Sunday, November 16, 2014

Food Additives Are On The Rise As FDA Scrutiny Wanes

“We do not know the volume of particular chemicals that are going into the food supply so we can diagnose trends,” said Michael Taylor, the FDA’s deputy commissioner for food. “We do not know what is going on post-market. The assessments need to be based on publicly available information where there is agreement among scientists,” he said. “It has got to be more than three employees in a room looking at information that is only available to them.”
Washington Post:
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.

And 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.”


The FDA defines a food additive as “any substance that is reasonably expected to become a component of food.” This vague definition makes the lucrative food-additive industry, which will be worth a reported $36.1 billion by 2018, susceptible to loopholes and other questionable behavior.

In the five decades since Congress gave the FDA responsibility for ensuring the safety of additives in the food supply, the number has spiked from 800 to more than 9,000, ranging from common substances such as salt to new green-tea extracts. This increase has been driven largely by demand from busy Americans, who get more than half their daily meals from processed foods, according to government and industry records.

Within the past six months, top officials at the FDA and in the food industry have acknowledged that new steps must be taken to better account for the additives proliferating in the food supply. The Center for Food Safety, an advocacy group, has responded more aggressively; it sued the FDA this year, saying the agency has abdicated its oversight of the additives approval process. The Grocery Manufacturers Association also provided seed money this spring to create a research center at Michigan State University to deal with the rising concerns over additives.

For new, novel ingredients — or when approved additives are used in new ways — the law says companies should seek formal FDA approval, which must be based on rigorous research proving the additive is safe. The agency uses the phrase “food additive,” in a narrow legal sense, to apply to substances that get this approval.

But many other additives are common food ingredients — vinegar is considered a classic example. The law allows manufacturers to certify, based on research, that such ingredients are already Generally Recognized as Safe, or GRAS. For both types of additives, FDA scientists initially conducted detailed reviews of the company’s research. The agency also published its own evaluation of that research in the Federal Register.

This oversight system shifted dramatically in 1997. In response to a shortage of staff members and complaints from industry that the process was too cumbersome and did not improve food safety, the FDA proposed new rules. The agency told companies that were going the GRAS route — which turned a years-long process into one of months — that they no longer would have to submit their research and raw data. The companies can share just a summary of their findings with the agency.

The FDA’s laundry list of negligent blunders is most often attributed to The Food Additives Amendment of 1958, which is responsible for launching the loosely defined blanket designation GRAS. According to the FDA, if an additive “is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use,” then it will not be subject to any further testing. One-third of the additives in the Dirty Dozen carry the GRAS distinction and are not subject to FDA testing.

But who exactly are these qualified experts? In 2012, researchers from the Journal of the American Medical Association analyzed 451 different GRAS claims submitted to the FDA and found that financially objective third parties executed none of the safety assessments. Even worse, the company who manufactured the food additive in the first place carried out more than 20 percent of the tests.

In part, FDA officials hoped that by streamlining the GRAS notification process, companies that previously avoided informing the agency of new additives would be encouraged to keep the government in the loop, current and former agency officials said.

The changes didn’t work out as planned. For starters, most additives continued to debut without the FDA being notified. Moreover, companies that did choose to go through the FDA oversight process largely abandoned the formal approval route, opting instead for the new, cursory GRAS process, even for additives that could be considered new and novel, according to agency documents and an analysis of those records by the Natural Resources Defense Council.

“They created a side door,” said Tom Neltner, a chemical engineer with the NRDC who has co-authored six academic articles about the FDA additives process over the past four years.

An average of only two additive petitions seeking formal approval are filed annually by food and chemical companies, while the agency receives dozens of GRAS notifications, according to an NRDC analysis of FDA data. Hundreds of other food chemicals and ingredients have been introduced without notifying the FDA at all, according to agency officials, trade journals and food safety groups.

FDA officials, food safety advocates and the food industry all agree there are problems. There are too many cases in which the agency is not notified of new additives or the science remains secret. But there’s no consensus about how to fix the system.

Industry trade groups say that the additives in today’s foods do not pose a public safety risk, but most agree improvements for better tracking and oversight are needed.

“It’s the right time to take a step back,” said Leon Bruner, the Grocery Manufacturers Association’s chief science officer. “There are problems with transparency. How can we be sure that the FDA is aware of ingredients?”

Six Wise:
In the United States, more than 3,000 substances can be added to foods for the purpose of preservation, coloring, texture, increasing flavor and more. While each of these substances is legal to use (at least here in the States), whether or not they are all something you want to be consuming is another story all together.

Propyl Gallate
This preservative, used to prevent fats and oils from spoiling, might cause cancer. It's used in vegetable oil, meat products, potato sticks, chicken soup base and chewing gum, and is often used with BHA and BHT. This chemical is used to preserve edible fats in sausage and lard and also has links to estrogenic activity and endocrine disruption.

BHA and BHT
Butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) are used similarly to propyl gallate -- to keep fats and oils from going rancid. Used commonly in cereals, chewing gum, vegetable oil and potato chips (and also in some food packaging to preserve freshness). The European Union classifies BHA as a known endocrine disruptor. BHT has been associated with the development of lung and liver cancer in lab rats. If a brand you commonly buy uses these additives, look for a different variety, as not all manufacturers use these preservatives.

Potassium Bromate
This additive is used in breads and rolls to increase the volume and produce a fine crumb structure. Although most bromate breaks down into bromide, which is harmless, the bromate that does remain causes cancer in animals. Bromate has been banned throughout the world, except for in the United States and Japan. This additive is recognized as a carcinogen by both the state of California and the International Cancer Agency. In California, a cancer warning would likely be required if it were used, which is why it is rarely used in that state.

Monosodium glutamate (MSG)
MSG is used as a flavor enhancer in many packaged foods, including soups, salad dressings, sausages, hot dogs, canned tuna, potato chips and many more. According to Dr. Russell Blaylock, an author and neurosurgeon, there is a link between sudden cardiac death, particularly in athletes, and excitotoxic damage caused by food additives like MSG and artificial sweeteners. Excitotoxins are, according to Dr. Blaylock, "A group of excitatory amino acids that can cause sensitive neurons to die." Many consumers have also personally experienced the ill effects of MSG, which leave them with a headache, nausea or vomiting after eating MSG-containing foods.

Aspartame (Equal, NutraSweet)
This artificial sweetener is found in Equal and NutraSweet, along with products that contain them (diet sodas and other low-cal and diet foods). This sweetener has been found to cause brain tumors in rats as far back as the 1970s, however a more recent study in 2005 found that even small doses increase the incidence of lymphomas and leukemia in rats, along with brain tumors. People who are sensitive to aspartame may also suffer from headaches, dizziness and hallucinations after consuming it.

Acesulfame-K
Acesulfame-K is an artificial sweetener that's about 200 times sweeter than sugar. It's used in baked goods, chewing gum, gelatin desserts and soft drinks. Two rat studies have found that this substance may cause cancer, and other studies to reliably prove this additive's safety have not been conducted. Acesulfame-K also breaks down into acetoacetamide, which has been found to affect the thyroid in rats, rabbits and dogs.

Olestra
Olestra is a fat substitute used in crackers and potato chips, marketed under the brand name Olean. This synthetic fat is not absorbed by the body (instead it goes right through it), so it can cause diarrhea, loose stools, abdominal cramps and flatulence, along with other effects. Further, olestra reduces the body's ability to absorb beneficial fat-soluble nutrients, including lycopene, lutein and beta-carotene.

Sodium Nitrite (Sodium Nitrate)
Sodium nitrite (or sodium nitrate) is used as a preservative, coloring and flavoring in bacon, ham, hot dogs, luncheon meats, corned beef, smoked fish and other processed meats. These additives can lead to the formation of cancer-causing chemicals called nitrosamines. Some studies have found a link between consuming cured meats and nitrite and cancer in humans.

Hydrogenated Vegetable Oil
The process used to make hydrogenated vegetable oil (or partially hydrogenated vegetable oil) creates trans fats, which promote heart disease and diabetes. The Institute of Medicine has advised that consumers should eat as little trans fat as possible. You should avoid anything with these ingredients on the label, which includes some margarine, vegetable shortening, crackers, cookies, baked goods, salad dressings, bread and more. It's used because it reduces cost and increases the shelf life and flavor stability of foods.

Artificial Colors
Food dyes are typically used to increase the visual appeal of nutrient-deficient food. Caramel color III and IV contain a chemical that was linked to tumors in a National Toxicology Program study. Blue 1, used to color candy, beverages and baked goods, may cause cancer. Blue 2, found in pet food, candy and beverages, has caused brain tumors in mice. Red 3 food coloring is used in cherries (in fruit cocktails), baked goods and candy. It causes thyroid tumors in rats, and may cause them in humans as well. Yellow 6 is found in many products, including backed goods, candy, gelatin and sausages. It has been found to cause adrenal gland and kidney tumors, and contains small amounts of many carcinogens. Like Yellow 6, Red 40 and Yellow 5 are contaminated with illegally high levels of benzidine and 4-aminobiphenyl, known carcinogens. The FDA has done nothing.

Yahoo:
Theobromine
An alkaloid found in chocolate, this additive used in breads, cereals, and sport drinks is deemed safe by the FDA—but only at a level 5 times less than the average person consumes it.

Propylparaben
A common preservative in tortillas and muffins, it has also been linked with decreased sperm count and testosterone levels in lab rats.

Diacetyl
Used as butter flavoring in microwavable popcorn, this compound is associated with severe respiratory diseases.

Phosphates
Found in more than 20,000 foods, this is the most common additive. High phosphate levels in the blood lead to an increased risk of cardiovascular disease.

Aluminum additives
Used as a stabilizer in many processed foods, it is linked with developmental difficulties during pregnancy as well as neurodegenerative disorders.

“Secret flavor” ingredients
FDA loopholes allow companies to hide the specifics of their “natural flavors,” making this a grab bag of potential health concerns.

More information:
» Center for Science in the Public Interest: Overview of Food Additives
» Six Wise: "Are Metals in Food Harming Your Child’s Behavior?"
» NPR: "Move Over, Yellow 6. More Natural Colors From Plants Are Coming"

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