Makes it illegal to knowingly alter, mutilate, destroy, obstruct, obscure or remove, by means of a sticker, tag or other device used to deter theft, or a price sticker, or otherwise, the whole or any part of the label including where applicable the expiration date displayed thereon, of any over-the-counter drug or cosmetic.
TITLE OF BILL: An act to amend the general business law, in relation to the sale of over-the-counter drugs
PURPOSE: To promote and protect the health and safety of purchasers of O-T-C drugs and cosmetics by enabling them to read such products' packaging or labels in a complete, unaltered and unobstructed condition, at the time of purchase or thereafter. Such labels are required by federal law and regulations.
SUMMARY OF PROVISIONS: Section 1. Changes the article heading of Article 38-A of the General Business law.
Section 2. Amends subdivision 2 of Section 820 of the General Business law, to make it unlawful for any retailer to knowingly alter, obstruct, obscure or remove, by means of a sticker, tag or other device used to deter theft, or a price sticker, or otherwise, the whole or any part of the label or packaging of any over-the-counter (O-T-C) drug or cosmetic as such label is required by the federal Food, Drug and Cosmetic Act, and by the Food and Drug Administration's (FDA) rules and regulations that implement the Act's label requirements for such products. Violators would be subject to the existing enforcement remedy contained in GBL Section 821. Under that provision, compliance with FDA rules and regulations constitutes a complete defense to any enforcement action.
JUSTIFICATION: At the very foundation of consumer protection for purchasers of O-T-C drugs and cosmetics are the labeling requirements of Chapters V and VI of the Federal Food, Drug and Cosmetic Act and the implementing regulations of the Food and Drug Administration. See, 21 C.F.R. Part 201, Subchapter C, et seq. (O-T-C drugs) and 21 FR Part 701 (cosmetics). Drug labels provide vital health and safety information including: indications, directions for use, warnings and precautions, drug interaction information, cautions and list of ingredients. Cosmetic labels must contain a designation of ingredients, a requirement of special importance for users who suffer particular allergic reactions.
In early 1990, the Department of Law's Bureau of Consumer Frauds and Protection conducted a random survey of drug stores operated by eight major chains located in the metropolitan New York City area in an effort to determine whether the labels of O-T-C drugs or cosmetics offered for sale to the public were being obscured or obstructed by the retailers' practice of superimposing upon such labels the store's own price stickers or security stickers or other devices intended to deter theft. The survey revealed that in a significant number of instances, retailers were obstructing or obscuring product labels by placing paper stickers or plastic devices over the manufacturer's product labels. This practice made it impossible, in many cases, for
prospective purchasers to read the labels before purchase. Even after purchase, consumers, in many cases, would be unable to read the labels because the removal of the retailer's stickers would result in the unintended destruction of the manufacturer's label as well.
Indeed, in one case, the cashier at a major drug retail chain store tore off the store's sticker from the principal display panel of an O-T-C drug product and, in doing so, destroyed the manufacturer's label at the same time. In general, this practice could have severe health and safety consequences. For example, the product in question in this particular case was "Collyrium Fresh Sterile Eye Drops" manufactured by Wyeth Laboratories. That part of the manufacturer's label destroyed by the store's cashier included crucial product warnings and cautions, as follows: Warnings: Do not use if solution changes color or becomes cloudy. Remove contact lenses before using. If you have glaucoma do not use this product except under the advice and supervision of a physician. Overuse of this product may produce increased redness of the eye. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Keep this and all medication out of the reach of children. Retain this carton for complete product information. Keep bottle tightly closed at Room Temperature, Approx. 77 degrees F/2S degrees C.
The Department of Law survey confirmed that the above described practice by retail drug stores is common and widespread. Case by case enforcement would not offer consumers the full protection that a legislative initiative offers. This bill builds upon an earlier law that addressed a related problem. In 1985, a survey published by the Department of Law revealed, inter alia, that retailers of O-T-C drugs were similarly obstructing the expiration date of such drug products offered for sale. See, Expiration Dating Of Over-The-Counter Drugs In New York, a Report by New York State Attorney General Robert Abrams, (January, 1985). Subsequently, the Legislature adopted an Attorney General's Program bill (L. 1986, Ch. 697) that included GBL Section 820(2), a provision that makes such practice unlawful. The present proposal would offer parallel protection for consumers with regard to the obstruction of labels.
LEGISLATIVE HISTORY: S.1936, 2011-12; S.2924: 2009-10; S.1332: 2007-08; S.1547: 2005-06; S.6400: 2003-04
FISCAL IMPLICATIONS: None.
EFFECTIVE DATE: This act shall take effect immediately.
STATE OF NEW YORK ________________________________________________________________________ 905 2013-2014 Regular Sessions IN SENATE (PREFILED) January 9, 2013 ___________Introduced by Sens. LAVALLE, LARKIN, RANZENHOFER -- read twice and ordered printed, and when printed to be committed to the Committee on Consumer Protection AN ACT to amend the general business law, in relation to the sale of over-the-counter drugs THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. The article heading of article 38-A of the general business law, as added by chapter 697 of the laws of 1986, is amended to read as follows: SALE OF OUTDATED AND LABEL OBSTRUCTED OVER-THE-COUNTER DRUGS S 2. Subdivision 2 of section 820 of the general business law, as added by chapter 697 of the laws of 1986, is amended to read as follows: 2. to knowingly alter, mutilate, destroy, obliterate or remove by means of a price sticker or otherwise the whole or any part of
[the expiration date displayed on]the label [or packaging], INCLUDING WHERE APPLICABLE THE EXPIRATION DATE DISPLAYED THEREON, of any over-the-coun- ter drug OR COSMETIC. FOR PURPOSES OF THIS SUBDIVISION, THE TERM "LABEL" SHALL MEAN THE LABEL REQUIRED BY THE STATUTES APPLICABLE TO AND REGU- LATIONS ISSUED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION. S 3. This act shall take effect immediately.EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD03783-01-3