Regulates the sale and distribution of sports dietary supplements

Summary of provisions

Section 1: Amends the public health law to add a new article 2-B regarding Sports dietary supplements.

The new section 290 of this act defines dietary supplements, sports dietary supplements, and synthetic botanicals for the purposes of the act.

The new section 291 of this act establishes that any person, firm, company, or group that sells or gives away as a promotion sports dietary supplements must provide to each individual a pamphlet produced by the manufacturer or distributor of the sports supplement which includes the following information:

* Whether the sports supplement includes any synthetic botanical ingredient and must identify such ingredients;

* Whether the sports supplement has been banned from use by the United States Anti-Doping Agency, the World Anti-Doping Agency, Major League Baseball, the National Football League, The National Hockey League, the National Basketball Association, NASCAR, or the NCAA;

* Any known negative adverse effects or herb-drug interactions that could result from the use of these supplements;

* Any additional information required by the commissioner

The commissioner will promulgate such rules and regulations necessary for the creation of this pamphlet.

The new section 292 of this act will prohibit the sale of sports supplements to any child under eighteen years of age.

The new section 293 of this act defines a violation of this act as a violation as defined in the penal law.

Section 2: Sets the effective date of this act.

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, known as 1,3-dimethylamylamine (DMAA) 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.

The surrounding events of the dangerous supplement DMAA highlighted many issues within the regulations in regards to dietary supplements that are governed by the Dietary Supplement Health and Education Act of 1994. The FDA acts as a reactive agency, only taking action once products show to be unsafe. A proactive agency would serve the public good and protect them for consuming harmful and potentially fatal products.

Many of the people that have been harmed by these products are young athletes and students who are ingesting products for a quick fix to weight loose or to gain muscle. However, these vulnerable populations are not aware of the risks of these products, in due part because they are not even told what the side effects are. Furthermore, we do not

know the long-term effects of these products on the developing body. From pressures from coaches, parents, the media and themselves, these children and teenagers are compelled to take these products. Underage people should not buy these products because of the unintended health risks that are associated with these products and the unknown long-term effects.

While there have been deaths and health incidents as a result of DMAA and other sport supplements, countless young athletes and professionals have had scholarships lost and ended careers because of testing positive for banned substance that was in a product. Athletes think these products are allowed since it's an over-the-counter product. Even athletes who are well informed of the ever-growing list of banned products cannot actually be aware of what they are putting into their body because each manufacturer or distributor uses different ingredient names from what is listed on the banned lists. It is impossible for athletes to be aware of what they are consuming unless they are told, we need to ensure that high school and college athletes are not having their future shattered because of deceptive practices from the dietary supplemental industry. Companies must disclose to their consumers if a product contains ingredients that are banned by major sports agencies and regulatory authorities and warn that these products could be banned my local and regional athletic agencies as well. While the FDA does not require such information, it is time for New York State to demand the safety and protection of our consumers

There has also been a rise in the use of synthetic botanicals in dietary supplements. These ingredients are chemicals that are created in laboratory to mimic certain products found inside herbs and plants. These products are then being sold and marketed as natural ingredients. Consumers think that since they are taking a "natural" supplement then it must be healthy, however, they are not ingesting a natural product. As part of furthering transparency in this industry and providing the citizens of New York with the best possible information for what they are ingesting, companies need to tell consumers whether their products contain synthetic botanicals or not.

Legislative history

New Bill

Fiscal implications

None to the state

Effective date

This act shall take effect on the one hundred and eightieth day after it shall have become law; provided, that, effective immediately, any rules and regulations necessary to implement the provisions of this act on its effective date are authorized to be completed on or before such date.