In recent decades, the use of plastics has proliferated. Overall, they have shown to provide a cost-friendly, durable and versatile solution to many consumer needs across virtually all categories of products regulated by the Food and Drug Administration (FDA). This includes food and beverages, cosmetics, medical devices, and many other categories and subcategories of products. Along with the ubiquitous use of plastics has come the widespread use of phthalates. The effects of the use of phthalates in consumer goods have gained significant attention by members of Congress, by the public health community and in litigation.

WHAT ARE PHTHALATES?

Phthalates, the diesters of 1,2-benezenedicarboxylic acid (phthalic acid), are a group of synthetic chemicals typically categorized by high-molecular-weight phthalates and low-molecular-weight phthalates.ⁱ High-molecular-weight phthalates are often used as plasticizers in the manufacture of flexible vinyl plastic, which is used in consumer products, flooring and wall coverings, food contact applications, and medical devices.ⁱⁱ Low-molecular-weight phthalates (also known as DEP and DBP) are used as solvents in personal-care products (including cosmetics, lotions and perfumes) and in lacquers, varnishes and coatings, including in some time-released pharmaceuticals.ⁱⁱⁱ

2008: CONGRESS BANS USE OF CERTAIN PHTHALATES IN CHILDREN’S TOYS AND CHILD CARE ARTICLES

In August 2008, section 108 of the Consumer Product Safety Improvement Act (CPSIA)^iv permanently banned the sale of “any children’s toy or child care article” containing more than 0.1 percent of three specified phthalates (di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP)).^v CPSIA also placed an interim ban on the sale of “any children’s toy that can be placed in a child’s mouth or child care article” containing more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) or di-n-octyl phthalate (DnOP).^vi

2014: CONSUMER PRODUCT SAFETY COMMISSION CONDUCTS FOLLOW-UP STUDY AND ISSUES REPORT

Section 108 of the CPSIA also required the U.S. Consumer Product Safety Commission (CPSC) to establish a Chronic Hazard Advisory Panel “to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles.”^vii The CPSC published its report in July 2014 (“the Report”), explaining its findings regarding health effects in animals, health effects in humans and human exposure to phthalates.^viii The Report set forth recommendations.^ix

Regarding health effects in animals, the Report summarized that “the most sensitive and most extensively studied is male developmental toxicity in the rat.”^x Exposure to pregnant dams causes “a syndrome indicative of androgen deficiency, referred to as the ‘phthalate syndrome’ in rats,” and “results in abnormalities of the developing male reproductive tract structures. . . . The phthalate syndrome is characterized by malformations of the epididymis, vas deferens, seminal vesicles, prostate, external genitalia (hypospadias), and by cryptorchidism (undescended testes).”^xi

For health effects in humans, the Report summarized that “[o]verall, the epidemiological literature suggests that phthalate exposure during gestation may contribute to reduced AGD [anogenital distance] and neurobehavioral effects in male infants or children. Other limited studies suggest that adult phthalate exposure may be associated with poor sperm quality.”^xii

Regarding exposure, the Report explained that “[o]verall, food, beverages, and drugs via direct ingestion, and not children’s toys and their personal care products, constituted the highest phthalate exposures to all subpopulations, with the highest exposure being dependent upon the phthalate and the products that contain it. DINP had the maximum potential for exposure to infants, toddlers, and older children. However, DINP exposures were primarily from food, but also from mouthing teethers and toys, and from dermal contact with child care articles and home furnishings.”^xiii

The Report recommended (1) retaining the permanent ban on DBP, BBP and DEHP; (2) making the interim ban on DINP permanent but lifting the bans on DNoP and DIDP; and (3) taking no action with DMP [dimethyl] or DEP [diethyl].^xiv The Report also recommended that U.S. agencies responsible for dealing with phthalate exposures from food and other products conduct the necessary risk assessments with a view to supporting risk management steps.^xv

2016: FOOD ADDITIVE PETITION NO. 6B4815: FDA DOES NOT ACT; LAWSUIT FILED IN 2021

In March 2016, a group of food safety groups submitted Food Additive Petition No. 6B4815 (the “Petition”), asking FDA to revoke its authorizations for uses of 30 ortho-phthalates^xvi in food packaging and processing materials, arguing that there is well-established evidence that FDA-approved phthalates leach out of these materials into food and drinks, and that phthalate exposure is linked to serious health harms, including birth defects, infertility, miscarriage, and irreversible harm to the developing brain.^xvii

Applying FDA’s tolerance-setting requirements under 21 C.F.R. § 171.18, the Petition proffered three overarching conclusions:

1. Ortho-phthalates are a class of chemically and pharmacologically related substances for purposes of determining safety pursuant to 21 U.S.C. 348 and 21 CFR Part 171.

2. The acceptable daily intake (ADI) for DEHP should be assigned to all ortho-phthalates.

3. The estimated daily intake for ortho-phthalates significantly exceeds the ADI, and therefore, the intentional use of ortho-phthalates as food contact substances is not safe as defined by FDA’s regulations.^xviii

In response, FDA rejected two requests in the petition, declaring that: (1) a food additive petition could not be used to ban a chemical’s use as a food additive under 21 U.S.C. § 348(b)(1), and (2) chemical uses “approved” by FDA prior to 1958 are exempt from the definition of food additives under 21 U.S.C. § 321(s) (those commonly referred to as “prior sanctioned”). Instead, FDA advised that a citizen petition under 21 C.F.R. § 10.30 was the proper channel for these requests.

FDA was still required to determine whether there is no longer “a reasonable certainty of no harm,” the applicable standard of safety for food additives and generally recognized as safe (GRAS) substances. FDA has yet to make this decision, and on December 7, 2021, the Environmental Defense Fund (and others) filed a petition for writ of mandamus with the U.S. Court of Appeals for the D.C. Circuit requesting that the court compel FDA to take final action on the Petition.^xix

2022: RENEWED CONGRESSIONAL ACTIVITY

On January 10, 2022, Rep. Raja Krishnamoorthi (D-IL), chair of the Subcommittee on Economic and Consumer Policy of the House Committee on Oversight and Reform, issued a letter to FDA requesting information on phthalates regulation and data to support FDA’s decision-making. The letter expressed concern that phthalates are endocrine disruptors that harm those exposed to high levels, citing fertility and reproductive problems, learning and behavioral disorders in children, and prenatal damage.^xxi The letter also explained that this harm disproportionately affects communities of color.^xxii

The letter tasked FDA with providing the subcommittee with the following information by January 24, 2022:

• Whether and when FDA will issue a decision on Food Additive Petition No. 6B4815
• Steps FDA is taking to evaluate the health effects of phthalates found in food packaging and processing materials
• Whether FDA is taking steps and which steps it is taking toward banning phthalates found in food packaging and processing materials
• What evidence FDA has that the 28 currently permitted phthalates can be safely included in products that touch food^xxiii

To date, no response from FDA has been made publicly available, and this issue is continuing to attract public attention.

ⁱ Meeker, et al., Phthalates and other additives in plastics: human exposure and associated health outcomes, PHIL. TRANS. R. SOC. B. 364, 2097-2113 (2009), doi:10.1098/rstb.2008.0268, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873014/pdf/rstb20080268.pdf.

ⁱⁱ Id. at 2098 (citations omitted).

ⁱⁱⁱ Id. (citations omitted).

^iv Consumer Product Safety Improvement Act, Pub. L. No. 110-314, 122 Stat. 3016 (2008), available at https://www.cpsc.gov/s3fs-public/cpsia.pdf.

^v 15 U.S.C. § 2057c(a). See also 16 C.F.R. § 1199.1.

^vi 15 U.S.C. § 2057c(b)(1).

^vii Id. § 2057c(b)(2).

^viii U.S. Consumer Prod. Safety Comm’n, Report by the Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives (July 2014), available at https://www.cpsc.gov/s3fs-public/CHAP-REPORT-With-Appendices.pdf.

^ix See id.

^x Id. at 1.

^xi Id. at 2.

^xi Id.

^xii Id. at 3.

^xiii Id. at 7-8.

^xv See id.

^xvi For purposes of simplicity, this article uses ortho-phthalates and phthalates interchangeably.

^xvii See Nat. Res. Def. Council, et al., Food additive petition regarding 30 ortho-phthalates submitted to FDA pursuant to 21 USC § 348 (Mar. 18, 2016), available at http://blogs.edf.org/health/files/2016/04/Ortho-phthalates_Food_Additive_Petition_3-18-16.pdf.

^xviii Id. at 2.

^xix In re Envtl. Def. Fund, et al., Case No. 21-1255 (D.C. Cir. Filed Dec. 7, 2021).

^xx Letter to Acting Commissioner Janet Woodcock (Jan. 10, 2022), available at https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2022-01-10.RK to Woodcock-FDA re Phthalates FINAL.pdf.

^xxi See id.

^xxii See id.

^xxiii See id.