Prohibits the sale and distribution of dietary supplements containing DMAA and foods containing an unsafe DMAA food additive.
TITLE OF BILL: An act to amend the public health law, in relation to prohibiting the sale and promotional distribution of products for human consumption containing DMAA
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 Article 13-C to the Public Health Law to regulate and ban the sale of DMAA. DMAA, as defined under this bill, means any of the prescribed chemicals contained in dietary supplements which are synthetically made chemical compounds that are designed to replicate chemical compounds that are allegedly contained naturally in geranium plants. DMAA stands for the class of chemicals that are of the Dimethylamylamine class or its derivatives.
The bill authorizes the NYS Department of Health, and local county health departments that exist in designated counties that carry out the duties of the NYS Health Department and state law, to enforce the provisions of this act. Enforcement would be accomplished as is the case with other violations of the public health law.
If a public health inspector finds a violation of this act or a citizen brings the possibility of such a violation to the attention of the public health inspector, who then deems that the act has been violated, then such suspected violator will be cited. Upon citation, an administrative hearing will be conducted to determine if the act was violated and a fine assessed. As with any administrative hearing determination, such determination can be reviewed in Supreme Court pursuant to an Article 78 proceeding.
Section 2: The effective date is immediate.
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-dimethylamylamine 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 not 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: Immediate.
STATE OF NEW YORK ________________________________________________________________________ 2377 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 AN ACT to amend the public health law, in relation to prohibiting the sale and promotional distribution of products for human consumption containing DMAA THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. The public health law is amended by adding a new article 13-C to read as follows: ARTICLE 13-C REGULATION OF DMAA SECTION 1397. DEFINITIONS. 1397-A. SALE OR PROMOTIONAL DISTRIBUTION OF PRODUCTS CONTAINING DMAA. 1397-B. ENFORCEMENT. 1397-C. PENALTIES. S 1397. DEFINITIONS. FOR THE PURPOSES OF THIS ARTICLE: 1. "DMAA" MEANS ANY OF THE FOLLOWING SUBSTANCES: (A) 1, 3-DIMETHYLAMYLAMINE; (B) 4-METHYLHEXANE-2-AMINE (IUPAC); (C) DIMETHYLAMYLAMINE (DMAA); (D) METHYLHEXANAMINE; AND (E) ANY OTHER SYNTHETIC OR MANUFACTURED DMAA AS PRESCRIBED BY THE COMMISSIONER. 2. "ENFORCEMENT OFFICER" MEANS THE BOARD OF HEALTH OF A COUNTY OR PART COUNTY HEALTH DISTRICT ESTABLISHED PURSUANT TO TITLE THREE OF ARTICLE THREE OF THIS CHAPTER, OR IN THE ABSENCE THEREOF, AN OFFICER OF A COUNTY DESIGNATED FOR SUCH PURPOSE BY RESOLUTION OF THE ELECTED COUNTY LEGISLA- TURE OR BOARD OF SUPERVISORS. ANY SUCH DESIGNATION SHALL BE FILED WITH THE COMMISSIONER WITHIN THIRTY DAYS AFTER ADOPTION AND SUCH DESIGNATION SHALL TAKE EFFECT THIRTY DAYS AFTER SUCH FILING. IF NO SUCH DESIGNATIONEXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD07852-01-3 S. 2377 2
IS MADE, THE COUNTY SHALL BE DEEMED TO HAVE DESIGNATED THE DEPARTMENT AS ITS ENFORCEMENT OFFICER. THE ENFORCEMENT OFFICER SHALL HAVE SOLE JURIS- DICTION TO ENFORCE THE PROVISIONS OF THIS ARTICLE ON A COUNTYWIDE BASIS. S 1397-A. SALE OR PROMOTIONAL DISTRIBUTION OF PRODUCTS CONTAINING DMAA. NO PERSON, FIRM, CORPORATION, PARTNERSHIP, ASSOCIATION, LIMITED LIABILITY COMPANY OR OTHER ENTITY SHALL SELL, OFFER TO SELL OR GIVE AWAY, AT EITHER RETAIL, WHOLESALE, OR FOR PROMOTIONAL PURPOSES, ANY PRODUCT FOR HUMAN CONSUMPTION WHICH CONTAINS DMAA. S 1397-B. ENFORCEMENT. 1. IF THE ENFORCEMENT OFFICER DETERMINES, AFTER A HEARING, THAT A VIOLATION OF SECTION THIRTEEN HUNDRED NINETY-SEVEN-A OF THIS ARTICLE HAS OCCURRED, A CIVIL PENALTY MAY BE IMPOSED BY THE ENFORCEMENT OFFICER PURSUANT TO SECTION THIRTEEN HUNDRED NINETY-SEVEN-C OF THIS ARTICLE. 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 AN OFFICER DESIGNATED TO ENFORCE THE PROVISIONS OF THIS ARTI- CLE, THE HEARING SHALL BE CONDUCTED PURSUANT TO PROCEDURES SET FORTH IN THE COUNTY SANITARY CODE, OR IN THE ABSENCE THEREOF, PURSUANT TO PROCE- DURES ESTABLISHED BY THE ELECTED COUNTY LEGISLATURE OR BOARD OF SUPERVI- SORS. NO OTHER PENALTY, FINE OR SANCTION MAY BE IMPOSED, PROVIDED THAT NOTHING IN THIS ARTICLE SHALL BE CONSTRUED TO PROHIBIT AN ENFORCEMENT OFFICER FROM COMMENCING A PROCEEDING FOR INJUNCTIVE RELIEF TO COMPEL COMPLIANCE WITH THIS ARTICLE. 2. ANY PERSON WHO DESIRES TO REGISTER A COMPLAINT UNDER THIS ARTICLE MAY DO SO WITH THE APPROPRIATE ENFORCEMENT OFFICER. 3. ANY PERSON AGGRIEVED BY THE DECISION OF AN ENFORCEMENT OFFICER, OTHER THAN THE COMMISSIONER, MAY APPEAL TO THE COMMISSIONER TO REVIEW SUCH DECISION WITHIN THIRTY DAYS OF SUCH DECISION. THE DECISION OF ANY ENFORCEMENT OFFICER SHALL BE REVIEWABLE PURSUANT TO ARTICLE SEVENTY-EIGHT OF THE CIVIL PRACTICE LAW AND RULES. 4. THE ENFORCEMENT OFFICER, SUBSEQUENT TO ANY APPEAL HAVING BEEN FINALLY DETERMINED, MAY BRING AN ACTION TO RECOVER THE CIVIL PENALTY PROVIDED IN SECTION THIRTEEN HUNDRED NINETY-SEVEN-C OF THIS ARTICLE IN ANY COURT OF COMPETENT JURISDICTION. S 1397-C. PENALTIES. THE COMMISSIONER MAY IMPOSE A CIVIL PENALTY FOR A VIOLATION OF THIS ARTICLE IN AN AMOUNT NOT TO EXCEED THAT SET FORTH IN SUBDIVISION ONE OF SECTION TWELVE OF THIS CHAPTER. ANY OTHER ENFORCEMENT OFFICER MAY IMPOSE A CIVIL PENALTY FOR A VIOLATION OF THIS ARTICLE IN AN AMOUNT NOT TO EXCEED THAT SET FORTH IN PARAGRAPH F OF SUBDIVISION ONE OF SECTION THREE HUNDRED NINE OF THIS CHAPTER. S 2. This act shall take effect immediately.