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. 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. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food? In December , 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.
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. Hemp seeds are the seeds of the Cannabis sativa plant. 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.
A cosmetic is defined in 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. 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. 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.
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. 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.
Can I import or export cannabis-containing or cannabis-derived products? The Drug Enforcement Administration DEA is the federal agency responsible for enforcing the controlled substance laws and regulations in the U. Please see here for information about importing or exporting food ingredients. 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. 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 , 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.
Does the FDA object to the clinical investigation of cannabis for medical use? 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:. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
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. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try? 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. Does the FDA have concerns about administering a cannabis product to children? 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. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
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. 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.
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. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. What should I do if my child eats something containing cannabis?
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. Are they safe? There is still some confusion surrounding this.
For example, if a sample is pulled 15 days before anticipated harvest, would harvest be allowed if there is a backlog at the testing laboratory and the results are not back in time? Additionally, does the day window mark the beginning of harvest or the end of harvest? Some fields may take multiple days to harvest and could conceivably be started before but finished after the day window closes. USDA is requesting public comment and information regarding this sampling and harvest timeline.
Testing procedures must ensure the testing is completed by a Drug Enforcement Administration-registered laboratory using a reliable methodology for testing the THC level. USDA has issued sampling and testing procedure guidelines in separate documents attached to this interim rule. Part of the reasoning for this is to allow the department flexibility as new technologies and procedures are developed over time.
Setting the testing and sampling procedures outside of the interim rule allows the guidance documents to be improved without going through an all-out rulemaking. These new rules acknowledge the statistical uncertainty that comes with sampling and testing a hemp crop for THC. The regulations allow for the inclusion of the measurement of uncertainty as laboratories report THC test results. Essentially, the measurement of uncertainty could be understood to be similar to a margin of error or for the economists in the room: confidence interval.
When the measurement of uncertainty e. If the 0. For example, say a laboratory reports a result of 0. The distribution ranges from 0. Again, for the economists and statistics nerds tuning in, think of a hypothesis test that fails to reject the null hypothesis that the result is statistically different than 0.
The measurement of uncertainty depends on multiple variables, such as the equipment being used, the methodology of the test, the sample size, the sample quality and other variables, and as such it will vary with each sample that is tested.
These new rules also acknowledge the fact that a farmer may unintentionally produce a crop that tests over the limit despite their efforts to produce a crop that complies with federal law. The rule determines that a producer does not commit a negligent violation if they produce plants that exceed the acceptable hemp THC level as long as they use reasonable efforts to grow the plant and it does not test at more than 0.
Although a farmer testing above 0. While states and tribes will differ in how they handle farmers who become negligent, at a minimum, if a farmer negligently violates a state or tribal plan three times in a five-year period, they will be ineligible to produce hemp for the next five years. Additionally, negligent violations are not subject to criminal enforcement action. Many were hoping for rules that would let farmers dispose of the plants in a more productive manner, such as composting or for soil amendments.
Farmers will put considerable time, cost and effort into the crop, and it would be a shame to have to completely destroy the product with nothing to show for it. Ultimately, this rule does not address this problem the way farmers hoped.
If a crop is above the THC limit, it is considered to be marijuana under the Controlled Substances Act and must be disposed of accordingly. Laws and regulations for the procedures of destroying a controlled substance are not set by USDA, and so the department was constrained in how it could address this issue. It will have to be collected for destruction by someone authorized to handle a Schedule I controlled substance, such as a DEA-registered reverse distributor or a federal, state or local law enforcement officer.
Farmers must document the disposal of the crop, which is now considered marijuana. These bills ranged from clarifying existing laws to establishing new licensing requirements and programs. At least six states— Alaska, Arizona, Kansas, Missouri, New Jersey and Oklahoma— enacted legislation in establishing hemp research and industrial hemp pilot programs.
States, already allowing for industrial hemp programs, continued to consider policies related to licensure, funding, seed certification, and other issues. For example, Tennessee amended its Commercial Feed Law to include hemp. Thirty-eight states and Puerto Rico considered legislation related to industrial hemp in At least four states—Florida, Nevada, New Mexico and Wisconsin—authorized new research or pilot programs. For a summary of state laws related to industrial hemp, click on the states in the map below or see the chart for a complete list of state statutes.
SB 6 Also, see Act or S. Create Account. State Industrial Hemp Statutes. This website uses cookies to analyze traffic and for other purposes. You consent to the use of cookies if you use this website. Continue Our online privacy policy. Creates an industrial hemp research program overseen by the Alabama Department of Agriculture and Industries to study hemp.
The department may coordinate the study with institutions of higher education. Alaska Stat. Directs the commissioner of natural resources to adopt regulations related to industrial hemp including approved sources or varieties of seed, testing requirements, and establishing isolation distances. Specifies registration requirements and allowable activities for registered producers of industrial hemp. Directs the department to establish fee levels to cover regulatory costs and annually review these fee levels.
Allows for the creation of a pilot program by an institution of higher education or the Department of Natural Resources. Defines both industrial hemp and cannabidiol oil. Amends definitions for hashish oil and marijuana. Clarifies that the addition of industrial hemp to food does not create an adulterated food product. Requires a report on or before Dec. Authorizes a pilot program for the research, growth, cultivation and marketing of industrial hemp and establishes the Industrial Hemp Trust Fund.
Allows for commercial hemp production, processing, manufacturing. Creates the Arkansas Industrial Hemp Program including a year research program.
Authorizes the State Plant Board to adopt rules to administer the research program and license growers.
Requires the State Plant Board to provide an annual report starting Dec. Establishes a separate program fund, which will include feeds collected and other sources of funding. Establishes registration for seed breeders. This division will not become operative unless authorized under federal law. Allows hemp cultivation for commercial and research purposes to be overseen by the Industrial Hemp Committee under the Department of Agriculture.
Establishes a seed certification program. Establishes a grant program for state institutions of higher education to research new hemp seed varieties. Establishes an agricultural pilot program for hemp research and directs the Connecticut Department of Agriculture to prepare a state plan. Requires licenses for the cultivation and processing of hemp. Establishes an industrial hemp research program overseen by the Delaware Department of Agriculture.
Allows the department to certify institutions of higher education to cultivate hemp for research purposes. Directs the Department of Agriculture and Consumer Services to authorize and oversee the development of industrial hemp pilot projects at certain universities. Commercialization projects may be allowed after two years with certain conditions. Authorizes the universities to develop pilot projects in partnership with public, nonprofit, and private entities; Requires a university to submit a report within two years of establishing a pilot program.
Establishes the state hemp program and directs the Department of Agriculture and Consumer Services, including a land registry and licensing, to submit a plan to USDA.
Provides requirements for the distribution and sale of hemp extract. Establishes an industrial hemp advisory council. Provides for licensing requirements for growers and processors as part of a state hemp plan. Authorizes certain colleges and universities to conduct research on the cultivation, breeding and development of hemp.
Excludes regulated hemp and hemp products from the definition of marijuana as a controlled substance. Establishes an industrial hemp pilot program overseen by the Hawaii Department of Agriculture. Allows the Board of Agriculture to certify hemp seeds.
Creates an industrial hemp pilot program which allows the Illinois Department of Agriculture or state institutions of higher education to grow hemp for research purposes. Requires institutions of higher education provide annual reports to the department. Allows the production and possession of hemp by licensed growers for commercial and research purposes.
Growers and handlers of hemp seeds must obtain a hemp seed production license. Nothing in this section allows anyone to violate federal law.
Directs the Department of Agriculture and Land Stewardship to establish a program, including licensing, fees and annual inspections, and to submit a state plan to USDA. Provides for the enforcement, fees and penalties.
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