Parker Waichman LLP Injury Alerts
HEALTH RISKS POSED BY SOFT DRINKS CONTINUE TO EMERGEJul 1, 2007
Obesity, Benzene Contamination and, Now, Increased Risk of Metabolic Syndrome, Make These Popular Beverages Anything but Harmless.
“Soft drinks,” are now a $61 billion a year industry with some 500 bottlers operating in the United States alone. Consumers have made soft drinks their favorite refreshments as well as a major component of the U.S. economy buying products and services from numerous other industries, while creating thousands of jobs. Flavorings are the number one product purchased, followed by metal cans and plastics used for packaging. Soft drink bottlers are a major consumer of corn syrup, advertising services, glass containers, boxes for shipping, bottle caps, storage space, fruits and vegetables, motor freight, carbonated water, sugar, and several other products and services that are needed to manufacture the vast array of soft drinks now on the market.
In the past few years, however, the carefree image associated with soft drinks has given way to a concern that these flavored beverages are associated with a growing number of potentially serious health risks.
OBESITY IN CHILDREN: Since the 1970s, rates of obesity have doubled in young children and adults, and tripled in teenagers. In fact, in 2003, Mark B. McClellan, then Commissioner of the FDA, declared that the agency intended to “confront the obesity epidemic ... to help consumers lead healthier lives through better nutrition.”
Unfortunately, as is often the case with promises made by politicians and government officials; the FDA has done little if anything to meet the crisis with a coordinated plan. Even with a “food” that has been proven to be a major contributor to obesity—soda—the FDA has consistently declined to place health notices on containers, require added sugars to be listed separately on labels, or to require multi-serving containers to list the number of calories for the whole container.
There is now no real doubt that soft drink consumption contributes to obesity and insulin resistance in children and hypertension in adults. One consumer watchdog refers to soda as nothing more than “liquid candy.”
BENZENE CONTAMINATION: There is also the issue of benzene in soft drinks that has generated a great deal of concern on both sides of the Atlantic. Again, however, the FDA has chosen to drag its feet while other countries, most notably the UK, have taken steps to more fully examine the potential health risks posed by benzene.
Acting on test results in the U.S. that found unacceptably high levels of benzene (a known carcinogen) in samples of popular soft drinks, Britain’s Food Standards Agency (FSA) ordered similar tests that yielded the same outcome.
The FSA, the British equivalent of the FDA in the U.S., tested 230 different drinks and found some contained benzene in concentrations of up to eight parts per billion (ppb).
Although the UK has no formal restriction on the amount of benzene in soft drinks, the legal limit permitted in drinking water is only 1 ppb. Thus, the FSA ordered retailers to halt all sales of four soft drinks found to contain benzene in excess of that level.
In the U.S., however, the FDA is being criticized by a number of consumer advocates and public watchdog organizations, such as the Environmental Working Group (EWG), for another less than stellar performance.
Benzene is a dangerous toxin that has been linked to leukemia and other cancers of the blood. It is a component of other carcinogens such as fossil-fuel exhaust fumes.
One of the problems with benzene is that its carcinogenic effects are currently quantified in terms of life-time exposure. The exact amount of benzene and the duration of exposure needed to produce a serious health risk are far from certain. In minute amounts, the potential for harm is even less definite.
People living or working near high concentrations of exhaust fumes are exposed to far greater daily doses of benzene than have been found in soft drinks and drinking water, yet most governments and the World Health Organization (WHO) have set extremely low guidelines for the chemical when it is likely to be consumed by humans in a commercial product or public water supply.
Thus, while many experts and health officials are not alarmed by the presence of small amounts of the toxic chemical, others are not as willing to assume that low levels of benzene contamination are harmless or without potentially dangerous long-term effects on humans.
If you asked most people how a poisonous chemical like benzene could wind up in a commercially produced soft drink, they would answer that it would probably be the result of a breakdown in the packaging process. They would be right, and wrong, however.
While there have been some episodes of benzene leaking into commercial products, such as soft drinks and bottled water, from faulty equipment or other outside sources, they have been isolated and quickly remedied by recalls of the lots of potentially contaminated products.
The far more problematic source of benzene contamination in commercially produced drinks has nothing to do with mechanical breakdowns or human error. Instead, it is the by-product of a few simple chemical reactions between ingredients mixed together in the drinks themselves. This problem is on a global scale.
Over 15 years ago, in an investigation that was never made public, and after which the beverage industry promised to “reformulate” its ingredients and otherwise “get the word out” about the problem, the FDA found unacceptable amounts of benzene in a number of soft drinks.
The culprit was a chemical reaction any child could perform with a store-bought chemistry set. Sodium benzoate (a preservative added to extend shelf-life by killing bacteria under acidic conditions) and ascorbic acid (vitamin C - artificially added to prevent spoilage and extend shelf-life or naturally occurring in fruits and vegetables) can react to produce benzene at levels above permissible limits.
Ascorbic acid will react with metals (like iron and copper found in
water) to create hydroxyl radicals. Meanwhile, when exposed to an acidic environment (as found in many soft drinks), sodium benzoate breaks down into benzoic acid. When the “free radical” hydroxyl reacts with the benzoic acid, the carbon dioxide is removed and what is left is benzene.
Since the matter was handled informally in 1990-1991 and all parties concerned seemed to have come to a reasonable agreement that the problem needed to be addressed and resolved, no action was taken by the FDA to impose penalties or regulations on the soft drink industry. Reformulation and dissemination of the information by the industry was to be the solution.
One reason for the rather lax way in which the problem was handled was the fact that the risks posed by benzene were (and still are for that matter) looked at as a consequence of life-time exposure to the chemical. The problem was regarded as a short-term one that would be resolved long before any harm to humans might occur.
Follow-up tests in 1993 found no contamination and an article in the Journal of Agriculture and Food Chemistry discussed the problem, although not in a forum that the public was likely to read.
The problem now seems to be that 15 years of informality has caused the message to have been lost. This can be attributed to new soft drink companies (since 1993), foreign companies that may not have gotten the message at all or only to a limited extent, small companies that do not have sophisticated quality control systems, and literally thousands of new soft drink products containing both sodium benzoate and ascorbic acid (launched worldwide in past five years).
Thus, testing by independent labs prompted by consumer advocates or as a result of disclosures by whistleblowers (or internal documents) from within the industry have identified levels of benzene in some soft drink samples as being up to 5 times the limit for drinking water set by WHO of 10 ppb.
While the ingredients that produce the benzene are common in a wide range of soft drinks, their presence is hardly necessary. Vitamin C is an ingredient that adds nothing to the product itself. In fact, it is now used as an advertising gimmick to boost sales or to allow the marketing of soft drinks to children as health drinks.
Although experts see the problem as one that is easily remedied since ascorbic acid is not critical a critical additive and can safely be left out of soft drinks, the EWG sees voluntary agreements as unworkable.
In fruit and vegetable drinks where ascorbic acid occurs naturally, sodium benzoate can actually be eliminated as an additive to avoid the chemical reaction problem altogether.
Two important issues that have fueled the current debate and which consumer advocates believe must be resolved are: (1) the public’s right to know what is contained in commercial products that are marketed for human consumption; and (2) the need for regulations that place the same restrictions on benzene in soft drinks as those already in place with respect to drinking water.
While the FSA seems to be serious about its probe and the actions it is prepared to take to protect the public from even an uncertain degree of harm, the FDA has found itself caught up in a series of missteps.
In April, 2006, the FDA denied any evidence of a benzene problem. Then, a few days later, the agency backtracked and admitted its scientists had found benzene in soft drinks at levels greater than the “safe” standard set for drinking water.
Although the FDA attempted to excuse the about-face by claiming that the levels detected (above 5 ppb) still do not pose a health hazard, the position is in clear conflict with the FSA actions and the WHO view that since “benzene is carcinogenic to humans" no safe level of exposure can be recommended.”
Adding even more controversy to the FDA’s actions in 2006 week was the revelation that research by the EWG discovered an FDA report that showed some soft drinks contained unsafe levels of benzene.
The 2003 report known as the Total Diet Study incorporated data from research done between 1995 and 2001 that showed 19 of 24 (79%) diet soda samples tested contained benzene levels above 5 ppb.
According to the EWG, benzene levels as high as 55 ppb were found and the average level detected was 19 ppb. Both figures far exceeded the 5 ppb tap water standard.
In a separate study, the FDA found one cola containing a benzene level of 138 ppb. That study was looking for volatile organic compounds in foods and appeared in a 2003 issue of the Journal of Agricultural and Food Chemistry.
Thus, the EWG and consumer advocates are concerned over the FDA’s apparent lack of candor vis-à-vis the public. The assumption had been that between 1991 and 2006 the original problem with benzene had been corrected under the voluntary agreement and was only now resurfacing.
It appears, however, that the problem may never have been completely addressed by the soft drink industry between 1991 and 2005 and that the FDA was aware of the non-compliance since at least 1995.
This brings into question the FDA’s commitment to keeping benzene at safe levels in the food supply and it may also demonstrate the influence of the American Beverage Association has on the agency’s determinations. (Certainly, such influence has long been evident in the agency’s incestuous relationship with the pharmaceutical industry). In any event, it certainly showed that the so-called voluntary agreement by the soft drink industry to reformulate its products and monitor benzene levels may have been nothing more than an empty promise.
Metabolic Syndrome Risk: Now, according to a large community-based study, all soft drinks (diet or regular) are associated with substantially increased metabolic syndrome risk among middle-age adults.
The study conducted by Ramachandran S. Vasan, M.D., of Boston University, and colleagues, and reported online in Circulation, Journal of the American Heart Association, found that men and women who drank more than one soda daily had a 48% adjusted higher prevalence and 44% higher roughly eight-year adjusted incidence of the cluster of heart disease risk factors than those who drank less.
These results from an analysis of the Framingham Heart Study extend the previous findings that soft drink consumption contributes to obesity and insulin resistance in children and hypertension in adults.
The unanticipated lack of difference in risk between artificially-sweetened and regular drinks implies that soda intake may be a marker for overall eating habits that contribute to risk, stated a spokesperson for the American Heart Association.
A person with metabolic syndrome has almost a fourfold risk of having a heart attack over the next 10 years.
In the Framingham Heart Study, there were 8,997 person-observations, of which 6,039 person-observations were among participants free of metabolic syndrome at baseline. The mean age was 52.9 in this prospective cohort.
Participants were followed for three consecutive periods spanning 1987 to 1995 with a physical exam, food frequency questionnaires, and fasting plasma lipid, glucose, and triglyceride measurements about every four years.
Overall metabolic syndrome was defined having at least three of the following risk factors:
Waist circumference at least 35 inches for women or at least 40 inches for men.
- Fasting blood glucose at least 100 mg/dL.
- Serum triglycerides at least 150 mg/dL.
- Blood pressure at least 135/85 mm Hg.
- High-density lipoprotein cholesterol lower than 40 mg/dL for men or 50 mg/dL for women.
About 35% of the participants (in the doctor administered questionnaire) reported that they typically drank at least one 12-ounce soft drink per day. However, 22% reported drinking an average of at least one diet or regular soda per day on the self-administered food frequency questionnaire.
In multivariable analysis adjusting for age, sex, physical activity, smoking, and intake of fat, total calories and other dietary factors, metabolic syndrome prevalence findings were:
- 48% higher among participants who reported drinking at least one diet or regular soft drink daily compared with those who did not report drinking soda on the physician-administered questionnaire.
- 180% higher among participants who drank one diet soda per day than those who reported drinking less than one a week on the self-administered questionnaire.
- 181% higher among participants who drank one regular soda per day than those who reported drinking less than one a week on the self-administered questionnaire.
Similarly, the adjusted incidence was considerably higher with regular soft drink consumption but similar between regular and diet soda drinkers. The findings were:
- 44% higher among participants who reported drinking at least one diet or regular soft drink daily compared with those who did not report drinking soda on the physician-administered questionnaire.
- 153% higher among participants who drank one diet soda per day than those who reported drinking less than one a week on the self-administered questionnaire.
- 162% higher among participants who drank one regular soda per day than those who reported drinking less than one a week on the self-administered questionnaire.
Incidence of individual metabolic syndrome traits was also 25% to 32% higher among participants who drank at least one soft drink per day.
The results were similar whether soda was caffeinated or decaffeinated. The reason for the similarity between findings with sugar- versus
Artificially-sweetened drinks was unclear; however, the similar metabolic hazard posed by both regular and diet soft drinks is significant given the lack of calories in the latter, according to the researchers, who did note that residual dietary confounding could have played a part because greater soft drink intake has been linked to more calorie and saturated and trans fats intake and less fiber, dairy, and physical activity.
The team stated that public health policy to limit overall soft drink consumption might be beneficial, however one expert recommended a more global approach to the problem, stating: "For any given person among us it's not a bout stopping one food product, it's really about eating more fruits and vegetables, keeping our calories down, getting our exercise levels up, moderate restriction of salt…and making sure your portion size…is kept appropriate."
Thus, the public’s acceptance of soft drinks, without reservation, over the past 30 years may have come with a heavy cost in terms of health risks that cannot be undone unless a conscious effort is made to significantly restrict their consumption regardless of whether they are sweetened with sugar or an artificial sweetener.
As always, the attorneys at Parker Waichman LLP are dedicated to bringing the public the most up-to-date information regarding consumer products, pharmaceuticals, medical devices, toxic substances, and other substances with the potential to inflict serious injuries or death. If you or a loved one has suffered an injury (or death) that may be attributable to any product, do not hesitate to contact us at www.yourlawyer.com for a free and thorough case evaluation