Food additives on the rise as FDA scrutiny wanes

The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

fda.gras.approvedAnd in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show.

“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food.

The FDA has received thousands of consumer complaints about additives in recent years, saying certain substances seem to trigger asthmatic attacks, serious bouts of vomiting, intestinal-tract disorders and other health problems.

At a pace far faster than in previous years, companies are adding secret ingredients to everything from energy drinks to granola bars. But the more widespread concern among food-safety advocates and some federal regulators is the quickening trend of companies opting for an expedited certification process to a degree never intended when it was established 17 years ago to, in part, help businesses.

A voluntary certification system has nearly replaced one that relied on a more formal, time-consuming review — where the FDA, rather than companies, made the final determination on what is safe. The result is that consumers have little way of being certain that the food products they buy won’t harm them.

“We aren’t saying we have a public health crisis,” Taylor said. “But we do have questions about whether we can do what people expect of us.”

‘Natural’ helps sell $40 billion worth of food in the U.S. every year—and the label means nothing

Nothing makes Americans buy a food product quite like the fabulously ambiguous word “natural.”

chobani.yogurtThe top 35 health claims and food labels include words most anyone who has been to a supermarket in the past five years should recognize—ones like “natural,” yes, but also “organic,” and “fat free,” and “carb conscious,” and “100 calories.”  These phrases helped the food industry sell more than $377 billion worth of masterfully marketed food items in the United States during the past year, according to data from market research firm Nielsen.

The list of lucrative food labels is long, and, at times, upsetting.

Many of these labels are pasted onto food packages for good reason. It’s imperative, after all, that consumers with celiac disease be able to tell which food items are gluten free, or that those with milk allergies be able to tell which are made without lactose.

But some are utterly meaningless. Take food labeled with the word “natural,” for instance. Actually, remember it, because it’s probably the most egregious example on supermarket shelves today. The food industry now sells almost $41 billion worth of food each year labeled with the word “natural,” according to data from Nielsen. And the “natural” means, well, nothing. The US Food and Drug Administration (FDA) doesn’t even have an official definition or delineation of what “natural” actually means. The only thing the FDA has regarding the word is this statement, on its website:

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

market.naturalIt’s hardly the only misleading adjective the food industry is swinging around these days. The word organic, while a bit less nebulous, still means a good deal less than one might think. Several others, including ones that reference antioxidants, proteins, calcium and other vitamins and minerals, are confusing consumers by tricking them into believing certain food products are healthier than they actually are, a recent study found. And the trend is only likely to get worse. Many of the top grossing food labels are still growing—and fast.

(This is satire): FDA recalls food, out of an abundance of caution

Saying it was vitally important that citizens avoid consuming any of the affected items, the U.S. Food and Drug Administration issued a nationwide recall of all food Wednesday. “We are asking all Americans to return any edible products they own to the store where these items were purchased or to discard such items immediately,” margaret_hamburgsaid FDA commissioner Margaret Hamburg at a morning press conference, specifying that under no circumstances should Americans eat grains, meats, produce, nuts, dairy products, processed foodstuffs, sweets, spices, or any other source of sustenance, nor should they feed any of these foods to animals or leave them within the reach of children.

“If you are eating something right now, please discontinue doing so. We will let you know when it is okay to consume food again.” Hamburg noted that salt, baking soda, and all foods manufactured before 2002 were unaffected by the recall.

FDA rule could end consumer access to antibacterial soaps

Food safety nerd Don Schaffner says antimicrobials have a role, and I usually agree with Don (right, not exactly as shown).

 77fdonuts1In an effort to maintain consumer access to the benefits of antibacterial soaps, the American Cleaning Institute (ACI) and the Personal Care Products Council, along with input from leading independent scientists, filed extensive comments with FDA on its proposed rule. The comments demonstrate to the Agency that consumer antibacterial soaps are safe, effective, and promote public health.

The FDA’s proposal could eliminate the public’s access to safe and effective antibacterial soaps, including kitchens in the home and at daycare facilities.

Antibacterial soaps “are critical to public health because of the importance hand hygiene plays in the prevention of infection,” wrote the groups in their joint June 16 comments to FDA. “Washing the hands with an antiseptic handwash can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water.”

FDA appears to have not considered that the consumer category includes use of antibacterial soaps in public areas such as schools, airports, daycares, and other facilities. Consumer antiseptic products reduce the level of bacteria on skin, which reduces the risk of infection and disease.

sopranos.don't.fuck.with.usElimination of these products would put the general population at risk. For example, individuals using public restrooms would no longer have access to antiseptic hand soaps. 

The Topical Antimicrobial Coalition, which comprises ACI and the Council, estimated the costs of the proposed rule – associated with preventable gastrointestinal illnesses – that would occur if antiseptic hand wash products were not available.

The number of new cases of foodborne illness caused by bacteria such as E. coli, Salmonella, Shigella, and Campylobacter could range between 250,000 and 7.5 million, based on projections by Dr. Donald Schaffner, Professor at Rutgers University’s Food Science Department.

The groups’ comments also take issue with assertions in the proposed rule that challenge the safety of antibacterial ingredients.

“No scientific studies currently exist to demonstrate a correlation between the active ingredients considered in the proposed rule and adverse health effects on consumers. As a result, there are no measureable benefits of the proposed rule.”

Should have been done initially: FDA issues clarification on using wood shelving in artisanal cheesemaking

Recently, you may have heard some concerns suggesting the FDA has taken steps to end the long-standing practice in the cheesemaking industry of using wooden boards to age cheese. To be clear, we have not and are not prohibiting or banning the long-standing practice of using wood shelving in artisanal cheese. Nor does the FDA Food Safety Modernization Act (FSMA) require any such action. Reports to the contrary are not accurate. 

cheese.wood.boardThe agency’s regulations do not specifically address the use of shelving made of wood in cheesemaking, nor is there any FSMA requirement in effect that addresses this issue. Moreover, the FDA has not taken any enforcement action based solely on the use of wooden shelves. 

At issue is a January 2014 communication from the agency’s Center for Food Safety and Applied Nutrition to the New York State Department of Agriculture and Markets’ Division of Milk Control and Dairy Services, which was sent in response to questions from New York State.  

The FDA recognizes that this communication has prompted concerns in the artisanal cheesemaking community. The communication was not intended as an official policy statement, but was provided as background information on the use of wooden shelving for aging cheeses and as an analysis of related scientific publications. Further, we recognize that the language used in this communication may have appeared more definitive than it should have, in light of the agency’s actual practices on this issue.  

The FDA has taken enforcement action in some situations where we have found the presence of Listeria monocytogenes at facilities that used such shelving. Since 2010, FDA inspections have found Listeria monocytogenes in more than 20 percent of inspections of artisanal cheesemakers. However, the FDA does not have data that directly associates these instances of contamination with the use of wood shelving. 

In the interest of public health, the FDA’s current regulations state that utensils and other surfaces that contact food must be “adequately cleanable” and “properly maintained.” Historically, the FDA has expressed concern about whether wood meets this requirement and these concerns have been noted in its inspectional findings. However, the FDA will engage with the artisanal cheesemaking community, state officials and others to learn more about current practices and discuss the safety of aging certain types of cheeses on wooden shelving, as well as to invite stakeholders to share any data or evidence they have gathered related to safety and the use of wood surfaces. We welcome this open dialogue.

Uh-huh: FDA promises help, not crackdown, on FSMA rules

When someone says they’re going to educate someone else, things have really gone off the rails.

The goal is to inform, with rapid, reliable, relevant and repeated information.

Fonzie_jumps_the_sharkAccording to The Packer, the U.S. Food and Drug Administration is looking to educate before it enforces new food safety laws.

Roberta Wagner, deputy director for regulatory affairs for the FDA’s Center for Food safety and Applied Nutrition told a June 11 workshop at United Fresh 2014 that all rules for the Food Safety Modernization Act are due from the agency in 2015.

Part of FDA’s challenge is creating a new way of treating inspections. For example, Wagner said that looking independent third-party audits showed new ways to determine whether a company has a culture of food safety.

“What we’re learning is that there is a line of questioning that help establish whether there is a food safety culture in a facility or on a given farm and we don’t have that line of questioning,” she said. ”We need to ask different questions to assess if there is a food safety culture in a given facility or in a growing operation.”

Wagner said the FDA also may want to give industry credit for making voluntary corrections. To do that, she said the agency plans capture more data on voluntary compliance.

“To elicit the culture change, we literally have to start with the way we hire, what we look at in our investigators, how we train our investigators and how we establish compliance strategies,” she said.

Food safety culture really has jumped the shark.

What about Listeria? Pregnant women advised to eat more fish

I was talking with daughter Braunwynn today about her future academic and travel plans. She also wanted to know my preferred way to cook pork chops.

But this is about fish, and as Braunwynn said when she was in Brisbane, “How can I go back after this?”

amy.pregnant.listeriaWe are fortunate in Brisbane to have a fabulous supply of seafood.

The U.S. Food and Drug Administration said women and children should eat more fish, but sidestepped the issue of raw or undercooked seafood for pregnant women.

It’d be nice for all the mothers out there, who are already inundated with contradictory messages, if FDA consolidated toxin and microbiological risk information into a cohesive message. For example, pregnant women shouldn’t be eating any refrigerated ready-to-eat seafood like salad or smoked salmon.

Liz Szabo of USA Today writes that federal officials for the first time are recommending that young children and pregnant or breastfeeding women eat a minimum of two to three servings a week of fish that is low in mercury, in order to give them important health benefits.

Current guidelines, released a decade ago, focused on limiting the amount of fish consumed by women who are pregnant or breastfeeding, due to concerns about contamination from methylmercury, which can cause brain damage, especially to developing brains, said Elizabeth Southerland of the Environmental Protection Agency, which released the new guidelines along with the Food and Drug Administration.

That advice apparently scared a lot of women into avoiding fish altogether. Research has shown that 21% of pregnant women ate no fish at all in the past month, said Stephen Ostroff, acting chief scientist at the FDA. Even among women who consumed fish, half ate fewer than 2 ounces a week.

braun.sorenne.2.aug.14But fish contain heart-healthy oils, such as omega-3 fatty acids, says Edward R.B. McCabe, medical director of the March of Dimes Foundation. There’s also limited evidence that fish oils may promote a baby’s brain development. McCabe praised the agencies’ decision to encourage more fish consumption, along with a balanced diet.

So now, instead of telling these women to eat no more than two servings of fish a week, officials advise them to eat at least two servings and up to three servings a week of fish that’s low in mercury. Officials continue to advise women to avoid four fish with higher mercury levels: shark; swordfish; king mackerel and tilefish from the Gulf of Mexico. Those four fish make up less than 2% of fish sold in the USA, Ostroff says.

Nine of the 10 most frequently sold fish in the USA are lower in mercury, Ostroff says. The fish used in fish sticks and other commercial products is also usually low in mercury, he said. Fish that are lower in mercury include shrimp, pollock, salmon, canned light tuna, tilapia, catfish and cod, he said.

“The health benefits far outweigh any risk,” Ostroff says.

The draft’s updated advice did recommend that pregnant or breastfeeding women limit their consumption of white (also called albacore) tuna to 6 ounces a week.

Why assume conspiracy when stupidity works? Keep your government hands off my cheese

The U.S. Food and Drug Administration has, apparently, started to enforce a rule  after the FDA’s Center for Food Safety and Applied Nutrition issued citations to several New York State cheesemakers for the use of wood shelves, which prompted an inquiry from the state government, which allows the practice.

cheese.wood.boardIn response, the FDA clarified its position, saying that the use of wood shelves violates a provision of its Current Good Manufacturing Practice regulations that requires “all plant equipment…to be adequately cleanable.” The agency is applying this interpretation to all imports as well — an important aspect, since the majority of cheeses imported from Europe are aged on wood.

With the Intertubes that discussion has, within 24 hours, turned conspiratorial.
“A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community,” according to the Wisconsin blog Cheese Underground.

Naturally, conservatives and libertarians see this move as yet another assault on liberty by the Obama administration. It’s not. It’s a dumb mistake by the F.D.A., not a metaphor for overreach that implies the government should also stop regulating coal emissions and health insurance policies

This afternoon, responding to the uproar in the cheese world, FDA. issued a statement saying it was willing to work with artisanal cheese makers to determine if some cheeses could be safely made on wooden boards. The agency is “always open to evidence that shows that wood can be safely used for specific purposes, such as aging cheese,” the statement said, according to the Associated Press.

Any government agency needs to clearly and effectively communicate risk-based decisions, and provide the evidence to back a particular decision.

Otherwise, a risk information vacuum is created, and others will rush in to fill that space.

Foodborne illness source attribution: FDA, federal partners create interagency food safety analytics collaboration (IFSAC) web resource

The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and USDA’s Food Safety and Inspection Service (FSIS) have developed a Web resource about the Interagency Food Safety Analytics Collaboration (IFSAC) that highlights their work and creates an ongoing resource to share information with the public.

This series of Web pages, hosted by the CDC, includes information on the analyses and other activities of this tri-agency partnership.

Meeting.1Established in 2011, IFSAC seeks to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use. Projects and studies aim to identify foods that are important sources of illnesses. The current focus of IFSAC’s activities is foodborne illness source attribution, defined as the process of estimating the most common food sources responsible for specific foodborne illnesses.

To learn more about this work, please visit the IFSAC Web page.

Food fraud: FDA urged to address economically-motivated food adulteration as a unique issue

Emphasizing the specific risks posed by the intentional and fraudulent adulteration of food ingredients for economic gain, the United States Pharmacopeial Convention (USP) has submitted a public comment letter to the U.S. Food and Drug Administration (FDA) urging the FDA to reconsider its strategy to address Economically-Motivated Adulteration (EMA) of food ingredients.

food-fraud“Economically-motivated adulteration of food ingredients is a significant concern, with its own challenges, posing a threat to public safety, eroding consumer confidence in the integrity of food and disrupting markets by placing control of the supply chain in the hands of criminals,” said Ronald Piervincenzi, Ph.D., chief executive officer at USP. “EMA should be addressed as its own unique category of food adulteration.”

USP recommends that FDA considers a framework tailored to the specific nature of EMA. While USP agrees that it is not ideal to handle EMA under a typical food-defense/vulnerability approach, the organization says EMA would be equally misplaced under preventive controls. The suggested approach would include a vulnerability assessment mostly focused on determining the likelihood of EMA occurring, but also including a component of public health risk assessment; a second component would be a vulnerability control plan to mitigate these risks.