A new federal law that regulates the sales of cold and allergy products could help bring immunity supplements in from the cold. On April 8, 2006, the Combat Meth Act went into effect. The act, which places nonprescription drugs that contain ephedrine, pseudoephedrine, and phenylpropanolamine behind the counter, also sets limits on how much consumers can purchase during any 30-day period. A flurry of state laws under consideration could impose further restrictions. The changes might help boost demand for dietary supplements that activate the immune system.
A new federal law that regulates the sales of cold and allergy products could help bring immunity supplements in from the cold. On April 8, 2006, the Combat Meth Act went into effect. The act, which places nonprescription drugs that contain ephedrine, pseudoephedrine, and phenylpropanolamine behind the counter, also sets limits on how much consumers can purchase during any 30-day period. A flurry of state laws under consideration could impose further restrictions.
The changes might help boost demand for dietary supplements that activate the immune system. After Oklahoma passed a law similar to the Combat Meth Act in 2004, sales of pseudoephedrine products plunged by 16%, while sales of other cold and allergy products rose by 24%, according to 2005 data from Information Resources Inc. (Chicago). The effect of tighter requirements on dietary supplement sales is far from certain, however. A less restrictive law implemented in Illinois did not produce a similar effect. Moreover, most natural immune enhancers tend to perform different functions and have different mechanisms of action than cold and allergy products.
Immune enhancers have been itching for a rebound since a controversial study that appeared in the July 28, 2005, issue of the New England Journal of Medicine (NEJM) questioned the benefits of the herb echinacea. The strong reception received by several immunity products at Natural Products Expo 2006, held in Anaheim, CA, in March, suggests that things may be looking up for the category.
Echinacea Study Findings Questioned
A study published in the July 28, 2006, issue of NEJM raised doubts about the popular herb echinacea’s ability to offer relief from colds. However, experts from several trade groups were quick to rebut the study findings.
After giving either a placebo or one of three preparations of Echinacea angustifolia to 399 volunteers who had been infected with a rhinovirus, the researchers who conducted the study concluded that “extracts of E. angustifolia root, either alone or in combination, do not have clinically significant effects on infection with a rhinovirus or on the clinical illness that results from it.”
Critics pointed out, however, that the study used a dosage equivalent to 900 mg of E. angustifolia extract per day. According to American Herbal Products Association (Silver Spring, MD) president Michael McGuffin, the appropriate dosage should have been 3 g or more. Moreover, in a letter to NEJM, American Botanical Council (Austin, TX) president Mark Blumenthal pointed out that both the World Health Organization (Geneva) and the Canadian Natural Health Products Directorate (Ottawa, ON, Canada) recommend a dosage that is 330% higher.
American BioSciences Inc.’s (Blauvelt, NY) Avemar, an ingredient made from wheat germ by yeast fermentation that optimizes metabolism and immune-system function, won the Best New Product of the Year award at Nutracon during this year’s Natural Products Expo show. According to Richard Kreider, PhD, a member of Nutracon’s scientific review panel and director of Baylor University’s (Waco, TX) Exercise and Sport Nutrition Laboratory, the product is supported by a combination of animal studies and human clinical trials. “The studies were well done, both from the theoretical and applied standpoints, and the results showed that it had both mechanistic and overall immunological impact,” Kreider says. Avemar is sold as a medical food in Hungary and was introduced as a dietary supplement in the United States in 2005. Because it is generally recognized as safe (GRAS), it is also a component in Avé, an instant drink mix that is sold as a retail product.
According to American BioSciences, Avemar supports several mechanisms of immune-system regulation by affecting the balance of cellular and humoral immune activity. The company says that the ingredient also improves the ratio of Th1 and Th2 cytokines, which help other immune cells counteract pathogens.
Rick Jahnke, vice president and cofounder of American BioSciences, says he hopes the award will make the medical community more familiar with the product. “It has always been our goal to focus first and foremost on helping people achieve their health potential,” Jahnke says. “We work with university and private researchers to identify extremely well-researched natural compounds that have never been marketed as natural compounds, often because synthetic versions of them are on track for drug development.”
Another ingredient that may support immune health is Tinofend, a unique extract of the ayurvedic herb Tinospora cordifolia. The herb, which is commonly known as guduchi in Asia, is an Indian shrub that is thought to offer protection against inflammation and allergies. In a double-blind, placebo-controlled trial published in the January 2005 issue of the Journal of Ethnopharmacology, the extract was shown to provide relief from nasal discharge and obstruction, itching, and sneezing. For the study, researchers from the Indira Gandhi Medical College (Nagpur, India) randomly assigned 75 volunteers to receive either 300 mg of Tinofend three times per day, or a placebo, for eight weeks. At baseline and at the end of the study, the researchers performed several tests, including nasal smears and white blood cell counts. They also kept track of various allergy symptoms experienced by the volunteers during the trial. Overall, the researchers concluded that the recorded differences between the treatment and control groups were highly significant.
According to Blake Ebersol, marketing coordinator at Geni Herbs (Noblesville, IN), which supplied the Tinofend extract used in the study, the ingredient provides a complex of phytochemicals that enhance the activity of the immune system. To ensure the potency of the extract, Geni uses herbs from a cultivar that has a specific phytochemical profile. “It has more of certain kinds of the plant’s beneficial compounds, such as sterols, polysaccharides, and polyphenols,” Ebersol explains, adding that a patented water extraction method helps preserve the herb’s beneficial compounds. Tinofend, which is manufactured in an ISO 9001:2000 and HACCP facility, complies with Proposition 65 requirements, is free of pesticides, and is certified kosher and halal.
Chr. Hansen (Milwaukee), one of the world’s largest manufacturers of probiotic cultures, is expanding into the U.S. immunity market through collaboration with Jarrow Formulas (Los Angeles). In April, both companies announced that Jarrow would manufacture and distribute Fem-Dophilus, a probiotic supplement that helps maintain healthy vaginal flora and may help reduce the risk of urogenital infections. Fem-Dophilus, which contains the probiotic strains Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, is based on Chr. Hansen’s Urex-cap-5 concept, which is supported by more than 20 years of research. Fem-Dophilus is also coated in a proprietary polysaccharide matrix that protects the bacteria from stomach acid, ensuring that the probiotics survive until they reach the lower intestine.
“It has been established that women with an unhealthy intestinal microflora profile are at a higher risk of developing urinary and vaginal infections,” says Peilin Guo, MS, RD, Jarrow’s vice president of functional foods. “Fortunately, scientific and clinical studies indicate that external beneficial microflora can colonize the intestinal and vaginal tract, and help maintain the health of the vaginal and urinary tracts. This suggests that the daily ingestion of certain probiotics might provide a natural, safe, and effective means in supporting women’s health.”
Honorary Probiotics Professorship Awarded to Food Scientist
Robert Hutkins, PhD, a professor of food science and technology at the University of Nebraska–Lincoln, is the first recipient of the Khem M. Shahani Professorship in Food Science and Technology. The professorship commemorates the life and work of Khem Shahani, founder of Nebraska Cultures Inc. (Walnut Creek, CA).
“Research on probiotic bacteria was pioneered more than 40 years ago by Dr. Shahani,” says Hutkins, who specializes in the molecular basis of probiotic metabolism. “Now, this field is regarded as one of the most important research areas in all of microbiology. This award is not only an important personal honor for me, but it is also evidence of the university’s commitment to research on the biology of these important bacteria.”
“All of us at Nebraska Cultures are extremely pleased that Dr. Hutkins was chosen for this professorship,” adds Michael Shahani, director of operations at Nebraska Cultures. “His exceptional record as a teacher, researcher, and author makes him an ideal choice. He regularly lectures and gives seminars for Nebraska Cultures, both domestically and internationally, and we feel fortunate to have such a knowledgeable and engaging spokesman.”
Steen Andersen, vice president of Chr. Hansen’s Human Health and Nutrition unit, says the agreement with Jarrow is an important step in its strategy for the global commercialization of the Urex-cap-5 concept. “We are pleased that the concept is now also available in the United States, which is clearly one of the most important global markets for probiotics,” Andersen says. “Jarrow Formulas is a good strategic fit for us, as they have a strong reputation for their focus on high quality and efficacious product solutions, and they are one of the leading marketers of probiotics in the United States.”
“We are very excited about our partnership with Chr. Hansen and the opportunity to be the first in the U.S. market with a clinically documented oral probiotic concept that addresses women’s health,” adds Jarrow Rogovin, president of Jarrow Formulas. “We’re convinced that a lot of women will benefit from this novel probiotic concept. The introduction of Fem-Dophilus will solidify our position as a leading provider of value-added probiotics in the United States.”