These Are the Comments of Richard Rose to FDA's Request for Comments on the "Development of a List of Pre-Dietary Supplemen

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These are the comments of Richard Rose to FDA's Request for Comments on the "Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients" and the reasons Hemp Flower Products should be considered an ingredient existing before the passage of DSHEA.

This has been submitted to: https://www.federalregister.gov/documents/2017/09/06/2017-18812/development-of-a-list- of-pre-dietary-supplement-health-and-education-act-dietary-ingredients-public#open- comment

This submission is a stakeholder comment to your "Development of a List of Pre-DSHEA Dietary Ingredients" issue. My name is Richard Rose and I'm an award-winning food industry professional of 37 years now retired, and also a well-known commercial producer of numerous Hempseed foods starting in 1994, months before DSHEA. Here I am representing the Hemp Food Association, which I founded in 1998.

While the Dietary Supplement Health and Education Act (DSHEA 1994) is only 23 years old, it is a well-documented fact that humans and animals have consumed Hemp Flower Products for many millennia around the world, including the USA where Hemp has been grown continuously since at least 1606. This is because the resin adhering to the flowers as well as fine particles of flower are inevitably consumed when the seed is eaten or pressed for its edible oil. This sticky resinous adherent on the outside of the shell of the hempseed is difficult to remove, even today, and often include Hemp Flower fines. With at least 12,000 years of safe continuous use around the world, FDA must consider Hemp Flower Products, in their natural form, as an existing ingredient for the purposes of DSHEA, and not as a New Dietary Ingredient any more than water, heirloom apples, or ancient rye varieties. This is the case for not only compounds found in the resin such as Cannabidiol (CBD) or Terpenes, but also for the other Hemp Flower Products, namely whole or shelled* hempseed, hempseed oil, hempseed oil presscake, hempseed sprouts, or hemp flower as a human or animal food, or dietary supplement.

It is in that context I make this submission.

Hemp (genus "Cannabis," also known for centuries as "Hemp") is considered by many historians to be one of mankind's oldest cultivated crops. The use of the seed for food is many millennia older than even use of soybean for food. Hemp has been used in human cultures since prehistoric times, at least since the end of the Pleistocene era. From Africa to China and Japan to Scandinavia to Eastern and Southern Europe to the Americas, Hempseed has been an essential commodity to eat, grow, and trade. High in essential amino (23%, edestin and albumin types) and fatty (25%, including omega-3 and GLA) acids, vitamins and minerals, and fiber (35%) it was highly versatile and could be eaten, fed to animals, converted to oil for eating or lamps, or planted as a seed or fiber crop years later. Even the protein type is called "edestin," from the Greek edestos meaning "to eat."

In the US, Hemp enjoys a legal exemption from the Controlled Substances Act (stalk and nonviable seed), protections for viable seed, flower and cultivation in Section 7606 of the 2014 Farm Bill, and protections afforded by the Ninth Circuit Court in 2004 as to incidental THC remaining in the product, even enough to trigger a Driving Under the Influence charge in some states.

Since the seed is in the flowering tops of the female, the outside of the calyx surrounding the seed comes into direct physical contact with the resin next to it, then the resin on the calyx touches the perianth of the seed, to which it adheres, along with small particles of flower. Even with modern cleaning methods removing that resin from Hempseed is difficult if not impossible, one study shows as high as 50 parts-per-million THC remaining in common health food store hempseed oil from Canada. So difficult in fact, that the Hempseed oil industry won a suit in 2004 to be allowed to leave any amount of THC undisclosed in their oil, due to this sticky resin.

Hemp has long been one of mankind's most popular plants, and our evolution is intertwined with that of it. Since humans have been eating hempseed for at least 12,000 years, we have also been consuming small amounts of Hemp resin and flower all that time. Hempseed’s function as a nutritious food and source of vegetable oil is significant, and its ability to hold that nutritional value for years was prized. Discovering its fibrous properties was most likely a byproduct of seed collection for food. The most-predominant Cannabinoid in Hemp resin by far is Cannabidiol (CBD). Therefore, as a species we've been consuming CBD and Hemp flower for millennia, as have been our animals.

Although FDA may want proof of domestic commercial activity for Hemp Flower Products prior to 1994, for such a common food it is as ridiculous as using such criteria for other ancient ingredients as water, olive oil, or millet. The relatively short window for product introduction you allow for consideration is a tiny fraction of the time Hempseed has been a food, far pre- dating written record.

Hemp has been called one of the oldest known cultivated crops. The use of Hemp most likely predates the dawn of agriculture. Ancient Chinese texts and archeological evidence suggest that Hempseed use for food in China reaches back into the early Neolithic period and perhaps to the late Paleolithic.

Examples of early dates for Hempseed recovered in East Asia are quite old (4800, 3500, and 2500 BP) yet with one exception from Japan (10,000 BP) not as old as some from northern Europe (7000 and 5000 BP). Moldova (6000 BP), Hungary (5000 BP), Sweden (2000 BP), Italy (1900 BP), Switzerland (1800 BP), the Netherlands (1900 to 1750 BP), the British Isles (1600 BP), Norway and Denmark (1150 to 1100 BP) all have sites where ancient Hempseed has been found.

Early humans gathered Hempseed for food prior to, or along with, their use of it for fiber. In regions where Hempseed was common they were often considered a famine food, eaten only

2 during times of shortage of more desirable foods. However in ancient northern China, Hempseed was one of the four most important grains. Today, Hempseed is enjoyed as a snack food throughout China.

For millennia in China it was an indispensable component in porridge upon which impoverished farmers survived, and they "considered themselves fortunate if they had enough to last a whole year" of Hempseed mixed with molasses.

Hempseed was formally recognized in the Chinese book "Pen Ts'ao Kang Mu" (1596 CE). The text’s compiler referred to works from previous authors dating back centuries before his time in his discussion of Hempseed use as both a food. According to him, the Chinese had developed Hemp cultivars to such an extent that seeds grew as large as garden peas and were reputed to have been of the highest quality. Today it's a widely-accepted food for the elderly in China, supplying easily-digestible protein and dietary roughage.

Also in China the oldest agricultural treatise (1600 BCE) is the "Xia Xiao Zheng" which names Hempseed as one of the main food crops that were grown then, along with millet, wheat, beans, and rice.

Records from a Chou Dynasty state banquet show that boiled Hempseed was served in cereal dishes in 1000 BCE.

Just as they have for generations, farmers living in remote mountainous regions of southwestern China still make porridge with Hempseed, and the seeds are also commonly parched, milled, and mixed into buttered tea by Tibetan peoples such as those living in northwestern Yunnan province. The Hmong have long made a bean curd similar to tofu from the milk of the Hempseed.

Rice farming is younger than Hemp farming in Japan. Evidence of Hempseed use dating to about 10,000 years BP has been found in Japan. These are the oldest known Hempseeds in the world and belong to the early Holocene period.

Hempseed was found in an excavated latrine in Japan, indicating that Hempseed was eaten by people at that time (710 CE). Hempseed was also a part of the traditional Japanese diet, eaten as porridge. When armies of the feudal age went to war in Japan, they often subsisted on balls of ground Hempseed and brown rice gluten to keep them strong. In contemporary Japan, Hempseed is found in the diet as part of the traditional shichimi (seven spices) seasoning powder used to flavor udon noodles, and also a dish called Asanomi ("asa" means "Hemp").

For many centuries people living in the northwestern Himalayan foothills of India and Nepal have grown Hemp for fiber and also roasted and ate the seeds. In modern India, Hempseed is still eaten by many poor people. An Indian food called bosa consists of the seeds of goose grass and Hemp, and another, referred to as mura, is made with parched wheat, amaranth or rice,

3 and Hempseed. Badil, a chutney mix featuring Hempseed, is one of the traditional dishes of a tribal people located in India.

A smooth paste condiment consisting of ground Hempseed with chopped onions, chili peppers, and turmeric is commonly served throughout the Nepali Himalayas as a savory and nutritional supplement in the ubiquitous staple dish of beans and rice.

In ancient Persia (present-day Iran), Hempseed was used as a source of food and oil since at least the tenth century CE. A sixth-century edible preparation in Persia contained Hempseed and was called sahdanag, the "royal grain" or "king’s grain." The Jewish people had a lengthy and valuable association with the multipurpose Hemp plant, and learned to make sahdanag from the Persians, preserving their name for it long ago. This adopted meal of roasted Hempseed became well-liked during the medieval period in Europe, where immigrant Jewish merchants sold it in marketplaces.

In Pakistan, Iran, and Turkey, baked Hempseed are sold by street vendors and are popular among children as nuts.

Hempseed is an ancient crop in Russia, with a range reaching far to the north. A collection of Russian manuscripts probably written during the 1550s provides details about how a proper Russian home should be managed. In the sections dealing with food products, it indicates that provisions of Hempseed and Hempseed oil should be stored in the home. It also includes three references to Hempseed used principally as an oil source but also how to make Hempseed cakes. Hemp along with cereal crops were important trade items in Russia for centuries.

The Altai nomads of northern Russia cultivated early Hemp crops and used it as a food source rather than a fiber crop (300 BCE). They relied mainly on the oil but the high content of protein made it a valuable food that was also easy to transport.

Russians and Poles bruise or roast Hempseed, mix them with salt, and eat them on bread. There are many Baltic and Eastern European ethnographic references to people preparing and eating Hempseed. In Poland, Hempseed was stewed into a popular porridge eaten in monasteries, military barracks, and among the less-affluent.

Russians traditionally used few fats besides butter, Hempseed oil, and imported olive oil. Hempseed or its oil were used in a variety of dishes, either integrated into the meal directly or the oil was used as the medium in which the dishes were cooked, and Hempseed was a common part of food grants or donations to the needy in the 16th century.

In Latvia and Lithuania, as well as in Poland and Ukraine, a soup made from Hempseed, known as semientiatka, is eaten ritually on Christmas Eve. In the Zemaitija region, boiled potatoes were served with Hempseed. In Estonia, Hempseed was traditionally used in preparations of butter, milk, and porridge and in Finland, Hempseed were consumed as a ground meal mixed with barley, buckwheat, and salt. This preparation served as a "dipping foodstuff for boiled

4 turnip roots." When cereal meal was in short supply, Finns sometimes added "hempen meal" with flour to produce bread. Oil derived from pressed Hempseed was an important part of traditional societies in Finland, Russia, Poland, and other Eastern European countries. Hempseed is also revered in ritual settings. On March 25 Lithuanians traditionally celebrated Stork Day with a feast dedicated to remembrance of Angel Gabriel’s announcement that heaven chose Mary to be the Mother of Jesus. In the nineteenth century, Samogitians (a Lithuanian ethnic group) prepared special foods for this feast day, including pastries made of Hempseed and krupninkas (spiced honey liquor made with sweet vodka seasoned by herbal mixtures). Throughout Lithuania eating these ritual pastries and special breads baked from a mixture of many grains, and including Hempseed, assured an abundant harvest.

A Lithuanian tale related to the beginning of Lent concerns the epic battle of Gavenas and Mesinas in the threshing barn at midnight between Shrove Tuesday and Ash Wednesday, 40 days before Easter. The protagonist Gavenas symbolized Hemp, while Mesinas represented bacon or ham. During the Lenten fast, foods were prepared with Hempseed oil since animal fat and meat were forbidden. Thus the beginning of Lent represented the victory of Gavenas and the defeat of Mesinas. In another Lithuanian tradition, before Candlemas on February 2, the maidens pooled their money and bought liquor, which they boiled together with poppies, Hempseed, and honey; roughly symbolizing happiness, well-being, and love. In both Latvia and Ukraine, a dish made of Hempseed was prepared for Three Kings Day on January 6.

Hempseed butter is typically spread on toast or rye bread, or may be used as an additive in various recipes. Chefs use Hempseed butter as an ingredient in many local dishes, as it is said to impart a pleasant accent to the overall flavor.

The first literary evidence that ancient Greeks consumed Hempseed cakes appeared around the middle of the fourth century BCE. During this time at special gatherings were eaten "kannabides," which translates as "a confection of Cannabis seeds and honey." Several centuries later, the famous Greek physician Claudius Galen tells us that cakes containing Hempseed were still being eaten. A dish was served after the main meal in the form of "small cakes" at banquets and was popular among the Romans of his time. The Greek physician Dioscorides (40-90 AD) describes and extols the benefits of Hempseed, including the use of Hempseed for food.

The ancient nomadic Scythians have an even older history with Hemp, trading along the Silk Road.

Hempseed use was widespread across temperate Eurasia early on, and after about 2000 BP in other major regions such as Africa. For example, Suto tribal women "grind up [hemp] seeds with bread or mealie pap [porridge] and give it to children when they are being weaned."

Hempseed has been found in a well dated to the Middle Ages in the Czech Republic. These seeds indicate cultivation and use of Hempseed for food. In the Medieval period in Prague hempseed was added to gruel.

Hempseed was found in a tomb dated to the fifth century BCE in Brandenburg, northern Germany.

Hempseed dated to the Gallo-Roman period in northern France found the seeds among stored food plants in the burnt attic of a granary building dated to the end of the second century CE. In 1534 Rabelais praises Hempseed in his book "The Histories of Gargantua and Pantagruel," saying that Hemp is the king of the vegetable world and that Hempseed is part of any great meal.

Many Hempseeds from Roman times up through the Middle Ages have been recovered from sites in the British Isles, suggesting Hemp began to be cultivated in this region in Anglo-Saxon times.

The presence of Hemp in Italy during Roman times is supported by the discovery of nine Hempseeds found along with many seeds of other useful plants at the bottom of a storage vat near Pompeii. Ancient Hempseeds have also been recovered from sites in Italy that date to the sixth to seventh centuries CE. In addition, ancient Cannabis seeds were discovered in northern Italy and dated to the tenth to twelfth centuries CE.

Maltos, a Scandinavian drink formulated with Hemp, was sold in the US in 1895.

In Canada, cultivation of Hemp was widespread by the 19th century, and prospective migrants were even offered free plots of land and Hemp seed to cultivate as an incentive. The Doukhobors, a sect of spiritual Christians which arose in 18th-century Russia, migrated to Canada in the late-19th century to escape persecution. They brought its traditional uses to the newly-established territories along with the seeds themselves, and even after Cannabis was outlawed in 1923 it was widely used in soups, cereals and other foods.

In "Hemp: American History Revisited-- The Plant with a Divided History" is the mention that colonial Americans brewed Hemp flowers as a tea.

In 1937, Ralph Loziers, as general counsel of the National Institute of Oilseed Products, testified before the Ways and Means committee of the U.S. House of Representatives. He noted that Hempseed was used for food in many Asian countries as well as in part of Russia and referred to its significance in this regard: "It is grown in their fields and used as oatmeal. Millions of people every day are using Hemp in the Orient as food. They have been doing this for many generations, especially in periods of famine." Loziers also claimed that Hempseed was the finest bird seed available.

The California food company Sharon's Finest introduced many commercial Hempseed products into national distribution, including Hemp Hummus (containing Hemp flowers, Hemp stalk, and Hempseed), HempRella cheese alternative, Hempeh Burger and Hempseed oil. All are pre- DSHEA, being introduced before October 1994.

As you can see, it makes no sense to regulate after 12,000 years of safe continuous use around the world nonpsychoactive Hemp Flower Products such as CBD. I implore FDA to in fact consider Hemp Flower Products to be ingredients introduced prior to the DSHEA cut-off date.

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*= although shelling hempseed is a post-DSHEA invention, shelled hempseed remains substantially similar to whole hempseed.

Attachments to the Submission

Hempeh Burger introduced to national US distribution in September 1994.

HempRella cheese alternative, introduced to national US distribution in September 1994.

Hemp Hummus containing Hemp stalk, Hemp flowers, and Hempseed, introduced to US distribution in early 1994.

Hemp resin is extremely hard to remove from the seed shell thus has long been in the Hempseed food and oil humans and animals consume, as this study reveals. Table II from Holler, J., et al. 2008. "D9-Tetrahydrocannabinol Content of Commercially Available Hemp Products". Journal of Analytical Toxicology, Vol. 32, July/August 2008.

Most of the planet’s CBD molecules are in Hemp, and always have been.

Many Hemp Flower Products come from the Hemp flowers or tops, including whole seed, shelled seed, oil, protein powder, flower, terpenes, and CBD.

Hmong making tofu just as they have for millennia, using Hempseed. Photos and text by RC Clarke.

Hempseed sold on the streets even now in China, where a billion people still eat it weekly just as their ancestors have for millennia. Photo by RC Clarke.

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