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Ingesting cbd oil with thc intended for topical use only

CBD vs. THC: What’s the Difference?

Kendra Cherry, MS, is an author and educational consultant focused on helping students learn about psychology.

Verywell Mind articles are reviewed by board-certified physicians and mental healthcare professionals. Medical Reviewers confirm the content is thorough and accurate, reflecting the latest evidence-based research. Content is reviewed before publication and upon substantial updates. Learn more.

Steven Gans, MD is board-certified in psychiatry and is an active supervisor, teacher, and mentor at Massachusetts General Hospital.

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Cannabis contains over 113 different chemical compounds known as cannabinoids. Cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC) are two types of chemical compounds derived from cannabis. In recent years, interest has grown in the potential health effects and benefits of cannabis. Much of this interest has centered on these two cannabinoids.

This interest is likely to continue to grow as cannabis and marijuana products become legal in more states. A number of different products have emerged that contain CBD, THC, or both that are designed to alleviate ailments such as stress, anxiety, and insomnia. In order to understand the side effects and potential benefits of these products, it is important to first understand the differences between CBD and THC.

What Is CBD?

Cannabidiol, usually referred to as CBD, is the second most prevalent chemical compound found in cannabis. First discovered during the 1940s, CBD has recently become more popular as a natural treatment for a range of conditions. It can be derived from hemp or from marijuana. Hemp-derived CBD still contains trace amounts of THC, while marijuana-derived CBD may contain more.

What Is THC?

Delta-9-tetrahydrocannabinol, or THC, is the main psychoactive ingredient in cannabis. According to the National Institute on Drug Abuse (NIDA), THC activates the brain’s reward system by signaling the release of the brain chemical dopamine. Dopamine is a neurotransmitter that plays an important role in mood and pleasure. By triggering a higher-than-normal release of dopamine, THC causes people to experience feelings of euphoria. THC is often administered by smoking marijuana, but it can also be found as an ingredient in capsules, edibles, and oils.

CBD vs. THC: Key Differences

THC and CBD have an effect on the endocannabinoid system, a system that plays an important role in maintaining homeostasis. Researchers are still working to understand the ins and outs of this complex system, but they do know that it is associated with processes including memory, appetite, sleep, mood, and fertility.

While THC and CBD share similarities, there are some key differences between the two compounds.

Psychoactive (produces a high)

Sourced from marijuana

Non-psychoactive (does not produce a high)

Typically sourced from hemp

Psychoactive Properties

CBD and THC affect different receptors in the brain. Because of this, CBD typically does not have psychoactive effects—in other words, it won’t cause you to get high.

THC, on the other hand, does have psychoactive effects. It is the compound that produces the high that people associate with marijuana.

Chemical Structure

Both CBD and THC have a chemical structure that is similar to the body’s natural endocannabinoids. Endocannabinoids are neurotransmitters that act in the brain.

Neurotransmitters are chemical messengers that relay signals between nerve cells in the body. They play an important role in a wide range of functions including sleep, pain, appetite, mood, and the immune system.

CBD and THC have the same molecular structure, but there are differences in how these molecules are arranged that are responsible for the differing effects they have. By mimicking endocannabinoids, they bind with receptors and cause different effects in the body.

Sources

While CBD can come from either hemp or marijuana, it is often derived from hemp in order to avoid the addition of larger amounts of THC. THC, on the other hand, is derived from marijuana.

CBD that comes from marijuana may contain more THC, which may not be ideal for people who are trying to avoid THC. Some CBD products that are produced from cannabis, for example, may contain more THC than the label suggests.

Potential Benefits of CBD and THC

While research on the potential health benefits of THC, CBD, and other cannabinoids is still in the early stages, there is evidence that these substances may be helpful for conditions including:

  • Epilepsy
  • Glaucoma
  • Symptoms of HIV/AIDS
  • Pain
  • Opioid dependence
  • Irritable bowel syndrome (IBS)
  • Inflammatory bowel syndrome (IBD)
  • Multiple sclerosis
  • Sleep difficulties
  • Movement disorders

While CBD and THC often have similar effects and are often used to treat many of the same ailments, there are some differences.

CBD is often used to alleviate symptoms associated with:

  • Anxiety
  • Inflammation
  • Migraines
  • Seizures

THC, which may be administered as medical marijuana, may be used to alleviate symptoms of a number of conditions. It may be helpful for conditions such as:

  • Glaucoma
  • Insomnia
  • Nausea; it may be helpful for alleviated nausea caused by cancer treatment
  • Pain associated with conditions such as arthritis, fibromyalgia, and migraine headaches
  • Poor appetite; including appetite problems caused by cancer treatment
  • Tremors

FDA-Approved Medications

While cannabis itself has not been FDA approved to treat any condition, there are a few drugs approved by the U.S. Food and Drug Administration (FDA) that contain CBD or THC.  

  • Epidiolex contains CBD and has been approved to treat seizures associated with two severe types of epilepsy—Dravet syndrome and Lennox-Gastaut syndrome
  • Marinol and Syndros are drugs that contain dronabinol, a synthetic THC. These drugs are used to treat nausea and vomiting caused by chemotherapy during cancer treatment.
  • Cesamet contains nabilone, a synthetic substance that is similar to THC. This drug is used to treat weight loss and appetite problems associated with chemotherapy and HIV/AIDS.

Side Effects of CBD and THC

Some research suggests that CBD and THC are generally safe and result in few side effects.

However, while these substances appear safe, that does not necessarily mean that you won’t experience some unwanted effects. Some adverse effects that have been reported include:

  • Changes in mood and appetite
  • Drowsiness
  • Feelings of anxiety or other mood changes
  • Nausea and dizziness

THC use may also result in unpleasant side effects such as increased heart rate, dry mouth, and memory loss.

Marijuana itself can have a number of short-term and long-term adverse effects, including impaired short-term memory, altered judgment, and impaired coordination. Research also suggests that marijuana can alter brain development and may lead to cognitive impairment.  

NIDA also notes that THC alters how the hippocampus and orbitofrontal cortex function. These areas of the brain are important in the formation of new memories and the ability to shift attention from one thing to the next. This not only affects a person’s ability to learn and form new memories, but it also makes it difficult for people to perform difficult tasks.  

Legality of CBD and THC

When choosing products containing CBD or THC, it is also important to consider their legality. Both marijuana and THC are included in the U.S. Controlled Substances Act, which means that they are not legal under federal law. As of July 2020, 33 states and Washington, D.C. have enacted policies allowing medical marijuana and products containing THC to be prescribed by a doctor. Some states also allow recreational use of marijuana and THC-containing products.

Although CBD in certain forms is legal in most states, the specifics of the legality of any THC or CBD product can vary from one state to the next. Several states have also approved the use of marijuana and THC for recreational purposes.

Because the laws regarding the use of cannabis and cannabis products are rapidly changing, you should always check your state’s laws before using products containing CBD or THC.

How to Take CBD and THC

Both THC and CBD can be consumed in a number of different forms. THC may be consumed as marijuana by smoking, but a number of other cannabis products are also available including:

  • Oils
  • Tinctures
  • Sprays
  • Vape products
  • Edibles including gummies and chocolates
  • Beverages containing marijuana oil

Like THC, CBD can also be consumed in a number of different forms. CBD oils can be formulated for vaping, although there have been recent concerns about the health dangers posed by vaping.

It can also be added to lotions and salves to apply to skin. It is important to note that the effects of these topical products will be localized since they are not being ingested.

CBD can also be taken orally as a tincture, oil, capsule, or spray. Edible CBD products are also popular and include gummies, candies, and beverages.

When choosing CBD products, it is also important to consider its formulation. Isolate products contain only CBD. Broad-spectrum products contain other cannabinoids with the exception of THC, while full-spectrum CBD products contain CBD, THC, and other cannabinoids.

Which One Should You Take?

The product you choose may depend on the effects you are trying to achieve. If you are trying to reduce stress or sleep better, for example, CBD may provide benefits without the negative side effects associated with THC. THC might be a better choice for symptoms or conditions for which the substance has demonstrated benefits, such as tremors or poor appetite.

Some research suggests that the potential therapeutic effects of THC and CBD tend to be greater when the two cannabinoids are taken together at the same time.   This phenomenon is known as the entourage effect.

Taking CBD along with THC has also been shown to help reduce some of the unwanted effects that THC may have. For example, one study suggests that CBD may potentially reduce some of the negative cognitive effects of regular cannabis use.   For example, people who use cannabis, particularly when it has high THC levels, may have a greater risk of experiencing psychiatric symptoms such as paranoia, anxiety, and psychosis. Studies have found, however, that CBD may help mitigate these effects.

One study found that CBD helped block some of the potential psychiatric effects of THC.   The authors of the study suggest that such findings have important implications for the use of cannabis products. People who are prone to unwanted side effects, for example, may be able to still gain the potential health benefits by sticking to products that are low in THC and higher in CBD content.

It is also important to remember that CBD and THC work in a number of different areas of the brain and researchers do not yet fully understand the effects that these cannabinoids have, either alone or in conjunction with one another.

Some evidence suggests that the combined effects of CBD and THC may be dependent on dose. A 2019 study, for example, found that low doses of CBD actually played a role in amplifying the psychoactive effects of THC, while high doses of CBD reduced THC’s effects.  

Drug Testing CBD or THC

Because THC is the main psychoactive substance in marijuana, it can be detected on most standard drug tests. CBD may be detectable as well, but many drug tests are not designed to look for cannabidiol.

However, many CBD products do contain trace amounts of THC. While these amounts are small, they may still be detectable if you are consuming large quantities of CBD or if the products you are using contain more THC than the packaging label claims.

Research has found, for example, that as many as 70% of CBD products are mislabeled and contain significantly more THC than labels suggest.   Because of the lack of regulation of these products, it is difficult to know exactly how much THC you are actually getting.

Both THC and CBD are stored in body fat, which means that both can potentially be detected on drug tests for some time after you have stopped using them.

Before You Take CBD or THC

THC and CBD may also have an effect on some health conditions and can interact with certain medications, so you should always use caution before taking these products. These substances might impact how medications are metabolized by your body. They can also heighten feelings of anxiety in some cases.

Before choosing a THC or CBD product, it is important to check your state laws to ensure that these products are legal where you live. Federal law mandates that hemp-derived CBD products should contain less than 0.3% THC, but even those trace amounts are still illegal in some states.

A Word From Verywell

Both THC and CBD may have a number of benefits, but you should always talk to your doctor first before you try any products containing these cannabinoids. Both CBD and THC hold promise for alleviating symptoms and even treating some medical and mental health conditions, but research in this area is still relatively new and further investigation is needed.

FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

Consumer Information

FDA Communications

Regulatory Resources

Questions and Answers

Below are a number of frequently asked questions and answers on this topic.

1. What are cannabis and marijuana?

A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.

2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?

A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.

The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.

3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?

A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

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.

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.

4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?

A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.

FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.

Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.

The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).

5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

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.

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).

FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.

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).

6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?

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.

7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?

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.

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.

8. Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

9. Can THC or CBD products be sold as dietary supplements?

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.

There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. 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.

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.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).

Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.

10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

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.

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.

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.

11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.

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 )

12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

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).

Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”

The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.

These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.

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.”

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).

If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.)

FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.

14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

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.

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

15. Can I import or export cannabis-containing or cannabis-derived products?

A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.

Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).

Research and Expanded Access

16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

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.

Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:

  • For a Schedule I controlled substance under the CSA, DEA provides researchers with investigator and protocol registrations and has Schedule I-level security requirements at the site cannabis will be studied.
  • NIDA provides research-grade cannabis for scientific study. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. Cannabis of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute cannabis for research purposes.
  • Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs in CDER depending on the therapeutic indication. Based on the results obtained in studies conducted at the IND stage, sponsors may submit a marketing application for formal approval of the drug.

17. Does the FDA object to the clinical investigation of cannabis for medical use?

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:

  1. Providing information on the process needed to conduct clinical research using cannabis.
  2. Providing information on the specific requirements needed to develop a drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its Guidance for Industry: Botanical Drug Development, which provides sponsors with guidance on submitting IND applications for botanical drug products.
  3. Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
  4. Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.

18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?

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.

19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?

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.

Children and Pregnant/Lactating Women

20. Does the FDA have concerns about administering a cannabis product to children?

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.

21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?

A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding. [7] Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.

22. What does the FDA think about making CBD available to children with epilepsy?

A. The 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 the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

23. What should I do if my child eats something containing cannabis?

A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.

Pets and other Animals

24. I’ve seen cannabis products being marketed for pets. Are they safe?

A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.

Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.

If you have concerns that your pet is suffering adverse effects from ingesting cannabis or any substance containing cannabis, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

25. Can hemp be added to animal food?

A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.

With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.

26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.

In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

[2] Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.

[3] Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.

[4] Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.

[5] Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.

[6] Campolongo, et al. Perinatal exposure to delta-9-tetrahydrocannabinol causes enduring cognitive deficits associated with alteration of cortical gene expression and neurotransmission in rats. Addict Biol 2007; 12(3-4): 485–495.

Do Topical CBD Products Actually Do Anything for Pain?

You don’t need me to tell you that CBD (cannabidiol) is everywhere. You can eat it, you can drink it, you can vape it, you can even bathe in it. And although there’s still plenty to learn about this fascinating little compound, fans of it claim that it has some pretty impressive benefits—particularly when it comes to managing pain.

Personally, I always keep a few jars of it at my desk to help with the shoulder and neck muscle tension inherent in a job consisting mainly of typing and holding a phone next to my face. But it turns out that the research behind these claims is pretty sparse, to say the least. Here’s what you need to know before you give topical CBD a try.

What is CBD?

Cannabidiol, commonly referred to as CBD, is a cannabinoid, a type of compound found in cannabis (marijuana). Unlike the more well-known cannabinoid THC (tetrahydrocannabinol), CBD does not produce a high.

Both THC and CBD act on a system of receptors in your body called cannabinoid receptors. You have cannabinoid receptors throughout your body and, so far, researchers have identified two major types: CB1 (found primarily in the central nervous system, including parts of the brain and spinal cord) and CB2 (found mainly in immune system tissues). Interestingly, both have been found in skin. Researchers have also found that while THC can bind to and activate both types of receptors, CBD seems to modulate and somewhat block the effects of CB1 and CB2 receptors. So, any effect that CBD has on CB receptors may actually be more related to regulating and even counteracting some of the actions of THC and other cannabinoids in the brain.

Why does the body have receptors for compounds in cannabis? Well, it doesn’t exactly. Cannabinoids like THC and CBD are similar enough to compounds that your body naturally makes, called endocannabinoids, that they can interact with this system. Normally, the endocannabinoid system is thought to play a role in a variety of functions in the body, helping to regulate things like parts of the immune system, the release of hormones, metabolism, and memory.

If you’re ingesting something that only has CBD in it and no THC, you won’t have significant effects in the brain. This is why CBD is often referred to as being “non-psychoactive,” although that’s clearly a bit of an oversimplification because it does do something to the central nervous system.

More recent research suggests that many of CBD’s effects may occur outside of CB receptors, Jordan Tishler, M.D., medical cannabis expert at InhaleMD in Boston, tells SELF. In fact, according to a recent review published in Molecules, CBD may have effects on some serotonin receptors (known to play a role in depression and anxiety), adenosine receptors (one of the neurological targets for caffeine), and even TRPV-1 receptors (more commonly associated with taste and the sensation of spiciness).

“It actually is a very promiscuous compound,” Kevin Boehnke, Ph.D., research fellow in the department of anesthesiology and the Chronic Pain and Fatigue Research Center at the University of Michigan, tells SELF. “It will bind to receptors in multiple different pathways,” which makes it difficult to know how it might cause noticeable effects.

“Cannabidiol is a super messy drug,” Ziva Cooper, Ph.D., research director of the UCLA Cannabis Research Initiative in the Jane and Terry Semel Institute for Neuroscience and Human Behavior and the department of psychiatry and biobehavioral sciences, tells SELF. “It has lots and lots of targets and it’s not clear how much of its effects on each target contribute to the potential pain relieving effects.”

All of this points to how hard it is to study the specific effects of CBD on its own—which might be why it’s tempting to claim that it’s the cure for everything without a whole lot of research to actually back up all of those claims.

Here’s what the research says about using CBD for pain.

The most common medical reason for which people report using CBD is to manage chronic pain, followed closely by managing arthritis or joint pain. But does it actually work?

When the National Academies of Sciences, Medicine, and Engineering evaluated decades of cannabis research, they concluded that “in adults with chronic pain, patients who were treated with cannabis or cannabinoids are more likely to experience a clinically significant reduction in pain symptoms.”

But that’s not quite as exciting for CBD as it sounds: “We don’t know cannabidiol’s effects on its own,” says Cooper, who was part of the National Academies committee that put together this report. “[The conclusions about cannabis and cannabinoids] were based on what we know about THC or THC plus cannabidiol.”

In fact, the most compelling research they found for using cannabinoids for pain came from a large review and meta-analysis published in JAMA in 2015. For the study, researchers looked at results from 79 previous studies of cannabinoids and various medical conditions, including chronic pain. However, of those studies, only four involved CBD (without THC)—none of which were looking at pain. So although we might assume that CBD is doing something to help address pain—according to the studies involving the whole cannabis plant—we don’t have great evidence to prove it.

“It might be that cannabidiol by itself is helpful for pain, but at this point we don’t know that,” Cooper says.

The studies we do have about CBD for pain are all animal studies. For example, in a 2017 study published in Pain, researchers gave rats an injection into one of their knee joints to model osteoarthritis. Rats then either received doses of CBD or saline directly into an artery in the knee joint. Results showed that, after receiving CBD, rats showed less inflammation in the joint area and fewer pain-related behaviors (like shaking or withdrawing the affected paw or not being able to bear weight in that paw) compared to those that received saline.

Another study published in 2016 in the European Journal of Pain also looked at arthritis in rats but did so with a topical formulation of CBD. After the rats received an injection into one knee joint to model arthritis, they received a gel that contained either 10 percent CBD (in four different total amounts) or 1 percent CBD (the control) on four consecutive days. The gel was massaged into the rats’ shaved backs for 30 seconds each time.

Then the researchers measured the inflammation in each rat’s knee joint, the level of CBD that made it into their bloodstream, and their pain-related behaviors. They found that the rats that were given the two highest doses of CBD showed significantly lower levels of inflammation and lower pain behavior scores compared to those that got the control. The two lower doses didn’t show much of an effect.

But if you’re reading this, you are probably not a rat, which means these results aren’t directly applicable to your life. Although we know that rats do share much of our physiology—including CB1 and CB2 receptors—these studies don’t really tell us if humans would have the same results with CBD.

“There’s really no substitute for doing proper human studies, which are difficult, expensive, and ethically complicated,” Dr. Tishler says. And we simply don’t have them for CBD and pain.

The only thing that comes close is a Phase 2 clinical trial using a proprietary CBD transdermal gel (meaning it’s meant to go through the skin into the bloodstream) in 320 patients with knee osteoarthritis over 12 weeks, which has not been peer-reviewed to date. Unfortunately, in almost all of the study’s measures of pain, those who received CBD didn’t have statistically different scores from those who got placebo. But “they found some reductions in pain and improvements in physical function,” Boehnke says.

So…is CBD cream just an expensive placebo?

It’s totally possible (and actually pretty likely) that any effect you get from a commercially available topical CBD product is a placebo effect or related to some other aspect of the product. But there are a few things going on here that are more complex than they seem.

First off, we don’t know much about the correct dose of CBD needed for a pain-relieving effect. The doses in the rat studies that were effective were pretty large (for a rat, obviously). And the human participants in the Phase 2 clinical trial we mentioned received 250 mg of synthetic CBD topically per day—as much as many consumer topical CBD products contain in a single jar.

And even though the lotion was applied topically in the rat study, it wasn’t applied locally to the knee. Instead, the researchers were really using the topical application to get it into the rats’ bloodstream, or what’s called systemic administration. But you’d likely need a different dose for it to be effective locally (if you applied it just to your aching shoulder, for instance) in a human. We have no idea what that dose should look like.