In the News

Food Safety Modernization Act Edges Toward Vote

FDA Cracks Down on Supplement “Spiking”; AHPA Reacts

Pesticide Exposure Linked to ADHD in Children

Homeopathy Prevents Leptospirosis Infection

Food Safety Modernization Act Edges Toward Vote

On August 12, 6 US Senators released S. 510, a bipartisan agreement called the FDA [US Food and Drug Administration] Food Safety Modernization Act. This move guarantees full debate on the bill this September. The bill was passed unanimously by the Health, Education, Labor and Pensions (HELP) Committee last November but has been stalled in the Senate since July.

Lawmakers brokering the agreement were HELP Committee chairman Tom Harkin (D, Iowa); ranking member Mike Enzi (R, Wyoming); Food Safety Modernization Act authors Dick Durbin (D, Illinois) and Judd Gregg (R, New Hampshire); and lead cosponsors Chris Dodd (D, Connecticut) and Richard Burr (R, North Carolina). The Senators allege that the bill would empower the US Food and Drug Administration to order product recalls, increase the frequency of plant inspections, and require all facilities that manufacture, process, pack, or hold food to have preventive control plans in place to prevent adulteration of food products.

At present, 2 major proposals remain unresolved: an exemption for smaller businesses from some of the bill’s requirements and a restriction on the use of bisphenol A. In light of a spate of US food-borne illness outbreaks in the past few years, the bill has broad consumer and mainstream industry support, including from the Center for Science in the Public Interest and the Grocery Manufacturers of America. According to the Centers of Disease Control and Prevention, 300 000 people in the United States are hospitalized every year due to food-borne illness and about 5000 die. Whether the bill is overkill, however, is still in question: Numerous natural products industry members and small restaurant owners are opposed to the bill, stating it is too overbearing.

 For an overview of the Food Safety Modernization Act, go to www.opencongress.org/bill/111-s510/show and click on the “Official Summary” arrow at the bottom.

FDA Cracks Down on Supplement “Spiking”; AHPA Reacts

FDA aims to curb what it regards to be an “emerging trend” of dietary supplements spiked with prescription drug ingredients and sold as wholly “natural” remedies. Warning consumers that unstudied pharmaceutically active ingredients are increasingly cropping up in products promoted for bodybuilding, weight loss, and sexual enhancement, the agency details actions it has taken against such products on a new web page: www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm207647.htm. This page lists cases of spiked supplements dating back to 2006 and reminds consumers that FDA can test only a small fraction of suspect products currently on the market.

The American Herbal Product Association (AHPA) noted that the announcement was no surprise given recent statements from agency sources. In May, FDA Principal Deputy Commissioner Dr Joshua Sharfstein testified to Congress that of all the agency’s dietary supplement regulation concerns, the greatest was the pharmaceutical spiking of supplements because of the serious threat these additions pose to consumers. AHPA sees these statements and actions as a warning to the natural products industry that any knowing addition of pharmaceutical elements to supplements may result in felony indictments against the responsible parties.

The FDA crackdown also serves as a warning to companies that may inadvertently market spiked products containing drugs added by remote manufacturers. In order to bolster industry awareness of established Good Manufacturing Practices, AHPA is presenting a 2-day seminar on “Microscopic Identification of Popular Botanical Materials” on November 13-14, 2010, at the University of Southern California’s School of Pharmacy in Los Angeles.

As a proactive step, readers may wish to visit the quality assurance section of the website for Integrative Medicine: A Clinician’s Journal (www.imjournal.com). Along with numerous free articles on quality assurance issues, the site includes a form for clinicians to query manufacturers and/or suppliers about their quality control and quality assurance practices. More than simply asking questions, the form asks for documentation to provide verification that companies are, in fact, performing the quality assurance tests they claim to be doing. It is easy to answer yes to a question on a form; it is more difficult to provide proof. To find the form, in the menu bar of the IMCJ website, click on “Resources and Content.” The second listing on the drop-down menu is “Quality Assurance.” On the corresponding web page, you will see “The IMCJ Supplement Quality Audit Form.”

Pesticide Exposure Linked to ADHD in Children

Children exposed in utero to organophosphate (OP) pesticides were more likely to develop attention disorders by preschool, according to a study published online in Environmental Health Perspectives. This study adds to a growing body of evidence that OP pesticides, designed to attack the nervous systems of insects, adversely affect the human brain.

The Mexican-American mothers participating in the study conducted through the University of California-Berkeley were recruited during pregnancy by the Center for the Health Assessment of Mothers and Children of Salinas (CHAMACOS). Researchers chose women from the Salinas Valley of California because it is an area of intensive agriculture where more than 235 000 kg of pesticides are applied annually.

 To test if the women absorbed pesticides and then passed them onto their children, the researchers analyzed 6 OP metabolites in urine samples collected from the mothers during pregnancy and from their children several times after birth. The presence of these metabolites indicated exposure to OP pesticides used in the region. The children's behavior was assessed at the ages of 3.5 years (n = 331) and 5 years (n = 323) using reports from the mothers and standardized psychological tests.

The results indicated that as the concentration of OP metabolites in the urine of pregnant women increased, so did the likelihood that their children's test scores would be consistent with a clinical diagnosis of attention deficit hyperactivity disorder (ADHD). The association was stronger at age 5 years and more pronounced in boys than in girls. Prenatal exposures had a greater association than did exposures after birth: a 10-fold increase in levels of measured pesticide metabolites in the mother's urine during pregnancy correlated to about a 500% increase in the likelihood of attention issues in their 5-year-olds, whereas a 10-fold increase in levels of metabolites in the children's urine at 5 years of age corresponded to a 30% higher likelihood.

Studies like this one are the subject of a new database designed to track published epidemiologic and real-world exposure studies. The Pesticide-Induced Diseases Database currently contains 383 entries of epidemiologic and laboratory exposure studies and is the brainchild of the national environmental and public health group Beyond Pesticides. To view the database, go to www.beyondpesticides.org/health/.

Homeopathy Prevents Leptospirosis Infection

In the largest study of homeopathy ever conducted, researchers found that a homeopathic intervention effectively battled Leptospirosis. The study, conducted in 2007 on the entire population of Cuba (11 million people), was published in a recent issue of the journal Homeopathy.

Leptospirosis is a zoonotic infectious disease prevalent in tropical regions during periods of heavy rain; humans contract the disease through contact with contaminated water.

Each year, Cuba’s government forecasts possible trends of disease incidence. In late 2007, the government had only enough Leptospirosis vaccine to treat 15 000 high-risk people in the midst of a developing epidemic. Thus, the decision was made to treat the hardest-hit unvaccinated populations with a homeopathic medicine prepared from dilutions of 4 circulating strains of Leptospirosis. The Cuban National Vaccine Institute prepared the dilution and collected data to measure the impact of the intervention by comparing the data to historical trends and data from nonintervention regions.

The homeopathic medicine was given to the 2.3 million inhabitants of the 3 provinces most prone to outbreaks. Within a month, the number of Leptospirosis cases had fallen from the forecast of 38 cases per 100 000 per week to 4 cases per 100 000 per week, significantly fewer than the historically based forecast. The 8.8 million residents of the other provinces did not receive homeopathic treatment, and the incidence of the disease unspooled there as forecast.

Although more research is warranted, this large study has shed light on the possibility of reducing disease incidence and controlling epidemics safely via use of homeopathy.