We are formulating inks for a label on the outside of a plastic cup.

The label reaches all the way to the top lip of the cup, so it is likely that the person drinking from the cup will physically have their mouth in contact with the label and will ingest some of the liquid contents that have come into contact with the outside of the printed label. Is this a direct food contact application, and must the printing on the label be cleared under the FDA regulations for direct food contact?

There are two possible answers, depending on the intended use for the cup.

1. If the labeled cup is used as food or beverage packaging, it is reasonable to expect that substances that have the potential to migrate from the label will be ingested by mouth contact along with the food, and any inks, coatings or adhesives used to manufacture the label must be FDA compliant. They must meet any applicable requirements for composition and extraction testing, or it must be shown that any migration of uncleared component substances is below the level of regulatory concern.
2. If the labeled cup is intended for use solely as a household container, it may fall under the “FDA housewares” exemption, which holds that materials used to manufacture empty containers, dinnerware, eating utensils or appliances sold to consumers for home use do not require food additives clearance.

In both cases, it is advisable to obtain legal confirmation that the inks, coatings or adhesives used to manufacture the label and the finished article comply with all regulations that apply for the intended use.