Category Archives: Health Research

Nuts To Peanut Allergy: New Treatment Is Working

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The National Institutes of Health has announced that a recent experimental treatment demonstrated a way that a skin patch could reduce allergic reactions to peanuts – one of the most common food allergies.

A treatment called oral immunotherapy has been shown in recent tests to be able to reduce, by feeding small amounts of a food to which one is allergic, allergic reactions to a point the ‘patient’ can, after repeated treatments, consume reasonable amounts of the allergenic food without having a negative reaction to it.

Another approach to dealing with the same issue, called epicutaneous (on the skin) immunotherapy, or EPIT, is being studied, as well.

A phase 1 study of the oral immunotherapy approach demonstrated the safety and tolerability of a wearable patch developed by DBV Technologies. The patch, named Viaskin, delivers small amounts of peanut protein through the skin.

An ongoing trial to further evaluate peanut EPIT is sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR). Researchers randomly assigned 74 peanut-allergic volunteers, ages 4 to 25 years, to either a high-dose (250 micrograms peanut protein), low-dose (100 micrograms peanut protein), or placebo patch. Each day, the participants applied a new patch to an arm or between their shoulder blades. After one year, the researchers assessed the treatments’ success. Success was defined as being able to eat at least 10 times more peanut protein than they could eat before starting EPIT. Results were published online on October 26, 2016, in the Journal of Allergy and Clinical Immunology.The low-dose and high-dose regimens offered similar benefits (46% and 48% success, respectively, compared with 12% in the placebo group). Treatment success was higher among the younger children, ages 4 to 11 years, than the older ones, where there was minimal benefit.

Nearly all study participants followed the EPIT regimen as directed. None reported serious systemic reactions to the patch, although most experienced mild skin reactions, such as itching or rash, where the patch was applied.

The clinical benefit seen in younger children highlights the promise of this innovative approach to treating peanut allergy,” says Dr. Daniel Rotrosen, director of NIAID’s Division of Allergy, Immunology and Transplantation. “Epicutaneous immunotherapy aims to engage the immune system in the skin to train the body to tolerate small amounts of allergen, whereas other recent advances have relied on an oral route that appears difficult for approximately 10 to 15% of children and adults to tolerate.”

Because EPIT appears to cause few, if any, systemic reactions and appears to be well tolerated, it may be possible to administer it for longer periods of time. The CoFAR study will continue to assess the long-term safety and effectiveness of peanut EPIT in this group. Additional studies in larger groups of children will be needed before the patch could be approved for wider use.

Consumers Want ‘Clean’ Food Labels; Now Professionals’ Tool Helps Them Define What Is, Isn’t, ‘Clean’

 

Every so often (every fifteen minutes or so, it sometimes seems!), a new food-related ‘buzz word’ catches the ear of consumers – sometimes almost at the same time it attracts the attention of food industry professionals. Not long ago, the ‘new’ word, or phrase, was ‘clean labels‘ – meaning, among other things, labels free of multi-syllable, unpronounceable words naming ingredients no one without a science degree can understand.

Consumers want ‘clean’ labels – and the products behind them to be healthier, less likely to initiate or compound health issues, than too many existing products are, or appear to be.

Complex additives are put into food products for an assortment of reasons, including flavor enhancement (salt and other spices being good examples), an ability to hold various ingredients in a liquid, semi-liquid or solid formula (emulsifiers and stabilizers), and shelf life-extending (salt again, as well as other things). Some of these reasons have seemed to make sense to product producers, but increasingly, they make less if any sense to consumers. That, and the fact that consumers are increasingly demanding healthier, ‘greener’ foods, are leading causes of the clean label movement.

The tool at https://gocleanlabel.com/about/ was created by a professional for professionals, but consumers, too, can use it to learn more about the clean label movement and, more specifically, to answer questions they have about specific ingredients. Questions such as ‘what is this’ and ‘what is it meant to do’. You also can use it to identify still-being-used materials that are, or aren’t, ‘clean’.

Both food processors and retailers are making strong steps to ensure fewer potentially harmful (or simply unnecessary) chemicals are added to foodstuffs. Undoubtedly, there are people who feel the industry isn’t moving fast enough – people who would, in effect, throw the baby out with the bathwater: Good chems out with not-so-good (or absolutely bad!) ones.

Ultimately, members of the consuming public need to take a greater interest in educating themselves about food additives, and learn how to make reasoned decisions about what they’re OK with putting in their bodies, and what they’re not.

I am working on a feature (for fooddive.com) about the new nutrition label that has been developed by the FDA. It is tentatively scheduled to become mandatory on a majority of food products (all except those produced in relatively small volumes) in 2018. But there’s already some push-back from at least one organization, and you can expect more push-back as a result of what we can only imagine will be dramatic, drastic changes of direction by the incoming presidential administration.

The thrust of my piece concerns the fact that changes to the nutrition label, while very much a separate issue from the overall additives one, reflect the fact that both industry, which had a hand in shaping the proposed label, and government are struggling – and that is not too strong a word – to deal with increasing scientific knowledge about foods and with changing consumer expectations.

As a courtesy to the readers of this blog, I will post a short note when my fooddive.com feature on that topic is published. (FYI, I write regularly on ingredients for fooddive.com. And as I’ve done for most of the past 40 years, I also regularly scan food trade publications – and now, web sites, too – around the world for both industry trends and consumer attitude shifts for this blog, which originated in the mid 1970’s as a column for trade publications in the U.S., Canada, Australia and New Zealand.)

(By the way, between them, this blog and my other one, YouSayWHAT.info, have been read in no fewer than 80 countries in the last year!)

Seaweed-based stabilizer/emulsifier Banned for Organic Foods in U.S.

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It’s called carrageenan, and if you closely read content labels, you’ll notice it’s in a lot of things – as a thickener, an emulsifier (to help hold other ingredients in the appropriate mix), and as a stabilizer. It’s also said to increase shelf life – a feature of questionable value, given that food processors often are best-guessing the long-term viability of their products when they put ‘best by’ or ‘use by’ dates on them.

(I still have a too-large bottle of dry curry that is in the neighborhood of 20 [or more!] years old. While it no doubt is not as potent as it once was, it’s still a viable product in my kitchen – able to contribute both flavor and heat to dishes without resulting in, as an un-viable spice might, stomach distress or worse.)

The U.S.D.A.’s National Organics Standards Board (NOSB) ruled last week that, as of 2018, carrageenan will no longer be allowed in products labeled as ‘organic’.

Does that mean carrageenan is ‘dangerous’, or that it potentially poses some kind of threat to consumers? Not necessarily. For all intents and purposes, that ruling simply acknowledges that, because it is exposed, during processing, to chemicals that fall outside the definition of ‘organic’. Carrageenan will continue to be used as a product-building aid in processed foods not, as no ‘processed food’ could be, described as ‘organic’.

Carrageenan is derived from a type of seaweed harvested primarily in the Philippines, Indonesia and East Africa. During commercial processing, it is exposed to assorted chemicals so it ends up as a fine powder, in no way resembling seaweed one might encounter ‘in the wild’.

CivilEats.com has a highly informative article on carrageenan here.

I can’t help but wonder what what kind of ‘organic’ product would need a stabilizer or an emulsifier. So I also can’t help but wonder why the U.S.D.A.’s National Organics Standards Board agonized – as they apparently did, not over just months, but years – as to whether carrageenan should in any way be associated with something said to be ‘organic’.

I don’t, as my wife would say, git it.

Organics now represent in the neighborhood of 11% of all produce sold (at retail) in the U.S. And organics’ share-of-market is growing – just as, hardly coincidentally, processed foods sales are slipping down an icy slope. The reason is simple: Not just Millennials, but older generations, too, are fed up with ingredients labels full of ‘stuff’ they can’t even pronounce and have no clue what it is or why it’s there. A sizable number of them have taken stands against the likes of Red No. 40, Yellow No. 5 and Blue No. 1 – synthetic colorings used to make food look better. They have, so far as we know, no effect on taste, but opposers of them contend they might affect us in some other, nefarious way.

(A quick aside: Why, pray tell, do forty or more shades of red exist, as food colorings? Or five or more shades of yellow? And not one of them a pastel!)

It is truly frightening to think of the tens of bunches of money being wasted on [1] developing all those odd colors and their counterparts in other food ingredients and [2] investigating and regulating same. Part of the problem is, of course, we have more people than viable jobs.

When I lived in England, from 1971-76, in the first of the offices I worked (for a year), every so often – I think it was weekly, but perhaps it was bi-weekly – an employee of a contractor came in and wiped down all the telephone handsets, probably aided by something less potent than the sprays restaurant servers use on tables between guests. On the first such visit I witnessed, I was astonished, and I was astonished again every time I saw this ritual repeated. It seemed perfectly pointless, and a waste of my employer’s money, to engage someone to provide this ‘service’.

Yet here we are in 2016, when a significant majority of U.S. supermarkets have a sanitary lotion dispenser available just inside the door – so no one should have to (heaven forbid!) touch a cart handle they haven’t subjected to a sanitary wipe-down after wiping down their own hands! (What have the most obsessed of those shoppers been doing/touching before entering their local food dispenser’s shop?)

It’s partly because some shoppers/consumers do think that way that the NOSB has banned carrageenan from ‘organics’. That seaweed—sourced ingredient probably poses no harm to humans, but better safe than sorry, right?

Litigation lawyers would, of course, disagree.

Food Allergies Can Lead To Asthma: Study (And Again on the Anti-Gluten-Free Movement!)

 

This item is a bit outside the course of what this blog normally covers, but it is food-related, and it does provide information about a subject people in the food trade and/or with an interest in children’s health should pay attention to.

A recent study, reported on last month in BMC Pediatrics, noted that, “Childhood food allergy is associated with impaired quality of life, limited social interactions, comorbid allergic conditions, and significant economic cost; Importantly, a severe allergic reaction resulting in anaphylaxis can be life threatening, and food allergens are the most common cause of anaphylaxis and anaphylaxis-related mortality in children and adolescents; Recent estimates have reported food allergy prevalence figures between 4 and 8 %, however, these studies are limited in size and scope or rely on participant reporting rather than healthcare provider-based diagnosis.”

Put another, simpler way, the researchers found evidence that food allergies can contribute significantly to the development of asthma. (Yeah, I know, why didn’t they just say that??)

This may be putting the solution in front of the cure, but it would seem to me – no expert in such things! – that studies such as this one, which represent significant advances in medical science and knowledge, point to a need for [1] greater testing tools to ascertain what, if any, foods very young kids may be allergic to, and [2] approaches to dealing with, and curing, childhood allergies to prevent both life quality and budget busting costs down the road.

And, at the risk of sounding like I’m on an anti-gluten-free bandwagon (which I sort of am!), the food industry needs to stop fostering trends that, truth be told, truly are against the interests of a majority of the audience(s) they serve.

The cut-out-gluten case is a, um, case in point: As we reported recently, only a fairly miniscule portion of the U.S. population (with similar percentages likely elsewhere) has celiac disease – “About 1 in 100 people — about 1 percent — have celiac disease, an inherited autoimmune disease that causes damage to the small intestine when gluten is ingested,” according to The Celiac Disease Foundation; and, from the same source, “About .4 percent of people have a doctor-diagnosed wheat allergy, according to a 2006 study; In those people, a true allergic response to wheat (which contains gluten) can include skin, respiratory and gastrointestinal symptoms.”

But as this blog pointed out recently, people without or with little risk of celiac disease could be doing themselves a disservice by going ‘gluten-free’. And, by implication, the ever-increasing number of companies declaring their processed food products to be ‘gluten-free’ are both deceiving and even putting at risk some of their consumer clients.

I find it both disturbing and disheartening that companies either fail to explore or disregard scientific

studies that strongly suggest they should stop wasting money on removing gluten from products and focus, instead, on making their products truly healthier for those who’ll consume them.

They should ignore what the latest ‘pair of dimes’ says, and go with the truth: Gluten-free is not, for most consumers, a solution to anything. And it’s truly detrimental for many of them!

Sugar Group’s Payment For Favorable ‘Research’ Shifted Views in the ‘60’s

Dr. Cristin E. Kearns
Researcher Dr. Cristin E. Kearns in her office at the University of California San Francisco. She recently revealed that prominent nutritionists were paid by the sugar industry for favorable ‘research’ reports in the 1960’s.Photo: Elizabeth D. Herman for STAT News

One of the individuals who helped draft the 1977 U.S. Senate committee report that paved the way for the nation’s first dietary guidelines was paid in the 1960’s by the sugar industry to produce a report playing down the importance of sugar in coronary heart disease.

As nutrition debates raged in the 1960s, prominent Harvard nutritionists published two reviews in a top medical journal downplaying the role of sugar in coronary heart disease. Newly unearthed documents reveal what they didn’t say: A sugar industry trade group initiated and paid for the studies, examined drafts, and laid out a clear objective to protect sugar’s reputation in the public eye.

That revelation, published Monday in JAMA Internal Medicine, comes from Dr. Cristin Kearns at the University of California, San Francisco, a dentist-turned-researcher who found the sugar industry’s fingerprints while digging through boxes of letters in the basement of a Harvard library.

Dr. Cristin E. Kearns


Documents that Dr. Cristin E. Kearns calls the “sugar papers” are kept  in her office at the University of California San Francisco. Photo:Elizabeth D. Herman for STAT News

Her paper recounts how two famous Harvard nutritionists, Dr. Fredrick Stare and Mark Hegsted, both now deceased, worked closely with a trade group called the Sugar Research Foundation, which was trying to influence public understanding of sugar’s role in disease.

The trade group solicited Hegsted, a professor of nutrition at Harvard’s public health school, to write a literature review aimed at countering early research linking sucrose to coronary heart disease. The group paid the equivalent of $48,000 in 2016 dollars ($6,5000 in then-current dollars) to Hegsted and colleague Dr. Robert McGandy, though the researchers never publicly disclosed that funding source, Kearns found.

Hegsted and Stare tore apart studies that implicated sugar and concluded that there was only one dietary modification — changing fat and cholesterol intake — that could prevent coronary heart disease. Their reviews were published in 1967 in the New England Journal of Medicine, which back then did not require researchers to disclose conflicts of interest.

That was an era when researchers were battling over which dietary culprit — sugar or fat — was contributing to the deaths of many Americans, especially men, from coronary heart disease, the buildup of plaque in arteries of the heart. Kearns said the papers, which the trade group later cited in pamphlets provided to policymakers, aided the industry’s plan to increase sugar’s market share by convincing Americans to eat a low-fat diet.

Nearly 50 years later, some nutritionists consider sugar a risk factor for coronary heart disease, though there’s no consensus. Having two major reviews published in an influential journal “helped shift the emphasis of the discussion away from sugar onto fat,” said Stanton Glantz, Kearns’s coauthor and her advisor at UCSF. “By doing that, it delayed the development of a scientific consensus on sugar-heart disease for decades.”

Marion Nestle, a nutrition expert at New York University who was not involved in the paper, said she’s still not convinced by those who argue that “sugar is poison” — a person’s total calorie consumption could matter more. But she called the UCSF findings a “smoking gun” — rare, hard evidence of the food industry meddling in science.

“Science is not supposed to work this way,” she wrote in an accompanying commentary. “Is it really true that food companies deliberately set out to manipulate research in their favor? Yes, it is, and the practice continues,” Nestle added, noting that Coca-Cola and candy makers have both tried recently to influence nutrition research.

In a statement, the sugar trade group said industry-funded research has been unfairly criticized.

“We acknowledge that the Sugar Research Foundation should have exercised greater transparency in all of its research activities,” said the trade group that now calls itself the Sugar Association. Beyond that, “it is challenging for us to comment on events that allegedly occurred 60 years ago, and on documents we have never seen.”

“Sugar does not have a unique role in heart disease,” the group maintained. “We’re disappointed to see a journal of JAMA’s stature” using “headline-baiting articles to trump quality scientific research.”

A thin-framed, soft-spoken woman who blushes often when she speaks, Kearns is an unlikely crusader against the sugar industry. Trained as a dentist, Kearns said she was shocked to hear a keynote speaker at a 2007 dentistry conference — on diabetes, no less — tell her there is no evidence linking sugar to chronic disease. She quit her job and devoted herself full-time to uncovering documents that show the sugar industry’s influence over public policy and science.

She has now amassed 2,000 pages of internal documents. She keeps them in two banker’s boxes in her cubicle at UCSF, along with photos of decaying teeth, and show-and-tell boxes of sugary Cocoa Pebbles and Cinnamon Toast Crunch.

Her previous work has shown how the sugar industry influenced a federal dental research program to shift attention to other efforts — such as finding a vaccine for tooth decay — instead of exploring the benefits of eating less sugar.

For her latest paper, Kearns flew to Boston in 2011 and spent several days in Harvard Medical School’s Countway library, thumbing through boxes of letters that Hegsted left behind.

Hegsted was, in Nestle’s words, “a hero of nutritionists”: After helping draft “Dietary Goals for the United States,” the 1977 Senate committee report that paved the way for the nation’s first dietary guidelines, he went on to oversee the human nutrition unit at the Department of Agriculture.

Paging through the letters, Kearns was “shocked” by his level of cooperation with the sugar industry, she said.

Here’s what she found: In the 1950s, the Sugar Research Foundation identified a strategic opening to increase sugar’s market share by getting Americans to eat a low-fat diet, based on research that blamed fat and cholesterol for causing high blood pressure and heart problems, according to a 1954 speech by the trade group’s president.

John Hickson, the Sugar Research Foundation’s vice president and director of research, was closely monitoring nutrition research. In an internal memo Kearns uncovered from 1964, he proposed that the trade group “embark on a major program” to counteract “negative attitudes towards sugar,” in part by funding its own research to “refute our detractors.”

Hickson first recruited Stare, chair of the Harvard public health school’s nutrition department, to join the foundation’s scientific advisory board. In July of 1965, just after articles linking sucrose — ordinary table sugar — to coronary heart disease appeared in the Annals of Internal Medicine, he approached Hegsted for help. Hickson struck a deal to pay Hegsted and McGandy, both overseen by Stare, $6,500 ($48,000 in 2016 dollars) for “a review article of the several papers which find some special metabolic peril in sucrose …” Kearns found.

Hegsted asked Hickson to provide the articles for the review. Hickson sent at least five articles that threatened the sugar industry — which suggest he aimed for the researchers to critique them, Kearns and her coauthors argue.

Hickson set the objective for the review: “Our particular interest had to do with that part of nutrition in which there are claims that carbohydrates in the form of sucrose make an inordinate contribution to the metabolic condition, hitherto ascribed to aberrations called fat metabolism,” he wrote to Hegsted.

“I will be disappointed if this aspect is drowned out in a cascade of review and general interpretation,” Hickson wrote.

“We are well aware of your particular interest in carbohydrate and will cover this as well as we can,” Hegsted replied, according to Kearns.

Letters show the scientist communicating with his funder not just at the outset, but while writing the review, Kearns found. In April 1966, Hegsted wrote to the sugar trade group to report that his review had been delayed because researchers in Iowa had produced new evidence linking sugar to coronary heart disease. “Every time the Iowa group publishes a paper we have to rework a section in rebuttal,” Hegsted wrote.

Letters indicate Hickson reviewed drafts of the paper, though it’s not clear whether his trade group made any edits or comments.

“Am I going to get another copy of the draft shortly?” Hickson asked Hegsted, according to Kearns.

“I expect to get it down to you within a week or two,” Hegsted replied.

Hickson got a final draft a few days before Hegsted intended to submit it for publication. The funder was happy: “Let me assure you this is quite what we had in mind and we look forward to its appearance in print,” Hickson wrote.

When the papers were published the following year, authors disclosed other industry funding, but made no mention of the Sugar Research Foundation.

Hegsted’s reviews examined a wide range of research. He downplayed and dismissed papers that argued that sugar was a cause of coronary artery disease. He found merit only in those that saw fat and cholesterol as a culprit.

Glantz, Kearns’s coauthor, said the major problem with the review is that it was not even-handed: In the cases where sugar was implicated, Hegsted and colleagues dismissed entire classes of epidemiological evidence. But they didn’t hold studies that implicate fat to the same standard, Glantz said.

He said the level of the Harvard researchers’ cooperation is clear: “The industry says, ‘Here are some papers we’re really unhappy with. Deal with them,’” Glantz said. “They then did. That, to me, was the thing that I found the most amazing.”

Glantz said the sugar industry used a similar playbook to the tobacco industry, whose internal documents he has written about extensively. The letters reveal how sophisticated the sugar executives were in swaying public opinion, he said. They closely tracked the research and were careful about which influential scientists to approach.

“By dealing with them with a light touch, they got what they wanted,” Glantz said.

Glantz, Kearns, and their coauthor, Laura Schmidt, acknowledged that their research was limited by the fact that they could not interview the protagonists because they are dead.

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Dr. Walter Willett, who knew Hegsted and now runs the nutrition department at Harvard’s public health school, defended him as a principled scientist.

“He was a very hard-nosed, data-driven person, who had a record for standing up to industry interests,” including losing a job at the USDA for standing up to the beef industry, Willett wrote in an email. “I very much doubt that he changed what he believed or would conclude based on industry funding.”

Willett said today, research has become more clear, showing that refined carbohydrates and especially sugar-sweetened beverages “are risk factors for cardiovascular disease,” while “the type of dietary fat is also very important.” But he said that at the time Hegsted and colleagues were writing, evidence for fat as a risk factor for coronary heart disease was “considerably stronger” than for sugar, and he would agree with “most of the interpretations” the researchers made.

“However, by taking industry funding for the review, and having regular communications during the review with the sugar industry,” Willett acknowledged, it “put him [Hegsted] in a position where his conclusions could be questioned.”

“It is also possible that these relationships could induce some subtle bias, even if unconscious,” he added.

Willett called the historical account a “useful warning that industry funding is a concern in research as it may bias what is published.” He said it is “doubly a concern in reviews because this inevitably involves some judgment about the interpretation of data.”

But Willett, whose professorship is named after Fredrick Stare, said Stare and his fellow researchers broke no rules. Conflict-of-interest standards have changed dramatically since the 1960s, he noted.

Since 1984, the New England Journal of Medicine has requested authors to disclose conflicts. And the journal now requires authors of reviews not to have “major research support” from relevant companies.

NEJM spokeswoman Jennifer Zeis said the journal now asks authors to report all financial conflicts during the 36 months prior to publication, and also conducts a rigorous peer review that “aids us in guarding against potential conflicts of interest.”

Glantz said the journal should attach an editorial note “describing what actually happened” with the review. “The provenance of the paper is very misleading,” he said.

Zeis said the journal plans to take no action.

Meanwhile, Kearns is continuing her campaign to reveal more internal documents from the sugar industry.

In a recent interview at a UCSF food court, she steered clear of the “gigante” chocolate chip cookies and chose a chicken sandwich and a fruit cup. She said she’s driven in part by her experience as a dentist, when she saw patients whose mouths were wrecked by tooth decay — one of whom needed dentures at age 30.

The federal government is getting on board with researchers like Kearns who have been warning of the perils of sugar — new dietary guidelines recommend less than 10 percent of a person’s daily calories come from added sugars.

Indian School Kids’ Milk Is Awash with Water

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Indian school kinds awaiting midday meal — and watery milk.

A surprise, sunrise inspection of a food preparation facility servicing 11,000 school children in India’s Uttar Pradesh province found 292 liters (308.5 quarts) of water in just 192 liters (202.8 quarts) of milk.

Radha Krishan Tivari, assistant director in the basic education department who held the surprise inspection, told The Times of India that schoolchildren were drinking milk that was more than 150 per cent water.

“We were simply stunned,” he told the paper last Thursday. “The visit to the kitchen of Nav Prayas, an NGO [non-government organization] we hired to supply milk and midday meals, left one dismayed.” He said the NGO supplies food to 131 schools, including 107 primary and 27 higher primary government schools.

He said that one student, speaking anonymously, said that many kids are unable to eat the food “as the quality is so bad.”

A report on the surprise inspection will be forwarded up the government chain, and the NGO will not be receiving payments for at least two recent months.

42 States Getting $21.8 million To Implement Food Safety Rule

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The U.S. Food and Drug Administration is awarding a total of $21.8 million to help 42 states implement the FDA Food Safety Modernization Act (FSMA) produce safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

“As efforts for a nationally integrated food safety system advance, this funding will play a vital role in establishing programs at the state level to educate growers and provide technical assistance to ensure high rates of compliance with the produce safety rule,” said Melinda Plaisier, associate commissioner for regulatory affairs at the FDA.

In March 2016, the FDA announced the funding opportunity, which was available to all states and U.S. territories, to begin the planning for and development of a state produce safety program.

The cooperative agreement between the FDA and the states provides awardees with the resources to formulate a multi-year plan to implement a produce safety system, develop and provide education, outreach and technical assistance, and develop programs to address the specific and unique needs of the growers in their farming communities.

State agencies are important because they have a better understanding and knowledge of the specific growing and harvesting practices in their areas and many have long standing relationships with produce growers and produce associations.

States and territories were classified into five tiers of funding eligibility based on the estimated number of farms growing covered produce within their jurisdictions. The funding opportunity is for five years, subject to the availability of funding from Congress. Further information on state awardees can be found here.

“The states were key partners to the FDA as FSMA’s produce safety provisions were being developed. [Friday’s] funding announcement demonstrates the FDA’s commitment to keep working closely with the states as we begin to implement the provisions,” said Dr. Stephen Ostroff, deputy commissioner for foods and veterinary medicine at the FDA. “A robust federal-state partnership in produce safety will help protect American consumers from food-borne illness and benefit public health.”

Larger farms will need to comply with certain aspects of the produce safety rule requirements beginning in January 2018, with smaller produce operations having additional time to comply. The FDA intends to continue to work with growers to ensure that they understand the provisions and expectations for their implementation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.