at the federal level.

But even those who contend it is illegal say enforcement is a low priority for prosecutors and police.

Texas lawmakers approved a restrictive medical cannabis law in 2015, called the Compassionate Use Act, that allows dispensaries licensed by the Department of Public Safety to make and sell CBD products that have greater percentages of active ingredients than the bulk of those now found at retail outlets. But the DPS has only allowed three dispensaries to obtain licenses -- with each required to pay an initial $488,520 administrative fee -- and the law only permits them to sell to patients suffering from a rare form of epilepsy and referred by a doctor.

“We legalized CBD through the Compassionate Use Act -- that’s it,” said state Rep. Stephanie Klick, R-Fort Worth, a leading sponsor of the bill that created the state law. “Even if it is a hemp-derived product (instead of marijuana-derived), Texas has not legalized hemp.”

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But Klick’s view hasn’t stopped wellness centers, natural products retailers and vape shops that sell over-the-counter CBD produced out of state from opening throughout Austin and other Texas metro areas, based on the premise that it’s legal under federal law and not prohibited by state law at low levels of active ingredients. The stores have been capitalizing on nationwide hype touting CBD as something of a wonder therapy for everything from chronic pain to insomnia.

‘Hard-pressed to prosecute’

If such retail CBD actually is illegal in Texas, the penalty for a first-time offense is likely a Class A misdemeanor for selling it and a Class B misdemeanor for possessing it, according to the Texas District and County Attorneys Association. The group — which provides education, training and legal research to prosecutors — agrees with Klick that CBD is illegal in Texas outside the Compassionate Use Act, although enforcement has been scant and that opinion doesn’t appear to have been tested in court.

“That is how we interpret the current state of the law in Texas, but I don’t think it should surprise people to find out that (prosecutors) don’t think it’s the best use of their limited resources” to pursue a case involving a substance that isn’t intoxicating, said Shannon Edmonds, a staff attorney for the organization.

“Prosecutors have limited resources, and they have to make difficult decisions on how best to use those resources,” he said.

A case in point is Travis County, where a need to prioritize in an overburdened court system was among the drivers of a program enacted this year allowing first-time offenders caught with small amounts of actual marijuana — cannabis containing high levels of tetrahydrocannabinol, or THC, the euphoria-inducing component — to avoid criminal charges by taking a class instead.

Travis County District Attorney Margaret Moore and County Attorney David Escamilla both consider CBD — which doesn’t produce a high — to be illegal in Texas outside the Compassionate Use Act, according to their spokespersons. But Escamilla, whose office handles misdemeanors, isn’t focused on the issue.

“Technically, (CBD) is illegal,” said Dan Hamre, first assistant county attorney. “But on a case-by- case basis, we would be hard-pressed to prosecute anything like that. I doubt that the arresting agencies would even bring anything to us.”

Some other local law enforcement authorities disagree that all CBD sold outside the Compassionate Use Act is against state law, however.

Williamson County District Attorney Shawn Dick said his understanding is that retail CBD is legal in Texas if it’s sold as part of a product containing no detectable levels of THC.

Austi9n police Lt. Oliver Tate, who oversees a number of narcotics teams in the department’sArticles

organized crime division, said retail CBD is legal if it contains no more than 0.3 percent THC —

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which has been the federal definition of industrial hemp and is widely cited by retailers and other proponents as among the evidence that it is lawful.

Stay connected to Statesman: SubscribeFor comparison, the Compassionate Use Act allows the state’s three licensed dispensaries to

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produce and sell CBD products containing up to 0.5 percent THC. Marijuana for recreational

purposes generally contains from 9 percent to more than 30 percent THC.

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Tate said he sought and received guidance on the issue directly from the Department of Public

Safety. DPS officials didn’t address requests from the American-Statesman to comment on the legality of retail CBD or on what guidance the department provided to Tate. Instead, the DPS

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referenced a previous written statement saying it considers “a product with any detectable level of THC” to be illegal in Texas outside the Compassionate Use Act, although the department didn’t

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mention CBD specifically and noted that its position isn’t binding on other law enforcement agencies. clearUserState=true)

Melvin Patterson, a U.S. Drug Enforcement Administration spokesman, said it’s a misconception that CBD products containing O.3 percent THC or less are legal at the federal level.

The DEA recently downgraded a formulation of CBD in a new prescription-only epilepsy drug called Epidiolex on its list of controlled substances after the Food and Drug Administration approved Epidiolex as a treatment. But Patterson said all other CBD remains on the list of Schedule 1 substances considered to have no currently accepted medical use and high potential for abuse, despite the definition of industrial hemp.

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Regardless, the unlikelihood of enforcement would seem to make the question of CBD’s legality moot. But some observers contend the lack of a clear regulatory framework amid the retail boom has put consumers in jeopardy because they have little way of knowing what’s actually in the products or any recourse if it isn’t what’s advertised.

‘Complex and ambiguous’

Kyle Hoelscher, a Corpus Christi attorney and pro-marijuana activist, said he generally supports “flouting the law” on cannabis but advises clients that CBD probably is illegal in Texas and that they should be careful about purchasing it at retail stores anyway because it’s unclear what it might contain.

As for CBD itself, “the law is so complex and ambiguous, very learned people can have very different opinions on what a line of statute means,” Hoelscher said. “It’s highly unlikely that someone is going to go to jail (just for CBD), but I cannot sit here and say that it is my legal opinion that it is a legal chemical” outside the Compassionate Use Act.

Fears also have arisen that the burgeoning number of retail CBD shops across the state will undermine the Compassionate Use Act.

Morris Denton, chief executive of Compassionate Cultivation in Manchaca — one of the three medical cannabis dispensaries licensed under the restrictive law -- said he considers it likely that some customers potentially eligible to use his regulated products have opted instead for retail alternatives seemingly available at any corner store because they aren’t aware of the difference.

If state lawmakers “just allow (retail CBD) to run unchecked and they don’t expand the Compassionate Use Program (to include greater patient eligibility), then I think the program is in danger,” Denton said.

He said he’s also worried for patients, because “people are buying just basic, generic olive oil (in some cases) and thinking they’re getting all these benefits” from CBD.

The retail market “has run amok, and it is going to take a whole lot of effort to clean it up,” Denton said.

Klick, who helped sponsor the Compassionate Use Act, said she hopes to begin that process during next year’s session of the Legislature. She said her office is researching methods of better regulating the booming market for retail CBD, such as by enacting truth-in-labeling requirements or possibly

expanding the Compassionate Use Act.

Whatever action state lawmakers ultimately take, however, restricting the availability of CBD to fewer Texans might be a political nonstarter. The Texas Department of State Health Services briefly considered a plan last spring that would have forced retail stores to stop selling food and supplements infused with CBD, but the agency backed off after a public outcry.

CBD hasn’t gotten any less popular in the ensuing months, judging by the steady stream of customers entering Austin American Shaman, a new CBD retailer in North Austin, on a recent weekday. The store, which opened last month, is the first Austin franchise of Kansas City-based CBD American Shaman.

Elsie Dietrich, who owns the Austin store with her husband, Gene, said all of American Shaman’s products are independently tested to verify their contents, and all of them can be legally sold in Texas.

The last part of that statement appears to be open for debate, but Dietrich said she’s not concerned.

“We’ve seen (CBD) help so many people,” she said. “There are people that come through here that legitimately have so many issues. To us, if we are helping people get off opioids, it’s worth the risk.”

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