Federal Restrictions On Phthalates Are Long Overdue

Recent stories about harmful chemicals in processed foods have put consumer safety front and center for lawmakers across the country. Both California and New York are considering bans on Red Dye No. 3 and other potentially hazardous substances found in candies, fruit cups and other tasty treats.[1]

But consumers continue to be subjected daily to chemicals known to cause cancer, reproductive harm and birth defects, and little is being done to stop such exposure.

The substances, called phthalates, are found in just about every corner of our lives, and the health risks have been known for decades, but no comprehensive federal legislation regulates their use.

In 2008, Congress was sufficiently concerned about the hazards phthalates posed to young children that it wrote them into the Consumer Product Safety Improvement Act.[2] The CPSIA is primarily known as the vehicle that banned harmful levels of lead from paints and other products to which children could be exposed, but Section 108 bans the use of phthalates beyond a certain limit in children’s toys and child care products.

Phthalates, also called plasticizers, are used to increase the durability and flexibility of plastics. They are found in hundreds of household products including vinyl flooring, lunch boxes, shower curtains, lubricating oils, and personal-care products such as soaps, shampoos and hair sprays.

They are present in automobile upholstery and backpacks, as well as the PVC plastics used to make plastic packaging, garden hoses and medical tubing. The bottom line is that phthalates are everywhere. It is impossible to avoid them.

Exposure is a given. People eat and drink foods that come into contact with products containing phthalates, and they breathe phthalate particles in the air. Young children — even those not playing with phthalate-laden toys or sucking on contaminated pacifiers — crawl on vinyl flooring, touch household objects and put dust-covered hands in their mouths.

Phthalates fall into categories based on their chemical composition. These include:

• Di(2-ethylhexyl) phthalates, found in just about every type of plastic product;
• Di-n-butyl phthalates, used in wire and cable insulation, gloves, tubing, garden hoses, shoes, and personal care products including nail polishes and some perfumes and other products containing fragrances; and
• Diisononyl phthalates, found in PVC products as well as non-PVC products such as inks and pigments, adhesives, sealants, paints and lacquers.

The list of commercially available phthalates is actually quite lengthy — about 30 — but the path between exposure and serious health risk appears to be quite short.

More research is needed to fully understand the effects of phthalate exposure on humans, but potential risks identified by scientists include cancer, birth defects, developmental delays, neurological disorders and reproductive system harm.[3]

The European Union first started banning phthalates from children’s products in 1999. In 2018, alarmed by new data, EU member states voted unanimously to prohibit the use of four widely used phthalates in a concentration equal to or greater than 0.1% by weight in any consumer products sold within the EU.[4]

In January, a regulatory notice suggested that additional phthalates could be added to the EU’s restricted list in the future.[5]

On this side of the pond, phthalates are still used across a wide range of consumer products with few constraints. Without commensurate action from Washington, many states have begun enacting their own phthalate restrictions.[6]

California requires Proposition 65 notices on all products containing phthalates.[7] Nineteen states have adopted the Model Toxics in Packaging Legislation created by the Toxics in Packaging Clearinghouse.[8] This legislation prohibits the intentional introduction of phthalates during the manufacture and distribution of packaging and packaging materials.

But products containing phthalates remain ubiquitous in the U.S., and there appears to be no path toward seriously mitigating exposure or banning their use.

The CPSIA specifically targeted children’s toys and child care products — making it unlawful to manufacture for sale, sell, distribute in commerce or import any such items that contain concentrations of more than 0.1% of certain phthalates, or any that could be placed in a child’s mouth with concentrations of more than 0.1% of other phthalates.

In all, eight categories of phthalates were implicated in the CPSIA. Toys and child care products are, however, just the tip of the iceberg.

Plastics used to manufacture everything from watch straps to food packaging still contain excessive amounts of phthalates. So young children continue to be exposed — as do their parents, older siblings and other adults who regularly come into contact with phthalates.

Under the CPSIA, the Consumer Product Safety Commission was required to appoint a chronic hazard advisory panel for the purpose of examining the potential health effects of phthalates, including “the likely levels of children’s, pregnant women’s, and others’ exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products.”

The panel was charged with reviewing “all relevant data, including the most recent, best available, peer-reviewed, scientific studies.”

Fast forward to the present. Aside from toys and child care products, there are few federal restrictions on phthalate use.

The U.S. Food and Drug Administration, which monitors the use of phthalates in food packaging, did issue an action effective May 20, 2022, that amended its food additive regulations to exclude the use of 25 plasticizers, including 23 phthalates, in packaging and other applications that come into contact with food.[9]

The sole reason given for the change was that these uses had been abandoned. The agency, however, denied a separate petition by public interest groups requesting revocation of its food additive regulations to no longer allow food contact use of 28 phthalates.[10]

A citizen petition that sought a ban on food contact use for certain phthalates and revocation of sanctioned authorization of other phthalates based on alleged safety concerns was similarly denied because, according to the FDA, it “did not demonstrate through scientific data or information” that these actions were warranted.[11]

The public outcry was immediate. Earthjustice, a signatory to the rejected petitions, questioned why Congress would consider phthalates too dangerous for use in children’s toys back in 2008, yet the FDA would allow their use with food and beverages.

On Sept. 26, 2022, the FDA announced that it was reopening the comment period on its request for information regarding use and safety data for the remaining phthalates authorized for use in food contact applications.[12]

The reason given for the extended comment period was that stakeholders needed “more time to develop and submit data, other information, and comments for this request for information.” The new deadline for comments was Dec. 27, 2022.

The FDA’s initial decision not to impose a complete ban on the use of phthalates appeared to discount or simply ignore compelling arguments of scientists and environmental groups regarding the hazards posed by phthalates. The announcement that it would finally start reviewing actual data on phthalate safety comes many years after public health advocates first sounded the alarm.

How or when the agency will issue a response to the petitions is anyone’s guess, but for the time being nothing has changed. Consumer alerts and Proposition 65 notices can only do so much in an era of warning overload.

Until the U.S. joins its European counterparts and mandates the elimination of high concentrations of phthalates in consumer products — especially plastic packaging that comes into contact with food — its entire population will continue to serve as lab rats.