7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?
13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
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.
Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.
CBD stands for cannabidiol and it's one of hundreds of cannabinoids (compounds) found in the hemp and marijuana plants. Legal CBD products are derived from industrial hemp plants, specifically Cannabis sativa, which contain high levels of CBD and small amounts of tetrahydrocannabinol (THC).
Like R+R Medicinals’s oil, the full-spectrum tincture from Joy Organics is USDA organic, but this one comes in more than one delicious flavor, including fresh lime, tranquil mint, orange bliss, summer lemon, and tropical sunrise. There is also an unflavored option.
What is CBD?
CBD doses, or strengths, are measured in milligrams of CBD per serving. For CBD oil, this is typically expressed as milligrams of CBD per 1 milliliter dropper. If you prefer CBD gummies, look at the packaging to see how much CBD is in one gummy or one serving of gummies.
There are three types of CBD: full-spectrum, broad-spectrum, and CBD isolate. Full-spectrum oils have all the natural compounds found in the cannabis plant, including trace amounts of THC. Because of this combination, full-spectrum formulas tend to have stronger potencies. Broad-spectrum and CBD isolate products are both THC-free, but unlike broad-spectrum, CBD isolate doesn't contain any secondary cannabinoids.
Charlotte’s Web makes its organic CBD oil with Colorado-grown hemp. Concentrations range from 7 milligrams to 60 milligrams of CBD per 1 milliliter serving, and each tincture is U.S. Hemp Authority certified. According to testers, the original formula has a calming effect, which contributed to a better night’s sleep.
We really valued when brands listed lab test results alongside their products, preferably from a third party. These results help verify the quality of their CBD oil and go a long way creating transparency between brands and consumers. In the lab results, we specifically looked at the cannabinoid and terpene profiles of each product strain. The more transparency here, the better.
Things we don’t like:
Spruce is the best CBD oil we found in terms of overall relief and is a relatively newcomer onto the scene, founded in 2018. They work with two family-owned farms in Colorado and Kentucky to produce their 100% natural and pesticide-free CBD oil drops. Spruce drops come in two potency levels – 750 mg and 2400 mg for folks who need maximum strength relief. Along with their topical cream, Spruce runs these products through 3rd party, independent U.S. lab testing to make sure every batch is up to their quality standards, and they’ve never failed one of those tests for pesticides or other contaminants. For me, relief has been amazing with Spruce. I have restless leg syndrome and don’t sleep very well, but as soon as I started taking these drops, those issues immediately vanished. Mike uses it daily too. I’ve talked to several other Spruce customers as well that suffer from anxiety, chronic pain, and other issues, and they all say that Spruce helps them significantly with their daily struggles. Check out the other reviews on their site for yourself.
NuLeaf Naturals has been around since 2014 and get all of their CBD products from therapeutic hemp plants grown on licensed farms in Colorado. Similar to other products we liked, NuLeaf tinctures are whole-plant extracts, meaning they occur naturally and aren’t synthetic. These drops come in containers from 240 mg to all the way to 4850 mg and contain about 50mg cannabinoids per milliliter of oil. It’s also non-GMO and 100% organic – zero pesticides or other nasty chemicals that could potentially have harmful side effects. NuLeaf drops work well too for several types of relief – we’ve talked to folks first-hand about the benefits they’ve seen with everything from anxiety to pain relief, even in pets. Overall, very good full spectrum product that is worth trying if you haven’t found the CBD oil that works for you yet.
Joy Organics is a really cool company that has a focus on giving back to the community while also making some great CBD products. Their CBD oil tinctures come in 4 dosages and 4 flavors: mint, orange, lemon, and non-flavored. The thing we really love most about Joy Organics though is their transparency of product information – they list just about everything, from microbial analysis to contaminant analysis and a full ingredients label. They even have a dedicated page that lays out their entire production process in detail. Overall, this is a great product that is THC free, lab tested, kosher, organic, and provided relief for a lot of people.
Things we don’t like:
CBD (cannabidiol) has significantly risen in popularity over the several years, and with good reason. CBD occurs naturally in cannabis plants and the oil can be a really effective solution for several types of relief. CBD oil can help everything from anxiety to pain relief, sleeping disorders, stress reduction, and other issues that our bodies deal with on a day-to-day basis. So, we did the research to find out which manufacturers are making the best CBD oil in the USA. Typically, CBD is taken in one of two forms – drops (tinctures) or topical creams. We’ll focus on drops this time around. Our findings and the factors that went into our research are below. Let us know if you have any questions!