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)].
In 2015, Governor Greg Abbott signed into law what’s known as the Texas Compassionate Use Act, which allows the use of CBD oils to treat seizures caused by intractable epilepsy. The Act legalizes oils containing CBD for treatment of epilepsy, as well as other chronic medical conditions for those who have not responded positively to use of federally approved medications.
So. According to the Controlled Substance Act definition itself, certain parts of the cannabis plant are clearly illegal, while others fall into a grayer area. One of these – for the most part – is CBD extracted from the “legal” parts of the cannabis plant, and non-marijuana industrial hemp plants, which, as defined by Section 7606 of the Farm Bill are cannabis plants with less than 0.3 percent THC.
Although several clinical studies focused on the health effects of CBD, the results available so far were not enough to convince the FDA to approve it as a drug. The FDA does not agree with its use as a dietary supplement either, but as long as sellers publish the appropriate disclaimers (like those on the CBDPure website and labels), it’s not up to them.
The passing of SB 218 through the Kentucky legislature created a new subsection of KRS 260.850m to 260.289, in which the Industrial Hemp Advisory Board outlines the purpose of an industrial hemp research program, establish license provisions, and create new requirements and license application procedures. This state’s approach is for the potential medical and industrial applications.