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Marinol

Marinol, a registered trademark of Unimed Pharmaceuticals, Inc. is the commercial name for a product containing dronabinol, which is synthetic Δ9-tetrahydrocannabinol. more...

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Δ9-THC is a naturally occurring component of marijuana.

Marinol is the only FDA-approved cannabinoid and is prescribed as an appetite stimulant, primarily for AIDS and chemotherapy patients. Compare Sativex, a mouth spray for neuropathic pain of multiple sclerosis sufferers approved for use in Canada.

Many users complain that not only is the cost of Marinol greater than the cost of the amount of marijuana needed to produce the same effect, but it is also lacking in many of the properties of the whole plant, which contains hundreds of different cannabinoids. However, Marinol is available for free to those who can demonstrate their financial need to Roxane and Unimed Pharmaceuticals. In addition, it takes over an hour for Marinol to reach full effect, but its duration is longer and it is available in controlled dosages, avoiding the uncontrolled strengths that occur when smoking marijuana. It is difficult to maintain an exact level of effect (which is important to most medical users), as well as making its use difficult for people suffering from nausea and vomiting, since they often expel the medication before it takes effect.

Regulatory history

Since at least 1986, the trend has been for THC in general, and especially the Marinol preparation, to be downgraded to less and less stringently-controlled Schedules of controlled substances, in the U.S. and internationally.

On July 13, 1986, the Drug Enforcement Administration issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II"(DEA 51 FR 17476-78). This permitted medical use of Marinol, albeit with the severe restrictions associated with Schedule II status. For instance, refills of Marinol prescriptions were not permitted. At its 1045th meeting, on April 29, 1991, the Commission on Narcotic Drugs, in accordance with article 2, paragraphs 5 and 6, of the Convention on Psychotropic Substances, decided that delta-9-tetrahydrocannabinol (also referred to as delta-9-THC) and its stereochemical variants should be transferred from Schedule I to Schedule II of that Convention. This released Marinol from the restrictions imposed by Article 7 of the Convention.

An abstract published in the April-June 1998 issue of the Journal of Psychoactive Drugs found that "Healthcare professionals have detected no indication of scrip-chasing or doctor-shopping among the patients for whom they have prescribed dronabinol". The authors suggested that Marinol had a low potential for abuse.

In 1999, Marinol was rescheduled from Schedule II to III of the Controlled Substances Act, reflecting a finding that THC had a potential for abuse less than that of LSD, cocaine, and heroin. This rescheduling comprised part of the argument for a 2002 petition for cannabis rescheduling in the United States, in which petitioner Jon Gettman noted, "Cannabis is a natural source of dronabinol (THC), the ingredient of Marinol™, a Schedule III drug. There are no grounds to schedule cannabis in a more restrictive schedule than Marinol™".

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Showcase: fortifiers and Omega-3s
From Prepared Foods, 5/1/05

Functional beverages offering health benefits have become more popular. PURAC offers natural mineral lactates and gluconates, which are highly soluble, allergen-free, non-GMO and kosher. Exhibiting neutral flavor and good in viva bioavailability, PURAC's minerals are well-suited for juices, enhanced water, sports drinks and fortified carbonated beverages. PURAC recently commissioned a study to measure consumer attitudes and preferences for minerals in beverages. Contact the company to learn the results. PURAC, Health and Nutrition Department, 847-634-6330

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ADM's vitamin enrichments can boost your product's nutritional value and market profile, without affecting taste. These added nutrients usually are mixed in at very small inclusion rates, and sometimes are difficult to accurately scale and distribute uniformly throughout the base food. ADM's vitamin/mineral premixes offer both convenience and quality insurance, as the company accurately tests, formulates and blends mixtures of actives (vitamins, minerals, phytochemicals, etc.) with suitable carriers. ADM, Amy Chiligiris, 217-451-4795

This company's ingredients are uniquely capable of promoting health while improving quality, taste and texture. Manufacturers are turning to GTC Nutrition for their formulation needs to satisfy the needs of today's health-conscious consumers. GTC Nutrition offers NutraFlora prebiotic fiber, which promotes calcium absorption and immune health, and enhances flavors, as well as CalciLife prebiotic mineral formulation, which provides added calcium, encourages calcium absorption and masks off-notes. GTC Nutrition, Trina O'Brien, 800-522-4682, generalinfo@gtcnutrition.com, www.gtcnutrition.com

L-carnitine, a vitamin-like substance, enables the generation of energy from fat. Clinical research suggests that L-carnitine supplementation helps in supporting cardiovascular health, weight management and exercise performance and recovery. Lonza's L-Carnitine Crystalline and L-Carnitine L-Tartrate are GRAS for use in certain conventional foods, including energy beverages, fruit juices and herbal teas. Both products are highly water-soluble, odorless and form colorless solutions. L-Carnitine L-Tartrate imparts a pleasant, fruity flavor. Lonza, Tom McMahon, 201-316-9321, thomas.mcmahon@lonza.com, www.carnitine.com

The Grande Custom Ingredients Group has developed a Black Cherry Protein Fortified Beverage, using Grande Ultra 8020 hydrolyzed whey protein. Using a proprietary process, Grande is able to hydrolyze the proteins for improved absorption and digestibility with minimum bitterness and a mild flavor. All Grande Ultra Whey proteins are produced using Grande's exclusive three-step, cold filtration process, and include Grade A, instantized, low-lactose, heat-stable and 85% protein versions. Grande Custom Ingredients Group, Michelle Koehler, 800-772-3210, michelle.koehler@grande.com, wvnv.grandecig.com

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Solbar's Solgen 3/S (3%) and Solgen 10/S (10%) natural soy extracts have high levels of genistein and daidzein, known to reduce total and LDL-cholesterol, and elevate HDL-cholesterol. Solgen 3S and 10/S highly soluble soy isoflavones, with the benefits of a "less-beany" flavor, are designed specially for a variety of beverages, soy milks, yogurts and powders. The newest family of Solpro 900 isolated soy proteins includes Solpro 950, designed for nutritional health beverages. Solbar, Gary Brenner, +972-8-8632111, solbar@solbar.com, www.solbar.com

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These concentrated fish oils and powder are formulated to be rich in omega-3 fatty acids, specifically in DHA or EPA. Lipid Nutrition's extended Marinol product range offers various formulations with omega-3 concentrations up to 40% in DHA. The company's Marinol High Stability Powders improve stability, smell and taste of the end-product. All Marinol products can be utilized in dietary supplements and are GRAS for functional food applications such as bars, margarines, dairy spreads, yogurts and pasta sauces. Lipid Nutrition, Patrick Luchsinger, 815-730-5208, patrick.luchsinger@ croklaan.com, www.croklaan.com

Specializing in custom, condition-specific micronutrient blends, Seltzer Nutritional Technologies assists in R&D, from ideation through final product approval and subsequent line extensions. Seltzer helps its customers stay ahead of the market by identifying scientifically supported nutraceuticals, recognizing functional synergistic nutrient relationships to enhance marketability, and ensuring product compatibility and integrity. As both a raw materials distributor and premix specialist, Seltzer has the market positioning to ensure ingredient access and quick processing turnarounds. Seltzer Nutritional Technologies, Hugh Lippman, 800-735-8137, hugh@seltzerchemicais.com

With its fine texture and light golden color, this flaxseed ingredient blends well into fruit or yogurt smoothies and soy milk products. BevGrad[TM] contains all of the nutrient-dense properties of flaxseed, making it a rich source of "vegan-friendly" and allergen-free omega-3 fatty acid, soluble and insoluble fiber, lignan phytoestrogens and antioxidants. With the inclusion of very low levels of BevGrad, manufacturers are able to enhance their labels with omega-3 nutrient content claims. Pizzey's Milling USA, Mary Ekman, 877-804-6444, mary@pizzeys.com

An insoluble dietary fiber with the benefits of soy, FI-1 Soy Fibre[R] is odorless and tasteless, reduces net oaths and calories, adds dietary fiber, improves yield, improves mouthfeel and is GMO-free. The product's consistent particle size promotes easy incorporation into both liquid and dry formulations. Its neutral flavor and white color make it the right fiber for applications including: baked goods, breakfast foods and pasta products. The Fibred Group, Dennis Drake, 800-598-8894, dennis@fibred.com, www.fibred.com

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Recent clinical results of Enzymotec's CardiaBea[TM], obtained from professor Peter Jones' human study, conducted at the Mary Emily Clinical Nutritional Research Unit at McGill University in Canada, confirm its significant superior effects on the body's total lipid profile. The ingredient lowers cholesterol, triglyceride and oxidative stress levels. Adding CardiaBeat to beverages provides a complete package of unique cardiovascular health benefits. It addresses the health needs of populations that suffer from diabetes, obesity, heart disease and hypertension. Applications include dairy and soy-based beverages and yogurts. Enzymotec Ltd., Ayala Berenson, +972-4-6545112, info@enzymotec.com

RFI Ingredients can provide a turnkey fortified beverage formula for your healthy beverage offerings. Whether manufacturers are interested in an energy drink fortified with all-natural caffeine from guarana or yerba mate; an antioxidant offering with our phytonutrient-based OxyPhyte[R] antioxidant line; or a wheat grass and spirufina-bused greens drink mix, RFI offers the finished products. They are available in a ready-to-drink or powder mix format. RFI Ingredients, 800-962-7663, ellens@rfiingredients.com, www.rfiingredieats.com

Docosahexaenoic acid (DHA), an omega-3 fatty acid, supports brain, eye and heart health throughout life. Martek DHA[TM] is a highly purified oil from a patented, vegetarian source (algae), ideal for food and beverage applications because it is stable, has a consistent composition, is free of oceanic pollutants, will not compromise flavor, aroma or texture, and is safe for all consumers including pregnant women and children. Martek Biosciences Corporation, info@martekbio.com, www.martekbio.com

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Micro-component systems that provide body, texture and consistency are necessary for any beverage manufacturer hoping to expand his business. Continental Custom Ingredients is an international manufacturer of ingredient systems for the food industry. CCI provides complete ingredient systems, including stabilizer and emulsifier systems, nutritional fortification and custom blending. The company's kosher-approved, Grade A certified blending facility in Illinois and its subsidiaries throughout North America allow CCI to provide the highest-quality materials for the best value. Continental Custom Ingredients, Gary Smith, 800-323-9489, gsmith@cci-us.net

Calcium reduces the risk of osteoporosis and high blood pressure, and also can be a weight-management aid. Magnesium, synergistic with calcium in bone maintenance, often is overlooked. Research demonstrates a correlation between magnesium consumption and heart health. Phosphorus is in functional food ingredients including calcium and magnesium phosphates, and is essential for proper growth and development; it is essential in maintaining bone mass. Astaris LLC, Barbara Heidolph, 314-983-7940, barbara_b_heidolph@astaris.com

The long-chain omega-3 fatty acids (specifically EPA and DHA) found in OmegaPure[TM] can be easily incorporated into healthful beverages to increase daily intake of omega-3s. OmegaPure is taste-free and odorless, and offers customer-friendly labeling opportunities with the FDA health claim. Contact the company to learn how to incorporate OmegaPure into drinkable yogurts, fruit smoothies or juices. Omega Protein, 877-866-3423, www.omegapure.com

Fibersol-2 is a readily dispersible, tasteless source of dietary fiber (90% min. DSB) with many beneficial physiological properties. It is perfect for beverages, including sports drinks and fortified waters, processed foods, baked goods, dairy products and dietetic foods. The fiber has very impressive functional characteristics, including acid and heat stability, low viscosity, clear solution, prebiotic and high solubility. Matsutani America, Bob Heard, 217-875-9819, BHeard@MatsutaniAmerica.com, www.MatsutaniAmerica.com

Scientific research associates diets rich in tomatoes and tomato products with a lower risk of degenerative diseases. Researchers attribute the lower risk to the high lycopene content, and other tomato phytonutrients. LycoRed products are designed to fortify food with these tomato phytonutrients. LycoRed produces LycoMato[R] as a non-hygroscopic, free- flowing powder from spray-dried, lycopene-rich tomato pulp. It has a low-sugar, high-dietary fiber, high-phytonutrient content. LycoRed Natural Products, a division of MANA Inc., Dave Thomas, 608-783-0872, davetlycored@charter.net

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Choline is an essential nutrient with many health benefits that can be easily formulated into beverages. Using only 110mg of choline per serving is an excellent source of choline, according to the FDA. That is easily achieved with Balchem's USP-grade choline chloride-at low cost and low impact on the flavor profile. Choline benefits everyone from pregnant mothers to newborns, athletes and senior citizens, as confirmed by many well-controlled scientific studies. Balchem Corporation, Lucien Hernandez, 845-326-5681, LHernandez@Balchemcorp.com

As a leading supplier of custom-engineered nutritional solutions that combine innovative technology, exceptional quality and superior customer service, The Wright Group delivers only the finest products and services to the functional food and nutritional supplement industries. Utilizing its SuperCoat[R] microencapsulates and SuperBlend[R] custom premixes, the company's team of research and development professionals have the expertise and latest ingredient knowledge of how to work with clients to ensure effective nutrient delivery in a variety of product applications. The Wright Group, Joel McSpadden, 337-783-3096, Joel@wenrich.com

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Dietary fibers' natural and functional characteristics make them a salubrious food ingredient additive for chemical and mechanical stability. J. Rettenmaier manufactures fibers from natural sources: oats, wheat, bamboo, cottonseed, cellulose, apples and oranges. Each fiber has different length spectrums and absorption properties. Flow and handling characteristics, water/oil absorption, baking time, shelflife, surface texture and processing rates can be modified. Due to the high fiber content (up to 98%), neutral taste and color, fiber enrichment without sensory change improves many foods. J. Rettenmaier USA, Richard Karnemaat, 269-679-2340, info@jrsusa.com, www.jrsusa.com

BASF helps make beverages, food and dietary supplements better with a broad portfolio of nutritional ingredients, backed by technical support and expertise, and reliable partners that provide custom blends. The company's advanced, proprietary microencapsulation technology enables omega-3 fatty acids to be added to beverages, creating a meaningfully nutritious product. BASF, Barry Kaufman, 973-245-6378, kaufmab@basf.com

ORAFTI offers ground-breaking nutritional and functional properties with the soluble, all-natural fiber RAFTILINE[R] (inulin), RAFTILOSE[R] (oligofructose) and Synergy 1. Healthy benefits include improved calcium absorption, "invisible" fiber enrichment, improved mouthfeel, and enhanced gastrointestinal health through prebiotics. RAFTILOSE and RAFTILINE replace fat and sugar in food, beverage and nutraceutical applications--without adversely affecting taste or mouthfeel. RAFTILOSE Synergy 1 offers enhanced calcium absorption at lower use levels. ORAFTI, John Martin, 610-889-9828, JMartin@orafti-us.com, www.orofii.com

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