TITLE OF BILL:
to amend the general business law, in relation to the sale of
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.
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
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
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.
S.1936, 2011-12; S.2924: 2009-10; S.1332: 2007-08; S.1547: 2005-06;
This act shall take effect immediately.