A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.
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:
To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA. Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
U.S. laws and regulations concerning CBD are determined at the state level. Currently, 33 states have legalized CBD use for medical purposes, and 10 states (Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, Vermont, and Washington) and the District of Columbia have legalized marijuana for recreational use. In states such as New York, Minnesota, and Connecticut, pharmacists are required to dispense the products in authorized dispensaries. Marijuana-derived CBD oil is still considered illegal under the Controlled Substances Act in accordance with the DEA’s classification of marijuana as a Schedule I substance. 2
Cannabidiol (CBD) is gaining popularity across the United States. Pharmacists must be able to answer patients’ questions about CBD and make recommendations. This article will provide specific information about CBD, including laws, how to select a non–FDA-approved CBD product, indications for use, side effects and warnings, drug interactions, dosing and directions, pharmacokinetics, and the future of CBD oil. After reading this article, pharmacists should feel confident about counseling patients about CBD and recommending CBD products.
Selecting a Non–FDA-Approved CBD Product
The inhibition of CYP2C19 by CBD can increase levels of carisoprodol, citalopram, clopidogrel, diazepam, phenytoin, proton pump inhibitors (PPIs), valproic acid, and warfarin. As a strong CYP3A4 inducer, CBD may lessen the efficacy of amlodipine, atorvastatin, buprenorphine, bupropion, diltiazem, eplerenone, fentanyl, loperamide, midazolam, paclitaxel, pioglitazone, sildenafil, solifenacin, tamsulosin, testosterone, topiramate, zolpidem, and other 3A4 substrates. 7
CBD is metabolized in the liver, mainly by CYP2C19, CYP3A4, and UGT. This can lead to interactions with prescription drugs, OTC medications, and herbal supplements. 1,14
CBD was first isolated from the Cannabis sativa plant in the 1930s. CBD is a nonpsychoactive part of the plant, whereas delta-9-tetrahydrocannabinol (THC) is the major psychoactive part of the plant. In the 1970s, researchers evaluated CBD as a pharmacologic agent. 1 Epidiolex, a 100 mg/mL oral solution with less than 0.01% THC, became the first FDA-approved CBD-containing drug in June 2018. 2 The drug is Schedule V and indicated only as an anticonvulsant for Lennox-Gastaut syndrome or Dravet syndrome in patients aged 2 years and older. 3
Yes. As of December 2018, CBD is legal nationwide (federally), so long as CBD formulas contain less than 0.3% THC.
According to The American Animal Hospital Association, CBD can reduce pain and stress in dogs, and boost their dopamine levels, thereby lifting their mood. CBD also affects the canine endocannabinoid system by reducing inflammation and lowering cancer cell reproduction.
Yes, in fact third-party testing happens three different times during their processing: 1) when the plants are harvested, 2) mid-way through processing, and 3) the finished product. You can access the QR code on each product or go the AnandaProfessional website and enter the lot number on your bottle. From there, you can view the testing report and verified potency for your individual bottle, along with reports validating your product is free of pesticides and other contaminants.
CBD Fruit Chews
CBD refers to only one of a whole family of beneficial compounds found in hemp called cannabinoids. Each cannabinoid has potential health benefits. Full spectrum hemp contains the whole family and is superior in its health benefits compared to CBD alone (called isolates).
Ananda Professional CBD products are tested at every step of the manufacturing process to ensure quality, purity, and potency with no contaminants. They use certified cannabis and food testing labs to verify the consistency of each product.
CBD (cannabidiol) is a naturally occurring compound and one of over 100 active cannabinoids found in cannabis. Both industrial hemp and marijuana are cannabis plants, however, industrial hemp is bred to be high in CBD and low in THC. (Marijuana is bred to be high in THC and low in CBD. THC is the compound in marijuana that causes a “high.”) CBD is not a psychoactive, so there is no “high.” Rather, it boasts numerous health benefits, in addition to a feeling of clarity, focus, and relaxation. Not only is CBD safe for humans and pets, but it has very few side effects.
Dosage varies greatly for each individual. In fact, each person’s dose will be determined by their response to it. Thus, it is best to talk with a nutritionist or herbalist to identify your dosage needs and starting point.