cbd tincture legalDecember 15, 2021
The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).
When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.
A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.
15. Can I import or export cannabis-containing or cannabis-derived products?
Below are a number of frequently asked questions and answers on this topic.
26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.
A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.
Questions and Answers.
As also discussed above (see Question #5) the agency also issued a draft guidance in July 2020, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, for individuals considering clinical research in this area.
23. What should I do if my child eats something containing cannabis?
The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.
Research and Expanded Access.
A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:
Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.
A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.
The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).
“So how do we make a distinction when … basically looking at the plant structure, you really can’t tell the difference?” DeBacco, one of the cannabis course professors, asked us on the campus quad after class (located in the university’s largest lecture hall, due to its popularity).
Connecticut is looking to capitalize. Legislation to start the state’s industrial hemp program was passed rapidly by state officials this spring.
Cannabis pollination can also stunt the growth of female plants, which is problematic if you’re cultivating the plant for fibers. George Washington made the mistake of allowing his hemp crop to undergo pollination, and it ruined his harvest.
CBD versus THC.
Cohen said this green rush could help dairy farmers in Connecticut and across the nation. Nearly 3,000 U.S. dairy farms folded in 2018 alone.
But in hemp, THC synthase is genetically dormant, Apicella said. As a result, some hemp plants can make loads of CBD because there is no internal competition for making THC.
“Hemp,” by contrast, cannot legally contain more than 0.3 percent THC. There are almost no restrictions on the hundreds of other compounds made by the plant, such as terpenes (which are responsible for weed’s “distinctive” aroma).
To make CBD, farmers can grow up to 4,000 hemp plants in an acre. A single hemp plant can make about a half kilogram of plant material for CBD extraction.
“If they don’t get pollinated, the buds will essentially just keep growing and keep producing cannabinoids,” Apicella said.
To grow an all-female group, “you snip a part of a plant off, and you put it in soil with a little rooting hormone and that cutting is actually genetically identical to that first mother plant that you took from,” Apicella explained, raising his arms and pointing to a long row of hemp plants. “So these are all genetically identical to one of the mother plants we have in here.”
Most CBD products are illegal — but only if someone is checking.
If your supplier makes a mistake, it might taint your CBD with THC — a consequence that can be problematic if your job randomly drug tests. Poor extractions can also leave behind the chemical solvents, which is hazardous in the case of butane, or even pesticides.
The first thing you need to know is that our bodies make their own natural versions of these compounds called endocannabinoids.
Let’s just say that again because it is a bit mind-blowing. A hemp crop — that is federally legal and only makes CBD — can become marijunana. Studies have found that if two certifiable hemp plants hook up, most of their offspring will be able to make THC. In fact, some of these seedlings will ONLY make THC.
The wild card for hemp growers is pollination. Most flowering plants boast both male and female parts. They’re hermaphrodites that can mate with themselves. But a cannabis plant is an exception, in that it is almost always either female OR male. And when the plants reproduce sexually, their traits mix and once dormant genes — like those behind THC production — can suddenly be replaced with active versions.
Why you shouldn’t assume CBD is a cure-all.
“There is a certain consumer expectation that we have here in America when we interact with our products, and cannabis should be no different,” Ferrarese said. “Cannabis, as a consumer packaged good, should have to meet those same standards for purity, identity and composition.”
That tension is something two professors and their students are trying to better understand at the University of Connecticut, which launched the nation’s only college course on growing weed earlier this year.
“It happens all the time,” said Rino Ferrarese, COO of the medical marijuana extractor CT Pharma, who is frustrated by low-quality and tainted products flooding the CBD market. Under Connecticut law, Ferrarese’s company must ensure their products match the labels on their bottles — which they accomplish through pharmaceutical-grade extraction.
Cannabis is abundant in the wild — meaning an outdoor hemp field is one gust of pollen away from accidentally breeding marijuana.
I’ve come upon it in pharmacy chain stores and gas stations. My dog kennel sells CBD (cannabidiol) gummies for pets, and multiple massage spas in the D.C.-metro area offer “CBD-infused relaxation” through lotions, oils and sprays. There are at least four cafes within a 15-minute walk of the White House that sell CBD coffee.