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California's Retroactive Phthalates Ban Now Effective

Client Alert | 1 min read | 01.06.09

On January 1, 2009, California's ban on certain phthalates in certain children's products went into effect. The statute, Assembly Bill 1108 ("A.B. 1108") was signed into law in October 2007. A.B. 1108 prohibits the manufacture, sale, or distribution in commerce of any toy or child care article containing DEHP, DBP, or BBP in concentrations exceeding 0.1 percent. A.B. 1108 further prohibits the manufacture, sale, or distribution in commerce of any "toy or child care article intended for use by a child under three years of age if that product can be placed in the child's mouth" containing DINP, DIDP, or DnOP in concentrations exceeding 0.1 percent.

California's A.B. 1108 is similar in many respects to the federal provision banning specified phthalates, Section 108 of the Consumer Product Safety Improvement Act ("CPSIA"). On November 17, 2008, Consumer Product Safety Commission ("CPSC") General Counsel Cheryl Falvey issued an advisory opinion letter stating that the CPSC will not apply the federal phthalate ban retroactively. Following publication of this advisory opinion, the California Attorney General submitted a letter to the CPSC on December 3, 2008, stating that California will apply its phthalates ban retroactively. In this letter, the California Attorney General also argued that the California phthalate ban is not preempted by the federal phthalate provision. The CPSC has subsequently indicated that it "respects the law as passed in California and its implementation," but has not issued an official written response addressing California's preemption analysis. Whether courts will conclude that the California statute is preempted by federal law remains to be seen.

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Client Alert | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...