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A05610 Summary:

BILL NOA05610D
 
SAME ASSAME AS S05823-C
 
SPONSORRozic
 
COSPNSRHevesi, McDonald, Aubry, Simon, Novakhov
 
MLTSPNSR
 
Add 391-oo, Gen Bus L
 
Relates to establishing restrictions on the sale of over-the-counter diet pills and dietary supplements for weight loss or muscle building; prohibits the sale of over-the-counter diet pills or dietary supplements for weight loss or muscle building to people under 18; exempts certain protein powders, protein drinks and foods.
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A05610 Actions:

BILL NOA05610D
 
03/17/2023referred to consumer affairs and protection
03/21/2023reported referred to codes
03/22/2023amend and recommit to codes
03/22/2023print number 5610a
04/18/2023amend and recommit to codes
04/18/2023print number 5610b
04/25/2023reported
04/27/2023advanced to third reading cal.174
05/09/2023amended on third reading 5610c
05/16/2023amended on third reading 5610d
06/01/2023passed assembly
06/01/2023delivered to senate
06/01/2023REFERRED TO CONSUMER PROTECTION
06/05/2023SUBSTITUTED FOR S5823C
06/05/20233RD READING CAL.663
06/05/2023PASSED SENATE
06/05/2023RETURNED TO ASSEMBLY
10/13/2023delivered to governor
10/25/2023signed chap.558
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A05610 Memo:

NEW YORK STATE ASSEMBLY
MEMORANDUM IN SUPPORT OF LEGISLATION
submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A5610D
 
SPONSOR: Rozic
  TITLE OF BILL: An act to amend the general business law, in relation to establishing restrictions on the sale of over-the-counter diet pills and dietary supplements for weight loss or muscle building   PURPOSE: To ban the sale to minors of products marketed as diet pills and supple- ments for weight loss or muscle building.   SUMMARY OF PROVISIONS: Section 1 adds new section 391-0o to the general business law which: 1) Defines the following terms: dietary supplements for weight loss or muscle building; over-the counter diet pills; retail establishment; delivery sale; and delivery seller. 2) Prohibits the sale of over-the-counter diet pills or dietary supple- ments for weight loss or muscle building to minors except when prescribed by a health care provider and specifies the proof of legal age. 3) Sets forth age verification requirements, including that retail establishments require proof of legal age of purchase. Such verification is not necessary if an individual reasonably appears to be over the age of 25. Delivery sellers shall be required to use a form of shipping that requires an adult over the age of 18 to receive the package, and requires the person who signs for delivery to provide a valid, govern- ment-issued ID. 4) Establishes the attorney general's enforcement authority for violations, and provides for a civil penalty for a violation to be not more than $500 per violation. 5) Provides criteria for a court to consider in determining whether an over-the-counter diet pill or dietary supplement is labeled, marketed, or otherwise represented. for the purpose of weight loss or muscle building. Section 2 provides the effective date.   JUSTIFICATION: Eating disorders are a serious public health problem affecting youth and adults of all races, ages, and genders. The most common eating disorder, anorexia nervosa, has the second highest mortality rate of all mental health conditions. Eating disorders are diagnosed based on a number of criteria, including the presence of what clinicians call unhealthy weight control behaviors (UWCBs). One UWCB of particular concern is the use of pills or powders to lose weight or build muscle, which are often sold as dietary supplements. Although they are sold alongside multivitamins and other supplements largely regarded as safe, these products often contain unlisted, illegal pharmaceutical ingredients that pose serious risks. (1) Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the U.S. Food and Drug Administration (FDA) does not have the authority to require proof of safety or efficacy prior to the sale of these products. (2) While some voluntary certifications exist, there is no guarantee that a supplement contains the listed ingredients. These products have been linked to outbreaks of liver damage, some severe enough to require transplantation, and have even caused several high-profile deaths in recent years. (3) Despite the harms these products can cause, the perception of risk associated with them is still low. In 2022, the Senate and Assembly passed legislation to prohibit the sale of these dangerous diet pills and dietary supplements to minors, based on a list of covered products to be developed by the Department of Health. The legislation was vetoed, due to concerns about the efficacy of a static list of covered products and the capacity of the Department of Health to develop such a list. Regardless of their ingredients and efficacy, products may be marketed as weight loss drugs and have serious health and mental health risks. This legislation takes a new approach, focused on the way products are marketed, regardless of their ingredi- ents. The bill defines dietary supplements for weight loss or muscle building and over-the-counter diet pills as products that are labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building. This approach will target drugs based on their marketing - and associated harmful effects -rather than relying on a list of covered ingredients that the industry will soon work around. By implementing an age-based restriction on sales, we can draw attention to the health risks of using these products and reduce the incidence of use among youth.   LEGISLATIVE HISTORY: Similar to A431C (2022) - Passed Senate & Assembly; vetoed   FISCAL IMPLICATIONS: To be determined.   EFFECTIVE DATE: This act Shall take effect 180 days after it becomes law. Footnotes: (1) Cohen PA, Mailer G, DeSouza R, NealKababick J. Presence of banned drugs in dietary supplements following FDA recalls. J Am Med Assoc. 2014;312(16): 1691-1693. doi:10.1001/jama.2014.10308. (2) Cohen PA, Goday A, Swann JP. The Return of Rainbow Diet Pills. Am J. Public Health. 2012;102(9):1676-1686 (3) Morris S. Woman died after accidental overdose of highly toxic diet pills. The Guardian. https://www.theguardian.com/ society/2015/jul/23/womandiedaccidentaloverdose-highly-toxicdietpillselo ise-parry. Published July 23, 2015 (4) Singer N, Lattman P. A Workout Booster, and a Lawsuit. The New York Times. http://www.nytimes.com/2013/02/14/business/death- after-use-ofjack3dshowsgap-inregulation.html. Published February 14, 2013.
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A05610 Text:



 
                STATE OF NEW YORK
        ________________________________________________________________________
 
                                         5610--D
                                                                Cal. No. 174
 
                               2023-2024 Regular Sessions
 
                   IN ASSEMBLY
 
                                     March 17, 2023
                                       ___________
 
        Introduced  by  M. of A. ROZIC, HEVESI, McDONALD, AUBRY, SIMON, NOVAKHOV
          -- read once and referred to the Committee  on  Consumer  Affairs  and
          Protection  --  reported  and  referred  to  the Committee on Codes --
          committee discharged, bill amended, ordered reprinted as  amended  and
          recommitted  to  said  committee -- again reported from said committee
          with amendments, ordered reprinted as amended and recommitted to  said
          committee  --  reported  from  committee, advanced to a third reading,
          amended and ordered reprinted, retaining its place  on  the  order  of
          third  reading  --  again amended on third reading, ordered reprinted,
          retaining its place on the order of third reading
 
        AN ACT to amend the general business law, in  relation  to  establishing
          restrictions  on  the  sale of over-the-counter diet pills and dietary
          supplements for weight loss or muscle building
 
          The People of the State of New York, represented in Senate and  Assem-
        bly, do enact as follows:
 
     1    Section 1. The general business law is amended by adding a new section
     2  391-oo to read as follows:
     3    §  391-oo. Sale of over-the-counter diet pills and dietary supplements
     4  for weight loss or muscle building. 1.  For purposes of this section the
     5  following terms shall have the following meanings:
     6    (a) "Dietary supplements for weight loss or muscle building"  means  a
     7  class  of dietary supplement as defined in section three hundred ninety-
     8  one-o of this article that is labeled, marketed,  or  otherwise  repres-
     9  ented  for  the purpose of achieving weight loss or muscle building, but
    10  shall not include protein powders, protein drinks and foods marketed  as
    11  containing  protein  unless  the  protein  powder, protein drink or food
    12  marketed as containing protein contains an ingredient other than protein
    13  which would, considered  alone,  constitute  a  dietary  supplement  for
    14  weight loss or muscle building.
    15    (b)  "Over-the-counter  diet  pills"  means  a class of drugs labeled,
    16  marketed, or otherwise represented for the purpose of  achieving  weight
 
         EXPLANATION--Matter in italics (underscored) is new; matter in brackets
                              [ ] is old law to be omitted.
                                                                   LBD02273-14-3

        A. 5610--D                          2
 
     1  loss  that are lawfully sold, transferred, or furnished over-the-counter
     2  with or without a prescription pursuant to the federal food,  drug,  and
     3  cosmetic  act,  21  U.S.C.  section  301 et seq., or regulations adopted
     4  thereunder.
     5    (c)  "Retail  establishment"  means  any  vendor  that, in the regular
     6  course of business, sells dietary supplements for weight loss or  muscle
     7  building  or  over-the-counter  diet  pills  at  retail  directly to the
     8  public, including, but not limited to, pharmacies, grocery stores, other
     9  retail stores, and vendors that accept orders placed by mail, telephone,
    10  electronic mail, internet website, online catalog, or software  applica-
    11  tion.
    12    (d)  "Delivery  sale" means any sale of over-the-counter diet pills or
    13  dietary supplements for weight loss or muscle building to a consumer if:
    14    (i) the consumer submits the order for the sale by means  of  a  tele-
    15  phone  or  other  method of voice transmission, mail, or the internet or
    16  other online service, or the seller is otherwise  not  in  the  physical
    17  presence of the buyer when the request for purchase or order is made; or
    18    (ii) the over-the-counter diet pills or dietary supplements for weight
    19  loss  or  muscle  building are delivered to the buyer by common carrier,
    20  private delivery service, or other method of  remote  delivery,  or  the
    21  seller  is  not  in  the  physical  presence of the buyer when the buyer
    22  obtains possession of the over-the-counter diet pills or dietary supple-
    23  ments for weight loss or muscle building.
    24    (e) "Delivery seller" means a vendor, including online retailers,  who
    25  makes  delivery  sales of over-the-counter diet pills or dietary supple-
    26  ments for weight loss or muscle building.  Such  vendors  shall  include
    27  persons  who  accept  orders placed by mail, telephone, electronic mail,
    28  internet website, online catalog, or software application.
    29    2. No person, firm,  corporation,  partnership,  association,  limited
    30  liability  company,  or other entity shall sell or offer to sell or give
    31  away, as either a retail or  wholesale  promotion,  an  over-the-counter
    32  diet pill or dietary supplement for weight loss or muscle building with-
    33  in  this  state to any person under eighteen years of age. Retail estab-
    34  lishments shall  require  proof  of  legal  age  for  purchase  of  such
    35  products.  For  purposes  of this section, proof of legal age shall mean
    36  (a) a valid driver's license or non-driver's identification card  issued
    37  by the commissioner of  motor  vehicles,  the  federal  government,  any
    38  United  States  territory,  commonwealth  or possession, the District of
    39  Columbia, a state government within  the  United  States,  a  provincial
    40  government  of the dominion of Canada, or the city of New York, or (b) a
    41  valid passport issued by the United States government or any other coun-
    42  try, or (c) an identification card issued by the  armed  forces  of  the
    43  United States, indicating that the individual is at least eighteen years
    44  of  age,  or (d) a student identification card, provided such card indi-
    45  cates the date of birth of the individual. Such identification need  not
    46  be  required  of  any  individual  who reasonably appears to be at least
    47  twenty-five years of age; provided, however, that such appearance  shall
    48  not  constitute  a  defense  in  any proceeding alleging the sale of any
    49  over-the-counter diet pills and dietary supplements for weight  loss  or
    50  muscle building to an individual under eighteen years of age.
    51    3. (a) Any person operating a retail establishment may perform a tran-
    52  saction scan as a precondition for the purchase of over-the-counter diet
    53  pills or dietary supplements for weight loss or muscle building.
    54    (b)  In  any  instance  where the information deciphered by the trans-
    55  action scan fails to match  the  information  printed  on  the  driver's
    56  license  or  non-driver  identification card, or if the transaction scan

        A. 5610--D                          3
 
     1  indicates that the information is false  or  fraudulent,  the  attempted
     2  transaction shall be denied.
     3    (c) In any proceeding pursuant to subdivision five of this section, it
     4  shall be an affirmative defense that such person had produced a driver's
     5  license or non-driver identification card apparently issued by a govern-
     6  mental  entity,  successfully  completed that transaction scan, and that
     7  over-the-counter diet pills or dietary supplements for  weight  loss  of
     8  muscle  building were sold, delivered or given to such person in reason-
     9  able reliance upon such identification and transaction scan.  In  evalu-
    10  ating  the  applicability  of  such affirmative defense, the court shall
    11  take into consideration any written policy adopted  and  implemented  by
    12  the seller to effectuate the provisions of this section. Use of a trans-
    13  action scan shall not excuse any person operating a retail establishment
    14  from  the  exercise  of  reasonable diligence otherwise required by this
    15  section.
    16    (d) A retail establishment or employee  of  such  establishment  shall
    17  only  use  a  device  capable of deciphering any electronically readable
    18  format, and shall only  use  the  information  recorded  and  maintained
    19  through  the  use  of  such  devices, for the purposes contained in this
    20  subdivision. No retail establishment or employee of  such  establishment
    21  shall  resell or disseminate the information recorded during such a scan
    22  to any third person. Such prohibited resale  or  dissemination  includes
    23  but  is  not limited to any advertising, marketing or promotional activ-
    24  ities.  Notwithstanding the restrictions imposed  by  this  subdivision,
    25  such  records  may  be  released pursuant to a court ordered subpoena or
    26  pursuant to any other statute that specifically authorizes  the  release
    27  of such information. Each violation of this subdivision shall be punish-
    28  able by a civil penalty of not more than one thousand dollars.
    29    (e) A retail establishment or employee of such establishment may elec-
    30  tronically or mechanically record and maintain only the information from
    31  a  transaction scan necessary to effectuate this section.  Such informa-
    32  tion shall be limited to the following: (i) name, (ii)  date  of  birth,
    33  (iii)  driver's  license  or  non-driver identification number, and (iv)
    34  expiration date.
    35    4. Notwithstanding subdivision two of this section, a delivery seller,
    36  including an online retailer, who mails or ships  over-the-counter  diet
    37  pills  or  dietary  supplements  for  weight  loss or muscle building to
    38  consumers:
    39    (a) shall not sell, deliver, or cause to be  delivered  any  over-the-
    40  counter  diet  pills  or  dietary  supplements for weight loss or muscle
    41  building to a person under eighteen years of age; and
    42    (b) shall use a method of mailing or shipping:
    43    (i) that requires the purchaser placing the delivery sale order, or an
    44  adult who is at least eighteen years of age to sign to  accept  delivery
    45  of the shipping container at the delivery address; and
    46    (ii)  that  requires  the  person  who signs to accept delivery of the
    47  shipping container to provide proof, in the form  of  a  valid,  govern-
    48  ment-issued  identification bearing a photograph of the individual, that
    49  the person is at least eighteen years of age.
    50    5. Whenever there shall be a violation of this section, an application
    51  may be made by the attorney general in the name of  the  people  of  the
    52  state  of  New  York,  to  a  court  or justice having jurisdiction by a
    53  special proceeding to issue  an  injunction,  and  upon  notice  to  the
    54  defendant of not less than five days, to enjoin and restrain the contin-
    55  uance  of  such violation; and if it shall appear to the satisfaction of
    56  the court or justice that the defendant  has,  in  fact,  violated  this

        A. 5610--D                          4
 
     1  section,  an injunction may be issued by the court or justice, enjoining
     2  and restraining any further violations, without requiring proof that any
     3  person has, in fact, been injured or damaged thereby.  Whenever a  court
     4  shall determine that a violation of this section has occurred, the court
     5  may impose a civil penalty of not more than five hundred dollars.
     6    6.  When  determining whether an over-the-counter diet pill or dietary
     7  supplement is  labeled,  marketed,  or  otherwise  represented  for  the
     8  purpose  of  achieving  weight  loss or muscle building, the court shall
     9  consider, but is not limited to, the following factors:
    10    (a) whether the product contains:
    11    (i) an ingredient approved by the federal Food and Drug Administration
    12  for weight loss or muscle building;
    13    (ii) a steroid; or
    14    (iii) creatine, green tea extract, raspberry ketone,  garcinia  cambo-
    15  gia, green coffee bean extract;
    16    (b)  whether  the  product's labeling or marketing bears statements or
    17  images that express or imply that the product will help:
    18    (i) modify, maintain, or reduce body weight,  fat,  appetite,  overall
    19  metabolism, or the process by which nutrients are metabolized; or
    20    (ii) maintain or increase muscle or strength;
    21    (c)  whether  the product or its ingredients are otherwise represented
    22  for the purpose of achieving weight loss or building muscle; or
    23    (d) whether the retailer has categorized the  dietary  supplement  for
    24  weight loss or muscle building by:
    25    (i) placing signs, categorizing, or tagging the supplement with state-
    26  ments described in paragraph (b) of this subdivision;
    27    (ii)  grouping the supplements with other weight loss or muscle build-
    28  ing products in a display, advertisement, webpage, or area of the store;
    29  or
    30    (iii) otherwise representing that the product is for  weight  loss  or
    31  muscle building.
    32    § 2. This act shall take effect on the one hundred eightieth day after
    33  it shall have become a law.
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