The American Herbal Products Association (AHPA) has requested that the Food and Drug Administration (FDA) clarify its policy on over-the-counter drug-dietary supplement combination products following the recent launch of Bayer Healthcare’s new “analgesic phytosterol supplement,” Bayer Aspirin With Heart Advantage. The Bayer product includes 81mg of aspirin and 400mg of phytosterols, and bears both OTC drug and dietary supplement labeling and claims.

In a May 29 letter to the agency’s assistant commissioner for policy, AHPA cites two past warning letters issued to companies marketing OTC drug-dietary supplement combination products without first filing new drug applications. Additionally, the association references a May 30, 2000 letter in which FDA “strongly recommends” firms refrain from marketing these products due to “a number of significant health and policy issues.”
 
“Against this background, AHPA is asking for prompt clarification from FDA to avoid confusion among the public and regulated industries as to the agency’s policy,” said AHPA President Michael McGuffin. “If FDA has not changed its policy, we assume the agency should evaluate Bayer’s product in the same manner it evaluated the OTC drug-dietary supplement combinations cited in these previous warning letters. If, on the other hand, there is a new policy, it appears as if the marketplace may now be open to other OTC drug-dietary supplement products.”
 
In its letter, AHPA also urges the FDA to provide additional information, especially information addressing the reporting of adverse events associated with combination drug-dietary supplement products.

For more information visit www.ahpa.org.

A new company has entered the dietary supplements industry with Allera Health Products’ (St. Petersburg, FL) launch of its proprietary, science-backed immune support product, ImmunExtra®, into the US health food channel. The number of PhD’s and MD’s on staff and as advisors is notable, which is reflected in the quality and substantiation of its’ flagship product. Additionally, the company’s website features a link to MD’s who are available to answer health questions—a first in the industry, according to the company.

ImmunExtra comes to market after more than 15 years of research on the patented pinecone extract Proligna®, the basis for ImmunExtra. Extensive research indicates that this extract promotes immune cell development—also called PPC (Polyphenylpropenoid-Polysaccharide Complex), composed of lignin and polysaccharide, and is a potent antioxidant. ImmunExtra is the first and only product based on this compound.

Proligna should not be confused with pine-based extracts available in other products. There are over 30 peer-reviewed scientific studies describing important research on Proligna.

Additionally, clinical trials are currently underway at medical centers in California, Missouri and Texas.

For more information visit www.immunextra.com.

Sabinsa Corporation (Piscataway, NJ) announced that Sami Labs, its research and manufacturing arm in Bangalore, India, received funding from the government of India's Department of Scientific and Industrial Research (DSIR) to perform pilot trials on two novel research projects.

Sami Labs was awarded $185,000 under the Department's Technology Development and Demonstration Programme, designed to help promote India's research, development and technology advancements. The grant will be used in part to develop and test a plant-derived cosmetic active, with expected market availability in late 2008. In addition, the grant will assist Sami Labs in developing a novel method to manufacture Resveratrol utilizing Sami Labs' patented synthetic Demethylation strategy.

India's National Accreditation Board for Testing & Calibration Laboratories also successfully audited Sami Labs research & development and quality control labs. The accreditation certificate provides further validation of Sami Labs' equipment, analytical methods, data systems and regulation compliance.

Sabinsa Corporation is a manufacturer and supplier of herbal extracts, cosmeceuticals, minerals and specialty fine chemicals.

For more information visit www.sabinsa.com.

How, scientists wonder, do the French get away with a clean bill of heart health despite a diet loaded with saturated fats?

The answer to the so-called “French paradox” may be found in red wine. More specifically, it may reside in small doses of resveratrol, a natural constituent of grapes, pomegranates, red wine and other foods, according to a new study by an international team of researchers.

Writing the week of June 3 in the online, open-access journal Public Library of Science One, researchers report that low doses of resveratrol in the diet of middle-aged mice has a widespread influence on the genetic levers of aging and may confer special protection on the heart.

Researchers found that low doses of resveratrol mimic the effects of what is known as caloric restriction—diets with 20-30 percent fewer calories than a typical diet—that in numerous studies has been shown to extend lifespan and blunt the effects of aging.

Previous research has shown that resveratrol in high doses extends lifespan in invertebrates and prevents early mortality in mice given a high-fat diet. The new study, conducted by researchers from academia and industry, extends those findings, showing that resveratrol in low doses and beginning in middle age can elicit many of the same benefits as a reduced-calorie diet.

In the new study—which compared the genetic crosstalk of animals on a restricted diet with those fed small doses of resveratrol—the similarities were remarkable, said lead author Jamie Barger of Madison, WI-based LifeGen Technologies. In the heart, for example, there are at least 1,029 genes whose functions change with age, and the organ's function is known to diminish with age. In animals on a restricted diet, 90 percent of those heart genes experienced altered gene expression profiles, while low doses of resveratrol thwarted age-related change in 92 percent. The new findings, say the study's authors, were associated with prevention of the decline in heart function associated with aging.

The work of the Wisconsin team was funded by grants from the National Institutes of Health and DSM Nutritional Products of Basel, Switzerland.

Vote Hemp, a grassroots advocacy organization working to give farmers the right to grow non-drug industrial hemp, said it is pleased that Vermont Governor Jim Douglas allowed H.267, the Hemp for Vermont Bill, to become law without his signature. The bill overwhelmingly passed both the House (126 to 9) and the Senate (25 to 1).

The new law sets up a state-regulated program for farmers to grow non-drug industrial hemp, which is used in a wide variety of products, including nutritious foods, cosmetics, body care, clothing, tree-free paper, auto parts, building materials and more.  
Grassroots organizing by Vote Hemp and the Vermont-based advocacy group Rural Vermont mobilized farmers and local businesses, many of which pledged to buy their hemp raw materials in-state if they have the opportunity.

Vermont grows an average of 90,000 acres of corn per year, a small amount compared to Midwest states; however, the need for a good rotation crop exists nationwide. From candle makers to dairymen to retailers, Vermont voters strongly support hemp farming. Admittedly a niche market now, hemp is becoming more common in stores and products across the country every day. Over the past ten years, farmers in Canada have grown an average of 16,500 acres of hemp per year, primarily for use in food products. In Vermont, the interest in hemp includes for use in food products, as well as in quality and affordable animal bedding for the state’s estimated 140,000 cows.

For more information visit www.votehemp.com.

CROPP Cooperative, North America's largest farmer owned co-op, which markets products under the Organic Valley and Organic Prairie brands and Dakota Beef, the largest vertically integrated 100 percent Organic Beef producer in the US, have partnered to expand the US organic beef cattle supply in a multi-year agreement. Consumer demand for high-quality organic beef has been exceptional and this partnership will ensure supply to an increasingly savvy and discerning organic consumer. 

While other beef companies are struggling to supply the market with increased demand as traditional retailers take organic beef “behind the counter” and offer more choice cuts, Dakota Beef is flush with cattle and prepared to meet demand, according to the company. Innovative supply chain management and long-term partnerships with certified organic beef producers make this possible.

Dakota Beef, LLC is a certified 100 percent organic beef company. Organic Prairie is the meat brand from CROPP Cooperative, who also markets certified organic dairy, eggs, juice, soy and produce under the Organic Valley brand.