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How Long Does CBD Oil Take to Work?

To understand how long CBD takes to work, you first need a basic understanding of what CBD is, and how different variables can impact its onset of action. In general, CBD is absorbed into the bloodstream within 20 minutes to 2 hours depending on the method of delivery. 1 Other variables like the dosage, full spectrum or THC-free , consistency, and quality can also play a role in how quickly you begin to feel the benefits of CBD. How long does CBD oil take to work? It really depends on your goals and expectations, along with other variables like your age, body weight, and metabolism.

However, for anyone trying CBD for a more serious issue, consistency and patience needs to be part of your wellness routine for the full potential of CBD to be realized.

If you’d like to know more about what it takes to begin seeing results, read on as we explore the variables, but first watch my short video below!

How Long CBD Takes to Enter Your Bloodstream

As I mentioned above, the answer to how long CBD takes to work really depends on your own definition of the word “work.” Mild anxiety is going to be much quicker and easier to address than a more serious condition.

Simply put: the answer to this question isn’t a one-size-fits-all solution. It is a step by step approach that acknowledges how the benefits of CBD, and how long it takes to achieve them, may differ from different delivery methods and the issue at hand. For example: how long it takes CBD to work will differ drastically between sublingual oils, CBD capsules, and CBD topicals . So let’s get down to the nitty gritty!

Factor 1: Method of Intake

There are many different ways to consume CBD. Each of these methods has a different impact on how much, and how quickly, the CBD gets absorbed into your bloodstream. 2 This phenomenon is called bioavailability. It’s important to understand this because it will help you determine how much you’ll need to take to feel its effects; and you can also get an idea of how long it will take for your CBD to work.

CBD Bioavailability Chart

As you can see in the chart above, the consumption method of CBD is the biggest determining factor in how long it may take for CBD oil to work. The quickest and most bioavailable method of CBD consumption is through inhalation, but many states still prohibit the sale of CBD-rich hemp flowers for smoking. The next best is a sublingual oil or tincture, followed by ingestible CBD capsules and finally topicals.

Because CBD capsules have to travel through your digestive system, they have what’s known as a first-pass metabolism. This means that it’ll take longer to feel the effects of the CBD, or in medical terms – the bioavailability rate. (To clarify: this applies for all edible cannabis products, because all of them have to pass through your digestive system.)

On the other hand, CBD oil avoids first-pass metabolism by going straight through the capillaries under your tongue. This makes it the most effective method of delivery after smoking, and it means you’ll feel it quicker. 3 This is also the main reason we formulate our organic CBD oils with medium chain coconut oil . Because of its thin and viscous characteristics, it absorbs quickly when placed under the tongue.

There are other variables at play in how long it takes, but this should help you determine when your specific form of CBD will start working.

Factor 2: Dosage & Potency

The amount of CBD you’re taking every day will affect how quickly you will begin feeling its effects. In general, the more that you’re taking, the quicker you’ll feel it.

For example, if you take a high dose of CBD to Support a healthy Sleep Cycle , you’ll probably feel sleepy in about 15-30 minutes. In contrast, if you take a lower serving for general wellness or everyday aches or pains, it could take a few days of dosing to notice significant results. 4

How Much CBD Should I Take?

The bottom line is that when you’re choosing a CBD product, you should consider the type of results you’re trying to achieve and adjust your dosage accordingly. This may also include testing different consumption methods or a different application style. It can also depend on your body mass, and if you’re taking any prescription medications . 5

Everyone is different, and this is something you need to dial in for yourself. A full dropper of our 750 mg CBD oil is 25 mg, which we think is a great daily serving to start with. But some people take more, and some need less. CBD can be a powerful supplement, especially when it contains THC alongside it . So it’s best to consult with your doctor to determine the right dose for you and avoid any CBD side effects .

Factor 3: CBD Quality

We’ve said it time and time again: not all CBD products are created equally. Because this market is largely unregulated, many brands on the market do very little to maintain the quality of their products. 6 Some CBD brands use ingredients that have impurities, additives, and adulterants which will significantly effect the safety of your product. This is why you should always look for a third party lab test to know that you’re getting a high quality CBD product, along with the USDA organic seal.

We also recommend looking for a full spectrum CBD product, which contains more cannabinoids than just CBD. Just like CBD, these other cannabinoids don’t get you high ; but they do have a synergetic effect that heightens your body’s response through the “entourage effect.” 7 One of those cannabinoids is probably one you’ve heard a lot about, and that’s THC. In order for a product to truly be considered full spectrum, make sure it contains trace amounts of THC . The legal amount is no more than 0.3 percent of total dry weight.

The origin of the raw hemp plant material is another key factor that determines the quality of your product. Hemp is a powerful bioaccumulator, meaning that it soaks up all the nutrients and toxins in the soil it grows in. If the soil isn’t pre-tested for toxins, pesticides, or heavy metals, those things could end up in your CBD. That’s why you should only use CBD products made from hemp grown in the USA, and preferably in Kentucky. In addition, if the farmer uses synthetic fertilizers, or if the field doesn’t go through a multi-year crop rotation, there will be fewer nutrients in the soil and the hemp will contain less CBD. 8

You can avoid all of these problems by opting for an organic cannabis product that’s been certified organic by the USDA. As we explore in this article, the USDA has strict guidelines for organic farming and processing. This means that USDA certified organic products will be responsibly sourced and of higher quality. 9

Factor 4: Individual Biology

Although you can count on certain effects to take place, no two people respond exactly the same to CBD, even if they have the same consumption, the same delivery method , and the same body composition. One person could feel their CBD tinctures in 10 minutes, yet someone else could take the same dose and feel it in an hour. 10

There are several key considerations that fall into this category, and they all affect the amount of time it will take to feel CBD’s effects.

Body Weight

Like most cannabinoids, CBD is fat-soluble. Those who weigh more tend to have more fat cells in their body, which means that they’ll absorb and store CBD for longer in their body.

While this isn’t necessarily a bad thing, it does mean that people with more fat cells in their body will most likely need more time to adjust. It’s not all bad news, though: the higher your body mass, the longer it takes for CBD to work. 11

Metabolism

While individual metabolism does involve burning calories, it also affects how your body breaks down compounds like CBD . Depending on your age, your lifestyle, your digestive system, and your genetic profile, your metabolism can function at different rates. This is what we call our metabolic rate – and we all have different ones! 12

If you exercise regularly and have a high metabolism, you’ll feel the effects come on faster; but you’ll also feel it wear off more quickly. On the other hand, if you have a slow metabolism, you’ll notice that it takes longer to feel your CBD coming on; and it will stay in your body for longer.

Endocannabinoid Balance

CBD is part of a unique set of compounds called cannabinoids. These compounds interact with a biological system found in nearly all animals. It’s called the endocannabinoid system (ECS), and its cannabinoid receptors are found throughout your entire body. While we’re just beginning to understand how the ECS works, research suggests that it’s responsible for many of your biological functions like your mood, sleep, appetite, and pain response. 13

If your ECS is imbalanced, you could experience a large range of negative symptoms as a result. While the science is still out on this subject, CBD could help to alleviate these symptoms by attaching to the receptors and rebalancing your system. In general, the more your endocannabinoid system is imbalanced, the longer it will take to feel the effects.

While there’s no way to quantify how much of an imbalance you’re experiencing; you can probably gauge this yourself by assessing the severity of your symptoms.

Factor 5: Consistency

For some people, the positive effects come immediately. A lot of people will notice that they’re experiencing less stress, less tension, and better sleep after just one dose of CBD — but this is just from anecdotal reports. For others, it might take a few weeks to notice the powerful effects of CBD. So if you don’t feel it right away, be patient.

Some impatient people might give up after a few CBD doses and brush it off as snake oil that doesn’t work. While these people might be taking a bad-quality product, they’re also ignoring one of the key properties of CBD oil — take it consistently.

Regardless of what you’re feeling, the positive results come slowly. The key to getting the most benefits out of your CBD is consistency! A consistent, daily dose will eventually restore balance your ECS; and you’ll be glad you stuck with it.

Feeling Out How CBD Works for You

When you’re new to CBD, the first thing to know is that the effects take a few days to become noticeable. That means when you begin taking CBD every day, it’s good to be mindful of how your body responds to your daily CBD dosage. To discover its full effects, we recommend trying it for a full 30 days.

Your first 30 days on CBD is an important time to better understand your body and how it responds. Below we answer many of the most common beginners’ questions about CBD.

The potential therapeutic benefits that CBD oils and tinctures offer are becoming more recognized, making people more interested in getting started. The first 30 days can be a trial and error time in finding what works best for you, the individual. After reading these answers to the most common questions, you are likely to add a cannabis supplement into your everyday routine soon.

What Kind of CBD Should I Take?

For first time users, we always recommend starting with full spectrum CBD oil, which you take sublingually — which means a dropper of oil under your tongue for 30 to 60 seconds to let it absorb through the mucous membrane in your mouth.

Some people have trouble taking our CBD hemp oil under the tongue, and so they prefer the CBD capsules . They are also worth considering if you’re experiencing inflammation in the lower digestive tract, as capsules get further down into the gut.

People looking for pain relief in a specific area often apply a CBD lotion on the affected area, while avoiding the eyes and mucous membranes. For best results, we recommend pairing CBD lotion with sublingual oil, and using the same delivery methods at the same time everyday.

You’ll also always want to make sure whatever CBD product you are using has third party lab tests. The best companies have a QR code, and all of their company information, and testing lab information readily available to be reviewed before or after purchase. In order for CBD oil to work, you must first make sure that what you’re taking is real! If you can’t view the third party test results before making your purchase, then hold off until you can do more research.

Unfortunately, many unscrupulous brands sell fake CBD oil. 14 This is actually just hemp seed oil with a fake concentration listed on the bottle. You’ll also want to stay away from any brand that is making lofty health claims about its CBD oil. No medical claims regarding full spectrum CBD oil have been approved by the FDA, as of 2021. 15

What Time of Day Should I Take It?

This answer is different for everyone. The important thing is to find a time of day to best incorporate CBD into your daily routine. If you’re suffering from discomfort and inflammation during the day, maybe it’s best to take it in the morning. But if you’re using CBD because you’ve read reports that it can help you sleep, then taking it just before bedtime is your sweet spot.

How Often Should I Take CBD?

To begin, start taking CBD once per day, a full dropper of 25 milligrams, or 50 milligrams if you’re using our extra-strength CBD oils. See how you’re feeling and sleeping. For first time users, it can be good to “load dose” at first — taking larger than normal servings. That means, take a full dropper in the morning, and another full dropper before bedtime.

You will know if you have taken too much if you feel groggy in the morning, or if you experience diarrhea symptoms. 16 If you feel these side effects, dial back your current daily dosage to find something that works best for you.

How often you take CBD may also play a role in a drug test or work-related drug screenings. After taking CBD oil consistently for a period of weeks, the cannabinoids begin to build up within our systems, especially in fat cells, which could cause you to test positive during drug screenings. 17 If drug testing is a concern for your job, talk to your HR department before you start taking CBD consistently. You may also consider switching to a CBD topical, which has a far lower risk of showing up on a drug test.

How Long Does It Take For CBD Oil To Work?

It takes a few days for CBD to work, and it’s not something that you’ll notice right away. Be mindful of any pain, anxiety, and changes in sleep patterns as you work through your first week. Keep journal entries to track sleep and progress, and the amount of CBD you’re taking. This will help you be aware of the effects of CBD on your body. Understand that health benefits from natural supplements like CBD edibles, CBD tincture and oils don’t happen overnight. It takes time for the human body to adjust after implementing several different changes into our lifestyle. It also depends on the amount of CBD you’re taking to really experience the true effects of hemp derived CBD products .

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After One Month of CBD: How Will I Feel?

After a month of CBD usage, you’ll likely feel different. 18 But if you don’t believe us, try taking it for one month consistently, and then don’t take it for a week. Those bad feelings may return. That’s when you’ll know how CBD makes you feel , and you’ll be ready to order your CBD oil here. At Cornbread Hemp, we are passionate about producing our Flower-Only™ full spectrum, USDA organic hemp extract for consuming CBD in several different effective methods. And because our third-party lab partner tests every batch, you’ll never need to worry about potentially negative side effects from any harmful contaminants.

About the Author

Dr. Leslie Mudd, PharmD

A board certified oncology pharmacist with 25 years experience at the James Graham Brown Cancer Center in Louisville, Kentucky, Dr. Leslie Mudd now serves as the Cornbread Hemp resident pharmacist and medical expert. Read Dr. Mudd’s full author bio here .

References

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2. Bruni N, Della Pepa C, Oliaro-Bosso S, Pessione E, Gastaldi D, Dosio F. Cannabinoid Delivery Systems for Pain and Inflammation Treatment. Molecules. 2018;23(10):2478. Published 2018 Sep 27. doi:10.3390/molecules23102478. Under heading number 3.

3. Lucas CJ, Galettis P, Schneider J. The pharmacokinetics and the pharmacodynamics of cannabinoids. Br J Clin Pharmacol. 2018;84(11):2477-2482. doi:10.1111/bcp.13710. Discussed throughout the article.

4. Millar SA, Stone NL, Bellman ZD, Yates AS, England TJ, O’Sullivan SE. A systematic review of cannabidiol dosing in clinical populations. Br J Clin Pharmacol. 2019;85(9):1888-1900. doi:10.1111/bcp.14038. Under “Discussion” heading, 3rd paragraph

5. 10) Millar SA, Stone NL, Yates AS, O’Sullivan SE. A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans. Front Pharmacol. 2018;9:1365. Published 2018 Nov 26. doi:10.3389/fphar.2018.01365. Last paragraph before Author Contributions

6. VanDolah HJ, Bauer BA, Mauck KF. Clinicians’ Guide to Cannabidiol and Hemp Oils. Mayo Clin Proc. 2019;94(9):1840-1851. doi:10.1016/j.mayocp.2019.01.003. Under the “Finding a Quality Product” and Table 3.

7. Pavlovic R, Nenna G, Calvi L, et al. Quality Traits of “Cannabidiol Oils”: Cannabinoids Content, Terpene Fingerprint and Oxidation Stability of European Commercially Available Preparations. Molecules. 2018;23(5):1230. Published 2018 May 20. doi:10.3390/molecules23051230. 5th paragraph in the introduction

8. Girdhar M, Sharma NR, Rehman H, Kumar A, Mohan A. Comparative assessment for hyperaccumulatory and phytoremediation capability of three wild weeds. 3 Biotech. 2014;4(6):579-589. doi:10.1007/s13205-014-0194-0. Under the heading “Hyperaccumalative action by Cannabis sativa”

9. Hemp Production. Hemp Production | Agricultural Marketing Service. Accessed July 1, 2020.

11. Millar SA, Stone NL, Yates AS, O’Sullivan SE. A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans. Front Pharmacol. 2018;9:1365. Published 2018 Nov 26. doi:10.3389/fphar.2018.01365. Throughout article

12. Urasaki Y, Beaumont C, Workman M, Talbot JN, Hill DK, Le TT. Potency Assessment of CBD Oils by Their Effects on Cell Signaling Pathways. Nutrients. 2020;12(2):357. Published 2020 Jan 30. doi:10.3390/nu12020357. Throughout article

13. Pauli CS, Conroy M, Vanden Heuvel BD, Park SH. Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. Front Pharmacol. 2020;11:63. Published 2020 Feb 25. doi:10.3389/fphar.2020.00063. Throughout article

14. VanDolah HJ, Bauer BA, Mauck KF. Clinicians’ Guide to Cannabidiol and Hemp Oils. Mayo Clin Proc. 2019;94(9):1840-1851. doi:10.1016/j.mayocp.2019.01.003. Under the “Finding a Quality Product”

15. Meissner H, Cascella M. Cannabidiol (CBD) [Updated 2020 Mar 9]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: . Under “Indications” heading

16. Millar SA, Stone NL, Bellman ZD, Yates AS, England TJ, O’Sullivan SE. A systematic review of cannabidiol dosing in clinical populations. Br J Clin Pharmacol. 2019;85(9):1888-1900. doi:10.1111/bcp.14038. Table 1, Table 2, and Table 3

17. Spindle TR, Cone EJ, Kuntz D, et al. Urinary Pharmacokinetic Profile of Cannabinoids Following Administration of Vaporized and Oral Cannabidiol and Vaporized CBD-Dominant Cannabis. J Anal Toxicol. 2020;44(2):109‐125. doi:10.1093/jat/bkz080

18. Shannon S, Lewis N, Lee H, Hughes S. Cannabidiol in Anxiety and Sleep: A Large Case Series. Perm J. 2019;23:18-041. doi:10.7812/TPP/18-041. After 1 month of administration, the trial showed improvement in anxiety scores.

All rights reserved. The statements made regarding these products have not been evaluated by the Food and Drug Administration. The health effects and benefits of CBD products have not been confirmed by FDA-approved research. Hemp derived CBD products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to health information from licensed health care practitioners. Please consult your health care professional about potential interactions with prescription medication, or about other side effects before using any product. Taking too much CBD, and high doses of CBD may also cause undesired side effects. You should always consult with your doctor or another health care provider if you are considering making any changes to your lifestyle, diet or nutrition. Any CBD product is not intended for those who are pregnant or breastfeeding, please consult your doctor for more information before choosing to use CBD.

Cornbread Hemp works with cannabis plant suppliers who guarantee an equal to or less than 0.3 percent THC content. While there are no psychoactive side effects with these trace amounts of no more than 0.3% THC, it is possible that users may fail a drug test. Cornbread Hemp does not take any responsibility in the instance a customer fails a drug test while using any form of CBD products. Check state laws before travelling with any hemp derived CBD products.

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Labeling of Cannabidiol Products: A Public Health Perspective

1 The Center for Medical Cannabis Education, Del Mar, California, USA.

2 Helfgott Research Institute, National University of Natural Medicine (NUNM), Portland, Oregon, USA.

Douglas MacKay

3 Scientific and Regulatory Affairs, CV Sciences, Inc., San Diego, California, USA.

William Dolphin

4 Communications Department, Americans for Safe Access, Washington, District of Columbia, USA.

5 Graduate School of Education and College of Arts and Sciences, University of Redlands, Redlands, California, USA.

2 Helfgott Research Institute, National University of Natural Medicine (NUNM), Portland, Oregon, USA.

5 Graduate School of Education and College of Arts and Sciences, University of Redlands, Redlands, California, USA.

* Address correspondence to: Jamie Corroon, ND, MPH, The Center for Medical Cannabis Education, 428 8th Street, Del Mar, CA 92014, USA [email protected]

Abstract

Introduction: Interest in the therapeutic use of cannabidiol (CBD) has reached a fever-pitch in recent months, as CBD-containing products appear everywhere from online retailers to grocery stores and gas stations. The widespread availability of hemp-derived CBD products is confounding given that CBD is a U.S. Food and Drug Administration (FDA)-approved drug, and thus precluded from being added to food and beverages, or included in dietary supplements. The use by manufacturers of disease-related claims on marketing materials and product labels, along with the federal legalization of hemp in December 2018, has created political pressure on FDA to promulgate regulations.

Conclusions: Accurate and informative labeling of hemp and hemp-derived CBD products is an important public health issue. FDA-regulated product labels are considered an essential tool for protecting consumers and enabling informed decision-making. Untruthful or unsubstantiated health-related claims, and unallowed Drug Claims, in marketing materials and on labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. Furthermore, missing or inaccurate labeling of the amount of CBD, delta-9 tetrahydrocannabinol (THC), and potentially harmful contaminants such as pesticides, naturally-occurring yeast and mold or heavy metals may result in harm and/or lack of efficacy. Manufacturers of these products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements and drugs, both over-the-counter (OTC) and prescription, even though FDA has interpreted federal law as excluding them from these categories. As manufacturers prepare for forthcoming regulations, a better understanding of the basic framework for FDA labeling and marketing regulations for food, dietary supplements and drugs is warranted.

Background

Cannabidiol (CBD) is one of more than a hundred cannabinoids found in Cannabis sativa L., a plant more well-known colloquially as marijuana or hemp. 1 CBD was first isolated in 1940 and characterized structurally in 1963. 2,3 Interest in the therapeutic use of CBD has reached a fever-pitch in recent months, as CBD-containing products appear everywhere, from online retailers to grocery stores and gas stations.

Widespread availability of hemp and hemp-derived CBD products is confounding, given the position of the U.S. Food and Drug Administration (FDA), which maintains that CBD is an approved drug, 4 and thus precluded from being added to food and beverages, or included in dietary supplements. 5 To date, FDA enforcement has been limited to sending warning letters to manufacturers, largely for mislabeling or misbranding their products as unapproved new drugs, or for making claims that a product is indented to treat a disease condition on labels and marketing materials (FDA considers all sales materials, including consumer testimonials used in marketing, to be extensions of the label). 6–8 Political pressure on FDA is mounting. The agency had initially indicated it would expedite its deliberations regarding regulation of hemp-derived CBD products, 9 however, a late 2019 update promised only to inform stakeholders “as quickly as possible.” 10

The public health imperative

Accurate and informative labeling of CBD products is an important public health issue. Product labels, and associated marketing materials, provide vital information about that product’s composition and ingredients, as well as the potential risks and benefits of use. Unsubstantiated health-related claims, and unallowed drug claims, on labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. In addition, absence of disclosure of major food allergens or solvents or excipients, if present, would constitute misbranding; and inaccurate labeling of the amount of CBD, delta-9-tetrahydrocannabinol (THC), or potentially harmful contaminants such as pesticides, naturally occurring yeast and mold, or heavy metals may result in harm and/or lack of efficacy.

Manufacturers of hemp and hemp-derived CBD products intended to be sold and marketed as food or dietary supplements may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of such products, even though FDA has interpreted federal law as excluding them from these categories. Similarly, manufacturers of products intended to be sold and marketed as drugs must comply with a different, more rigorous, set of FDA regulations that are specific to that category.

What’s in a Label?

In the United States, the label of FDA-regulated products, which include food, beverages, dietary supplements, drugs, and more, represents the product’s identity card. Product labels provide important information about that product’s composition and ingredients, as well as the potential risks and benefits of use. FDA-regulated product labels are considered an important tool for protecting consumers and enabling informed decision-making. 11

Widespread mislabeling of hemp and Cannabis products has been documented by both independent researchers and the FDA and other organizations. 12,13 Underlabeling and overlabeling of both CBD and THC content have been reported. The actual contents of available products can vary considerably from what are disclosed on the label; sometimes no CBD is present at all. Inadequate label information also poses risks of unintended, unwitting, or overconsumption of THC, the primary intoxicating compound in Cannabis, as well as potentially harmful contaminants.

See also  Dogs Naturally Magazine CBD Oil

Identity and Composition

Identity

FDA regulations mandate that food, dietary supplements, and drugs prominently display a “statement of identity” as one of the dominant features of the principal display panel of the label. This descriptive statement is used to identify the product (e.g., “Crackers,” “Cereal,” “Herbal Supplement”) and allow consumers to easily interpret its intended use (e.g., food for nourishment, a dietary supplement to supplement the diet, or a drug for therapeutic purposes). A “statement of identity” is also important for hemp-derived CBD products. While the statement “Dietary Supplement” is required for products intended to supplement the diet, statements that identify other forms of CBD products, such as “Vape cartridge,” or “Ointment,” may help consumers more easily identify products that are not intended to supplement the diet.

Composition

Declarations related to the principal constituents of a food, dietary supplement, or drug are made within FDA-regulated Fact Panels. Most FDA product category requires a Fact Panel (i.e., Nutrition Facts, Supplement Facts, and Drug Facts) on the label to convey the information required for the safe, informed use of the product. For food and dietary supplements, the “Serving Size” and the “Servings Per Container” must also be stated within the Fact Panel. For prescription and over-the-counter (OTC) drugs, the active ingredients per dosing unit (e.g., tablet, capsule, and packet) and adequate directions for use are stated in the Drug Fact panel. The presence of Fact Panels on labels implies the product is in compliance with all FDA requirements for the corresponding category (i.e., food, dietary supplement, or drug).

CBD and THC content per serving is often intentionally absent from the label of hemp-derived CBD products marketed as dietary supplements. In the case of CBD, this omission is often intended to reduce the risk of enforcement actions by FDA or other federal agencies. In the case of THC, it may be due to the presumption that levels are low enough to be nonpsychoactive.

The presence of trace amounts of THC in hemp-derived CBD products is not unlike the presence of trace amounts of alcohol in certain beverages. For example, Kombucha products (i.e., fermented tea beverages) containing 0.5% or less alcohol by volume are not deemed alcohol beverages and not subject to Alcohol and Tobacco Tax and Trade Bureau regulations ( Table 1 ). 14

Table 1.

Allowable Amounts of Selected Ingredients

Labeling claim Legal threshold
Hemp 0.3% dry weight THC
Kombucha and N/A beer 0.5% ABV
No calorie 5 calories per serving
Fat free 0.5 g per serving
Sodium free, salt free 5 mg per serving
Sugar free 1.0 g per serving

The 2018 Farm Bill defines hemp as the plant Cannabis with a THC concentration of not more than 0.3% by dry weight. The Farm Bill does not define a level that applies to finished consumer products. However, the Farm Bill explicitly maintains FDA’s authority to determine a safe level for consumer products that it regulates such as foods, dietary supplements, cosmetics, and drugs.

ABV, alcohol by volume; THC, delta-9-tetrahydrocannabinol; FDA, Food and Drug Administration.

FDA allows “free from” claims for food products that contain trace amounts of sodium, fat, and sugar. However, hemp-derived CBD products should not carry a “THC-free” or similar claim until a specific legal threshold has been established. At least one consumer lawsuit has been filed based on a presumably faulty “THC-free” claim. 15 Similarly, if manufacturers use the term “Broad Spectrum” to suggest that a product is free of THC, then that needs to be defined in terms of an exact quantity and a specific analytical method.

Health-Related Claims on the Label

Health-related label claims are important because they communicate to consumers a given product’s intended use, potential benefits and harms, and anticipated effects. FDA guidelines describe four categories of allowable health-related claims on labels of food, dietary supplements, and drugs. These include the following: (1) Nutrient Content claims; (2) Structure/Function claims; (3) Health claims; and (4) Disease claims. Each category of claims requires a certain level of evidence for substantiation of the claim that is in accordance with FDA regulations.

FDA Nutrient Content Claims

Nutrient Content claims simply characterize the level of a nutrient in a food, food component, or dietary ingredient, using terms such as free, high, and low (e.g., “low-calorie,” “high-fiber,” “fat-free”). Claims that use these terms are only allowed for nutrients with established Daily Values (i.e., Reference Daily Intakes or Dietary Reference Value). Nutrient Content claims can also compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and light (e.g., “reduced-sodium,” “more fiber,” “light” [referring to reduced fat]). 16 The use of Nutrient Content claims is grounded in nutrition science to avoid arbitrary use of these terms and to help consumers accurately identify and compare the nutritional value of foods.

The use of terms such as free, high, and low, while currently prohibited, may be helpful for hemp-derived CBD products when referring to biologically active compounds such as phytocannabinoids (e.g., “high in CBD,” “THC free”). Standardized label terminology will reduce misuse of descriptive terms on labels and facilitate consistent communication to consumers. Industry stakeholders would benefit from engaging in an open process to reach consensus on harmonized constituent thresholds, as well as terminology for characterizing the composition of these products. Ultimately, appropriate terminology and thresholds should be negotiated with FDA and adopted by industry before being used in marketing.

FDA Structure/Function Claims

Structure/Function claims describe the role of a food or dietary ingredient in terms of its effect on the normal structure or function of the human body (e.g., “calcium builds strong bones,” “fiber maintains bowel regularity”). Labels of foods and dietary supplements, as well as drugs, can display Structure/Function claims. Structure/Function claims for conventional foods are limited to physical attributes such as taste, aroma, or nutritive value (e.g., beef provides iron to support hemoglobin levels). For dietary supplements, Structure/Function claims may include non-nutritive support (e.g., supports memory and focus), general well-being, and claims related to nutrient deficiencies (e.g., vitamin C prevents scurvy). Structure/Function claims do not require premarket approval by FDA; however, the manufacturer must have substantiation that the claim is truthful and not misleading. A notification with the text of the claim must be submitted to FDA no later than 30 days after marketing the product. 17

Claims related to a product’s effect on normal function may help set expectations for consumers of hemp-derived CBD products. Nondisease-oriented claims (e.g., promotes a restful sleep or fosters stress resilience) can be supported with the appropriate scientific evidence, if available. Manufacturers should avoid referring to specific disease states (e.g., insomnia or anxiety), and instead use appropriate terminology that describes the anticipated effect for most users. This framework for claims making would encourage marketers to conduct research on unique cultivars, formulations, and delivery technologies to determine if, in fact, different products lead to different effects.

It should be noted that the use of Structure/Function-type claims presents a risk of misinterpretation by consumers and misuse by manufacturers. The current use of Structure/Function claims for food and dietary supplements has been criticized because consumers may be confused and interpret a nondisease-oriented claim such as “promotes a restful sleep” as a therapeutic claim for a sleep disorder. 18

FDA Health Claims and Drug Claims

Health claims and Qualified Health claims (Health claims) describe the relationship between a food or dietary ingredient and reduced risk of a disease or health-related condition (e.g., “adequate calcium throughout life may reduce the risk of osteoporosis”). Health claims pronounce disease risk reduction and therefore require FDA preauthorization and a higher level of substantiation. Alternatively, they may be based on an authoritative statement of the National Academy of Sciences, or a similar scientific body within the U.S. government that has responsibility for public health protection or nutrition research. When a product bears a label claim that states or implies the product is useful in diagnosing, curing, mitigating, treating, or preventing a disease, that claim is considered a drug claim and designates that product as a drug according to the FDA. 19

Drug claims for prescription and OTC drugs are roughly analogous to Health claims for nondrugs but allow for statements beyond risk reduction (i.e., diagnosing, curing, mitigating, treating, or preventing). These claims are product-specific and subject to the most rigorous FDA premarket approval process, requiring both preclinical and clinical trials, including multiple phase 1–4 clinical trials. Results of these trials lead to clearly established indications and contraindications for use of the drug in specific diseased populations. 19

FDA regulations prohibit any product that has not received premarket approval as a drug from making a Drug claim on its label or in marketing materials. Epidiolex TM , an FDA-approved prescription form of CBD, can be marketed with Drug claims. Hemp-derived CBD products cannot.

Multiple manufacturers in the emerging CBD industry have made marketing statements that qualify as Health or Drug claims ( Table 2 ). FDA has delivered cease-and-desist letters to more than 40 companies since 2015—the number more than tripled to 22 in 2019—for making such claims about their CBD products in labeling, including claims that they treat, or even cure, Alzheimer’s disease, opioid withdrawal, pain, and anxiety. 20

Table 2.

Selected Examples of Labeling Claims Cited by Food and Drug Administration in Warning Letters

Company Location of claim Claim
Curale af, Inc. Webpage “CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.”
Advanced Spine and Pain, LLC (d/b/a Relievus) Facebook “Cannabidiol Fights Against Cancer CBD and other chemicals found in Cannabis have an anti-tumor effect and could be used to improve standard treatments. Please visit our website for more information!
Nutra Pure, LLC Webpage “Cannabidiol (CBD) Treats Neuropsychiatric Disorders”
PotNetwork Holdings, Inc. Webpage “Interestingly, however, in some lab studies, CBD has also shown the ability to kill cancer cells directly without the help of our immune system.”
Green Roads of Florida, LLC Webpage “[CBD] has antipsychotic properties, which makes it very useful for treating bipolar disorder.”
Natural Alchemist Alurent, Inc. Webpage “I was pleasantly surprised to find that CBD helped my arthritis…I have shared with my son and he states he is a big believer in CBD for. .. TBI [traumatic brain injury] after being acquainted with military personnel who have tried it.”
Dose of nature Facebook “CBD May Reverse Brain Deficits in Parkinson’s, Alzheimer’s”

To underscore the importance of FDA preapproval of all Drug claims, FDA requires labels of dietary supplements that make any claims to include a disclaimer which states that the FDA has not evaluated the claim(s) and that the product “is not intended to diagnose, treat, cure, or prevent any disease.” 21

Conclusion

Accurate and informative labeling of hemp and hemp-derived CBD products is an important public health issue. Untruthful or unsubstantiated health-related claims, and unallowed Drug claims, in marketing materials and labels of CBD products may create harm by enticing consumers to forgo more evidence-based medical interventions. Furthermore, missing or inaccurate labeling of the amount of CBD, THC, and potentially harmful contaminants such as pesticides, naturally occurring yeast and mold, or heavy metals may result in harm and/or lack of efficacy. Manufacturers of these products may reasonably be expected to understand and adhere to FDA regulations for labeling and marketing of food, dietary supplements, and drugs, both OTC and prescription, even though FDA has interpreted federal law as excluding them from those categories. As manufacturers prepare for forthcoming regulations, a better understanding of the basic framework for FDA labeling and marketing regulations for food, dietary supplements, and drugs is warranted.

Authors’ Contributions

Design, research, and article writing, oversight—J.C. Design, research, and article writing—D.M. Research and article writing—W.D.

Abbreviations Used

ABV alcohol by volume
CBD cannabidiol
FDA Food and Drug Administration
OTC over-the-counter
THC delta-9-tetrahydrocannabinol

Author Disclosure Statement

J.C., ND, MPH, is the Medical Director at The Center for Medical Cannabis Education, a for-profit clinical and consulting entity. D.M., ND, has no conflicts to disclose. W.D., MA, is a paid consultant for Americans for Safe Access Foundation, a 501(c)3 nonprofit educational organization.

Funding Information

No funding was provided for this article.

Cite this article as: Corroon J, MacKay D, Dolphin W (2020) Labeling of cannabidiol products: a public health perspective, Cannabis and Cannabinoid Research 5:4, 274–278, DOI: 10.1089/can.2019.0101.

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