December 27, 2022
We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) and Health and Human Services (HHS) about their request for information on Ortho-phthalates for Food Contact Use.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
The FDA has not done enough to reduce exposure to phthalates in foods. Phthalates are found in many items used in food preparation, contact, and packaging, such as nonstick cookware and utensils, feeding tubes, plastic wrap, bottle caps, food preparation gloves, and packaging of pre-processed foods.1,2,3 Research clearly shows that phthalates leach out of these products, resulting in phthalates being absorbed, inhaled, or digested.4
Phthalates are endocrine disrupting chemicals that have potential adverse effects for children and adults and can be detrimental even at low levels of exposure.5 They are especially dangerous for children, since exposures can increase the risk early puberty, asthma, eczema, and obesity. 1 Some phthalates are known carcinogens, and can also increase the risk of diabetes and cardiovascular disease.1 For adult males, they can decrease fertility and cause metabolic issues.1, 6 For adult females, they can decrease fertility and increase the risk of breast cancer.1 Also, higher levels of phthalates during pregnancy resulted in increased levels of progesterone, which can increase the risk of the mother’s postpartum depression. Prenatal exposure to phthalates has been found to correlate with a child’s later attention-deficit hyperactivity disorder (ADHD), lower IQ, and impaired social skills for children. It may also increase the risk for the child to develop cancer in childhood.2,5
We strongly urge the FDA to ban the remaining phthalates from materials that have contact with food, and to rigorously enforce this ban. They should ensure that these policy changes are adequate to protect the most vulnerable populations, such as children, pregnant woman, and communities of color “who frequently experience higher exposures” to phthalates.2 We agree with the public health experts who concluded that there “is no longer any basis for the agency to conclude that there is reasonable certainty of no harm from these uses, which is the legal standard for safety of food contact materials under the federal Food, Drug, and Cosmetic Act (see 21 CFR [updated September 19, 2019]”.2 While some of these chemicals have been previously listed as hazardous by the Food Contact Chemicals database (FCCdb), the FDA is not doing enough to ensure that these products do not reach the public via food contact use. For example, a 2021 study on bottle cap liners found that “more than one-third of the 141 tested brands contained the ortho-phthalates” and these phthalates were chemicals that were previously listed as priority hazardous substances.3 If there is not more effective enforcement, it endangers the lives of the adults and children today and in the future.
References:
1.Seymour M. What Are Phthalates and How Do They Affect Your Health. National Center for Health Research, https://www.center4research.org/what-are-phthalates/
2. Engel SM, Patisaul HB, Brody C, et al. Neurotoxicity of Ortho-Phthalates: Recommendations for Critical Policy Reforms to Protect Brain Development in Children. Am J Public Health. 2021;111(4):687-695. doi:10.2105/AJPH.2020.306014
3. Zimmerman L. Bottle cap liners test positive for phthalates and PVC. Food Packaging Forum. https://www.foodpackagingforum.org/news/bottle-cap-liners-test-positive-for-phthalates-and-pvc. July 19, 2021
4. Consumer Reports. FACT SHEET: Ortho-phthalates. https://advocacy.consumerreports.org/wp-content/uploads/2021/04/FACT-SHEET_-Ortho-phthalates-.pdf. 2021
5. Brown P, KrennHrubec K, Casciotti D, et al. Phthalates and Children’s Products.. National Center for Health Research, https://www.center4research.org/phthalates-childrens-products/
6. Defend Our Health. Known Uses of ortho-Phthalates in Food Contact Materials in the United States.https://defendourhealth.org/wp-content/uploads/2020/10/known_food_contact_sources_of_ortho-phthalates.pdf