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A07607 Summary:

Add §391-oo, Gen Bus L
Relates to the safety of dietary supplements; requires dietary supplements to bear certain labeling.
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A07607 Text:

                STATE OF NEW YORK
                               2017-2018 Regular Sessions
                   IN ASSEMBLY
                                       May 3, 2017
        Introduced  by  M.  of  A.  KAVANAGH -- (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

         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.

        A. 7607                             2
     1  exceeds an activity of a de minimis nature, then the subsequent facility
     2  that performed the additional manufacturing and/or processing is consid-
     3  ered the manufacturer.
     4    (c)  "Packer"  means  the  last  facility that physically packaged the
     5  dietary supplement without changing the form of the dietary  supplement.
     6  A  facility  is  considered the last facility even if the food undergoes
     7  further packaging of a de minimis  nature.  If  the  dietary  supplement
     8  undergoes  further  packaging  that  exceeds an activity of a de minimis
     9  nature, then the subsequent facility that performed the additional pack-
    10  aging is considered the packer.
    11    (d) "Distributor" means  any  person  engaged  in  wholesale  sale  or
    12  distribution of dietary supplements.
    13    2. A dietary supplement in package form shall bear a label containing:
    14    (a)  the  name  and  address  of  the  manufacturer, the packer if one
    15  exists, and the distributor of such dietary supplement;
    16    (b) the following statement: "Dietary supplements are not approved  by
    17  the U.S. government for safety and effectiveness before they are market-
    18  ed."; and
    19    (c)  the  national  toll-free telephone number of the American Associ-
    20  ation of Poison Control Centers.
    21    3. The commissioner of the department of health shall have the author-
    22  ity to petition any agency  of  the  United  States  government  for  an
    23  exemption from any provision of federal law that would otherwise preempt
    24  the requirements of this section.
    25    § 3. This act shall take effect immediately, except that subdivision 2
    26  of  section  391-oo of the general business law, as added by section two
    27  of this act, shall take effect on the one hundred eightieth day after it
    28  shall have become a law.
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