News Briefs

Allergy Sufferers Interested in Alternative Therapies

Sixty-two percent of respondents in a survey of allergy and asthma patients seen at a private allergy practice in the United States have expressed an interest in also being treated with complementary and alternative medicine (CAM), such as acupuncture or vitamin therapy, according to Reuters Health. In addition, the percentage of patients actually receiving CAM therapies, although small, appears to be growing rapidly. The findings were presented in November at the annual scientific meeting of the American College of Allergy, Asthma, and Immunology in Boston.

The findings are based on surveys conducted in 1998 and 2004 in the practice of William S. Silvers, MD, at the Allergy, Asthma and Immunology Clinic of Colorado in Englewood. The analysis included a total of 113 patients who completed questionnaires in 1998 and another 103 who filled out questionnaires in 2004. In both years, the percentage of respondents interested in discussing CAM held steady at around 67%. Likewise, the percentage of patients who discussed CAM with a primary care physician was identical in each survey—18%.

A slight increase from 16% to 19% was noted in the percentage of subjects who visited a CAM practitioner for a general medical need. A more pronounced rise, from 4% to 10%, was seen in the percentage that sought a CAM practitioner for allergy or asthma. The favored CAM therapy also changed between the two survey points. In 1998, the most popular CAM therapy was vitamin/mineral therapy, whereas in 2004 the most favored was acupuncture.

As noted above, most (62%) respondents preferred the combination conventional/CAM therapy. Just 8% of patients favored conventional medicine only, and 3% of patients were willing to abandon allopathic medicine and opt only for CAM. Twenty-seven percent said they did not know or were willing to go with whatever the doctor decided.

FDA Allows Qualified Health Claim for Monounsaturated Fat

The U.S. Food and Drug Administration (FDA) has announced the availability of a qualified health claim for monounsaturated fat from olive oil in reducing the risk of coronary heart disease (CHD). Limited but not conclusive evidence suggests that consumers may reduce their risk of CHD if they consume monounsaturated fat from olive oil and olive oil-containing foods in place of foods high in saturated fat, while at the same time not increasing the total number of calories consumed daily, the FDA says.

A qualified health claim on a conventional food must be supported by credible scientific evidence. Based on a systematic evaluation of the available scientific data, as outlined in FDA’s "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," FDA is announcing the availability of this claim on food labels and the labeling of olive oil and certain foods that contain olive oil.

Although this research is not conclusive, FDA intends to exercise its enforcement discretion with respect to the following qualified health claim: Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product [Name of food] contains [x] grams of olive oil.

FDA Announces Major Initiatives for Dietary Supplements

FDA also has announced three major regulatory initiatives designed to further implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). These initiatives include a regulatory strategy, an open public meeting, and a draft guidance document for industry. FDA intends to improve the transparency, predictability, and consistency of its scientific evaluations and regulatory actions to protect consumers against unsafe dietary supplements and dietary supplements making unauthorized, false, or misleading claims. The agency will continue its efforts of monitoring and evaluating product safety, ingredient safety, and product labeling, as well as ensuring product quality.

In the regulatory strategy, FDA will work collaboratively with its federal and other partners to improve the evidentiary base it uses to make safety and enforcement decisions about dietary ingredients and dietary supplements. FDA says it also will implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements.

The process begins with a "signal detection," which means identifying an issue of concern. Signals of a possible safety concern can come from federal, state, and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. When the quality or quantity of these signals indicates that there may be a public health problem, FDA then may seek input from an independent third-party review.

To further the effective implementation of this requirement, FDA held a public meeting on Nov. 15 designed to seek public comment on the type, quantity, and quality of evidence manufacturers should provide the FDA in a new dietary ingredient notification.

FDA says the third initiative reflects its commitment to fully implement DSHEA by asking for comments on a draft guidance document on the amount, type, and quality of evidence a manufacturer should have to substantiate a claim made under 403 (r)(6) of the Federal Food, Drug, and Cosmetic Act. While the act, as amended by DSHEA, requires substantiation for such claims, it does not define the term. The draft guidance document provides manufacturers flexibility in the precise amount and type of evidence that constitutes adequate substantiation. The draft guidance is available for viewing at www.cfsan.fda.gov/~dms/dsclmgui.html.