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

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.