Proposition 65 Warning Labels and Over-the-Counter Drugs

Question Posed:

Do over-the-counter (OTC) drugs need to have Proposition 65 warning labels?

Answer Provided:

Yes, unless they meet the specific exemption in HSC 25249.10(a) for exposures where federal law governs warning in a manner that preempts state authority. The only example I am aware of is for nicotine in OTC smoking cessation products like gum and patches. It is important to note that the manufacturers, despite having had the full support of the FDA, still had to fight a long and arduous process in court to reach this outcome.


**Article contents valid as of 2019-03-14

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