In the News

FDA Seeks to Restrict Antibiotics in Livestock

Adverse Event Reporting Guidance for Supplements Finalized

N-acetylcysteine May Offer Relief to Trichotillomaniacs

Fish Oil During Pregnancy May Halt Pediatric Allergy

FDA Seeks to Restrict Antibiotics in Livestock

The US Food and Drug Administration (FDA) announced in mid-July that it intends to restrict many routine uses of antibiotics in farm animals in an effort to curb the spread of dangerous bacteria in humans. In written testimony to the House Rules Committee, Joshua Sharfstein, MD, principal deputy commissioner at FDA and a pediatrician, recommended that the food industry cease feeding antibiotics to healthy livestock. He cited a report by the Union of Concerned Scientists that nearly 70% of antibiotics used in the United States is dosed to healthy chickens, pigs, and cattle to encourage their growth or to prevent illnesses. Sharfstein further asserted that antibiotics should no longer be administered to food animals without the supervision of a veterinarian.

The hearing was held to discuss a measure proposed by Representative Louise M. Slaughter (D, New York), chair of the House Rules Committee. The bill, HR-1549, would ban 7 classes of antibiotics important to human health from use in food animals and would restrict other antibiotics to therapeutic and preventive uses. An equivalent bill in the Senate, S.619, sponsored by Senator Edward Kennedy (D, Massachusetts), is still in committee.

Much of this testimony summarized information that has been accepted for years by medical groups, and HR-1549 is supported by the American Medical Association. Many farm organizations dispute these claims, however, arguing that there are no studies connecting antibiotic-resistant diseases to antibiotic use in food-animal production. The farm lobby also cites Iowa State University research claiming that a ban on antibiotics for growth promotion in the pork industry would raise production costs by $13 per kg (2.2 lb) and increase the retail price of pork by 2%. Lawyers for the lobby also insist that requiring veterinary approval for antibiotics would add undue paperwork burdens and expense to farmers.

The farm lobby’s opposition makes passage of the bill unlikely, but advocates see the committee hearings as a step forward and, with FDA officials on their side, hope to see an antibiotic ban attached to upcoming healthcare reform legislation. If this is something of interest to you (as it should be), please follow up with your local congressperson to support the bill’s passage.

Adverse Event Reporting Guidance for Supplements Finalized

Released on July 14, new US Food and Drug Administration (FDA) guidance to the dietary supplement industry concerning the reporting of adverse events augments and clarifies those first proposed in December 2007. The 2009 document contains guidance on all aspects of the adverse event reporting (AER) system, including recordkeeping requirements.

Revised AER regulations came into effect in December 2007, requiring all manufacturers, packers, distributors, and marketers of dietary supplements to notify FDA of any serious adverse event reports received in connection with their products. At that time, the American Herbal Products Association (AHPA) filed comments supporting the agency’s guidelines but asking for clarification of some details. AHPA has issued a statement applauding this 2009 AER guidance, noting that FDA has addressed each of the 2007 topics on which it had requested revisions. For instance, FDA clarified that AERs are considered “safety reports” that do not constitute an admission that the product involved caused or contributed to any serious adverse event.

In general, the new guidance reiterates that a serious adverse event is a reaction that resulted in the need for medical intervention, a hospitalization, or death,. A serious adverse event report must be submitted by the party whose name appears on the product label via FDA’s mandatory MedWatch Form 3500A, available at www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.

Reports must be submitted no later than 15 business days after the company receives them. Adverse reports may also be submitted by consumers using the voluntary MedWatch Form 3500, which will soon be available online.

Manufacturers must retain all records related to serious adverse events for a period of 6 years. During an FDA inspection, the agency is authorized to have access to all AER records that manufacturers are required to maintain. To read the full guidance, go to www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm171383.htm.

N-acetylcysteine May Offer Relief to Trichotillomaniacs

The amino acid N-acetylcysteine appears to reduce symptoms of trichotillomania, according to a report in the July issue of Archives of General Psychiatry. The disorder is characterized by the compulsive, recurrent pulling out of one’s hair that results in noticeable hair loss; there is presently no approved pharmaceutical treatment. The double-blind, controlled trial conducted at the University of Minnesota School of Medicine in Minneapolis concluded that N-acetylcysteine may be an inexpensive, well-tolerated treatment for trichotillomania and other repetitive or compulsive disorders.

For this study, 50 individuals with trichotillomania (45 women and 5 men, average age 34.3 years) were randomly assigned to receive 1200 mg to 2400 mg of N-acetylcysteine or placebo per day for 12 weeks. After this time, 56% of the patients taking the amino acid had significantly greater reductions in hair-pulling symptoms than those taking placebo. There were no reported adverse effects.

Researchers surmise that N-acetylcysteine acts on the glutamate system, the largest neurotransmitter system in the human brain, to alleviate repetitive impulses. The efficacy of N-acetylcysteine in this study lends further support to the hypothesis that therapies manipulating the glutamate system may target core symptoms of compulsive behaviors.

Because N-acetylcysteine is available in health-food stores, it’s cheaper than most insurance copayments and prescription pharmaceuticals. Before trichotillomaniacs can add N-acetylcysteine to their health regimens, though, future studies will have to evaluate its long-term effects as well as its capabilities when combined with behavioral therapy.

Fish Oil During Pregnancy May Halt Pediatric Allergy

Supplementing with omega 3–rich fish oils during pregnancy and lactation may reduce the risk of food allergy and eczema in the corresponding children, according to a new study from Sweden published in a recent issue of the journal Acta Paediatrica.

For the randomized, placebo-controlled, double-blind study, the research team recruited 145 pregnant women who had allergies or had partners or other children with allergies. Starting in the 25th week of pregnancy and continuing for between 3 and 4 months of breastfeeding, the women were randomly assigned to receive either daily fish oil supplements providing 1.6 g of eicosapentaenoic acid (EPA) and 1.1 g of docosahexaenoic acid (DHA) or placebo. Following a battery of examinations of the infants, including blood tests for Immunoglobulin E (IgE)—the predominant antibody associated with an allergic response—the researchers observed only a 2% prevalence of food allergy in the omega-3 infant group, compared to 15% in the placebo group. Furthermore, the incidence of IgE-associated eczema was one-third less (8%) in the omega-3 infant group, compared to 24% in the placebo group.

The study leaders deduced that EPA and DHA inhibit IgE antibody production by changing the fluidity of the membranes of immune cells and reducing the levels of the omega-6 fatty acid arachidonic acid (AA). By inhibiting the metabolism of AA, the formation of the less inflammatory eicosanoids is favored, which may be linked to a lessened allergic reaction in the children.

This trial adds to the growing body of evidence of the benefits of omega-3 fatty acids.