Burkholderia cepacia complex outbreak linked to a no-rinse cleansing foam product, United States - 2017-2018.

In March 2018, the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention, California Department of Public Health, Los Angeles County Department of Public Health and Pennsylvania Department of Health initiated an investigation of an outbreak of Burkholderia cepacia complex (Bcc) infections. Sixty infections were identified in California, New Jersey, Pennsylvania, Maine, Nevada and Ohio. The infections were linked to a no-rinse cleansing foam product (NRCFP), produced by Manufacturer A, used for skin care of patients in healthcare settings. FDA inspected Manufacturer A's production facility (manufacturing site of over-the-counter drugs and cosmetics), reviewed production records and collected product and environmental samples for analysis. FDA's inspection found poor manufacturing practices. Analysis by pulsed-field gel electrophoresis confirmed a match between NRCFP samples and clinical isolates. Manufacturer A conducted extensive recalls, FDA issued a warning letter citing the manufacturer's inadequate manufacturing practices, and federal, state and local partners issued public communications to advise patients, pharmacies, other healthcare providers and healthcare facilities to stop using the recalled NRCFP. This investigation highlighted the importance of following appropriate manufacturing practices to minimize microbial contamination of cosmetic products, especially if intended for use in healthcare settings.

A role for PPARalpha in the control of SREBP activity and lipid synthesis in the liver.

Inclusion of the PPARalpha (peroxisome-proliferator-activated receptor alpha) activator WY 14,643 in the diet of normal mice stimulated the hepatic expression of not only genes of the fatty acid oxidation pathway, but also those of the de novo lipid synthetic pathways. Induction of fatty acid synthase mRNA by WY 14,643 was greater during the light phase of the diurnal cycle, when food intake was low and PPARalpha expression was high. Hepatic fatty acid pathway flux in vivo showed a similar pattern of increases. The abundance of mRNAs for genes involved in hepatic cholesterol synthesis was also increased by WY 14,643, but was associated with a decrease in cholesterogenic carbon flux. None of these changes were apparent in PPARalpha-null mice. Mice of both genotypes showed the expected decreases in 3-hydroxy-3-methylglutaryl-CoA reductase mRNA levels and cholesterol synthesis in response to an increase in dietary cholesterol. The increase in fatty acid synthesis due to WY 14,643 was not mediated by increased expression of SREBP-1c (sterol regulatory element binding protein-1c) mRNA, but by an increase in cleavage of the protein to the active form. An accompanying rise in stearoyl-CoA desaturase mRNA expression suggested that the increase in lipogenesis could have resulted from an alteration in membrane fatty acid composition that influenced SREBP activation.

2000-2001 food label and package survey: an update on prevalence of nutrition labeling and claims on processed, packaged foods.

The food label is an important tool for improving the public's understanding of the health benefits of following a nutritious diet. The Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA) has continued to study food labels with its Food Label and Package Survey (FLAPS). Data from the 2000-2001 FLAPS characterize various aspects of the labeling of processed, packaged foods, including nutrition labeling and various types of label claims. The FDA used a multistage, representative sample of food products from the Information Resources Inc (IRI) 1999 supermarket database as the basis for the FLAPS sample. The final FLAPS database consists of 1281 foods. An estimated 98.3% of FDA-regulated processed, packaged foods sold annually have nutrition labels, with an additional 1.7% of products exempt from nutrition labeling requirements. Health claims (4.4%), structure/function claims (6.2%), and nutrient content claims (49.7%) were identified on food labels. In addition to the resource this survey provides to CFSAN in assessing health and nutrition information on the food label, registered dietitians and other health professionals can use FLAPS data to assist consumers in choosing a more nutritious diet to improve their health and well-being.