senate Bill S2377A

Prohibits the sale and distribution of dietary supplements containing DMAA and foods containing an unsafe DMAA food additive

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Bill Status


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor
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actions

  • 17 / Jan / 2013
    • REFERRED TO HEALTH
  • 07 / May / 2013
    • REPORTED AND COMMITTED TO FINANCE
  • 24 / May / 2013
    • AMEND (T) AND RECOMMIT TO FINANCE
  • 24 / May / 2013
    • PRINT NUMBER 2377A
  • 11 / Jun / 2013
    • COMMITTEE DISCHARGED AND COMMITTED TO RULES
  • 11 / Jun / 2013
    • ORDERED TO THIRD READING CAL.1240
  • 12 / Jun / 2013
    • PASSED SENATE
  • 12 / Jun / 2013
    • DELIVERED TO ASSEMBLY
  • 12 / Jun / 2013
    • REFERRED TO HEALTH
  • 08 / Jan / 2014
    • DIED IN ASSEMBLY
  • 08 / Jan / 2014
    • RETURNED TO SENATE
  • 08 / Jan / 2014
    • REFERRED TO HEALTH
  • 04 / Feb / 2014
    • 1ST REPORT CAL.99
  • 10 / Feb / 2014
    • 2ND REPORT CAL.
  • 11 / Feb / 2014
    • ADVANCED TO THIRD READING
  • 26 / Mar / 2014
    • PASSED SENATE
  • 26 / Mar / 2014
    • DELIVERED TO ASSEMBLY
  • 26 / Mar / 2014
    • REFERRED TO HEALTH

Summary

Prohibits the sale and distribution of dietary supplements containing DMAA and foods containing an unsafe DMAA food additive.

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Bill Details

See Assembly Version of this Bill:
A4613A
Versions:
S2377
S2377A
Legislative Cycle:
2013-2014
Current Committee:
Assembly Health
Law Section:
General Business Law
Laws Affected:
Add §391-s, Gen Bus L; add §1311, Pub Health L

Sponsor Memo

BILL NUMBER:S2377A

TITLE OF BILL:
An act
to amend the general business law and the public health law, in relation
to prohibiting sale and distribution of dietary supplements containing
DMAA and foods containing an unsafe DMAA food additive

PURPOSE: The purpose of this bill is to prohibit the
sale or gift of
DMAA used for human consumption either at retail, wholesale, or to be
used for promotional purposes. DMAA is a synthetic or manufactured
chemical compound that is intended to synthesize chemical compounds
that are allegedly contained naturally in geranium plants. These
synthetic or manufactured Geranium products are incorporated into
certain dietary supplements, but have been demonstrated to be harmful
to some of those who have consumed them. This bill bans the sale of
such dietary supplements that contain DMAA.

SUMMARY OF PROVISIONS:

Section 1: Adds a new section 391-s to the General Business Law.

This new section bans the sale or give away for promotional purposes
of any dietary supplements containing DMAA or any food product
containing an unsafe DMAA food additive in New York by any entity.
The section also defines these terms and establishes that this ban
shall be enforced in a manner laid out in section 1311 of the Public
Health Law.

Section 2: Adds a new section 1311 to the Public Health Law.

This new section allows municipalities or political subdivisions to
designate which entity shall enforce the ban laid out in &391-s of
the General Business Law and gives the Commissioner of the Department
of Health concurrent jurisdiction to enforce the DMAA ban.

This section allows for the imposition of a civil penalty against any
entity found to have violated the DMAA sale ban, pursuant to a
hearing. Civil penalties shall not exceed $500 per violation.
Entities have the right to appeal decisions. Entities may use the
defense that they had no knowledge that a product being sold
contained DMAA or DMAA additives.

Section 3: Establishes an date of sixty days after the Passage of the
law.

JUSTIFICATION: In April 2012, the Food and Drug
Administration (FDA)
sent a letter of Warning to ten manufacturers of dietary supplements,
telling them that the agency did not consider the chemical DMAA,
which can also be known as 1,3-dimethvlamylamine or
methylhexaneamine, to be a true dietary ingredient and that those
companies had failed to prove that this chemical is safe for human
consumption. This action came after the FDA had received forty-two
different reports of possible adverse health effects linked to
products containing DMAA. These adverse effects included cardiac,


nervous, and psychiatric disorders and also possible fatalities. The
US military pulled all products containing DMAA from its PX stores in
December of 2011 after reports linked DMAA containing products to the
deaths of two servicemen. Authorities in Canada, the United Kingdom,
Australia, and New Zealand have all taken action to curtail or ban
the sale of products, such as dietary supplements, that contain DMAA.
DMAA is known to mimic the functions of adrenaline in the human body.
It acts to constrict blood vessels, increasing blood pressure and
increasing awareness and focus, which is why it is commonly used as
an aide to lengthen and enhance exercise sessions. Its effects are
similar to the now banned supplement Ephedra. In fact, DMAA is used
as a substitute for Ephedra by multiple supplements' manufacturers.

DMAA containing products are marketed as energy boosters and sold as
supplements for individuals engaging in heavy and strenuous
exercises, such as body building. The chemical was first patented
back in 1944 as a possible nasal decongestant, but by the late 1970's
had been pulled from the shelves as the regulations on
pharmaceuticals and other drugs were tightened. All the DMAA used
today is manufactured. Dietary supplement manufacturers claim that
these chemicals are similar to ones that could be found naturally
occurring in geranium extracts and commonly market them as natural
geranium products. As noted before though, these chemicals are not
extracted from geraniums and the only documentation used by
manufacturers as proof of their claims is a single study in a now
defunct journal from the mid-1990's.

The reality is that DMAA is no a 'natural' substance, but a synthetic
chemical that exhibits many of the same dangers to humans as was
found to be the case with the now banned Ephedra. This is why the US
military, the FDA, and health authorities in several other countries
have taken action to protect the public from the possible dangers of
this chemical.

It is ironic that these questionable and potentially dangerous dietary
supplements are being purchased by persons who are attempting to
enhance their physical well being and health. New York State should
not lag behind in its actions to protect our residents from this
dangerous substance.

LEGISLATIVE HISTORY: New bill.

FISCAL IMPLICATIONS: To be determined.

EFFECTIVE DATE: This act shall take wit on the
sixtieth day after it shall have become a law.

view bill text
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                 2377--A

                       2013-2014 Regular Sessions

                            I N  S E N A T E

                            January 17, 2013
                               ___________

Introduced  by  Sen.  KLEIN  -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health -- reported favora-
  bly from said committee and committed to the Committee on  Finance  --
  committee  discharged,  bill amended, ordered reprinted as amended and
  recommitted to said committee

AN ACT to amend the general business law and the public health  law,  in
  relation  to  prohibiting sale and distribution of dietary supplements
  containing DMAA and foods containing an unsafe DMAA food additive

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The general business law is amended by adding a new section
391-s to read as follows:
  S  391-S. DMAA DIETARY SUPPLEMENTS AND FOOD ADDITIVES; PROHIBITION. 1.
NO PERSON, FIRM, CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED  LIABIL-
ITY  COMPANY OR OTHER ENTITY SHALL SELL, OFFER TO SELL OR GIVE AWAY, FOR
EITHER RETAIL, WHOLESALE OR PROMOTIONAL PURPOSES, A  DIETARY  SUPPLEMENT
CONTAINING  ANY  QUANTITY  OF  DMAA, OR A FOOD CONTAINING AN UNSAFE DMAA
FOOD ADDITIVE.
  2. FOR PURPOSES OF THIS SECTION, THE FOLLOWING TERMS HAVE THE  FOLLOW-
ING MEANINGS:
  (A) "DIETARY SUPPLEMENT" MEANS A PRODUCT (OTHER THAN TOBACCO) THAT (1)
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) IS INTENDED FOR INGESTION IN PILL, CAPSULE,  TABLET  OR
LIQUID  FORM;  AND  (3) IS LABELED AS A "DIETARY SUPPLEMENT" PURSUANT TO
THE FEDERAL DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT, 21 U.S.C.  321,
AS AMENDED.

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD07852-06-3

S. 2377--A                          2

  (B)  "DMAA" MEANS 1, 3-DIMETHYLAMYLAMINE (ALSO KNOWN AS 1,3-DMAA, 1,3-
DIMETHYLPENTYLAMINE, 2-AMINO-4-METHYLHEXANE,  2-HEXANAMINE,  4-METHYL-2-
HEXANAMINE,   4-METHYL-2-HEXYLAMINE,  4-METHYLHEXANE-2-AMINE,  4-METHYL-
(9CI), DIMETHYLAMYLAMINE, GERANAMINE, AND METHYLHEXANAMINE).
  (C)  "FOOD" MEANS ALL ARTICLES OF FOOD, DRINK, CONFECTIONERY OR CONDI-
MENT, WHETHER SIMPLE, MIXED OR COMPOUND, USED OR  INTENDED  FOR  USE  BY
HUMANS  OR ANIMALS, AND SHALL ALSO INCLUDE ALL SUBSTANCES OR INGREDIENTS
TO BE ADDED TO FOOD FOR ANY PURPOSE. SUCH  TERM  SHALL  INCLUDE  CHEWING
GUM.
  (D)  "UNSAFE  DMAA  FOOD ADDITIVE" MEANS A FOOD ADDITIVE THAT CONTAINS
DMAA THAT HAS NOT BEEN RECOGNIZED BY THE COMMISSIONER OF AGRICULTURE AND
MARKETS AS SAFE, FOR THE PURPOSE OF ENFORCEMENT OF ARTICLE SEVENTEEN  OF
THE AGRICULTURE AND MARKETS LAW.
  3.   NOTHING   IN   THIS   SECTION   SHALL  APPLY  TO  NONPRESCRIPTION
OVER-THE-COUNTER DRUGS APPROVED OR REGULATED BY THE FOOD AND DRUG ADMIN-
ISTRATION.
  4. ANY ENFORCEMENT OFFICER, AS DEFINED  IN  SECTION  THIRTEEN  HUNDRED
ELEVEN OF THE PUBLIC HEALTH LAW, SHALL HAVE THE POWER TO IMPOSE UPON ANY
PERSON,  FIRM,  CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED LIABILITY
COMPANY OR OTHER ENTITY THE CIVIL PENALTIES AUTHORIZED BY SUCH  SECTION,
FOLLOWING  A  HEARING CONDUCTED IN THE SAME MANNER AS HEARINGS CONDUCTED
PURSUANT TO ARTICLE THIRTEEN-E OF THE PUBLIC HEALTH LAW.
  S 2. The public health law is amended by adding a new section 1311  to
read as follows:
  S  1311.  REGULATION OF DMAA.  1. FOR THE PURPOSE OF THIS SECTION, THE
TERM "ENFORCEMENT OFFICER" SHALL MEAN ANY ENTITY SO  DESIGNATED  BY  ANY
MUNICIPALITY  OR POLITICAL SUBDIVISION.  SUCH ENFORCEMENT OFFICERS SHALL
HAVE CONCURRENT  JURISDICTION  WITH  THE  COMMISSIONER  TO  ENFORCE  THE
PROVISIONS OF SECTION THREE HUNDRED NINETY-ONE-S OF THE GENERAL BUSINESS
LAW, PURSUANT TO RULES AND REGULATIONS PROMULGATED BY THE COMMISSIONER.
  2.  IF  AN  ENFORCEMENT  OFFICER  DETERMINES  AFTER  A  HEARING THAT A
VIOLATION OF SECTION THREE HUNDRED NINETY-ONE-S OF THE GENERAL  BUSINESS
LAW  HAS  OCCURRED, AND SUBSEQUENT TO ANY APPEAL PURSUANT TO SUBDIVISION
FOUR OF THIS SECTION HAVING BEEN FINALLY DETERMINED, A CIVIL PENALTY MAY
BE IMPOSED BY THE ENFORCEMENT OFFICER; PROVIDED, HOWEVER, THAT  NO  SUCH
PENALTY  SHALL EXCEED FIVE HUNDRED DOLLARS. WHEN THE ENFORCEMENT OFFICER
IS THE COMMISSIONER, THE HEARING SHALL  BE  CONDUCTED  PURSUANT  TO  THE
PROVISIONS  OF  SECTION  TWELVE-A  OF THIS CHAPTER. WHEN THE ENFORCEMENT
OFFICER IS A BOARD OF HEALTH OR IN A CITY WITH A POPULATION OF MORE THAN
ONE MILLION, THE DEPARTMENT OF HEALTH AND MENTAL HYGIENE, OR AN  OFFICER
DESIGNATED   TO   ENFORCE   THE  PROVISIONS  OF  SECTION  THREE  HUNDRED
NINETY-ONE-S OF THE GENERAL BUSINESS LAW, THE HEARING SHALL BE CONDUCTED
PURSUANT TO PROCEDURES SET FORTH IN THE COUNTY SANITARY CODE, OR  HEALTH
CODE  OF  SUCH  CITY,  OR IN THE ABSENCE THEREOF, PURSUANT TO PROCEDURES
ESTABLISHED BY THE ELECTED COUNTY LEGISLATURE OR BOARD  OF  SUPERVISORS.
NO OTHER PENALTY, FINE OR SANCTION MAY BE IMPOSED, PROVIDED THAT NOTHING
IN  THIS  SECTION  SHALL BE CONSTRUED TO PROHIBIT AN ENFORCEMENT OFFICER
FROM COMMENCING A PROCEEDING FOR INJUNCTIVE RELIEF TO COMPEL  COMPLIANCE
WITH SECTION THREE HUNDRED NINETY-ONE-S OF THE GENERAL BUSINESS LAW.
  3.  ANY  PERSON WHO DESIRES TO REGISTER A COMPLAINT FOR A VIOLATION OF
SECTION THREE HUNDRED NINETY-ONE-S OF THE GENERAL BUSINESS LAW MAY DO SO
WITH THE APPROPRIATE ENFORCEMENT OFFICER.
  4. ANY PERSON AGGRIEVED BY THE DECISION  OF  AN  ENFORCEMENT  OFFICER,
OTHER THAN THE COMMISSIONER, MAY APPEAL TO THE COMMISSIONER FOR A REVIEW
OF  SUCH  DECISION  WITHIN THIRTY DAYS OF SUCH DECISION. THE DECISION OF

S. 2377--A                          3

ANY ENFORCEMENT OFFICER SHALL BE REVIEWABLE PURSUANT TO  ARTICLE  SEVEN-
TY-EIGHT OF THE CIVIL PRACTICE LAW AND RULES.
  5.  IT SHALL BE A DEFENSE THAT ANY PERSON, FIRM, CORPORATION, PARTNER-
SHIP, ASSOCIATION, LIMITED LIABILITY COMPANY OR OTHER ENTITY THAT  SOLD,
OFFERED  FOR  SALE  OR GAVE AWAY, FOR EITHER RETAIL, WHOLESALE OR PROMO-
TIONAL PURPOSES, A DIETARY SUPPLEMENT, DID NOT HAVE KNOWLEDGE  THAT  THE
DIETARY  SUPPLEMENT  CONTAINED  ANY  QUANTITY  OF DMAA, OR THAT THE FOOD
CONTAINED AN UNSAFE DMAA  FOOD  ADDITIVE,  IF  SUCH  KNOWLEDGE  WAS  NOT
REASONABLY DISCOVERABLE.
  S  3.  This  act  shall take effect on the sixtieth day after it shall
have become a law.

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