Posts Tagged “FDA”
by The U.S. Food and Drug Administration
The U.S. Food and Drug Administration announced it has completed its evaluation of a variety of pineapple genetically engineered by Del Monte Fresh Produce (DMFP) to have pink flesh, concluding that there are no unresolved safety or regulatory questions about the pineapple. DMFP submitted information to the agency to demonstrate that the pink flesh pineapple is as safe and nutritious as its conventional counterparts. DMFP’s new pineapple has been genetically engineered to produce lower levels of the enzymes already in conventional pineapple that convert the pink pigment lycopene to the yellow pigment beta carotene. Lycopene is the pigment that makes tomatoes red and watermelons pink, so it is commonly and safely consumed.
In addition, after consulting with the FDA, DMPF plans to identify the food as “extra sweet pink flesh pineapple” on tags attached to the crown of the fruit. This will distinguish the pink flesh pineapple from DMFPs golden” extra sweet pineapple” which was introduced in the 1990s.
DMFP participated in a voluntary consultation with FDA’s Office of Food Additive Safety about the pineapple. During that consultation, DMFP submitted information to FDA scientists regarding characteristics of the new plant variety, the nature and effect of the genetic change, potential unexpected or unintended effects that could accompany the genetic change, and the nutritional assessment. After review of that data FDA scientists concluded that there were no unresolved safety or regulatory issues under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the genetically engineered pink flesh pineapple.
A consultation is not synonymous with FDA approval. Rather, it is voluntary and helps developers of food ensure that foods derived from new plant varieties are safe and comply with the FD&C Act and FDA’s regulations.
Although DMFP will market this pineapple in the United States, they are not planning on growing it here. The company is working with the government of Costa Rica on this matter.
by Hass Avocado Board
MISSION VIEJO, California – The U.S. Food and Drug Administration (FDA) has proposed new guidance for the use of the nutrient content claim “healthy” on food labeling, and fresh avocados meet the criteria. Long touted for the range of health and wellness benefits associated with them, avocados can finally bear the claim that sums it all up: avocados are healthy.
While 90% of consumers report that they purchase avocados based on the nutritional benefits they provide, 21% still say that the fat content in avocados is a barrier to purchase, despite the fact that the latest science demonstrates that the type of fat, rather than the total amount, is more important to good health.
The term “healthy” on food labels is regulated by the FDA and reserved for foods low in fat among other restrictions. The past definition, which was established more than 20 years ago, focused on total fat content per serving. The new proposed guidance from FDA gives consideration to the breakdown between good (unsaturated) and bad (saturated) fats in light of new evidence and dietary recommendations in the recently published 2015-2020 Dietary Guidelines for Americans (DGA). Avocados contain 8 g of fat per 50 g serving, over 75% of which are naturally good fats (monounsaturated and polyunsaturated fats). Avocados comply with the new FDA guidance because they have a fat profile of predominantly naturally good monounsaturated fats.
“With the pervasiveness of many chronic diseases in the US population, consumers are thinking about the ways to make healthy food choices for themselves and their families” said Emiliano Escobedo, Executive Director of the Hass Avocado Board (HAB). “We applaud the FDA for its efforts in updating the guidance on what makes a food healthy, and recognizing that good fats play an important role in healthy diets.”
For industry, this means fresh avocados can start to use the term “healthy” in marketing and communications as well as packaging and point-of-sale materials. HAB is updating its messages and materials to include the claim.
Avocados are a healthy fruit that provide a good source of fiber and folate per 50 g serving (one-third of a medium avocado), and nearly 20 vitamins, minerals and beneficial plant compounds that can enhance the nutrient quality of the diet. A healthy fruit, avocados are virtually the only fruit that contain monounsaturated fat, and they are sodium, cholesterol and trans-fat free. To learn more about the naturally good fats in avocados, the latest avocado nutrition research and fresh avocado recipes, visit LoveOneToday.com/goodfats.
Numerous new mandates for refrigerated carriers governing not only the condition and operation of equipment used transport foodstuffs but the capture and preservation of shipment temperatures, along with driver training requirements, These are due to become effective March 31.
The Food Safety Modernization Act (FSMA) has new rules approved by Congress and signed into law by the president in 2011.
The mandate requires the FDA [the U.S. Food and Drug Administration] to be an enforcement agency in the food supply chain. Violations of the mandate can lead to criminal prosecution.
While shippers and receivers are primary targets of the FSMA, refrigerated carriers become involved as the new rules require detailed temperature data to be collected and maintained, while imposing equipment and driving requirements as well.
There are three main broad areas where refrigerated truckers can be affected:
(1) They would be required to develop and implement written procedures – subject to record keeping, probably for a 12 month time period – that describes how they provide temperature data;
(2) Their practices for cleaning, sanitizing, and inspecting vehicles and transportation equipment;
(3) and establish requirements for the training of carrier personnel engaged in transportation operations, including a requirement for records that document the training.
While the FDA will not be telling shippers and carriers how to deliver foodstuffs, it will be in charge of establishing the framework for what’s required to deliver such goods and enforce those requirements. Thus, the FDA now becomes an integrated part of the supply chain. In effect, the FDA will become an enforcement agency – and one of their tools will be criminal prosecution.
Refrigerated fleets will feel specific impacts in several key areas of their operations:
- It will affect trailer designs, depending on shipper requirements resulting from the new rules;
- It will tighten sanitary cleaning requirements of said trailers;
- There will be a “pre-cool” requirement for many shipments;
- Temperature tracking will be mandated;
- Data exchange and retention will be mandated;
- Driver food safety training will be required and a record of that training must be kept on file for access upon request.
Food transportation companies will be required to adhere to certain sanitation standards to prevent food from becoming contaminated during transit under a new rule proposed by the U.S. Food and Drug Administration, according to a recent article by Reuters.
Carriers and shippers under the rule would be required to properly refrigerate food, clean vehicles between loads and protect food during transportation.
The rule is the seventh and final plank of the 2011 Food Safety Modernization Act, a sweeping initiative designed to reduce food-borne illnesses by giving the FDA greater powers to intervene before an outbreak occurs.
It would establish standards for vehicles and transportation equipment, transportation operations, information exchange, training and records.
“This proposed rule will help reduce the likelihood of conditions during transportation that can lead to human or animal illness or injury,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.
Excluded from coverage will be shippers, receivers or carriers whose operations generate less than $500,000 in annual sales. The rule also excludes food that is fully packaged and stable, and live food animals and raw agricultural commodities transported by farms.
The FDA proposes staggering the implementation of the rule based on the size of a business, ranging from one to two years after publication of the final rule. The proposed rule is open for public comment through May 31.
Looking for healthy food in your local supermarket produce department. 
Nuts are often cited for healthy reasons – and a new study on pistachios is favorable.
A Pennsylvania State University study published online this month in Hypertension, an American Heart Association Journal, reveals that including pistachios in a healthy diet may positively reduce the body’s response to the stresses of everyday life.
Adults with elevated cholesterol were enrolled in a randomized, controlled clinical trial comparing diets containing pistachios to a low fat diet. The results show that a healthy diet supplemented with pistachios helps decrease systolic blood pressure, peripheral vascular resistance and heart rate during acute stress. Cardiovascular responses were measured while participants engaged in a challenging mental arithmetic test and again as they immersed their foot in cold water.
The study conducted at Pennsylvania State University by Drs. Sheila G. West and Penny M. Kris-Etherton and colleagues examined how diets containing pistachios
(one-and-a-half and three ounces per day) versus a low-fat diet without pistachios, affect responses to stress on subjects with elevated LDL cholesterol, but normal blood pressure. This study is the first to show that including both salted and unsalted pistachios in a healthy diet helps reduce blood pressure and lessen the vascular load on the heart.
The people in the study were healthy, non-smoking men and women with elevated LDL cholesterol (commonly regarded as bad cholesterol) but normal blood pressure. All of the meals were provided and calorie levels were customized to maintain body weight. Pistachios were substituted for other foods in the diet to prevent weight gain. Participants followed three different diets – one low fat diet (25% fat ) without pistachios, and two with different levels of pistachios (approximately 1.5 oz or 10% of calories from pistachios and 3.0 oz or (20% of calories from pistachios). The pistachio diets contained higher amounts of potassium, healthy fats and protein. All diets were rich in fruit, vegetables, lean meats, and whole grains, consistent with current food-based dietary recommendations. Participant demographics and the diet design have been published previously.2
“Daily events, such as work stress, a tight deadline, or public speaking can increase blood pressure, and we know that we can’t avoid all of the stressors in our lives. These results are significant because they show that physiological responses to stress are affected by the foods we eat,” stated Sheila West, Ph.D., Associate Professor of Biobehavioral Health and the study’s lead author. Dr. West continues, “These changes in blood pressure occurred even though self-reported mood, anxiety, and tension were not changed.”
The largest drop in blood pressure, – 4.8 mm Hg, was associated with eating about one-and-a-half ounces of pistachios a day versus a -1.8 mm Hg on the low-fat diet and, -2.4 mm Hg, three ounces of pistachios per day. The diet containing three ounces of pistachios resulted in a significant decrease in peripheral vascular resistance, a measure of artery stiffness and heart rate versus the control diet. Fifty percent of the pistachios were given salted as a snack and the other half were unsalted and incorporated into recipes. Interestingly, although high sodium intake is typically associated with high blood pressure, the largest drop in in blood pressure was not associated with the lowest sodium diet. Pistachios do provide potassium (8% Daily Value) and magnesium (8% Daily Value) which are important in maintaining a healthy blood pressure.
“In addition, these results are very exciting because they demonstrate further benefits of pistachios on another risk factor for cardiovascular disease,” added Penny M. Kris-Etherton, Ph.D., R.D., Distinguished Professor of Nutrition, and a lead researcher for the study. Dr. Kris-Etherton adds, “Our previous research suggests including pistachios in a healthy diet lowers LDL cholesterol in a dose-response fashion2 and increases antioxidants in the blood.”
“This research adds to the growing body of literature on the health benefits of pistachios,” added Constance J. Geiger, Ph.D., R.D. who serves as a nutrition research consultant with the American Pistachio Growers. Dr. Geiger continues, “Nuts, such as pistachios, are an important part of a healthy diet.”
For more information and to read the full study, go to hyper.ahajournals.org.1
About the Study
The research support was provided by the Western Pistachio Association, now known as the American Pistachio Growers, with partial support from the NIH-supported General Clinical Research Center at Pennsylvania State University. It was first reported on in 2007. It is relevant because lowering blood pressure may reduce the risk for stroke and heart disease.
Pistachios Pack Powerful Nutrition
In recent years the U.S. Food and Drug Administration (FDA) recognized that tree nuts, including pistachios, may help reduce the risk of heart disease when eaten as part of a diet low in saturated fat and cholesterol. Since then, the American Pistachio Growers have committed to learning more about the nutritional benefits of pistachios and the nuts’ impact on other health issues affecting Americans today.
Pistachio Facts
Pistachios are a naturally cholesterol-free and sodium-free snack that contains just 1.5 grams of saturated fat and 13 grams of fat per serving, the majority of which comes from monounsaturated and polyunsaturated fat. A one-ounce serving of pistachios equals 49 nuts, which is more nuts per serving than any other snack nut. One serving has as much potassium (290mg, 8 percent) as an orange (250 mg, 7 percent) and 3 g of fiber making it a nutritious snack choice or ingredient to incorporate into daily diets.
About American Pistachio Growers
American Pistachio Growers (APG) is a voluntary trade association representing members who are pistachio growers, processors and industry partners in California, Arizona and New Mexico. These states represent 100% of the domestic commercial pistachio production. APG pistachios are the “Official Snack” of both USA men’s and women’s water polo teams and Miss California. For more information, visit http://www.AmericanPistachios.org.
___________________________________
¹West SG, Gebaurer SK, Kay CD, Bagshaw DM, Savastano DM, Diefenbach C, Kris-Etherton P. Diets Containing Pistachios Reduce Systolic Blood Pressure and Peripheral Vascular Responses to Stress in Adults with Dyslipidemia. Hypertension. 2012 Jun 4. [Epub ahead of print] doi:10.1161/HYPERTENSIONAHA.111.182147
2Gebauer SK, West SG, Kay CD, Alaupovic P, Bagshaw D, Kris-Etherton PM. “Effects of pistachios on cardiovascular disease risk factors and potential mechanisms of action: A dose-response study.” Amer J Clin Nutr. 2008;88:651–9.
3Kay CD, Gebauer SK, West SG, Kris-Etherton PM. “Pistachios increase serum antioxidants and lower serum oxidized-LDL in hypercholesterolemic adults.” J Nutr. 2010;140:1093-98.
Source: American Pistachio Growers
 Print Article |
 Send Article |
 Respond |
 Permalink |
 Share Article |
|
|
||||
 |
del.icio.us | |
 |
Diigo | |
 |
Digg This | |
 |
Fark | |
 |
Mr. Wong | |
 |
Newsvine | |
 |
||
 |
Slashdot | |
 |
StumbleUpon | |
 |
Technorati | |
 |
MySpace | |
 |
||
 |