In The News

FDA Approves Sales of Cloned Milk, Meat

FDA Cracks Down on Compounding Pharmacies Distributing Custom Hormones

Meta-Analysis Touts Bone Benefits of Soy

Mediterranean Diet for Pregnant Moms Wards Off Asthma, Allergies in Kids

FDA Approves Sales of Cloned Milk, Meat

The US Food and Drug Administration (FDA) on January 15 released its long-awaited final risk assessment on the safety of meat and milk from healthy, cloned animals and their offspring. The agency concluded that these products pose no risk to human health. The release of this document paves the way for the marketing of meat and milk from cloned cows, pigs, and goats in the United States in the future, without concurrent plans to label these foods as having derived from cloned animals.

The issue of allowing products from cloned animals into the US food chain has been a contentious one since the draft risk assessment, published in December 2006, elicited strong responses from opposing parties and some consumer groups during the FDA’s mandatory comment period.

For now, the FDA is still asking the industry to continue its voluntary moratorium on milk and meat from any cloned animals (thought to number a few hundred). How long the moratorium will remain in place, however, is unknown, since the request does not hold for progeny of cloned animals. Experts reason that products of cloned animals are not likely to make their way onto supermarket shelves any time soon because the high cost of cloning animals (said to be between $15000 and $20000 per animal) makes little economic sense at the present time. Instead, clones of the very-best breeding stock may be used to produce high-quality offspring destined for milk production or human consumption in later years.

Despite such assurances, there are troubling aspects to the issue of cloning animals for food purposes. The most immediate concern is the labeling of cloned material in foods, since the FDA does not plan to require manufacturers to make any declaration of cloned content on labels. Omitting this information, opponents say, would deprive consumers of the choice to opt out of cloned products. Furthermore, the technology raises issues of animal welfare, as well as the ethical and environmental implications of cloning. Insiders in the food industry expect that major battles over this issue will occupy Congress and the FDA for decades to come.

FDA Cracks Down on Compounding Pharmacies Distributing Custom Hormones

FDA government health officials began on January 9 to crack down on Internet sales by compounding pharmacies of custom-mixed hormones for menopausal women, a market created 5 years ago when doctors deemed prescription estrogen therapy too risky for many patients.

Citing safety concerns, the FDA sent letters to 7 pharmacies insisting that these companies cease their claims that "bioidentical hormone replacement therapy" (BHRT) products are a safer alternative to hormone replacement therapy (HRT). The FDA said that assertions regarding BHRT products are not supported by medical evidence and that the pharmacy operations are breaking the law by making false and misleading claims about these products. The FDA further contended that some mixes contain the hormone estriol, which the agency has not approved for sale in the United States.

Additionally, the FDA took some pharmacies to task for claiming that the products could prevent or treat serious diseases, including Alzheimer's, stroke, and some cancers. Officials said there is no credible evidence to support those claims and urge women instead to use the lowest effective dose of FDA-approved HRT drugs for the shortest time possible to combat the symptoms of menopause.

The market for BHRT products arose in 2003 after studies warned that replacement hormones made by drug companies raised the risk of heart attack, breast cancer, and stroke. Since that time, many women have turned to the estrogen, progesterone, and testosterone products sold by compounding pharmacies for relief of menopausal symptoms.

FDA warning letters were sent to Panorama Compounding Pharmacy of Lake Balboa, California; Saint John's Medical Plaza Pharmacy of Santa Monica, California; Murray Avenue Apothecary of Pittsburgh, Pennsylvania; Village Compounding Pharmacy of Houston, Texas; Pharmacy Compounding Specialties of Dallas, Texas; Reed's Compounding Pharmacy of Tucson, Arizona; and Pacifica Pharmacy of Torrance, California.

Many in the complementary and alternative medicine industry oppose this move by FDA, claiming it is driven by pharmaceutical interests and demonizes safe products that are helpful to many women.

Meta-Analysis Touts Bone Benefits of Soy

Menopausal women who increase their soy isoflavone consumption from dietary or supplemental sources for 6 months can boost bone-mineral density in the spine by almost 1 g, according to a meta-analysis of 10 randomized, controlled trials published in the February 2008 issue of the journal Clinical Nutrition. A total of 608 subjects provided data for the analysis, which reported the favorable effects were significant with consumption of approximately 90 mg of isoflavones per day.

Previous studies have reported conflicting results concerning bone health for postmenopausal women and soy isoflavones in doses varying from 40 to 99 mg/day. While the intake of isoflavones varied greatly among the trials used for this meta-analysis (ranging from 4.4 to 150 mg/day) and trial duration also varied (ranging from 3 to 24 months) the new meta-analysis results add to the debate by reporting that doses of 90 mg/day—or even slightly less—of soy isoflavones may improve bone density.

The study’s researchers report that isoflavone consumption was associated with an increase of 20.6 mg per sq cm in spine bone-mineral density (SBMD) compared to subjects consuming placebo. Moreover, isoflavone intake of more than 90 mg/day and lasting at least 6 months was responsible for a 28.5 and 27 mg per sq cm increase in SBMD, respectively. In addition, the spine bone mineral content was 0.93 g higher on average in subjects taking isoflavones compared to placebo.

Limiting bone loss in post-menopausal women could ease the burden of osteoporosis, a disease that affects half of all women over the age of 50 worldwide.

Mediterranean Diet for Pregnant Moms Wards Off Asthma, Allergies in Kids

Pregnant women who eat a Mediterranean diet rich in fish, fresh fruits and vegetables, legumes, nuts, dairy products, and olive oil may help protect their children against asthma and allergies, according to a study published January 15 online ahead of print in the journal Thorax.

The study followed 468 mother and child pairs from Menorca, Spain, from pregnancy up to 6.5 years after birth. The researchers collected information on maternal eating habits and on the children's subsequent asthma and allergy symptoms. Researchers rated the quality of the Mediterranean diet followed by the mothers as either high or low. A woman participating in the study who ate what was considered a high-quality Mediterranean had vegetables more than 8 times per week, fish more than 3 times per week, and legumes more than once per week. Women considered to be eating a low-quality Mediterranean diet also ate fresh fruit and vegetables but ate red meat instead of fish more than 3 to 4 times per week. About 36% of the mothers ate a low-quality Mediterranean diet during pregnancy, while the rest ate a high-quality Mediterranean diet.

The study found that mothers who ate a high-quality Mediterranean diet during pregnancy were significantly more likely to have children free of asthmatic symptoms and allergies than women who ate a low-quality Mediterranean diet.
Allergy and asthma symptoms were measured by the percentage of children who suffered from persistent wheezing and/or positive responses to skin test allergens. Of the 468 children tested, 13% had persistent wheezing, 17% had positive responses to skin test allergens, and almost 6% had asthma-like symptoms combined with positive skin-allergen tests, with the children of women eating a high-quality Mediterranean diet testing significantly lower on the allergy scales than their low-quality diet counterparts. Children's eating habits at the age of 6.5 years seemed to have little effect on their asthma or allergy risk, the study found.