As reported in HME News, November 2018 issue: Manufacturers and distributors are grappling with updates to California’s Proposition 65 that went into effect Aug. 30.

Prop 65 requires businesses to warn individuals in California about products containing 900-plus listed chemicals “known to the state to cause cancer, birth defects, or other reproductive harm.”

What’s new: standardized warning labels. Manufacturers must include them on these products, distributors must incorporate them into their websites and catalogues, and online retailers must use them to notify consumers before purchase.Hollister recently sent a letter to its customers, advising them that the gloves in its Apogee Plus Touch Free Intermittent Catheter System Kit, for example, may result in exposure to chemicals, including diisononyl phthalate or DINP, which is known to the state of California to cause cancer.

“Hollister will include the required warning on both the label and the (integral field unit) IFU of its Apofee IC Kit,” the letter reads. “However, distributors and suppliers also need to take appropriate action to ensure compliance with the new regulations.”

In September, distributor NDC, Inc., had its catalogues on hold to make sure featured products complied with the regulations.

“Our catalogues and also our website are being scrubbed,” said Ian Fardy, vice president of marketing for NDC. “As a distributor, we are responsible for understanding where our products go and where our customers sell into. We have a team working on it.”

The biggest danger from not complying with the regulations: lawsuits.

Even before the updates went into effect earlier this year, Prop 65-related lawsuits topped $25.8 million in 2017, according to the office of the California attorney general.

For other manufacturers like Cure Medical, the updates to the regulations serve as another talking point with its provider customers and users about its stance not to use chemicals like diphthalate to make its products flexible.

“When there are options to create intermittent catheters that work just as well as those made with standard chemicals, there’s really just no reason to use these chemicals anymore if you can avoid it,” said John Anderson, CEO of Cure Medical. “Cure Medical believes it’s the right thing to do, so we made the decision to go without DEHP or any Prop 65 chemicals in our products.”

Read Full Story here.

Note: Cure Catheters and Cure Closed Systems are not made with any Proposition 65 chemicals including DEHP/DINP, BPA or natural rubber latex.

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