STATE OF NEW YORK
________________________________________________________________________
9897
IN ASSEMBLY
February 21, 2018
___________
Introduced by M. of A. TITONE -- (at request of the Department of
Health) -- read once and referred to the Committee on Consumer Affairs
and Protection
AN ACT to amend the general business law, in relation to the safety of
dietary supplements
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Legislative purpose and findings. Dietary supplements may
2 provide health benefits to many people. However, instances of contam-
3 inated dietary supplements have in some cases caused serious injury to
4 persons residing in New York, including permanent injuries to children.
5 The accuracy and integrity of the ingredients of dietary supplements is
6 a vital public health interest. Accordingly, it is the purpose of this
7 act to facilitate investigation by the relevant agencies of the state of
8 New York into reports of illness caused by contaminated dietary supple-
9 ments. After due consideration, and in consultation with the department
10 of health, the legislature finds that the public health benefits real-
11 ized by the provisions of this act significantly outweigh any potential
12 impact on interstate commerce.
13 § 2. The general business law is amended by adding a new section 391-
14 oo to read as follows:
15 § 391-oo. Labeling requirements for dietary supplements. 1. For
16 purposes of this section the following terms shall have the following
17 meanings:
18 (a) "Dietary supplement" shall have the same meaning as set forth in
19 21 USC 321 ff, or any successor statute.
20 (b) "Manufacturer" means the last facility that physically manufac-
21 tured and/or processed the dietary supplement. A facility is considered
22 the last facility even if the dietary supplement undergoes further manu-
23 facturing and/or processing of a de minimis nature. If the dietary
24 supplement undergoes further manufacturing and/or processing that
25 exceeds an activity of a de minimis nature, then the subsequent facility
26 that performed the additional manufacturing and/or processing is consid-
27 ered the manufacturer.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD10130-01-7
A. 9897 2
1 (c) "Packer" means the last facility that physically packaged the
2 dietary supplement without changing the form of the dietary supplement.
3 A facility is considered the last facility even if the food undergoes
4 further packaging of a de minimis nature. If the dietary supplement
5 undergoes further packaging that exceeds an activity of a de minimis
6 nature, then the subsequent facility that performed the additional pack-
7 aging is considered the packer.
8 (d) "Distributor" means any person engaged in wholesale sale or
9 distribution of dietary supplements.
10 2. A dietary supplement in package form shall bear a label containing:
11 (a) the name and address of the manufacturer, the packer if one
12 exists, and the distributor of such dietary supplement;
13 (b) the following statement: "Dietary supplements are not approved by
14 the U.S. government for safety and effectiveness before they are market-
15 ed."; and
16 (c) the national toll-free telephone number of the American Associ-
17 ation of Poison Control Centers.
18 3. The commissioner of the department of health shall have the author-
19 ity to petition any agency of the United States government for an
20 exemption from any provision of federal law that would otherwise preempt
21 the requirements of this section.
22 § 3. This act shall take effect immediately, except that subdivision 2
23 of section 391-oo of the general business law, as added by section two
24 of this act, shall take effect on the one hundred eightieth day after it
25 shall have become a law.
