NCHR Testimony to FDA on Updating the “Redbook”

Anna Mazzucco, PhD, National Center for Health Research: December 9, 2014

My name is Dr. Anna Mazzucco.  Thank you for the opportunity to speak today on behalf of the National Center for Health Research.  After completing my Ph.D. at Harvard Medical School, I conducted research at the National Cancer Institute.  Those are the perspectives I bring today.

Our research center conducts research, analyzes data in the research literature, and then explains the evidence of risks and benefits to policymakers and consumers.  Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the resources that the FDA needs to do its job.  Our organization does not accept funding from chemical or consumer product companies, and therefore I have no conflicts of interest.

We applaud the agency for holding this meeting, and for its interest in expanding the Redbook to enhance the safety of the food and products we eat and use every day.  We enthusiastically welcome further action from the FDA on all substances over which the Center for Food Safety and Applied Nutrition has authority.  While the FDA has taken steps to address safety concerns regarding some substances, we strongly urge the agency to use its full authority to ensure the safety of all food-related and consumer products.  Specifically,

  • The FDA has banned bisphenol A from baby bottles and children’s cups.  Yet it is still present in the canned and bottled food consumed by everyone else, including pregnant women, nursing mothers, and young children.  The greatest risk of BPA is probably prenatal exposure, and yet pregnant women are constantly exposed to BPA in food containers.  In addition, BPA exposure can reduce the effectiveness of chemotherapy for breast cancer patients.[1]   The very limited ban on BPA must be expanded to include all food containers.  As the FDA has now acknowledged the harms of BPA, everyone should be afforded the same protections from it.
  • Current evaluation of food additives for carcinogenic activity is narrowly focused on genotoxic mechanisms of action.  The FDA should add tests for endocrine disruption to its toxicological evaluation of food contact substances and additives to ensure that all food contact substances, both old and new, are safe.  As studies show that BPA substitutes may have similar harmful endocrine-disrupting properties, such a step is critical to achieve meaningful change.[2]
  • Studies have raised health concerns about numerous ingredients in cosmetics, such as phthalates, linking them to cancer, infertility, brain development and other health problems.  The Consumer Product Safety Commission bans the most dangerous phthalates from toys and other products for children under 3, but there is enormous exposure for pregnant and nursing women as well as children over 3 and all adults. The FDA should implement stronger chemical safety requirements for these products which Americans use regularly and long-term.[3]  One study found that teenage girls use up to 17 personal care products a day.[4]
  • A 2010 Government Accountability Office report asserted that the FDA needs to strengthen its regulation of food safety and, in particular, its application of the GRAS designation.  We enthusiastically support the recommendations of this report, which included requiring companies to file GRAS studies with the FDA and to make them public.[5]  When will that be implemented?

Lastly, we ask that sufficient resources be dedicating to these safety programs in order for the FDA to be able to do its important work which we all rely on.

Thank you for the opportunity to address the panel today.

  1.  Barrett J.R. “Trumped Treatment?: BPA Blocks Effects of Breast Cancer Chemotherapy Drugs.” Environ Health Perspect 2009; 117:A75-A75.
  2. Viñas R, Watson CS. Bisphenol S disrupts estradiol-induced nongenomic signaling in a rat pituitary cell line: effects on cell functions. Environmental Health Perspectives.doi:10.1289/ehp.1205826. Advance publication January 17, 2013.
  3. Vastag, B., (2001). CDC Unveils First Report on Toxins in People, JAMA 285(14): 1827-1828.
  4. Environmental Working Group. 2008. Sutton R. Adolescent exposures to cosmetic chemicals of concern.
  5. GAO. Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). GAO-10-246. Washington, DC:U.S. Government Accountability Office (3 Feb 2010)