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Past News Items - December 2008


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In The News

Could FDAAA’s Section 912 Thwart the Functional Food Industry?

Chronic Intestinal Inflammation Linked to Stomach Cancer

Hibiscus Tea Can Lower Blood Pressure

Study: Traditional Chinese Indigo Treatment Alleviates Psoriasis




Released: 12/01/08


Could FDAAA’s Section 912 Thwart the Functional Food Industry?

Leaders in the functional foods and dietary supplements industries fear that the US Food and Drug Administration’s (FDA’s) recent revision of its Amendments Act (FDAAA) could discourage clinical research of functional foods and dietary supplements. The revision, known as Section 912, establishes a new provision of the Federal Food, Drug, and Cosmetic Act (FDCA), § 301 (ll), and prohibits shipment in interstate commerce of foods to which certain materials have been added. Concerns about the provision are centered on the possibility that it could prevent products from being marketed as dietary supplements if they contain a substance that has been subject to public clinical investigation. Substances most likely to be affected by such a change are probiotics, fish oil, and vitamins.

However, the potential impact on the food and supplements industry hinges on how, exactly, the act will be implemented by FDA. If the act were to be broadly interpreted, the restricted selling of such products could even include milk and bread fortified with vitamins.

Several industry organizations, including the International Probiotics Association and the supplement trade association Council for Responsible Nutrition, have registered protests to the proviso via the comments section of the posted version of Section 912. The comments section was closed to submissions at the end of November, but it may accessed via this link:

http://www.regulations.gov/search/search_results.jsp?css=0&&Ntk=All&Ntx=mode+matchall&Ne=2+8+11+8053+8054+8098+8074+8066+8084+8055&N=0&Ntt=FDA-2008-N-0389&sid=11DD99843B5C

Chronic Intestinal Inflammation Linked to Stomach Cancer

A multicenter research team led by members of the Columbia University Medical Center has uncovered a major contributor to the cause of stomach cancer. The team described for the first time that elevated levels of a single proinflammatory cytokine, an immune system protein called interleukin-1 beta (IL-1β), can start the progression towards stomach cancer. These results, published in the November 4 issue of Cancer Cell, lead researchers to believe that blocking the elevation of IL-1β may keep cancer from developing.

Stomach cancer, the second leading cause of cancer-related mortality in the world, may be triggered by an accumulation of IL-1β, which is itself induced by infection with the bacterium Helicobacter pylori (H pylori) in the gastrointestinal tract, say researchers. The study indicates that IL-1β works by activating a type of white blood cell known as myeloid derived suppressor cells (MDSCs); these cells appeared to be strongly proinflammatory. Interfering with IL-1β or the MDSCs may ultimately prevent the growth of cancerous tissues.

Research previous to this study had linked stomach cancer to chronic inflammation and H pylori infections with chronic inflammation. What had remained unknown was how these connections happened, given that H pylori infection is extremely prevalent and fewer than 1% of infected individuals actually develop stomach cancer. Since previous research also had linked H pylori infection to the overexpression of IL-1β, this research team developed a transgenic mouse model in order to investigate the specific role of IL-1β in gastric carcinogenesis.

Results demonstrated that the overexpression of IL-1β in the stomach is, indeed, the culprit. IL-1β overexpression mobilizes the recruitment of MDSCs, which initiates the progression of gastric inflammation into cancer. Furthermore, these findings help to explain why only a small percentage of those with H pylori infection develop stomach cancer: they have a genetic predisposition for high expression levels of proinflammatory cytokines.



Hibiscus Tea Can Lower Blood Pressure

According to new research presented to the American Heart Association (AHA), drinking tea made from hibiscus can lower blood pressure in prehypertensive and mildly hypertensive adults. The research, overseen by AHA scientists at Tufts University, tested 65 volunteers aged 30 to 70 years whose systolic blood pressure was 120 to 150 mm/Hg and whose diastolic blood pressure was 95 mm/Hg or less at the start of the study. Participants with the highest systolic blood pressure readings (129 or above, considered to be at risk for heart disease, stroke, and kidney disease) had a greater response to the hibiscus tea (in this case, the species Hibiscus sabdariffa, although there are more than 200 species), which was brewed from 3.75 g of unspecified plant material.

The 65 volunteers were split into 2 groups, the first drinking 3 cups of hibiscus tea per day for 6 weeks, while the second was administered a placebo beverage containing artificial hibiscus flavoring and color. Participants followed regular dietary and physical activity patterns, and their blood pressure was measured weekly.

Subjects in the first group experienced a 7.2% drop in their systolic blood pressure, compared to a 1.3% drop in the placebo group. Those with the highest systolic blood pressure (129 and above) saw their systolic blood pressure drop 13.2%, with their diastolic blood pressure down by 6.4%. In this subgroup, mean arterial pressure went down by 8.7%.

This study was funded by the US Department of Agriculture’s Agricultural Research Service and the New York-based food maker, Hain Celestial Group.



Study: Traditional Chinese Indigo Treatment Alleviates Psoriasis

An ointment made from indigo naturalis, a dark-blue plant-based powder used in traditional Chinese medicine, appears to be effective in treating plaque-type psoriasis, according to a report in the November issue of the AMA journal Archives of Dermatology.

Between May 2004 and April 2005, Taiwanese researchers conducted a randomized trial of an ointment containing indigo naturalis in 42 patients with treatment-resistant psoriasis. Participants enrolled in the study applied the indigo ointment to a psoriatic plaque on 1 side of the body and then a nonmedicated ointment to a parallel plaque on the other side of their body. The researchers assessed and photographed patients' skin plaques at the beginning of the study and again after 2, 4, 6, 8, 10, and 12 weeks.

After 12 weeks of treatment, the plaques treated with indigo naturalis ointment showed significant improvement in scaling, erythema (redness), and induration (hardening) when compared with the plaques treated with nonmedicated ointment. The authors noted that lesions treated with the indigo naturalis ointment-treated showed an 81% improvement, whereas lesions treated with the nonmedicated ointment-treated showed only a 26% improvement.

Of the 34 patients who completed the study, none experienced worsening psoriasis in the areas treated with indigo naturalis, while the treated plaques were completely or nearly completely cleared for 25 of them (74%). None experienced serious adverse effects beyond topical itchiness at the start of treatment.



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