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The company's claim of having a living cellular product would seem to automatically make their product regulated under section 351

The household-level covariates included socioeconomic status, which was categorized into five wealth quintiles (poorest, poor, middle, rich, and richest), the type of residence (rural or urban), the type of cooking fuel (categorized as: (1) clean fuels including electricity, liquefied petroleum gas (LPG)/natural gas, and biogas

This indicates a problem with solubility or, worse, contamination

Use only the ring finger (least pressure), apply with gentle tapping or pressing along the orbital bone (never on the lid), use 1 drop per eye maximum, avoid direct contact with the eye, allow to absorb before applying any moisturizer, and never rub or drag the periocular skin