FDA Delays Food Registration Period

Today was supposed to be the first day food facilities could re-register information with the Secretary of the Department of Human Health and Services.

But FDA has put on hold the biennial registration requirements. The government agency says on its website it is not accepting food facility registration renewals at this time.

FDA is delaying the registration renewals that are mandated under a 2011 law after the Grocery Manufacturers Association and numerous other trade associations recently sought guidance in meeting the registration requirements.

"It would be extremely inefficient and costly for companies to re-register shortly after October 1st based on the old procedures, only to find out later they have to do it all over again after FDA clarifies the new procedures in its guidance," wrote Leon Bruner, senior vice president, science and regulatory affairs, and chief science officer of the Grocery Manufacturers Association, in a Sept. 21 letter to the Office of Management and Budget. "Thus, it will be difficult, if not impossible, for food facilities to effectively and efficiently meet FSMA's registration renewal mandate without guidance from FDA."

The FDA Food Safety Modernization Act requires domestic and foreign facilities that manufacture, process, pack or hold food for consumption in the U.S. to register every two years starting with a renewal period stretching from October 1, 2012 through December 31, 2012. The requirements apply to beverages, conventional foods and supplements, said Justin Prochnow, a Denver-based shareholder with the international law firm of Greenberg Traurig, LLP.

FDA recommends companies check its website or sign up for FSMA updates to learn when the registration renewal becomes available.
The agency has explained the registration information will help it find the location and source of a bioterrorism event or foodborne illness.

EFSA Rejects French Study on GMO Corn

The European Food Safety Authority (EFSA) has concluded that a controversial paper by French scientists linking genetically modified (GMO) corn to an increase risk in cancer in rats is of “insufficient scientific quality to be considered as valid for risk assessment."

EFSA’s initial review, published Oct. 4, found the design, reporting and analysis of the study, as outlined in the paper, are inadequate. The agency also invited authors Séralini et al to share key additional information to enable the fullest understanding of the study.

Such shortcomings mean EFSA is presently unable to regard the authors’ conclusions as scientifically sound. The numerous issues relating to the design and methodology of the study as described in the paper mean that no conclusions can be made about the occurrence of tumors in the rats tested.

“Therefore, based on the information published by the authors, EFSA does not see a need to re-examine its previous safety evaluation of maize NK603 or to consider these findings in the ongoing assessment of glyphosate. EFSA assessed the paper against recognized good scientific practices, such as internationally agreed study and reporting guidelines," the agency said in a statement.

Per Bergman, who led EFSA’s work, said: “Some may be surprised that EFSA’s statement focuses on the methodology of this study rather than its outcomes; however, this goes to the very heart of the matter. When conducting a study it is crucial to ensure a proper framework is in place. Having clear objectives and the correct design and methodology create a solid base from which accurate data and valid conclusions can follow. Without these elements a study is unlikely to be reliable and valid."

EFSA’s preliminary review is the first step in a two-stage process. A second analysis will be completed by the end of October 2012, and will take into account any additional information from the study authors, who will be given an opportunity to supply study documentation and procedures to the agency to ensure the broadest possible understanding of their work. It will also include an overview of Member State assessments of the paper and an analysis from the German authorities responsible for the assessment of glyphosate.

Low Vitamin D Levels Increase Mortality

Low levels of vitamin D and high levels of parathyroid hormone are associated with increased mortality in black and Caucasian older adults, according to a new study accepted for publication in Journal of Clinical Endocrinology and Metabolism (JCEM). The findings also suggest the potential impact of remediating low vitamin D levels is greater in blacks than Caucasians because vitamin D insufficiency is more common in blacks.

Low levels of vitamin D have been directly associated with various forms of cancer and cardiovascular disease. Most studies regarding the health effects of low vitamin D levels have been conducted on persons of European origin, but the current study examines the relationship between vitamin D and mortality in blacks and Caucasians.

The Second National Report on Biochemical Indicators of Diet and Nutrition report published in April 2012 by the Centers for Disease Control and Prevention (CDC) found deficiency rates for vitamins and nutrients vary by age, gender, or race/ethnicity and can be as high as 31% for vitamin D deficiency in non-Hispanic blacks.

“We observed vitamin D insufficiency in one-third of our study participants. This was associated with nearly a 50% increase in the mortality rate in older adults," said Stephen B. Kritchevsky, PhD, Professor of Internal Medicine and Transitional Science at the Wake Forest School of Medicine, and lead researcher of the study. “Our findings suggest that low levels of vitamin D may be a substantial public health concern for our nation’s older adults."

For the study, 2,638 Caucasians and blacks aged 70-79 years were asked to fast for 12 hours, after which a blood sample was collected to determine levels of vitamin D. Every six months study participants were contacted to ascertain their medical condition. The study determined the proportion of deaths among participants of with different vitamin D levels. In addition to many health factors, the time of year was also taken into account due to the seasonal effects on vitamin D. Researchers found levels of vitamin D less than 30 ng/ml were associated with significantly increased all-cause mortality.

“We all know that good nutrition is important to overall health, and our study adds to a growing body of literature that underscores the importance of vitamin D and indicates that poor vitamin D nutrition is widespread," said Kritchevsky. “The good news is it’s easy to improve vitamin D status either through increased skin exposure to sunlight or through diet or supplements."

A 2010 study conducted by researchers from Emory University found almost 75% of healthy, low-income, minority children were low in vitamin D. They also found age and season were significant predictors of vitamin D deficiency, and most children get their vitamin D through fortified milk.

Study Says Metabolized BPA Poses Bigger Threat

Numerous studies have reported associations between bisphenol A (BPA) exposure and myriad adverse health and development effects, from cancer and neurological disorders to physiological defects and, perhaps, a cause of childhood obesity. Now, new research published in the journal PLoS ONE suggests metabolic changes that take place once BPA is broken down inside the human body pose a greater health threat than previously thought.

Of particular concern is that BPA exposure is correlated with disruption of estrogen signaling. The chemical’s molecular structure is similar to that of estradiol, one of the human body’s three main estrogens, suggesting that BPA binds to estrogen receptors. In binding to the estrogen receptor, BPA can disrupt the body’s endocrine or hormone system, with consequences especially worrisome for fetuses, infants and young children. Earlier this year,the U.S. Food and Drug Administration (FDA) banned BPA in baby bottles and sippy cups.

Scientists at UC San Diego School of Medicine said three-dimensional modeling suggests a metabolite of BPA—a molecule produced when BPA is metabolized or broken down by the body—actually binds to the estrogen receptor much more strongly than BPA itself. The finding could point the way to development of a new class of drugs designed to specifically inhibit excessive estrogen activity linked to disease.

In 2004, researchers in Japan discovered that another compound, dubbed MBP, was produced when BPA was metabolized. MBP has a 100-fold to 1,000-fold stronger bond to the estrogen receptor than BPA; however, the structural basis for MBP’s high affinity for the estrogen receptor was not investigated further.

For this study, the researchers creating 3D molecular models of MBP and BPA in the estrogen receptor and matching it against the crystal structure of estradiol in the estrogen receptor. They found that MBP’s longer structure allows both ends of the chemical to interact with the estrogen receptor in a way similar to estradiol. The shorter BPA molecule contacts the receptor at just one end, resulting in a weaker connection, providing an explanation for BPA’s lower affinity for the estrogen receptor.

The researchers said the 3D modeling supports the idea “that BPA is not the endocrine disruptor culprit. Instead, MBP is one (of perhaps several BPA metabolites) that causes disruption of estrogen signaling in humans and other animals."

They said research points to the need to measure MBP levels in urine and blood of patients suspected of BPA-mediated health effects, and may fuel development of a new therapeutic treatment for conditions linked to excessive estrogen levels and activity, such as some forms of breast and prostate cancers