Nutraceutical Industry News Briefs

In The News

Berkem’s Svetol Receives Bronze Award

GARDONNE, France—At the Health Ingredients Europe event in November, Berkem Group (www.berkem.com) competed for the best ingredient of 2006, and received the Bronze Award for its extract of decaffeinated green coffee, Svetol®. The ingredient is a green coffee bean extract standardized in active molecules; its innovative mechanism of action has been assessed in Berkem studies.

AHPA, AHP Release Draft GAP Proposal

SILVER SPRING, Md. & SCOTTS VALLEY, Calif.—The American Herbal Products Association (AHPA) and American Herbal Pharmacopoeia (AHP) jointly completed a draft document, “Good Agricultural and Collection Practice for Herbal Raw Materials” (GACP). According to the organizations, the goals of the draft GACP are to ensure herbal raw materials are accurately identified, not adulterated, conform to quality characteristics, and are harvested and cultivated in an environmentally sustainable manner. It is intended to apply to all herbal raw material producers. The groups are seeking comments through the review process; the draft can be found online through the AHPA (www.ahpa.org) or AHP (www.herbal-ahp.org) Web sites.

NBA Players, EAS Partner

NEW YORK—The National Basketball Players’ Association (NBPA) entered into a relationship with Abbott Nutrition’s EAS brand; EAS will supply products to the association for its members, and the groups will work together on educational programs. EAS will also have a presence at select NBPA-sanctioned events. Further, Abbott Nutrition announced Chicago Bulls’ Ben Gordon is a new professional athlete endorser for the company, joining “Team EAS”.

Brand New Brands Launches New Sleep Company

MILL VALLEY, Calif.--Brand New Brands launched a new company, called Dreamerz Foods Inc., based on all-natural products that promote healthy sleep and relaxation. Amanda Steele, Dreamerz Foods’ founder and chief executive officer (CEO), will lead Dreamerz Foods, the fourth company launched by Brand New Brands. Steele is a food industry veteran, having served in the beverage division of Nestlé USA, launching new brands including Nescafé Frothé and Nescafé Ice Java.

"We see a strong need for sleep products that really work without the side effects that worry consumers," Steele said. "Dreamerz allows people to treat themselves to a delicious dessert drink that helps them relax and fall asleep naturally."

Food News

D.D. Williamson Recognized for Kosher Standards

LOUISVILLE, Ky.--For outstanding commitment to kosher guidelines and standards, D.D. Williamson received the first Kosher Compliance Award from the Louisville Vaad Hakashruth. “Beyond maintaining high standards of kosher throughout the year, D.D. Williamson is also the world’s largest supplier of kosher for Passover caramel color,” said Avrohom Litvin, Kosher administrator of Louisville Vaad Hakashruth. Ted Nixon, D.D. Williamson’s chief executive officer (CEO), said the company was pleased to receive the award, and that “observing all governmental and religious requirements has always been critical to our value and beliefs.”

Financial News

NBTY Posts November Sales Gains

BOHEMIA, N.Y.—NBTY (NYSE:NTY) released preliminary results for its November 2006 revenues, showing a trend in increased sales in its domestic nutrition, direct response and European retail divisions. These divisions performed well even when factoring in the previously released preliminary results for October. The only sore spot was the company's North American Vitamin World division, which experienced an 8-percent revenues decline in November, combining for a 6-percent decline for the two-month period.

According to the company (www.nbty.com), November sales were particularly strong in the United States, where the nutrition division posted a 16-percent sales increase, as well as in the United Kingdom, where Holland & Barrett and GNC retail sales rose a combined 13 percent. While small in percentage of overall revenues, NBTY's Puritan Pride direct response business posted the biggest percentage gains, with sales jumping 38 percent in November and 29 percent in the two-month period. Overall revenues climbed 14 percent in November and 11 percent for the two months combined.

Nutraceutical Closes Steady 2006

PARK CITY, Utah—Nutraceutical Corp. (NASDAQ:NUTR) turned in a steady fiscal year 2006 (FY06), with slight upticks in revenues and earnings, and punctuated by a solid fourth quarter (4Q) performance. Revenues were down about $1 million to $35.6 million in 4Q, but increased more than $2 million to $150.4 for the year. Margins held fairly steady in fourth quarter, and throughout the year, and operating expenses were consistent with comparable fiscal 2005 percentages. Net income for 4Q held relatively flat at $3.1 million or $0.27 per share, while FY06 earnings rose 2-percent to $14.9 million or $1.30 per share, including a one-time gain of $7.0 million related to the sale of one the company's Park City buildings.

Bill Gay, chairman and chief executive officer, noted the company (www.nutraceutical.com) focused its fiscal 2006 efforts on, among other things, operational improvements, brand positioning and product innovations, as well as making capital improvements for the future. "We continued our historical focus on increasing market share in domestic health and natural food stores through marketing and sales programs with our retail store customers," he said. "Acquisitions and development of synergistic product categories will remain an integral part of our growth strategy as nutritional supplement growth rates continue to be relatively flat and competitive."

Studies & Research

NCCAM Evaluates Silymarin, Chronic Liver Diseases

BETHESDA, Md.—The National Center for Complementary and Alternative Medicine (NCCAM) is sponsoring a phase I/II clinical trial to evaluate the safety, tolerability and pharmacokinetics of orally administered silymarin (milk thistle extract; Legalon, Euromed USA) in patients with noncirrhotic chronic hepatitis C virus (HCV) infection or nonalcoholic fatty liver disease (NAFLD). One of the investigators, K. Rajender Reddy, M.D., professor of medicine and director of Hepatology at the University of Pennsylvania, points out that safe dose escalation is uncertain, because the disposition of silymarin in patients with chronic liver disease is not known and may differ according to disease etiology or disease severity. Furthermore, the relative contributions of the six principal components (isomers) of silymarin to its safety and efficacy profile have not been previously investigated in a clinical trial, he added. Researchers proposed to study a standardized form of silymarin systematically in a randomized, multicenter, double blind, placebo-controlled phase I trial. “The data obtained from this phase I study will allow for the identification of drug exposures that are both safe and dose proportional for a planned phase II study to determine the effectiveness of silymarin as a treatment for liver disease in HCV and non-alcoholic steatohepatitis (NASH) patient populations,” Reddy said.

GliSODin® Increases Antioxidant Capacity

MORRISTOWN, N.J.—GliSODin® (from P.L. Thomas and its partner Isocell) efficiently limited retinal oxidative stress by increasing plasma antioxidant capacity. In the study, published in Investigational Ophthalmology and Vision Sciences (47:E-Abstract 2089, 2006), researchers induced oxidative stress in a recognized model using light exposure to the eyes once a month for three months. Prior to the third exposure, GliSODin (10.8 mg/kg) or placebo was administered for seven days. Retinal response, levels of induced oxidants in eye tissues and blood antioxidant levels were measured. Light exposure did not demonstrate a significant difference between the active and control groups as measured by retinal degeneration; however, blood antioxidant capacity was increased by 30 percent in the GliSODin group. Furthermore, cell oxidant levels (measured by the potent oxidant superoxide anion) were increased by up to 50 percent in retinal cell layer and by 300 percent in the outer nuclear layer in all light exposed animals compared to control (P < .01). GliSODin supplementation decreased the superoxide anion levels significantly (P <.05). Researchers concluded light-exposure promotes retinal oxidative stress while GliSODin supplementation efficiently limits retinal oxidative stress.

Pycnogenol Defies Edema

HOBOKEN, N.J.—An antioxidant plant extract from the bark of the French maritime pine tree (as Pycnogenol®, Horphag/Natural Health Science) reduces edema, a typical side-effect of antihypertensive medications, by 36 percent. The eight-week study, published in the Journal of Clinical and Applied Thrombosis/Hemostasis (12, 4:440-4, 2006), included 53 hypertensive patients (at the G D'Annunzio University in Italy) suffering from edema of their ankles and feet as a result of taking antihypertensive medications (at the same dosage) for at least four months. Twenty-three patients were being treated with angiotensin-converting enzyme (ACE) inhibitors (Mavik® or Altace®) and 30 patients were being treated with nifedipine (calcium channel blockers; Adalat® or Procardia®). Of the 53 patients, 27 were also given 150 mg/d Pycnogenol for eight weeks, at which point edema was measured (using a strain gauge plethysmography) in supine position and standing. Those taking ACE inhibitors and Pycnogenol experienced a 35-percent decrease of ankle swelling and patients treated with nifedipine and Pycnogenol experienced a 36-percent decrease. According to Gianni Belcaro, M.D., and lead researcher, Pycnogenol helps defy a major side effect of antihypertensive medication. Furthermore, Pycnogenol has a blood pressure-lowering effect itself and thus helps to achieve a healthy cardiovascular system.

PUFAs a Positive in Pathophysiology

BROOKLYN, N.Y.—Substance abuse patients with anxiety disorders experienced decreased levels of anxiety after taking n-3 polyunsaturated fatty acids (PUFA) capsules; results continued six months after treatment stopped. In the three-month, double blind, randomized study, published in the Journal of Clinical Psychopharmacology (26, 6:661-665, 2006), 13 patients were given 3 g/d of n-3 PUFAS (as eicosapentaenoic acid and docosahexaenoic acid) in capsule form, while 11 received a similar looking placebo (containing vegetable oil). Feelings of anxiety were assessed using a questionnaire and scale at baseline and then monthly during treatment. Six PUFA group patients and eight placebo group patients were followed for an additional three months after treatment discontinued and administered the same questionnaire monthly. Patients who received the n-3 PUFA capsules showed a progressive decline in anxiety scores; patients who received placebos did not. After treatment ceased, comparison of the groups was still significant (P = 0.010). Anxiety scores remained significantly decreased in the PUFA group three months after treatment discontinuation, and the six-month follow-up score was also significant (P = 0.042). Researchers concluded the preliminary data indicates n-3 PUFA supplementation could be beneficial in the treatment of some patients with anxiety disorders.

Studies In Brief

Researchers from Georgetown University Medical Center report homeopathic preparations of saw palmetto may reduce prostate cancer growth (Integ Cancer Ther, 5, 4:362-72, 2006). ... Almonds lower the risk of oxidative damage to proteins by limiting blood glucose changes after a meal and by providing antioxidants; these actions may also underlie the link between consumption of nuts and decreased risk of coronary heart disease (J Nutr, 136:2987-2992, 2006). ... Vitamin D deficiency may adversely impact both mood and cognitive performance in older adults (Am J Geriatr Psychiatry, 14:1032-40, 2006). ... Researchers found no link between flavonoid consumption and risk of diabetes in a cohort of 35,000+ older women; however, those tippling at least once a week did have a reduced risk of the disease (J Nutr, 136:3039-45, 2006). ... Long-term use of vitamin E did not provide cognitive benefits to generally healthy older women and did not affect average performance on three cognitive functions—general cognition, verbal memory and category fluency—compared to placebo (Arch Intern Med, 166: 2462-2468, 2006). ... An academic team including epidemiologists and a cardiologist reported a review of existing trials shows folic acid can lower the increased homocysteine levels associated with in increased risk of heart attack and stroke (BMJ, 333:114-17, 2006). ... Oral supplements of glucosamine (500 mg tid) do not appear to impact insulin function or endothelial health in lean or obese subjects, according to research coordinated out of the National Center for Complementary and Alternative Medicine’s (NCCAM) diabetes unit (Diabetes, 55:3142-50, 2006). ... Parameters of kidney function, such as blood urea nitrogen and creatinine, were slightly reduced after the oral administration of vitamin E in rats; plasma level of electrolytes, also changed significantly (P < 0.00001) and ameliorated the metabolic and biochemical parameters of diabetic rats (Ann NY Acad Sci, 1084:411–431, 2006). ... Consumption of milk fortified with micronutrients zinc, copper, vitamins A, C and E, iron and selenium can significantly reduce the burden of common morbidities among preschool children in India, especially in the first two years of life (BMJ, DOI:10.1136/bmj.39035.482396.55). ... Contrary to previous case-control studies, researchers concluded coffee consumption does not increase myocardial infarction (MI) risk; coffee consumption of lees than or equal to five cups per week was nonsignificantly inversely associated with MI risk among older Swedish women (Am J Epidemiol, ePub, Nov. 16 ahead of print, 2006). ... Method performance data indicate the LC/MS method is analytically superior to the LC/ELSD method in assessing biotin levels in multivitamin and multielement dietary supplements (J Agric Food Chem, 54, 23:8710-6, 2006). ... A team from the University of Reading, University of Sheffield, England, and GlaxoSmithKline Nutritional Healthcare reviewed scientific data on natural products and bone metabolism, finding certain foods, herbs and other dietary ingredients have demonstrated benefits to various areas of bone health (Phytother Res., ePub online ahead of print, Nov. 14, 2006). Scientists reported there is now good evidence that dietary components and herbal products can influence complex balance between the deposition of matrix and mineralization and resorption, particularly by inhibiting bone resorption. ... After an earlier study suggested vitamin E supplements could possibly increase all-cause mortality, researchers from the U.S. National Institutes of Health (NIH) and the National Public Health Institute of Finland found higher serum levels of vitamin E may reduce the risk of total and cause-specific mortality. The prospective cohort study involved 29,092 Finnish male smokers aged 50 to 69 who participated in the Alpha-Tocopherol, Beta-Carotene (ATBC) Cancer Prevention Study (AJCN, 84, 5:1200-7, 2006). ... Low serum concentrations of vitamins B6, B12 and selenium predict subsequent disability in activities of daily living (ADLs) in women 65 years and older (Arch Int Med, 166:2335-2340, 2006). ... Supplementation with lutein for six months boosts levels of the carotenoid and its metabolites in the serum of elderly adults, both with and without age-related macular degeneration (AMD) (Invest Ophthalmol Vis Sci, 47:5234-42, 2006).