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.
Statement from FDA Commissioner Scot Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds. U.S. Food and Drug Administration Web site. Available at: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys. (Accessed May 7, 2019).
“There is a great deal of confusion regarding the legal status of hemp and why these products are so readily available versus marijuana-based CBD products. In 2014, the Farm Bill stated that hemp was different from marijuana, yet the Drug Enforcement Agency’s (DEA) position is that hemp comes from the cannabis sativa plant and as such falls under the controlled substance act. In 2004, the Hemp Industry Association won a court case against the DEA from the Ninth Circuit Court of Appeals that ruled the DEA didn’t have the authority to ban hemp under the CSA. “By that federal court ruling, similar to non-scheduled hemp food products, this allows Medical Marijuana, Inc. (including HempMeds®) to sell online and distribute to customers in the U.S. states,” said Dr. Stuart Titus, the company’s Chief Executive Officer.”
An NBC 5 investigation first brought the prosecution of CBD oil in Tarrant County to light. In an interview with NBC 5, the Tarrant County First Assistant District Attorney said Tarrant County is "going to enforce the law." When he says that any amount of CBD oil is illegal - and a misdemeanor offense if it does not contain THC - the law he is referring to is not one passed by Texas legislators. Texas legislators have not specifically made cannibidiol a controlled substance. A medical doctor, who serves as the DSHS Commissioner, added cannibidiol to the list of controlled substances.
President Obama’s execution of the Agricultural Act of 2014 is an integral piece to CBD oil’s legality. If a plant is deemed legal (where the determining factor is a THC level under .3%) that then makes all products made from the source material legal as well. Did you ever wonder why your hemp lotion 15-20 years ago was legal but “smoking a little weed” wasn’t? In this case, it’s all about the THC levels your plant doesn’t have.