Tag Archives: cancer

Comments of the Cancer Prevention and Treatment Fund on FDA draft guidance to industry on Acrylamide in foods

January 14, 2014

The Cancer Prevention and Treatment Fund strongly supports the Food and Drug Administration in its efforts to advise industry on reduction of acrylamide in food products.  The Grocery Manufacturers Association estimates that acrylamide is present in approximately 40% of the total caloric intake in a typical American diet.1 Given this near-ubiquity, and the fact that the chemical reaction which produces acrylamide also produces commercially desirable color, taste and texture characteristics, reduction of acrylamide represents a challenge.  However, the evidence of possible human harm necessitates its treatment as a significant public health issue. While this report represents an important step in FDA regulation of acrylamide and suggests many possible acrylamide reduction methods, we are concerned that this guidance is not specific enough in providing clear and concrete recommendations that can be implemented.  Although FDA guidance does not have the force of law or regulation, the addition of terms such as “when feasible” implies that the FDA is not serious in its efforts to persuade companies to substantially reduce acrylamide.  FDA monitoring of acrylamide in 2002 indicated wide variation even among products from the same food category –as much as 5 or 10 fold differences in several categories.  This is clear evidence that significant acrylamide reduction can be accomplished without losing desirable product qualities. Thus, although there is clearly much room for improvement, this report contains few immediately implementable guidelines for industry. Since 2002, it has been known that acrylamide is created in food products as the result of a reaction between carbohydrates and the amino acid asparagine at high temperatures during browning (i.e., the Maillard reaction).2  In addition to its known neurotoxic properties, both animal toxicology and human epidemiological studies suggest that acrylamide may be cancer-promoting, which has led to its carcinogen classifications by EPA, NTP and IARC.3,4,5,6 Higher dietary acrylamide consumption has been associated with increased risk of endometrial, ovarian, pancreatic, renal and possibly breast cancer.7,8,9,10.  Acrylamide is already regulated in drinking water and was classified by EPA as “likely to be a carcinogen to humans” and was classified by the National Toxicology Program as “reasonably anticipated to be a human carcinogen,” both more than a decade ago.  The European Food Safety Authority has been overseeing acrylamide monitoring within the European Union since 2007, and the European Commission has set recommended indicative values for acrylamide in food products, providing a quantitative framework for both assessment of reduction efforts and investigative action.  This is a very important health issue and we strongly urge the FDA to intensify its efforts and assert leadership of both the national and international efforts to regulate acrylamide and ensure public safety. Our areas of specific concern are the following:

  • While encouraging manufacturers to conduct their own testing, FDA should update and expand its own monitoring efforts.  Monitoring of acrylamide in food products over time is needed for any reduction efforts to be assessed and successfully implemented.  The current FDA monitoring strategy tested only several hundred foods in four geographic regions annually between 2002 and 2006, and the last publicly available information is from 2006.11  Given the wide range of acrylamide levels even within a single food category, more extensive and up-to-date monitoring is needed to adequately evaluate acrylamide levels and the success of reduction methods.
  • While this report encourages manufacturers to monitor acrylamide levels, it does not give any specific values which should prompt corrective efforts.  Without such guideposts, monitoring alone is unlikely to result in significant reductions.  Recommended target values or action levels, together with active monitoring, will allow FDA and manufacturers to directly access efficacy of reduction efforts and trigger investigation when needed.  The European Commission has set indicative values for acrylamide in food products, including separate values for products intended for infants and young children, and these values are intended to be gradually reduced.12  Indeed, these indicative values have been broadened to include more specific categories and some have already been lowered since their release in 2011, and the European Food Safety Authority is currently conducting a risk assessment at the request of the European Commission to determine if current recommendations are sufficiently protective.  Such a system provides a quantitative framework for reduction efforts and allows increased surveillance of items of special health importance.  Values at least as low as the 2013 European Commission indicative values should be adopted, with the shared intent of gradual lowering of these values as reduction efforts improve.
  • Without accurate and affordable detection techniques, manufacturers are unlikely to measure acrylamide in their products, especially when participation is voluntary.  This guidance encourages manufacturers to be aware of acrylamide levels in their food products.  This is a crucial step towards evaluating reduction efforts.  However, this vital imperative is followed by a discussion of both the technical limitations and expense associated with current methods of acrylamide detection.  While FDA has committed to improving these techniques, they remain costly and fraught with technical limitations, making widespread voluntary use, especially by small manufacturers, unlikely.  FDA should continue to investigate means to improve acrylamide detection and make specific recommendations to industry regarding best possible techniques in order to facilitate participation in monitoring.  As an example, the European Commission has recently set measurement uncertainty (MU) values and tasked the European Committee for Standardisation (CEN) with analytical standardization of LC-MS and GC-MS for acrylamide detection.  Such efforts, in addition to adoption of standard references, will increase consistency and improve confidence in acrylamide detection efforts.
  • In this guidance, the FDA specifically states that it does not intend to recommend one method over another.  This is unfortunate because it leaves both guesswork and legwork to industry.  FDA states that “this guidance is intended to suggest a range of possible approaches to acrylamide reduction and not to identify specific recommended approaches.”  The role of federal agencies should include evaluating reduction approaches to determine which are more efficacious and feasible than others, and providing that potentially useful information to industry, even if only to help identify and encourage prioritization of those approaches first, in addition to continuing research in this area.  Clear communication of superior and cost-effective approaches to acrylamide reduction may result in higher industry participation and more successful reduction efforts.
  • FDA monitoring since 2002 has shown that many foods contain higher levels of acrylamide than the level considered safe by the EPA for drinking water.  Some of the highest acrylamide levels are found in potato and cereal products which are common in the American diet.  These surveys also show that a healthy diet which includes whole grains can have significant acrylamide levels, potentially even higher than a diet which includes less healthful choices such as potato chips and French fries.  The FDA has maintained its message to consumers that a balanced, healthy diet is a way to manage concern over acrylamide consumption, when the evidence shows that this advice is not accurate. 
  • The effects of acrylamide reduction on overall product nutrition should be considered in the context of all health risks and benefits.  For example, lower temperature frying reduces acrylamide, but also requires longer cooking time, resulting in higher fat content in fried foods.  While we commend thorough consideration of all possible health implications of acrylamide reduction methods, FDA should also consider which outcomes can be more easily mitigated by other dietary or lifestyle interventions in order to fully assess risks and benefits.

Lastly, as acrylamide accumulates in food as a result of the handling and cooking process, rather than in the raw food itself, and is a serious human health concern, it could be viewed as source of food adulteration and regulated as such under Section 402(a) of the Federal Food, Drug and Cosmetic Act with action levels.  We ask that FDA consider these improvements to this draft guidance, and use its full authority to ensure that the public is sufficiently protected.

The Cancer Prevention and Treatment Fund

 For additional information, contact Anna Mazzucco at am@center4research.org or (202) 223-4000.

Public Comments on NIOSH Draft Intelligence on Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace

By Anna E. Mazzucco
December 16, 2013

Thank you for the opportunity to speak today.  My name is Dr. Anna Mazzucco, and I speak on behalf of the National Research Center for Women & Families, and our Cancer Prevention and Treatment Fund.  After completing my Ph.D. in cell and developmental biology at Harvard Medical School, I conducted research at the National Cancer Institute.  I speak today as a cancer biologist gravely concerned that these regulations lag behind the state of the science, and fall far short of protecting Americans from occupational causes of cancer.

In 2013, more than half a million Americans will die from cancer.  A 2003 joint report from the National Cancer Institute and the National Institute for Environmental Health Sciences stated that “exposure to a wide variety of natural and man-made substances in the environment accounts for at least two-thirds of all the cases of cancer in the United States.” Yet after reviewing the current state of regulatory policy and research efforts, the President’s Cancer Panel reported in 2010 that “environmental health, including cancer risk, has been largely excluded from overall national policy on protecting and improving the health of Americans.”   When notorious and decades-known carcinogens such as asbestos and radon are still present at unsafe or unknown levels in American workplaces, how can the public have confidence that our regulations can handle new and complex occupational hazards arising every day?  Only a few hundred out of more than 80,000 chemicals in use in the United States have been tested for safety.  We should be concerned.

The National Institutes of Health estimated the total cost of cancer in 2008 at $201.5 billion in both direct health care costs and the indirect cost of lost productivity due to premature deaths.   Another recent study estimated that cancer is responsible for 20 percent of all health care spending.  Disability days alone cost $7.5 billion in lost productivity each year.  And these numbers cannot attempt to capture the human value of lives lost.

Unfortunately, the NIOSH draft report represents a continuation of the status quo.  It reinforces a reactive rather than proactive approach to regulation.  It maintains historical policy positions which are no longer appropriate.  It  places burdens on workers rather than on industry.  And, it overlooks glaring gaps in regulation. This report does not provide sufficient information on proposed new policies that would add to redundancy between agencies, rather than eliminating redundancy.  Even more troubling, these new policies could allow a more permissive stance towards carcinogens in the workplace despite more stringent regulation of the very same agents by other federal agencies.

We have 5 Areas of concern that we want to emphasize:

  1. Safe exposure limits must be based on actual, not theoretical, workplace exposures. Real-life workplace chemical use involves multiple agents and complex exposures.  This report does not give any concrete statements on how to address the true chemical milieu to which workers are exposed.  There is no scientific reason to limit our safety analyses to single agents.  If the goal is to prevent chemical hazard exposure in the workplace, then we must start with the workplace, and not a theoretical framework which likely applies to very few real-life situations.
  2. Acceptable occupational risk assessments should be based on up-to-date, circumspect and truly representative information.  NIOSH uses a lifetime cancer risk increase of 1 in 1,000 as the acceptable regulatory threshold, while stating that “controlling exposure to lower concentrations is always warranted.” NIOSH admits that “an excess risk of 1 in 1,000 is one or more orders of magnitude higher than what the United States permits for the general public.” NIOSH justifies this questionable threshold with two arguments:  The first is the historic “benzene decision” made by the U.S. Supreme Court in 1980, where a 1 in 1,000 risk was used in a seemingly rhetorical example.  The second justification is that workers are a very small subset of the general population, and higher exposures for small numbers of people may be considered acceptable if they are comparable to the overall risks of employment itself.  We disagree with these nonscientific justifications.  There is increasing evidence that occupational carcinogens spread into the greater environment.  For example, trichloroethylene (TCE), an industrial solvent, is now present in approximately one-third of the U.S. water supply.   The maximum risk threshold acceptable to the EPA is 10-fold less than the NIOSH threshold – and given the overlapping exposures, that does not make sense.  The EPA considers 1 in 1,000,000 to be the target threshold for as many people as possible, but that is 1000 times lower than the NIOSH threshold. The bottom line is that there is no scientific basis for these differential safety standards, and we now know that occupational and environmental exposures frequently become indistinguishable.  For that reason, the workforce should be afforded the same level of protection as the general public.
  3. Safety determinations will only be as effective as the quality of the science they are based on.  This report outlines the use of linear modeling to extrapolate low-dose effects of carcinogens.  But linear modeling isn’t appropriate for chemicals with non-monotonic dose-response curves, such as endocrine disruptors.  In addition, bioaccumulation and multigenerational effects must be considered — otherwise, limits will be simplistic and inaccurate. When NTP/EPA/IARC classifications disagree, NIOSH says they will “adopt the classification determined to be most relevant to occupational exposures“.  This policy would allow for “down-classifying” of carcinogens based on workplace considerations.  Given the technical difficulty in distinguishing between occupational and greater environmental exposures, the public needs detailed information about this decision-making process, so that we can ensure that any down-classifications are justified by scientific evidence.  NIOSH should also consider making full use of the NTP Executive Committee before investing their own time and resources in classifying agents, in order to focus their efforts on the stated goal of reducing risks.
  4. A safe exposure level based on technical feasibility rather than safety places workers at risk. NIOSH plans to set the recommended exposure limit (REL) to the higher, detectable dose (the reliable quantitation limit).   This would directly place workers in potentially unsafe conditions, while rendering them powerless to detect or remove the agent to ensure safe levels.  If we want to instead guarantee safety to workers in this situation, NIOSH needs to ban these chemicals until more sensitive detection methods are developed.  That policy would protect workers while creating an incentive for industry to develop more sensitive diagnostic capabilities or find safer alternatives.
  5. Sensitive subpopulations require protections too.  Birth defects, childhood cancer, and adult cancers can all caused by in utero exposures.  The NIOSH draft report does not provide details on how sensitive subpopulations will be protected.  Just as NIOSH sets risk thresholds for all workers, it must have regulations which sufficiently protect everyone in that group.

We urge you to consider these changes, and use every resource at your disposal to ensure that our national policies regarding occupational carcinogens meet their goal of protecting Americans at work.  This will ensure a healthy society, thriving economy, and also safeguard our environment for generations to come.

For more information, contact Anna Mazzucco at (202) 223-4000 or am@center4research.org


Do lemons prevent cancer?

By Caroline Novas

A widely circulating e-mail claiming to be from the Institute of Health Sciences (or the Health Sciences Institute) in Baltimore states that lemons are a “proven remedy against cancers of all types” and that lemons are 10,000 times stronger than chemotherapy.  The e-mail also says that pharmaceutical companies have kept the truth from us because lemons are much less expensive than the less effective synthetic versions that companies can sell for a large profit.

Although there is an “Institute of Health Sciences” in Baltimore that is “dedicated to uncovering and researching most urgent advances in modern underground medicine,” the Institute’s web site has no article about the cancer-fighting properties of lemons. It does, however, contain numerous articles promoting unproven alternative medicines and treatments. Most certainly, is not a credible scientific or medical source.

Regardless of the source, the claims the e-mail makes are NOT correct. Lemons are not a “proven remedy against cancers of all types,” and no studies have ever been done that would compare the effectiveness of a lemon to chemotherapy.

A few studies indicate that lemons and other citrus fruits have naturally occurring substances that may have cancer fighting properties, namely modified citrus pectin and limonoids.  These properties have not been tested in humans.

Modified citrus pectin (MCP)

Modified citrus pectin is a carbohydrate found in the peels of citrus fruits modified to be absorbed into the intestinal tract for easier human consumption. In its natural state, pectin is an indigestible dietary fiber.  Animal studies have found that MCP can inhibit the spread of prostate, breast, and skin cancer to other organs. MCP makes it difficult for cancer cells to break off and spread, although it has no impact on the initial tumor.

However, there is almost no information about whether MCP is effective in humans.  One study that measured prostate cancer in humans treated with MCP after standard treatment failed, showed a slowing in the progression of the disease, as measured by doubling time for prostate specific antigen (PSA). The longer the doubling time for PSA in patients with prostate cancer, the better their prognosis is expected to be. Patients taking MCP for 12 months showed a statistically significant increase in prostate specific antigen doubling time (PSADT), when compared to the 12 month period before they began taking MCP.  Unfortunately, the study used no control group (men that did not take MCP after standard treatment failed) and therefore could not compare the survival rates of men who took MCP after standard treatment failed, with those who did not.


Limonoids are chemicals found in citrus peels that are responsible for lemons’ bitter taste. Research has found that at very high levels, limonoids are capable of slowing cancer cell growth and inducing apoptosis (cell death). However, studies have focused on animals and in vitro human breast cancer cultures (breast cancer cells removed from the human body and studied in a laboratory). As a result, there is little information about limonoids’ effectiveness in preventing or combating cancer in humans.

The bottom line

Although lemons have health benefits, the claims that “lemons are a proven remedy against cancer of all types” and “lemons are 10,000 times stronger than chemotherapy” are certainly false.  Furthermore, while a few studies have looked into the anti-carcinogenic properties of modified citrus pectin and limonoids and found some promising results, not enough research has been done to prove its effects on humans. It’s possible that in the future, after more research, a medicine will be developed to prevent or fight cancer using these ingredients; if so, it will probably be in much higher concentrations than found in nature

MCP and limonoids are not unique to lemons; they are found in all citrus fruits, which have many known health benefits and should be part of any healthy diet.


The Health Sciences Institute. http://hsionline.com/

Glinksy Vladislav and Avraham Raz. (2009). Modified citrus pectin anti-metastatic properties: one bullet, multiple targets. Carbohydrates Research. 28;344(14):1788-91

BW Guess et. al (2003). Modified citrus pectin (MCP) increases the prostate-specific antigen doubling time in men with prostate cancer: phase ll pilot study. Prostate Cancer and Prostatic Diseases. 6, 301-304

Polouse SM, Harries ED, and Patil BS. (2005) Citrus limonoids induce apoptosis in human neuroblastoma cells and have radical scavenging activity.  Journal of Nutrition. 135(4): 870-7