A3131

An Act concerning drugs and supplementing Title 24 of the Revised Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. As used in this act:

“Commissioner” means the Commissioner of Health. “Department” means the Department of Health.

“Gluten-containing grain” means the same as that term is defined by paragraph (1) of section (a) of 21 C.F.R s.101.91.

“Major food allergen” means the same as that term is defined by subsection (qq) of 21 U.S.C. s.321.

“Over-the-counter drug” means any drug, intended for use in humans, that contains a label that meets the requirements of 21 C.F.R. s.201.66, including (1) a “Drug Facts” panel; or (2) a statement of the “active ingredient” or “active ingredients” with a list of those ingredients contained in the compound, substance, or preparation. “Over-the-counter drug” shall not include a grooming and hygiene product.

“Prescription drug” means any drug, intended for use in humans, which is required by federal or State law or regulation to be dispensed only pursuant to a prescription. “Prescription drug” shall include cancer drugs and anti-rejection drugs, but shall not include any “controlled dangerous substance or compounded drug” as defined by section 2 of P.L.2017, c.254 (C.24:6M-2).

2. a. Any over-the-counter drug or prescription drug that contains an ingredient derived directly or indirectly from a major food allergen or a gluten-containing grain shall bear a label indicating the presence of that ingredient. The label shall identify each ingredient and, where applicable, specify the type of gluten-containing grain. This information shall be displayed in a manner that is conspicuous and easily understandable to consumers.

b. (1) Any over-the-counter drug or prescription drug that is not labeled in accordance with this act shall be deemed misbranded in violation of the provisions of R.S.24:5-1 et seq. The commissioner may order the correction of the label on any over-the-counter drug or prescription drug that is determined to be misbranded pursuant to this paragraph, and any order shall be complied with during the time specified.

(2) The department may conduct any investigation it deems necessary to verify the accuracy of any labeling or non-labeling of over-the-counter drugs or prescription drugs pursuant to this act.

(3) Any person who misbrands an over-the-counter drug or prescription drug as provided in this subsection shall be liable for the following penalties:

(a) For a first offense, a penalty of $500;

(b) For a second offense, a penalty of $1,000;

Any penalties imposed under this subsection shall be recovered in accordance with the provisions of R.S.24:17-1 et seq.

c. The department shall adopt rules and regulations pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), as are necessary to implement this act.

3. This act shall take effect on the first day of the 25th month next following the date of enactment, except that the Commissioner of Health may take any anticipatory administrative action in advance as shall be necessary for the implementation of this act.

STATEMENT

This bill requires labeling of any over-the-counter drug or prescription drug that contains an ingredient derived directly or indirectly from a major food allergen or a gluten-containing grain.

Specifically, the bill provides that the label is to identify each ingredient and, where applicable, specify the type of gluten-containing grain. This information is required to be displayed in a manner that is conspicuous and easily understandable to consumers.

The failure to label an over-the-counter drug or prescription drug that contains an ingredient derived directly or indirectly from a major food allergen or a gluten-containing grain would constitute misbranding in violation of pre-existing food and drug labeling, except that there would be an additional penalty of $500 for a first offense, $1,000 for a second offense, and $2,000 for any third or subsequent offense. The bill provides that the Department of Health is responsible for administering and enforcing the bill’s provisions.

This bill, based on similar federal legislation introduced by United States House Representative Kelly Morrison of Minnesota, seeks to enhance consumer safety for individuals with allergies or gluten sensitivities. It is the intent of the sponsor to require clear labeling of allergens and gluten on over-the-counter drugs and prescription drugs, enabling consumers to make informed decisions and avoid adverse reactions.