When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.
7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?
A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.
A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.
15. Can I import or export cannabis-containing or cannabis-derived products?
This week, Congress agreed to the final version of the 2018 Farm Bill, and President Trump is expected to sign the legislation within days. But this is not your typical farm bill. While it provides important agricultural and nutritional policy extensions for five years, the most interesting changes involve the cannabis plant. Typically, cannabis is not part of the conversation around farm subsidies, nutritional assistance, and crop insurance. Yet, this year, Senate Majority Leader Mitch McConnell’s strong support of and leadership on the issue of hemp has thrust the cannabis plant into the limelight.
Under the 2018 Farm Bill hemp is treated like other agricultural commodities in many ways. This is an important point. While there are provisions that heavily regulate hemp, and concerns exist among law enforcement—rightly or wrongly—that cannabis plants used to derive marijuana will be comingled with hemp plants, this legislation makes hemp a mainstream crop. Several provisions of the Farm Bill include changes to existing provisions of agricultural law to include hemp. One of the most important provisions from the perspective of hemp farmers lies in section 11101. This section includes hemp farmers’ protections under the Federal Crop Insurance Act. This will assist farmers who, in the normal course of agricultural production, face crop termination (crop losses). As the climate changes and as farmers get used to growing this “new” product, these protections will be important.
For a little bit of background, hemp is defined in the legislation as the cannabis plant (yes, the same one that produces marijuana) with one key difference: hemp cannot contain more than 0.3 percent of THC (the compound in the plant most commonly associated with getting a person high). In short, hemp can’t get you high. For decades, federal law did not differentiate hemp from other cannabis plants, all of which were effectively made illegal in 1937 under the Marihuana Tax Act and formally made illegal in 1970 under the Controlled Substances Act—the latter banned cannabis of any kind.
Even CBD products produced by state-legal, medical, or adult-use cannabis programs are illegal products under federal law, both within states and across state lines. This legal reality is an important distinction for consumer protection. There are numerous myths about the legality of CBD products and their availability. Under the 2018 Farm Bill, there will be more broadly available, legal, CBD products; however, this does not mean that all CBD products are legal moving forward. Knowing your producer and whether they are legal and legitimate will be an important part of consumer research in a post-2018 Farm Bill world.
Third, the law outlines actions that are considered violations of federal hemp law (including such activities as cultivating without a license or producing cannabis with more than 0.3 percent THC). The law details possible punishments for such violations, pathways for violators to become compliant, and even which activities qualify as felonies under the law, such as repeated offenses.
On Apr. 17, 2017, Gov. Fallin signed HB 1559 , amending the law (effective Nov. 1, 2017), to exclude from the definition of marijuana “any federal Food and Drug Administration-approved cannabidiol drug or substance.”
The law as written requires physicians to “prescribe” CBD, which would break federal law. States with legal programs allow doctors to “recommend” as opposed to prescribe. However, the Texas Compassionate Use Program says that “prescription” is defined as “an entry in the compassionate-use registry” and three dispensing organizations were licensed by Dec. 15, 2017. “On June 10, 2019, Governor Greg Abbott signed House Bill 1325 into law, to allow for the production, manufacture, retail sale, and inspection of industrial hemp crops and products in Texas. This includes products for human consumption that may contain cannabidiol, also known as CBD, as well as certain other parts of the hemp plant… These products may not contain more than 0.3 percent concentration of tetrahydrocannabinol (THC).”
On June 1, 2015, Texas Governor Greg Abbott signed SB 339 , which allows the use of cannabis oil that is no more than 0.5% THC and at least 10% CBD for the treatment of intractable epilepsy. The bill requires patients to get approval from two certified specialists.
On May 14, 2018, Governor Jeff Colyer signed SB 282 into law, which allows the use and sale of CBD that contains no THC.
On Apr. 16, 2015 Georgia Governor Nathan Deal signed HB 1 (Haleigh’s Hope Act) into law, allowing the use of cannabis oil that is contains no more than 5% THC. According to the Georgia Department of Public Health, the law did “not address how low THC oil is made, purchased or shipped. The law only creates a procedure to ensure qualified persons will be protected from prosecution for having it in their possession.” On Apr. 17, 2019, Gov. Brian Kemp signed a bill that permits in-state production/sale of marijuana oil and allows growing licenses for up to six private companies, effective July 1, 2019.
On July 1, 2015, HB 32 became law after Gov. Matt Mead neither signed the bill nor vetoed it, allowing the use of hemp extract that contains at least 15% CBD and no more than 0.3% THC for the treatment of intractable epilepsy.
On Apr. 27, 2017, Gov. Eric Holcomb signed HB 1148 into law, allowing the use of cannabidiol that is at least 5% CBD and contains no more than 0.3% THC for treatment-resistant epilepsy.