Study: Probiotic in first three months of life reduces incidence of gastrointestinal disorders
CHICAGO — Giving an infant a probiotic during the first three months of life appears to reduce the onset of gastrointestinal disorders and result in lower associated costs, according to a study by Flavia Indrio of the Aldo Moro University of Bari, Italy, that was released earlier this week.
Infant colic, acid reflux and constipation are the most common gastrointestinal disorders that lead to a pediatrician referral during the first six months of life. They are often responsible for hospitalization, feeding changes, use of drugs, parental anxiety and loss of parental working days, according to the study background.
Researchers randomized 554 newborns in nine pediatric units in Italy to the probiotic Lactobacillus reuteri DSM 17938 (L reuteri DSM 17938) or placebo for 90 days, and asked parents to record in diary entries the number of vomiting episodes and evacuations, the duration of inconsolable crying and the number of pediatrician visits. Change in daily crying time, vomiting, constipation and the cost benefits of probiotic supplement use was measured during the three-month period.
At 3 months of age, the average duration of crying time (38 minutes vs. 71 minutes), regurgitations (2.9 vs. 4.6) and evacuations per day (4.2 vs. 3.6) differed in the probiotic and placebo groups, respectively. Probiotic use also was associated with a nearly $119 average savings per patient in each family.
"Driving a change of colonization during the first weeks of life through giving lactobacilli may promote an improvement in intestinal permeability; visceral sensitivity and mast cell density and probiotic administration may represent a new strategy for preventing these conditions, at least in predisposed children," the authors concluded.
FDA warns of flammability of cryogenic wart removers
SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.
Since 2009, FDA has received 14 such reports about over-the-counter wart remover products. Ten patients have described singed hair, blisters, burns or skin redness, the agency stated.
FDA issues final guidance distinguishing liquid dietary supplements from beverages
SILVER SPRING, Md. — The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages. "We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage," the agency stated. "This guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods."
According to the FDA, the most obvious representations about a product’s use are claims made for the product in its labeling and advertising. "However, a product’s name, packaging, serving size, recommended daily intake and other recommended conditions of use and composition, as well as marketing practices and representations about the product outside its labeling and advertising, can also be important determinants of whether the product is represented as a conventional food (and, thus, may not be marketed as a dietary supplement)," the agency wrote. "Although in some circumstances a single factor may be determinative of whether the product is represented as a conventional food, … in most circumstances a combination of factors would determine whether the product is represented as a conventional food."
The following is a run-down of the differentiators, as defined by the FDA:
- Labeling and advertising: Generally, products that bear statements that the product is intended to “refresh” or “rehydrate” represent the product for use as a beverage, i.e., a conventional food;
- Product name: Product or brand names that use such conventional food terms as “beverage,” “drink,” “water” or “soda” represent the product as a conventional food;
- Product packaging: Packaging characteristics that should be considered include the size, shape, color and design of the container or other packaging, the volume of liquid it holds, whether it is reclosable or designed to be consumed in a single serving, and the similarity of the packaging to packaging used for common beverages;
- Serving size and recommended daily intake: Liquid products that suggest through their labeled serving size and/or recommended daily intake (e.g., “Drink up to three 16-ounce bottles per day”) that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States are effectively being represented as conventional foods;
- Composition: Adding common dietary supplement ingredients to a beverage does not make it a dietary supplement per se. Products that are consumed primarily for taste rather than nutrition or health-related purposes are beverages;
- Other representations about a product: Other representations about a product include, for example, representations in publicly available documents, such as statements made in filings with government agencies such as the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
"FDA intends to consider all relevant factors in context when determining whether a product is represented as a conventional food," the agency stated.