Your product is not generally recognized as safe and effective for the referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, ______ is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
People think since you can purchase CBD at almost any corner store in Texas, that it must be legal. Even elected district attorneys have different opinions about the legality of CBD oil in Texas. In this article we’re going to take a look at the circumstances under which CBD oil is legal and the arguments some prosecutors are making to charge individuals who possess CBD oil in Texas.
CBD oil is a derivative of the hemp plant, therefore making it legal under federal law as long as it has less than .3 percent THC.
CBD Oil is legal everywhere, as long as it falls under the .3 percent threshold.
Selling CBD Oils without FDA Approval
CBD is no longer illegal under federal law. On January 1, 2019 – with the passage of the Agricultural Improvement Act of 2018 (also known as the Farm Bill Act) – it became legal to grow or possess hemp under federal law as long as it has less than .3 percent THC.
Under current federal law, unapproved sellers of CBD Oils who describe the medical benefits of CBD Oils should at the very least expect to get a Cease and Desist letter from the FDA with language along the lines of:
What most people don’t realize is the person charged with Possession of a Penalty Group 2 substance is charged with the entire weight of the substance, including “adulterants or dilutants.” In other words, a small eye dropper bottle of CBD oil with half an ounce of liquid could contain a second-degree felony amount of drugs. That means the person is facing 2 to 20 years in prison and up to a $10,000.
Texas Governor Signs Law Legalizing Hemp Production, CBD
The longer answer is far more interesting. It is important to first distinguish marijuana from hemp. Scientifically, both marijuana and hemp come from the “cannabis sativa” plant, according to the USDA. Marijuana, though in the same scientific family as hemp, is a much smaller plant. Hemp, the taller and more fibrous version of the sativa plant has a long history in the United States. In fact, George Washington grew hemp on Mount Vernon.
While we continue to analyze those numbers, we did obtain information from the Office of Court Administrations that shows the effect an elected District Attorney can have on the cases pursued by the office.
There are a few different ways to create legal CBD concentrates to sell. One is using pure CBD isolate which is made by processing and refining all of the cannabinoids and compounds out of the hemp flower except the CBD which contains no THC. CBD isolate is the least effective CBD product because all of the other supporting cannabinoids have been removed. Studies have shown that cannabis cannabinoids and compounds work together synergistically in what is called the Entourage Effect. You then add either cannabis-derived terpenes or synthetic terpenes to the CBD isolate to make your CBD wax or CBD shatter. Always make sure they use cannabis-derived terpenes because cannabis-derived terpenes are more therapeutic.
CBD concentrates, which include CBD Wax, CBD Shatter, CBD Crumble, CBD “Terp Coral” and CBD crystal all have one thing in common, they can not be “true” CBD concentrates without some type of dilution or remediation, meaning the removal of some of the hemp compounds to make the product legal.
A CBD concentrate is made by extracting hemp flower or biomass into oil through hydrocarbon, CO2 or alcohol, then taking the CBD oil from the extraction process, refine the oil or dilute the oil, to make it compliant with the law, then turn the oil into a CBD wax, CBD shatters or CBD crumble.
Here is why CBD Concentrates can not be true concentrates without dilution or remediation:
The definition of hemp or any legal hemp product is a hemp flower or hemp product that contains .3% total THC or less on a dry weight basis. Hemp products always start with either hemp flower or hemp biomass which contain .3% total THC or less. The main difference between the two is that hemp flower is trimmed up hemp which is usually sold as smokable hemp by weight or processed into hemp pre-rolls. Hemp biomass consists of the entire plant which is used for extraction to create CBD oil used for CBD tinctures, gels, salves, and more.
Once hemp is grown and matured, the CBD content on a percentage basis is about 8% while the total THC is about .3%. Next, when the hemp flower is extracted to create the CBD oil which is used to make CBD concentrates, the total THC goes from .3% to about 3%, making the product illegal. A concentrate by definition is making something stronger by removing water or other compounds. Extracting hemp flower increases the percentage of both CBD and THC 8-10x.
The second way to make legal CBD concentrates is to extract the hemp flower into CBD oil then use a chromatography machine to remove the THC from the oil which leaves all of the other cannabinoids in the oil. Using chromatography machines first requires the raw CBD oil from the initial extraction to run through a fractional distillation machine, which removes the majority of the cannabis compounds including the terpenes and leaving the cannabinoids in an oil form. Next, the CBD oil is diluted in toxic chemicals prior to being put through the chromatography machine. The chromatography machine splits the oil up into two fractions, one with THC and the other with CBD and other minor cannabinoids. The THC free oil can now be used to create legal CBD concentrates by adding back the cannabis terpenes or using synthetic terpenes.
So how are there legal CBD Concentrates on the market?
A third method, is using cultivar specific full spectrum oil from a solventless extraction technology or hydrocarbon machine. Cultivar specific means oil from one specific strain “proper word is cultivar” of hemp and diluting it with pure CBD which gives you a full spectrum CBD concentrate that is legal based on THC levels but still has unrefined full-spectrum CBD oil containing the original cannabis terpene profile of the specific hemp cultivar “strain”. CBD wax and CBD crumble products allow for the consistency of a product that comes from a unique hemp cultivar.