U.S. Food and Drug Administration
FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food
December 20, 2018
The U.S. Food and Drug Administration has completed its evaluation of three generally recognized as safe (GRAS) notices for hemp seed-derived food ingredients. The GRAS notices were submitted by Fresh Hemp Foods, Ltd. The agency has no questions about Fresh Hemp Food’s conclusion that the following ingredients are GRAS under their intended conditions of use: hulled hemp seed (GRN765), hemp seed protein powder (GRN771), and hemp seed oil (GRN778).
Foods containing hemp seed and hemp seed-derived ingredients are currently marketed in the US. Hemp seeds are the seeds of the hemp plant, Cannabis sativa. Although hemp is from the same species as cannabis (marijuana), the seeds themselves do not naturally contain tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis. 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 notices are for three different hemp seed-derived ingredients. The GRAS conclusions can apply to ingredients from 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. As stated on FDA and Marijuana: Questions and Answers, it is a prohibited act under section 301(ll) of the Federal Food, Drug, and Cosmetic Act to introduce into interstate commerce a food to which CBD or THC has been added.
The U.S. Food and Drug Administration has completed its evaluation of three generally recognized as safe (GRAS) notices for hemp seed-derived food ingredients.
What’s the difference between hemp and marijuana?
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- What is hemp?
- Hemp vs. marijuana: Does hemp also have THC?
- Can you smoke hemp?
- How are hemp varieties chosen?
- What is hemp used for?
- How is hemp used as a food product?
- How is hemp processed?
- How is hemp cultivated differently than marijuana?
- Is hemp cultivation legal in the U.S.?
- World history of hemp
- Frequently asked questions
Although hemp and marijuana are both classified biologically as cannabis, there are a number of important differences between them. Here we’ll break down the anatomy, history, use, and legality of the hemp plant to get to the heart of not only what distinguishes hemp from marijuana, but also what makes it such a viable, versatile commodity.
What is hemp?
A variety of Cannabis sativa L, hemp is a dioecious plant, which means it can be separated into male and female plants. These plants have served a wide variety of purposes for more than 10,000 years. We get fiber from the plant’s stems, protein from the seeds, oils from the leaves, and oils from the smokable flowers. Hemp fibers can be used to make items including paper, clothing, textiles, rope — even building materials.
Hemp fibers can be used to make items including paper, clothing, textiles, rope — even building materials. Photo by: Gina Coleman/Weedmaps
The whole hemp plant, from stalk to seed, can also be used to make fuel and feedstock. For more specific applications, hemp can be divided into four categories:
- Bast fibers
- Hurds, or shives
- Leaves and flowers
Hemp vs. marijuana: Does hemp also have THC?
Hemp produces a broad range of cannabinoids, including tetrahydrocannabinol (THC), the intoxicating cannabinoid in marijuana. However, hemp does not produce enough THC to create intoxicating effects.
Although hemp doesn’t produce a significant amount of THC, it is capable of producing the non-intoxicating cannabinoid cannabidiol (CBD) in high concentrations. In fact, hemp-derived CBD is rapidly becoming one of the most popular forms of the cannabinoid on the market today.
Many countries differentiate hemp from marijuana by the amount of THC produced by the plant. In the US, industrial hemp is defined as Cannabis sativa L. that does not contain more than 0.3% THC. The European Union has set the limit at 0.2%, while in the UK the limit is zero, unless growers have a cultivation license to grow industrial hemp with no more than 0.2% THC.
In the US, industrial hemp is defined as Cannabis sativa L. that does not contain more than 0.3% THC. Photo by: Gina Coleman/Weedmaps
Can you smoke hemp?
The short answer is yes. Though be aware that while hemp does have trace amounts of intoxicating compounds, that doesn’t mean it will get you high. Hemp plants don’t produce enough THC to have an intoxicating effect. CBD, though technically psychoactive, is a non-intoxicating cannabinoid and won’t produce any form of a euphoric high on its own.
But if the goal isn’t to get an intoxicating high, smoking organic hemp can be an enjoyable and efficient way to experience other cannabinoids like CBD. It’s also never been easier to experiment now that you can find organic hemp flower and pre-rolls online. And while hemp-derived CBD gummies and CBD oil might be all the rage, smoking hemp allows you to self-titrate in real-time — no waiting around for any subtle effects to kick in.
There’s the added bonus of increased bioavailability. Through the act of inhalation, your bloodstream absorbs CBD much faster than it would after eating an edible or using a tincture under your tongue. Your body will also have access to a lot more of the CBD in the smoke or vapor when it’s inhaled. When consumed, a CBD edible goes through the digestive tract, and some of the potency is lost in the process.
For a cleaner burn, consider lighting your hemp flower with hemp wick. Raw hemp wick coated in beeswax offers a slow burn from all-natural materials, which many users say produces a cleaner cannabis flavor than a lighter or match. The more you know.
For a cleaner burn, consider lighting your hemp flower with hemp wick. Photo by: Gina Coleman/Weedmaps
How are hemp varieties chosen?
Depending on the desired final product, hemp cultivars are chosen based on several factors, including:
- Stem quality
- Cannabinoid content
- Resistance to disease
- Time to harvest
- Hemp oil content
- Seed production per acre
CBD production, in particular, has become a major factor in recent years. As the CBD market continues to grow, more and more cultivars are also being chosen based on their CBD production and unique aromatic, or terpene, profiles.
Hemp-derived CBD oil has skyrocketed in popularity in recent years. Photo by: Gina Coleman/Weedmaps
What is hemp used for?
CBD oil is extracted from hemp leaves and flowers. More and more people are experimenting with CBD oil extracted from hemp plants as a wellness supplement, hence the ever-growing popularity of CBD-focused cultivation.
Hemp fibers are primarily used for textiles, paper, building materials, and other industrial products. Raw materials such as hurds, or shives, are short woody fibers typically found inside the stalk. They’re used for making bedding materials, absorbents, particleboard, ceiling panels, compost, and other industrial products.
Bast fibers make up the outer portion of the stalk and are typically split into three categories — primary, or line fiber, secondary, and tow. They are categorized according to their cell strength and cell wall thickness, which will determine the fiber’s strength, durability, and what it can be used for.
How is hemp used as a food product?
Hemp seeds are rich in protein, dietary fiber, vitamins, and minerals. They contain an optimal ratio of omega-6 to omega-3 fatty acids for healthful consumption. A 2008 study also found that hemp proteins are more digestible for humans than common soy protein isolates (SPIs) used in food products. Hemp seeds can be used as food directly or via oil produced from them. Seeds can also be ground up for flour or mixed with water to create hempseed milk.
How is hemp processed?
Processors use many types of processing techniques on hemp seeds and stalks. The technique used depends on the purpose of the final product.
Seeds can be consumed whole, or refined by being pressed or crushed to produce hemp seed oil and flour. These seeds are also hulled, or shelled, to make them more palatable. The remaining shells, which are rich in fiber, can also be used for making flour.
Seeds can be consumed whole, or refined by being pressed or crushed to produce hemp seed oil and flour. Photo by: Gina Coleman/Weedmaps
Hemp stalks are processed through decorticating, a multistep method for removing the long fibers from the rest of the plant. This can involve field retting, a process in which the plants are cut and laid out in the field for four to six weeks. During this time, any bacteria on the plant’s surface will break down the outer layer of the stalk. The retted stalks are then dried.
Water retting is another option. The stalks are immediately dried after harvesting then placed in water for a few days. The water softens the outer layer of the stalks and promotes the growth of additional bacteria, accelerating the process. Finally, chemical retting uses acids, bases, and special enzymes to break down the compounds that hold together the strong bast fibers.
How is hemp cultivated differently than marijuana?
Other key differences between hemp and marijuana have to do with cultivation and harvesting. Male hemp plants flower much faster than females and do not produce nearly as much fiber. In stark contrast to marijuana fields, which seek to banish all males, most female hemp fields include sporadically placed males.
Male hemp plants flower much faster than females and do not produce nearly as much fiber. Photo by: Gina Coleman/Weedmaps
The male hemp plants release pollen female plants use to produce seeds that are either planted for future crops or sold as food. In marijuana fields, male plants are typically eliminated to ensure the maximum production of sinsemilla (seedless) flowers.
While marijuana cultivation requires ample spacing to reduce the risk of mold or bacteria, hemp can be planted more densely. Most marijuana crops are planted with one plant per 4 square feet. Hemp plants that are grown for oil are planted at roughly 40 to 60 plants per 4 square feet. Those grown for fiber are even more densely planted at a rate of about 100 to 120 plants per 4 square feet.
Hemp plants are almost always cultivated outdoors, as opposed to marijuana plants, which are often planted in greenhouses or indoor grow operations. Because hemp is susceptible to the same predators, diseases, and insects that attack marijuana, many cultivators employ a technique called crop rotation, in which alternating crops are planted in the same place, to avoid any buildup of these organisms and to allow nutrients to return to the soil.
The specific order of crop rotation and types of crops being rotated with hemp will depend on the location of the farm. Hemp is also used as a rotational crop at farms where it is not the primary agricultural product.
Is hemp cultivation legal in the U.S.?
The 2014 Agricultural Act, more commonly known as the 2014 Farm Bill, includes section 7606, which allows for universities and state departments of agriculture to cultivate industrial hemp, as long as it is cultivated and used for research. Under the 2014 Agricultural act, state departments and universities must also be registered with their state, and defer to state laws and regulations for approval to grow hemp.
As part of the Agriculture Improvement Act of 2018 (aka the 2018 Farm Bill), the Hemp Farming Act of 2018 reclassified hemp (with less than 0.3% THC) from Schedule I, the federal government’s most restrictive classification of controlled substances, which are considered highly prone to abuse and without medicinal benefits. This move to federally legalize hemp allowed for its cultivation and distribution as a legal agricultural product.
Under the Hemp Farming Act, hemp cultivation is no longer limited to state departments and universities. In addition, the act gives hemp farmers the right to water, crop insurance, and federal agricultural grants, as well as legal access to national banking. Hemp may also be transported across state lines.
Prior to the Hemp Farming Act of 2018, 41 states had passed industrial hemp-related legislation. Thirty-nine of those states legalized statewide cultivation programs that defined hemp specifically to differentiate it from marijuana, establish licensing requirements, and regulate production.
The Hemp Farming Act now requires state departments of agriculture to consult with their governors and chief law enforcement officers on a regulatory program, which will then be submitted to the US Secretary of Agriculture for approval. According to Section 297B of the bill, state hemp regulatory programs must include a system to maintain information on all land where cultivation takes place, procedures for testing THC levels in hemp, and procedures for disposing of products that violate THC content restrictions.
World history of hemp
Hemp has been cultivated on a global scale for thousands of years. The oldest documented evidence of hemp cultivation is a rope, which dates back to 26,900 BCE, found in today’s Czech Republic.
Some of the earliest known prolific uses of hemp began in China about 10,000 BCE, where it was used for making clothing, rope, and paper. The Yangshao people, who lived in China from roughly 5,000 BCE, wove hemp and pressed it into their pottery for decorative purposes. From about 5,000 to 300 BCE, the plant was also grown in Japan and used for fiber and paper.
Cannabis played a large role in the Greco-Roman cultures as a source of fiber, intoxication, and medicine. Cannabis seeds were discovered in the ruins of Pompeii, and Greek rhetorician Athenaeus made note of hemp being used to make rope between 170 and 230 CE. Roman author and naturalist Pliny the Elder also made reference to a cannabis root decoction as a treatment for joint stiffness and gout in the first century BCE.
Exactly how and when hemp originated in the New World is still highly debated. Though long thought to be introduced to the Americas by Christopher Columbus, hemp has been discovered in Native American civilizations that predate Columbus’ arrival. William Henry Holmes’ “Prehistoric Textile Art of Eastern United States” report from 1896 notes hemp from Native American tribes of the Great Lakes and Mississippi Valley.
Hemp products from pre-Columbian native civilizations were also found in Virginia. Vikings, who used the plant for making rope and sails, may also have brought seeds with them when they attempted to colonize the New World.
Jamestown settlers introduced hemp to colonial America in the early 1600s for rope, paper, and other fiber-based products; they even imposed fines on those who didn’t produce the crop themselves. US presidents George Washington and Thomas Jefferson grew hemp.
Hemp was a prominent crop in the United States until 1937, when the Marihuana Tax Act virtually obliterated the American hemp industry. During World War II, the crop saw a resurgence in the US as it was used extensively to make military items including uniforms, canvas, and rope. The Department of Agriculture even released a short documentary, “Hemp for Victory,” in 1942, which promoted the plant as a useful crop for the war cause.
The World War II hemp resurgence was short-lived, though. Until the passing of the 2014 Farm Bill, the Controlled Substances Act of 1970 kept industrial production dormant. Today, hemp is rapidly becoming an indispensable resource for CBD oil and other CBD products.
Frequently asked questions
Is hemp a drug?
Hemp itself is a plant. But CBD, which might be considered a drug, can be made from hemp. The US Food and Drug Administration has approved a CBD-based drug as a treatment for epilepsy. And many people worldwide use CBD products to treat a variety of ailments, though much more research needs to be done on CBD’s efficacy against everything from cancer to acne.
Is hemp legal in Australia?
Certain parts of the hemp plant are legal in Australia. The government has more information.
Is hemp legal in NZ?
The country has a licensing program for those interested in growing certain cultivars of hemp that contain less than 0.35% THC.
What is hemp used for medically?
As stated above, CBD derived from hemp has a variety of uses. The most official is the FDA-approved drug to treat childhood epilepsy. Beyond that, more research needs to be done but scientists are looking at CBD to treat or ease symptoms of:
- Parkinson’s disease
- Alzheimer’s disease
- Pain, including chronic and neuropathic pain
- Post-traumatic stress disorder (PTSD)
- Sleep disorders
- Bipolar Disorder
- Social Anxiety Disorder
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Although hemp and marijuana are both varieties of cannabis, there is a difference between them. The differences between these cannabis varieties are primarily evident in the way each plant is used.