NJ A3131

Over-the-counter and prescription drugs containing ingredients derived from major food allergens or gluten-containing grains must bear conspicuous labels identifying each allergen ingredient and specifying the type of gluten-containing grain where applicable

Major food allergens and gluten-containing grains are defined by federal standards under 21 U.S.C. §321 and 21 C.F.R. §101.91 respectively

Drugs failing to comply with labeling requirements will be deemed misbranded, with penalties of $500 for first offense, $1,000 for second offense, and $2,000 for third and subsequent offenses

The New Jersey Department of Health is authorized to investigate labeling accuracy and order corrections to misbranded products

The law takes effect 25 months after enactment to allow implementation time