California Becomes First State in the U.S. to Pass Bill to Eliminate DEHP in IV Bags and Tubing

On August 26, the California Senate unanimously passed the Toxic-Free Medical Devices Act (AB 2300) by a bipartisan vote of 40-0, prohibiting the use of the harmful chemical DEHP (di(2-ethylhexyl) phthalate) in intravenous (IV) bags and tubing manufactured, sold, or used in the state. With the passage of this legislation, California will become the first jurisdiction in the United States to ban the use of phthalates in medical devices.

Timeline for the proposed bill:

• January 1, 2030: Prohibition on the manufacture, sale, or distribution in California of certain intravenous solution containers containing intentionally added DEHP in California begins.
• January 1, 2032: Extended compliance deadline applies to companies that have pending U.S. Food and Drug Administration (FDA) approval for DEHP-free alternatives or those that lack the necessary equipment to manufacture DEHP-free containers, subject to additional requirements such as providing specified notices to consumers.

They must notify customers of their development of substitutes by July 1, 2025, and confirm compliance through a public declaration by 2028.

• January 1, 2035: Prohibition extends to the manufacture, sale, or distribution in California of certain intravenous tubing containing intentionally added DEHP.
• Other Prohibitions: The bill prohibits the manufacture, sale, or distribution of intravenous tubing or solution containers containing unintentionally added DEHP and restricts the substitution of DEHP with other specified ortho-phthalates in revised or new products.

DEHP (Di-2-ethylhexyl phthalate):

DEHP (di-2-ethylhexyl phthalate) is a chemical used to make polyvinyl chloride (PVC) plastic more flexible and is found in about 60-70% of IV bags and tubing in California and nationwide, despite its links to breast, liver, lung and testicular cancer. DEHP leaches from the plastic into medications and fluids, posing serious health risks to patients.

Companies waiting for the U.S. Food and Drug Administration (FDA) to green-light their DEHP-free alternatives would get an extra two years for the phase-out, as would companies that lack the equipment to produce them. In both cases, companies would have to notify customers by July 1, 2025, that they have begun developing substitutes, and then provide a notification and online declaration by 2028 that they will comply with the extended deadline.

The measure would also prohibit the replacement of the plasticizer with any of the other “ortho-phthalates”:

1. Benzyl-butyl phthalate (BBP) (CAS no 85-68-7)
2. Dibutyl phthalate (DBP) (CAS 84-74-2)
3. Dicyclohexyl phthalate (DCHP) (CAS 84-61-7)
4. Di-(2-ethylhexyl) phthalate (DEHP) (CAS 117-81-7)
5. Diethyl phthalate (DEP) (CAS 84-66-2)
6. Di-isobutyl phthalate (DIBP) (CAS 84-69-5)
7. Di-isodecyl phthalate (DIDP) (CAS 26761-40-0)
8. Di-isononyl phthalate (DINP) (CAS 28553-12-0)
9. Di-n-hexyl phthalate (DnHP) (CAS 84-75-3)
10. Di-n-octyl phthalate (DNOP) (CAS 117-84-0)
11. Di-n-pentyl (DnPP) phthalate (CAS 131-18-0)
12. Diisoheptyl phthalate (DIHP) (CAS 71888-89-6)

Blood bags would be exempt from all the requirements.