Senate Bill S4151

                                BILL NUMBER:S4151

TITLE OF BILL:  An act to amend the public health law, in relation to
regulating the sale of sports dietary supplements

PURPOSE:  The purpose of the bill is to ban the purchase of sports
supplements by those under the age of 18. The bill will also require
that consumers receive a copy of a warning label when they purchase
certain products. These warning labels will tell the purchaser whether
the product contains banned ingredients as determined by certain
sports and regulatory agencies as well as stating specific side
effects and whether these product contain synthetic botanicals.  This
bill will protect those who are underage from the dangerous side
effects of these sport supplements. Furthermore, as a result of
loopholes and lax regulations in federal law consumers are not able to
determine what they are putting into their body and what is in these
products. This act does not affect the sales of caffeinated energy
drinks currently classified as supplements. This act will ensure that
consumers are getting accurate information about what they are
consuming and the risks that come with it.

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.