Prohibits the sale and distribution of dietary supplements containing DMAA and foods containing an unsafe DMAA food additive.
Ayes (61): Adams, Addabbo, Avella, Ball, Bonacic, Boyle, Breslin, Carlucci, DeFrancisco, Diaz, Dilan, Espaillat, Farley, Felder, Flanagan, Fuschillo, Gallivan, Gianaris, Gipson, Golden, Griffo, Grisanti, Hannon, Hassell-Thomps, Hoylman, Kennedy, Klein, Krueger, Lanza, Larkin, Latimer, LaValle, Libous, Little, Marcellino, Marchione, Martins, Maziarz, Montgomery, Nozzolio, O'Brien, O'Mara, Parker, Peralta, Ritchie, Rivera, Robach, Sampson, Sanders, Savino, Serrano, Seward, Skelos, Smith, Squadron, Stavisky, Stewart-Cousin, Tkaczyk, Valesky, Young, Zeldin
Excused (2): Perkins, Ranzenhofer
Ayes (61): Addabbo, Avella, Ball, Bonacic, Boyle, Breslin, Carlucci, DeFrancisco, Diaz, Dilan, Espaillat, Farley, Felder, Flanagan, Gallivan, Gianaris, Gipson, Golden, Griffo, Grisanti, Hannon, Hassell-Thomps, Hoylman, Kennedy, Klein, Krueger, Lanza, Larkin, Latimer, LaValle, Libous, Little, Marcellino, Marchione, Martins, Maziarz, Montgomery, Nozzolio, O'Brien, O'Mara, Parker, Peralta, Perkins, Ranzenhofer, Ritchie, Rivera, Robach, Sampson, Sanders, Savino, Serrano, Seward, Skelos, Smith, Squadron, Stavisky, Stewart-Cousins, Tkaczyk, Valesky, Young, Zeldin
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.
STATE OF NEW YORK ________________________________________________________________________ 2377--A 2013-2014 Regular Sessions IN SENATE 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 OFS. 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.