Question 

Is a drink box that doesn’t contact food (e.g., a wine bottle box) subject to regulations regarding its composition? Are there different regulations if a wine box is made of paper/cardboard and laminated with a polypropylene film versus one made only of paper? Lastly, do these articles fall under the requirements of California’s Proposition 65?

Answer 

Boxes that hold wine bottles do not require preclearance from FDA since their components would not be reasonably expected to become components of the wine. The glass would act as an effective barrier material in this regard.

California’s Proposition 65 (or the Safe Drinking Water and Toxic Enforcement Act of 1986) prohibits a company from knowingly exposing any individual to chemicals that the state of California deems to be carcinogens or reproductive toxicants without first providing a "clear and reasonable warning" to such individual. This law applies to exposure from any source so the response to your last questions would be, yes, these articles could be subject to Prop. 65 requirements, but because no ingestion of components of the box is likely, the application of the requirements would likely apply to inhalation exposure only.