Recent FDA Moves Suggests Agency Is Again Taking Its Role of "Protecting Public Health" Seriously

As a patient with type 1 diabetes, I have found myself at odds with the U.S. Food and Drug Administration (FDA) on a number of things the agency has done in recent years (actually since the 1980s), and perhaps even more so in recent years.  In fact, I once joked (only halfheartedly) that the acronym "FDA" stood for Fatal Drug Administration.  Indeed, for a number of years (under the leadership of chief Dr. Andrew von Eschenbach especially, he pushed for FDA to serve what he called its "clients", meaning the companies that the FDA regulates, rather than protecting public safety).  Staff in areas for brand new drugs exploded, while the queue of unapproved applications in generics also grew, yet the FDA never asked Congress for user fee authorization in generics during that time.  However, at the end of 2013, the FDA took two very important moves that might just give me reason to reconsider my belief that the FDA was looking out more for industry than it was for patient safety.  Both relate to the "Food" responsibilities at FDA, but given that cardiovascular disease is the #1 killer of people with diabetes, the first one is especially relevant, while the second one relates to big agribusiness routine abuse of medicines and has resulted in a rise of antibiotic-resistant viruses.

Item #1: Obituary for Twinkie the Kid?

On November 16, 2012, Huffington Post featured an article entitled "Twinkie The Kid, Dead At 85" (see http://huff.to/1dINwQt).  The article, of course, was a parody of the then-current news that Hostess, the manufacturer of Twinkies had filed for liquidation in a bankruptcy filing.  The maker of Twinkies cakes had flirted with death several times in recent years, and in 2012, when the parent company, Hostess (which had various names over the years, including Continental Baking Company and Interstate Bakeries) had finally filed for bankruptcy after failing to reach an agreement with the company's unions.  Unlike a bankruptcy reorganization, this one was a liquidation, which meant the company and all of its brands were dismantled.  But as author Mark Twain once wrote: "The reports of my death are greatly exaggerated", and so too was the reported death of the über-processed, junky snack food known as Twinkies.  Indeed, the Twinkie re-emerged to much fanfare under new ownership a year later (in 2013).  But the obituary for the Twinkie in Huffington Post may have been a premonition, only this time, it won't be finances or unions that kill it - it will be the recipe for Twinkies itself.

That's because the Twinkie (and virtually all Hostess cakes) is made primarily from hydrogenated fats.  It has a bunch of other highly-processed ingredients, some of which are mined, and an entire book entitled "Twinkie, Deconstructed" [http://www.twinkiedeconstructed.com/] by Steve Ettlinger was written to try and explain the ingredients in Twinkies.  (That book, incidentally, is highly-entertaining reading!)  Indeed, the creamy filling is pure hydrogenated fat and sugar.  The cake itself also has a lot of sugar and hydrogenated fat, which explains why they seemingly never spoil.  But the new nemesis of the Twinkie may be the U.S. Food and Drug Administration (FDA), and unless the company suddenly gets creative, because all of the Hostess cakes (including the namesake Twinkie, as well as Ding Dongs, Ho Hos, Chocodiles and others depicted in the commercial featured in the Huffington Post article) will cease to exist.  Nostalgia won't save them from using a banned ingredient, namely hydrogenated fat.

That's because in early November 2013, FDA did something doctors and nutritionists had been advocating for decades: it finally took steps to remove artificial trans fats (hydrogenated or partially hydrogenated oils) from the U.S. food supply.  See the news in the Federal Register at http://1.usa.gov/1aY5Ubk and a separate, more user-friendly article about the announcement from the FDA at http://1.usa.gov/1bsRrRy.

About Trans Fats

Trans fats are created when hydrogen is added to vegetable oils to make them more solid (vegetable shortening, a.k.a. "Crisco" is the usual result).  The result is an artificial product said to accumulate as plaque in the arteries.  If the FDA's decision is finalized, partially hydrogenated oils (trans fats) will soon be classified as food additives that can no longer be used without prior FDA approval.  A  final ruling by the FDA won't come until after a 60-day comment period, but Dr. Margaret Hamburg and the FDA's top food official, Michael Taylor, left little doubt that the agency's goal was to completely remove trans fat from the U.S. food supply.  The FDA and CDC jointly estimate that totally eliminating trans fats from the U.S. food supply could prevent 20,000 heart attacks and 7,000 deaths due to heart disease each year.

Its hard to believe it now, but once upon a time, trans fats were actually claimed by their promoters to be healthier than the lard, butter and the saturated animal fats they often replaced.  However, mountains of data since proven they are actually even worse for us than saturated fats are when it comes to heart disease, which is a major U.S. killer.  In 2006, after a campaign by public health advocates, the FDA finally started requiring food companies to add trans fats to food labels.  (On a related issue, there was news recently, see http://ow.ly/t2mG6 for details, that the FDA would likely be revising food labels in the near future.  The FDA won't say exactly when the changes will come, or what the new labels will include. But we're likely to see changes that make it easier to see calorie counts, more up-to-date serving sizes [right now, serving sizes are a joke] and more detailed information on added sugars including high fructose corn syrup.)  That was a good start, but the FDA's latest move may actually be the impetus to end routine use of these toxic ingredients in the U.S. industrial food supply found in your local supermarkets.  Indeed, trans fats would become an ingredient "not generally recognized as safe" and would need special permission from the FDA to be used.  The commercial food industry, especially commercial bakeries such as Nabisco (part of Kraft) will need to do some serious soul searching to find practical alternatives which are in bread, cookies and various other products including cake frosting sold in supermarkets.

Trans fats are very common in highly-processed foods, although they are also very common in commercial baked goods like biscuits, pie crusts, and frostings that aren't hand-made.  The FDA once estimated that in the late 1990s, 95% of prepared cookies, 100% of crackers, and 80% of frozen breakfast products sold in the U.S. contained trans fats.  The frying oils used in restaurants were also rich in them at that time, but the use of trans fats in frying foods (at places like McDonalds) has indeed declined significantly in recent years so that they’re relatively uncommon in fried foods sold in fast food joints today.  According more recent data from the FDA, trans fat intake among Americans declined from 4.6 grams per day in 2003 to around 1 gram in 2012.  Michael Jacobson, executive director of the Center for Science in the Public Interest, estimates that today, 75% of the trans fats is already is gone from the nation's food supply.  But, they still remain in things like Twinkies, so the FDA move is a good move.

The scientific evidence against these staples in processed foods is pretty overwhelming, namely that they provide absolutely no nutritional value at all, yet are implicated in the prevalence of heart disease (trans fats aren't the only factor, but it's a notable one).  That's why the FDA's announcement on November 7, 2013 that for the first time, it believes that trans fat can no longer be considered "generally considered as safe" drew a lot of praise from doctors.  Trans fats are made by adding hydrogen to vegetable oil (most commonly, genetically modified soybean oil) in a process that is hardly new.  In fact, in what was perhaps a great irony, Paul Sabatier won the 1912 Nobel Prize in Chemistry for discovering the hydrogenation method that activists are now fighting to remove from our food today. His research detailed the way nickel could be used as a catalyst to create chemical reactions between hydrogen molecules and other compounds, which laid the groundwork for the creation of hydrogenated oils.

Why Industrial Food Producers Loved Trans-Fats

Trans fats became very popular because of their versatility in industrialized food production which dominates U.S. supermarket shelves.  Trans fats make processed foods "shelf-stable," able to stay on supermarket shelves for months without going bad.  Fast food restaurants also liked trans fats because they could be used repeatedly in commercial deep fryers without having to be replaced, according to the American Heart Association.  As already noted, that industry largely abandoned trans fats nearly a decade ago.

Kantha Shelke, a scientist with the Institute of Food Technologists in Chicago, told NPR that the the use of trans fats in things like cookies or doughnuts means the products don't leave a ring of oil behind on a paper towel and don't start tasting rancid after a few weeks.  Also, this type of fat doesn't have a strong taste of its own so you can use lots of it without ruining the flavor.

"It's really absolutely perfect [for industrial food production], and it's also perfect for the American style of shopping: You buy boxes and boxes of crackers, put them in your pantry," says Shelke. "You open this box six months or eight months or a year later, and it would still taste and smell just as good as it was on the day you bought it!"

The use of these fats really exploded as the food system in the U.S. became increasingly industrialized, but so did the adverse the health effects.  However, since the FDA started requiring labeling of trans fats separate from other fats, much of the food industry has already started to migrate to more traditional oils, and trans fat usage has declined as food manufacturers and processors found alternatives.  In a statement, the Grocery Manufacturers of America said that since that 2005 food manufacturers have already lowered trans fats in products by more than 73%.  However, the FDA says that today, 12% of all packaged foods still contains a partially hydrogenated oil, the formal name for trans fats, which is why the FDA feels the time is right now to eliminate them completely.

U.S. Not Alone in Efforts to Get Rid of Trans-Fats, WHO Also Advances the Issue

The U.S. is hardly alone in the move to try and eliminate these industrial fats from its food supply food.  In 2004, Denmark made it illegal (see http://ow.ly/Tpi9303f0uU for more) for any food to have more than 2% trans fats. Offenders risk hefty fines or even prison terms.  Other countries are also working to reduce trans fat in their food supplies. Policies in Brazil, Costa Rica, the Netherlands and South Korea have proven effective over the past two decades (showing that countries from Latin America to Europe to Asia are dealing with the issue), the World Health Organization says. The WHO has also called for completely eliminating trans fat from the global food supply, though the WHO lacks any enforcement capability.

Giant food-processor Cargill Inc., which now sells partially hydrogenated shortening to commercial customers, said it will help them switch to alternatives.  Another big maker, Archer Daniels Midland Co., said it [trans fats] is a steadily declining business and that it sells low- and zero-trans-fat oils.  These big industrial food suppliers are now working with clients to find suitable alternatives.

Junk Foods That Are Ahead of the Curve?

Pepsico's Frito-Lay snack unit saw the handwriting on the wall nearly a decade ago and did take a lead in product reformulation when it began selling "zero trans fat" snacks before all packaged foods were required to list the amount of trans fat on the nutrition labels.

Nevertheless, some of the company's snacks, now cooked in corn, canola and/or sunflower oil, still fall into the 0.0 to 0.5 gram range, a spokesman said.  That's because the FDA permits them, if there's less than half a gram of trans fats per serving, to list the amount of trans fats in their products as zero.

Other food categories may require modification.  They remain staples in things like boxed cake mixes and frostings, as well as such mundane categories as breakfast cereals (for example, Post Fruity Pebbles sugary breakfast cereal relies on trans fats).

Food processors should not be surprised; the moves to eliminate trans fats in restaurants (notably, New York City banned them for use in restaurants in 2004 and other big cities including San Francisco did the same) has been growing and the industry has (for the most part) found suitable alternatives, including non-hydrogenated, genetically modified soybean or canola oil that is used for deep fat frying many foods.  Fast food chains have already eliminated trans fats from much of their menus (except for their baked goods, such as hamburger buns, which come from third-party suppliers who rely heavily on trans fats in their production and so the products will stay fresher, longer) a number of years ago, and no one's french fries or chicken nuggets suddenly disappeared as a result.

The evidence has been mounting against trans fats over the past few decades after numerous studies linked trans fat to higher LDL, or bad cholesterol, as well as to heart attacks and strokes. The Institute of Medicine said in a widely-cited 2002 report that "there is no safe level" of the ingredient (see http://1.usa.gov/1hF26wQ for reference).  As I noted, the turning point really came in 2006 when the FDA mandated that processed food makers must disclose the presence of trans fat on their nutrition labels, at which point food manufacturers began (in earnest) switching to more traditional oils rather than have the negatively-perceived ingredient show up on their "Nutrition Facts" labels.

Microwave Popcorn, Commercial Baked Goods Still Loaded With Trans-Fats

Aside from the products already mentioned, certain food products are still heavily dependent on trans fats.  For example,  things like microwave popcorn, frozen pies and all kinds of mass-produced baked goods. Often, food companies use just a little bit, but the new rules would require them to reformulate their recipes.  A complete ban on trans fats would be a bigger deal for food manufacturers, according to Ms. Shelke. She says food companies can drop the trans fats, but their products won't be quite the same.

"They have to go back to re-educating consumers that cookies don't last forever," says Shelke.

Although the packaged baked goods might have a shorter shelf life, the FDA is hoping consumers' lives will be be longer as a result.

The FDA move seemed to have few opponents, even among residents of states generally opposed to big government.  One Houston resident, when asked about whether the move was too "nanny state", wasn't opposed to the FDA move.  He rationalized his response as follows:

"I think the government should have control over things that we create, just like any drug," the man said. "I don't want the government telling me I can't eat duck fat. But telling me I can't eat crude oil that's been refined and turned back into something that resembles margarine I have no problem whatsoever with. That isn't something you're getting out of an animal. You cannot make trans fats in your home kitchen. So why the hell should a company be able to sell them to you when they know it's bad for you?"

The FDA press release on the announcement can be found at http://1.usa.gov/1dIVusV and the announcement in the Federal Register with information such as the docket number and whom to send comments to can be found at http://1.usa.gov/1fhYdhA.  Comments to the FDA were due on January 7, 2014, although U.S. law permits public comments on any guidance at any time, even if the practical impact may result in the agency giving late comments less consideration (if any at all).  As to whether “Twinkie the Kid” can cheat this particular death round remains to be seen.

Item #2:  Routine Use of Antibiotics in U.S. Industrial Meat Production

Separately, on December 11, 2013, the FDA took steps that are within the agency's authority to crack down on widespread use of antibiotics in the nation's food supply.  See coverage in the New York Times at http://nyti.ms/1bXhYeO) and the FDA’s announcement at http://1.usa.gov/1cASPF0.

As the Los Angeles Times reported (see http://lat.ms/Mljay8) at the beginning of 2012, only 20% of the antibiotics sold in the U.S. are actually given to people who are sick with bacterial infections, such as ear and urinary tract infections or pneumonia.  In fact, most of the penicillin, tetracycline and other antibiotic drugs used in the U.S. today are given to livestock -- and to make matters even worse, most of the livestock given these antibiotics are aren't even sick.


"We feed antibiotics to sick animals, which is completely appropriate, but we also put antibiotics in their feed and in their water to help them grow faster and to compensate for unhygienic conditions. said Dr. Gail Hansen, a veterinarian and senior officer for the Pew Campaign on Human Health and Industrial Farming, a project aimed at phasing out overuse of antibiotics in food production, who added "If you have to keep the animals healthy with drugs, I would argue you need to re-examine the system. You don't take antibiotics preventively when you go out into the world."

The FDA's latest move is (at this point) voluntary and will be phased in over a three year period because the FDA believes that's actually the fastest and most effective way to achieve its goal.  The FDA told Reuters that approximately 25 to 27 companies would be affected by the voluntary three-year phase-out of the use of antibiotics in the raising of animals for food production.  William Flynn, deputy director for science policy at the Center for Veterinary Medicine at the FDA, said during a call with reporters that Zoetis Inc. and Eli Lilly & Co.'s Elanco unit sell a large percentage of those products and it has already started speaking with those companies about compliance with the phase-out.

As might be expected, the big meat processors like Smithfield Farms, as well as others like Tyson Foods, Inc., Hormel Foods Corp. and others all claimed that the FDA move was a huge mistake, but don’t believe them.  Critics say they need to clean up their act, although their response (so far) has been to push for so-called “Ag-gag” bills, which is already the law in Utah, Iowa, Missouri.  Similar legislation has been appearing, and reappearing in almost a dozen other states, including Nebraska, Indiana, Wyoming, Arkansas, North Carolina, Minnesota, Pennsylvania and New Hampshire, which basically makes it a criminal offense to even photograph industrial "farms" (see http://www.wnyc.org/story/273133-states-consider-so-called-ag-gag-bills/ for an interesting discussion on that) that’s now routine in modern American farming.  Many of these bills are reportedly efforts to combat terrorism, eco-terrorism or otherwise (at least if one believes the bills’ sponsors in the legislature), and yet, the real outcome seems to be criminalizing information.

However, the FDA's move on antibiotic use was actually precipitated by a number of true citizen's petitions which the FDA basically ignored, followed by lawsuits which the FDA lost.  In other words, the FDA was sued and lost, hence it had to do something on the matter, and finally moved in 2013 to actually do so.  Some of the petitions and lawsuits go back to 2009 or even before.  More recently, on March 23, 2012, the FDA lost a lawsuit filed by the Natural Resources Defense Council, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists (UCS).  One Court noted the issue in its 2012 decision: "Research has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be--and has been--transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products."

On June 4, 2012, the courts ruled that the FDA had been dragging its feet for years and ordered the FDA to take action in order to protect public health from the overuse of antibiotics in animal feed by instructing FDA to reconsider two previous citizen petitions which urged the agency to revoke approvals for all non-therapeutic uses of antibiotics in livestock production.  For years, scientists, health care organizations, and government agencies had warned that the widespread use of antibiotics to hasten animal growth and compensate for unsanitary and over-crowded feedlots resulted in diminishing effectiveness of these essential medicines to treat infections in people.  The term antibiotic resistance has become more common in recent years.

"The Court's order pushes the agency one step closer to meaningful action to curb the dangerous overuse of antibiotics in animal feed," said Avinash Kar, NRDC health attorney. "The Court calls out FDA's protracted foot-dragging on the problem of antibiotic resistance and requires the agency do its job to protect our food, our health and our families."

In recent years, some pathogens have evolved to withstand the drugs (antibiotics) that previously was used to kill them.  The World Health Organization sees this threat as dire. "A post-antibiotic era, in which common infections and minor injuries can kill, far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century," the organization notes.

Urinary tract infections caused by drug-resistant E. coli are increasingly common, as are infections caused by methicillin-resistant Staphylococcus aureus (MRSA) — rates of which doubled at academic hospitals between 2003 and 2008.  The WHO also notes that gonorrhea, which used to respond well to common antibiotics, "may soon become untreatable as no vaccines or new drugs are in development."

However, the most recent move by the FDA was greeted more favorably by the meat industry but decidedly less so by critics.  The Natural Resources Defense Council, a non-profit environmental advocacy group that was among the organizations that sued the FDA for changes bashed the FDA's plan, saying it fails to require any change in the use of antibiotics."

FDA's policy is an early holiday gift to industry," NRDC health attorney Avinash Kar said in a statement. "It is a hollow gesture that does little to tackle a widely-recognized threat to human health. FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased."

The Center for Science in the Public Interest noted in a statement the proposal "requires the drug companies who profit from sales of their drugs to initiate the process. The good news is the agency has pledged to evaluate levels of compliance and inform the public after 90 days if the drug industry is cooperating with the relabeling effort."

Having said this, even this move (however late and toothless) is still a much-needed step in the right direction, although its one which some would say the U.S. Department of Agriculture (USDA) kind of promoted (at least unofficially) to address downright filthy feedlots routinely used in industrial meat production.  To give you an illustration of just what this means, animals are fed antibiotic-laced food and stand in 1-2 inches of feces.  The runoff pollutes waterways around these "farms".  According to Iowa Citizens for Community Improvement, a group that is trying to fight factory farming in Iowa, using data from the state's Department of Natural Resources, the number of "impaired waterways" in the state over the past decade, although all of that degradation can't be laid at the feet of livestock farms — Iowa also has massive amounts of corn farming, which also results in leaching of algae-causing nitrogen and phosphorus. However, farming hogs has scaled up over the same time frame (see http://bit.ly/1ekYwF5 for more details).  On the latter issue, I should note that the Chinese seem very eager to copy U.S. industrial food production methods to feed its billion people inexpensive meat.  China has been on a meat-eating binge, having doubled its consumption in the last two decades of economic growth.

In September 2013, Virginia-based pork producer Smithfield Foods Inc. was acquired by Shuanghui International Holdings Ltd., but the company legally changed its name on January 21, 2014 to the less-distinctively Chinese WH Group Ltd., in a $4.7 billion acquisition deal, meaning the company sold at a 31% premium.  The deal made Smithfield shareholders very happy, and also passed the Justice Department's requirements.  China itself has been plagued by routine food processing scandals at home (does anyone remember the poisoned infant formula incident that made world headlines in 2008?), so the Chinese government viewed the Smithfield acquisition as a way of helping the country produce meat more cheaply at home using methods that are now already widely-deployed in the United States.

China seems to want to emulate U.S. food industrialization, regardless of the health consequences.  I suppose its marginally better than what they have presently, but one could hardly call it an “advancement”, but they’ll have to deal with the longer-term health consequences down the road, something the U.S. has been slow to do itself.

On the issue of industrial meat production, a relatively new documentary released on December 10, 2013 in cooperation with Rolling Stone magazine (see http://rol.st/ID5xs3) gives a closer look at what American "farming" looks like today.  I'll give you a hint: images of animals grazing happily on open fields is a big myth.  The reality, as documented to some extent in the film I addressed a few years ago "Food, Inc." (see my post at http://goo.gl/X0iiun for details), is very different.  Although the Rolling Stone film focuses more on the issue of animal cruelty which is an eye-opener by itself, the conditions (which China now wants to adopt) have certainly become a major health threat that has grown exponentially over time.

In the end, these two recent FDA moves, regardless of what prompted them, does suggest (to me, at least), that the era of the FDA serving "clients" it is tasked with regulating, is less important today than is the goal of public safety.  That certainly doesn't mean things are perfect at FDA.  There's still a revolving door between senior executives in the drug and biotech companies into the management roles at the FDA (and USDA) which is a significant conflict-of-interest that still hasn't been resolved, but it IS a step in the right direction.