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FDA Issues New Guidance on Antibiotics

The Food and Drug Administration has tried for more than three decades to pass limits on sub therapeutic use of antibiotics in poultry and livestock. Each time, they’ve been turned away by Congress, which is lobbied heavily by agricultural and drug industry interests.


It’s a cyclical tale, for sure, but one that becomes more interesting as public interest and scientific evidence on the issue increases. Now, for the first time in several years, the FDA is going at the industry again. In a draft guidance issued yesterday, the agency recommended banning the use of antibiotics to promote growth in animals.


What’s at stake, the FDA and numerous health experts claim, is the future potency of antibiotics for humans. Drugs like tetracycline and penicillin transfer from animals to the people who consume them, and their overuse has given rise to new strains of antibiotic-resistant superbugs.


“Antimicrobial resistance, and the resulting failure of antimicrobial therapies in

humans, is a mounting public health problem of global significance,” the draft guidance document reads.


Industry groups like the National Pork Board, in response, say that the FDA is overreacting. They claim that there is not enough scientific evidence to support such claims. Furthermore, they point out that the majority of producers do give antibiotics for health reasons only, and not to promote growth. MORE…

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Related Topics: FDA, Rules & Regulations, Wellness News |

GAO Report Slams Supplement Sellers

Ever since it became exempt from pre-market approval by the Food and Drug Administration in 1994, the supplement industry has reassured consumers and retailers that it can regulate itself. The ensuing years have cast some doubt on that assertion, and now there’s a report from the Government Accountability Office that makes it look like the Wild West out there in the aisles.


supplements.jpg“Deceptive”, “questionable”, “dangerous”. These are words the GAO used to describe practices employed by sellers and manufacturers it recently investigated. Representatives scoped out brick-and-mortar and mail-order retailers, posing as elderly customers seeking relief for diabetes, memory loss, cancer and other ailments. One herbal supplement seller told investigators that ginseng could cure cancer. Another recommended taking gingko biloba along with asprin to enhance memory — a combination that studies have shown may increase the risk of internal bleeding.


The GAO also found evidence of metals such as lead and mercury, as well as pesticides, in all but three of the 40 herbal supplements it tested. None of the metal levels violated federal regulations, though 16 of the 40 appear to exceed the acceptable threshold for pesticides.


The Council for Responsible Nutrition, a trade group that represents the supplement industry, claims that the 22 retailers who were investigated are “outliers” that don’t accurately represent the whole. That’s hard to believe when you consider that sellers were picked at random. The GAO didn’t just happen to light on the several worst practitioners out there. MORE…

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Related Topics: FDA, Ingredients, A Healthy Dish |

DNA Test Kits Face More Scrutiny

Earlier this year in our print magazine, Whole Health, we noted the re-emergence of DNA-based tests designed to predict future health conditions like diabetes. The thinking is that if a person knows they are pre-disposed to a certain condition, they can take preventative steps now to prevent that from becoming a reality.


It’s a noble idea, and — with the advances DNA testing has made in a few short years — perfectly feasible that one day soon we will have the ability to analyze biological markers in each and every one of us to predict our future health.


pathway_box3.jpgAs of this week, federal regulators apparently remain unconvinced: After a letter from the Food & Drug Administration was made public, Walgreen’s announced it was pulling back from offering a saliva swab test kit and analysis by a third-party company, San Diego-based Pathway Genomics.


For the nation’s largest drug store chain, this isn’t small change. There was quite a bit of buzz over the original announcement unveiling the service. The marketing pitch highlighted Pathway’s ability to analyze the DNA contained in the swab for a host of health conditions and diseases. Besides diabetes, the list includes obesity and Alzheimer’s, among others. MORE…

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Health Benefits of Nuts

Supermarkets might want to check their inventory of nuts. Look in the grocery aisle for the cans and jars, the bulk section next to produce, and anywhere else these little gems are merchandised. Chances are sales will start going up very soon, thanks to a study that really cracks the shell on the connection between nut consumption and health.


nut_pile.jpgFirst, some background. Nuts have had it pretty good for a few years now. It was the late 1990s when a new round of studies began taking a fresh look at the nutritional profile of walnuts, almonds, pecans and the like. One of the biggest findings has been that nuts have the ability to lower cholesterol and undo the effects of LDL or “bad” cholesterol.


The U.S. government concurred with these initial conclusions and in 2003 the Food & Drug Administration bestowed a qualified health claim on most nuts, stating that eating about two ounces daily could reduce the risk of heart disease.


Now, a new report published in the May issue of the Archives of Internal Medicine has found that people who ate even higher quantities of nuts (about 2 ½ ounces) every day lowered total cholesterol levels by 5%, and dropped their LDL cholesterol levels by 7%. In so doing, the ratio of bad to good cholesterol tipped to favor the good side. MORE…

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Related Topics: Natural/Organic, FDA, A Healthy Dish, Rules & Regulations |

They Don’t Got Milk

To borrow from the Shakespeare’s Juliet: “What’s in a name? That which we call milk by any other name would taste as great…”


soy_milks.jpgAlas, if you’re the National Milk Producers Federation, you’d have quite a bone to pick with Juliet. It’s been the group’s long-standing position that terms like “milk” should refer exclusively to dairy products from animals — not soybeans, almonds or rice.


“The FDA has allowed the meaning of ‘milk’ to be watered down to the point where many products that use the term have never seen the inside of a barn,” said Jerry Kozak, President and CEO of NMPF, in a release announcing a new petition drive to get the Food and Drug Administration to correct the “misappropriation of dairy terminology on imitation milk products.”


The organization, which last appealed to federal regulators in 2000 (without success), is reviving its campaign because the alternative dairy industry has grown beyond milk, and is now using terms like yogurt, ice cream and cheese to describe their non-dairy products.


“You don’t got milk if it comes from a hemp plant, you can’t say cheese if it’s made from rice, and faux yogurt can’t be made from soy and still be called yogurt,” says Kozak. In its petition, the NMPF notes that some manufacturers have adopted wording such as “cheeze” in order to circumvent the controversy.


But the NMPF has noticed and is asking dairy fans to help prod the FDA into action. The group has set up a special Facebook page that allows people to comment and post photos of non-dairy products such as rice milk, coconut milk ice cream and soy cheese. MORE…

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Report: National Regulation on Sodium Needed

Hearing the demands coming from regulators and consumers, more and more manufacturers are cutting back on sodium in the foods they make. Just last week General Mills announced it will cut sodium by 20% in most of its products, and companies like Kraft, ConAgra and others have started marketing around their lower sodium counts.


salt1.jpgBut according to a report released today by the Institute of Medicine, this isn’t enough. What’s really needed, the authors state, is national regulation that will gradually bring sodium consumption more in line with recommended guidelines. Currently, Americans consume 50% more sodium each day than they should, increasing their risk for hypertension and cardiovascular disease.


“What is needed is a coordinated effort to reduce sodium in foods across the board by manufacturers and restaurants — that is, create a level playing field for the food industry,” according to the briefing.


Since sodium is such an ingrained taste — you don’t always know when it’s there, but you certainly know when it’s not — the IOM recommends gradually stepping down amounts rather than cut out a bunch of it all at once. Ideally, consumers wouldn’t notice much of a difference.


A story in today’s Washington Post reported, via anonymous sources within the Food and Drug Administration, that the FDA has already begun taking the steps outlined by the IOM report. This afternoon, the FDA issued a statement saying that, in fact, it is not currently working on regulations and hasn’t made any plans in that direction. MORE…

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Mind Your Claims

The FDA has sent out warning letters to 17 food manufacturers claiming that certain products violate the Federal Food, Drug, and Cosmetic Act. The development follows last October’s statement by FDA commissioner Margaret Hamburg urging companies to review their nutrition claims.


Yesterday’s letters serve as a reminder that the agency is serious about holding manufacturers accountable for the promises they make to their customers. The vast majority of companies making health claims have been careful to include studies, research findings and other data supporting their claims on their websites, or otherwise make them available to consumers.


Even so, the FDA is saying companies continue to overreach, or neglect to balance their claims with statements that point out other nutritional aspects that are not so healthy.


For example, many of the manufacturers on this most recent list were cited for making claims such as “0 grams of trans fat” – a statement that, in and of itself, is accurate. However, many of these products contain significant amounts of saturated (bad) fats, or cholesterol, or sodium. FDA regulations state that if these nutritional elements exceed a certain amount, then manufacturers must include an ancillary notice next to any front-panel health declarations that directs the consumer to the Nutrition Facts panel.


There, they’ll see that the product does not have any trans fats as stated but, Wow, it’s loaded with saturated fat, cholesterol or sodium. No thanks, I’ll pass. MORE…

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Related Topics: Nutrition Labeling, FDA, Rules & Regulations, Wellness News |

Food Safety Report Scares Up New Data

Attempting to quantify the health-related costs associated with foodborne illness is, at best, an inexact science. There are so many variables to weigh. Some, like medical expenses and lost wages, are fairly obvious and easy to calculate. Research can reveal some pretty concrete numbers for those types of factors.


What about pain and suffering? Or the cost of financial burdens placed on a family whose primary wage-earner died as the result of a foodborne pathogen?


This “Big Picture” approach was taken with the new report: Health-Related Costs from Foodborne Illness in the United States (no mistaking the topic here, eh?). The study was authored by Robert Scharff, an assistant professor in the Department of Consumer Sciences at Ohio State University (and a former U.S. Food and Drug Administration economist). The report itself was sponsored by the Produce Safety Project at Georgetown University.


The most astounding revelation in this study is that Scharff came up with a new number for the cost of foodborne illness: $152 billion. What makes that figure such an eye-opener? Past official government estimates have topped only $35 billion.


“The cost of foodborne illness is significantly greater in this report than in some past studies, but only because this study included costs of all pathogens and a more comprehensive measure of economic cost,” wrote Scharff in the report. “It is my hope that the improvements made here will lead to better decision-making, both at the legislative and regulatory level.”


MORE…

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Michelle Obama’s Plan for Childhood Obesity

logo_letsmove.gifThere have been numerous efforts over the years to tackle childhood obesity in this country, but nothing so ambitious as what First Lady Michelle Obama announced on Tuesday. The new initiative she’s spearheading, dubbed Let’s Move, seeks to bring together government agencies and the private sector — basically, anybody and everybody that impacts children’s health — to combat the problem. The ultimate goal: Eliminate childhood obesity within a generation.


No doubt, it’s a sweeping response to a sweeping problem, with one in every three children in this country considered “obese”. As the name suggests, Let’s Move looks to get kids off the couch and moving around. There are many thoughtful food-related proposals, as well.


Expanding access to healthy foods is one of the major themes. Schools, for one, could soon see reform as the new plan looks to update the National School Lunch Program to include more healthy options. Neighborhoods where fresh, healthful food is hard to find, known as “food deserts” (which we wrote about here), are also a focus. Listen up, supermarkets: The administration’s 2011 budget calls for a $400 million investment to bring grocery stores to these underserved neighborhoods. That’d probably include generous tax breaks for any retailers that move in.


The Let’s Move agenda also looks to invest in educating consumers and enhancing transparency at the shelf level. MORE…

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Related Topics: FDA, Marketing & Outreach, Wellness News |

The Latest Twist in the BPA Saga

And just when we were starting to think the storyline had gone stagnant: Last week the Food and Drug Administration stated that they had “some concerns” about health risks posed by bisphenol-A, or BPA, the chemical used to strengthen plastic that appears in food packaging, baby bottles and other reusable containers.


The statement goes against one the agency made in 2008 that said the chemical was safe. That decision was a disappointment to many in the environmental and medical community — a disappointment compounded by a report that came shortly after from the National Toxicology Program (part of the National Institutes of Health) criticizing the FDA’s stance.


babybottle.jpgSo what made the FDA change its mind? Credit the progressive new attitude coming from the Obama administration, under whom the agency has taken aggressive steps to safeguard public health. There’s also been the increased media attention on studies linking BPA to various ailments, from cancer to impaired brain development.


“I think that they could no longer hide from the evidence,” said Alex Formuzis, spokesman for the Environmental Working Group, when I interviewed him earlier today. “The facts were so stacked against their former position that they had no place to go.”


The chemical and manufacturing industries, for their part, are stating that the evidence is inconclusive. The American Chemistry Council released a statement saying they are “disappointed that some of the recommendations are likely to worry consumers and are not well-founded.”


But consumers have already made up their mind. MORE…

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Related Topics: FDA, Food Safety/Recalls, Rules & Regulations |

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REFRESH is a blog without peer. As a web-based companion to Penton Media’s Supermarket News (SN) and SN Whole Health magazines, REFRESH offers unique content on the subjects of supermarkets, wellness and sustainability. The interactive format attracts retail food industry professionals, lifestyle advocates and everyday consumers. We invite you to read on and get REFRESHed!

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