Section 391-O. Sale or promotional distribution of dietary supplements containing ephedra  


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  • 1.  No  person,  firm,  corporation,  partnership,
      association,  limited  liability  company, or other entity shall sell or
      offer to sell or give away, as either a retail or wholesale promotion, a
      dietary supplement containing any quantity of ephedra  within  New  York
      state, except as authorized by subdivision three of this section.
        2.  For  purposes  of  this  section,  the  following  terms  have the
      following meanings:
        (a) "dietary supplement" means (1) a product (other than tobacco) that
      is intended to supplement the diet and that bears  or  contains  one  or
      more of the following dietary ingredients: a vitamin, a mineral, an herb
      or  other botanical, an amino acid, a dietary substance for the use by a
      person to supplement the diet by increasing the total daily intake, or a
      concentrate, metabolite, constituent, extract, or combinations of  these
      ingredients;  (2)  intended  for  ingestion in pill, capsule, tablet, or
      liquid form; and (3) labeled as a "dietary supplement" pursuant  to  the
      federal  Dietary  Supplement Health and Education Act, 21 U.S.C. 321, as
      amended.
        (b) "ephedra" means any natural or synthetic  form  of  ephedrine  and
      ephedrine alkaloids.
        3.  (a)  Nothing  in  this  section  shall  apply  to  nonprescription
      over-the-counter drugs approved  or  regulated  by  the  Food  and  Drug
      Administration.
        (b)  This section shall not apply to ma huang (ephedra sinica) sold or
      dispensed by any practitioner of oriental medicine, whose  qualification
      to  use  ma huang and other herbs is explicitly established via evidence
      of an active certification issued to  such  individual  from  an  entity
      accredited  by the National Commission of Certifying Agencies (NCCA) and
      who is not otherwise required to be licensed by the state of  New  York,
      or  any  physician  or  any  practitioner of acupuncture licensed by the
      state of New York as long as it is not sold or dispensed  as  a  dietary
      supplement for weight loss, for body building, or as an "energy food".
        4.  Any  person,  firm, corporation, partnership, association, limited
      liability company, or other entity that violates the provisions of  this
      section  by selling, offering to sell, or giving away as either a retail
      or wholesale promotion, a dietary supplement containing any quantity  of
      ephedrine alkaloids shall be subject to a civil penalty of not more than
      five  hundred  dollars  per  violation,  recoverable in an action by any
      enforcement  authority  designated  by  any  municipality  or  political
      subdivision.
        5.  It  shall  be  a  defense  that  any  person,  firm,  corporation,
      partnership, association, limited liability  company,  or  other  entity
      that  sold,  offered  for  sale,  or  gave  away  as  either a retail or
      wholesale promotion a dietary supplement, did not  have  knowledge  that
      the  supplement  contained  any quantity of ephedrine alkaloids, if such
      knowledge was not reasonably discoverable.