New York State Senator Jeffrey Klein (D-Bronx) introduced a bill (S. 4151) on March 12 that seeks to create new category definitions for sports performance supplements—to the concern of many in the dietary supplements industry. The bill would also mandate some pretty stringent disclosure policies for this segment of the dietary supplements market.
What the Bill Says
The bill’s stated aim is “to amend the public health law in relation to regulating the sale of sports dietary supplements.” If passed, it would affect sports supplements on several fronts.
First, the bill would establish a very specific definition of a sports dietary supplement, separate from the currently existing definition of a dietary supplement under federal law.
Under the Dietary Supplement Health and Education Act of 1994, a dietary supplement is federally defined as “a product (other than tobacco) intended to supplement the diet 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 foruse by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.”
Senator Klein’s bill, however, carves out a separate definition of a sports dietary supplement: “a dietary supplement, having more than one ingredient, which is sold, marketed or distributed to enhance a person’s physical performance or to increase a person’s metabolism…” Interestingly, however, the bill specifically excludes from this definition liquid dietary supplements that contain caffeine.
The proposed legislation also attempts to define a synthetic botanical ingredient as “synthesized through human manufacturing practices and that is not extracted from a plant or herb.” This runs counter to federal law, however, which currently has no lawful definition of what a synthetic botanical comprises. (FDA recently addressed the topic of synthetic botanical ingredients in the first version of its new dietary ingredient draft guidance. The agency listed specific manufacturing processes that might render an ingredient synthetic—a list that many industry members disagree with.)
Secondly, and understandably alarming to industry members, the legislation would require that every product sold in New York that is deemed a sports dietary supplements would have to be accompanied by a “pamphlet” produced by the manufacturer or distributor. This pamphlet would not only need to identify any synthetic botanical ingredients in the formulation; it would also need to disclose whether any of the ingredients in the formulation have been banned by any of eight anti-doping organizations and national sports leagues, including the U.S. Anti-Doping Agency, the World Anti-Doping Agency, Major League Baseball, the National Football League, etc. Additionally, the pamphlet would need to include information on “any known adverse effects and any known herb-drug interactions that could result from the use of such sports dietary supplements.”
Finally, the bill would ban the sale of sports dietary supplements to any person under 18 years of age.
Klein Against Supplements?
This all-out assault on sports supplements follows fairly closely on the heels of another Senator Klein–sponsored bill that was introduced on January 17 (S. 2377), which calls for a complete ban on products containing DMAA (1,3-dimethylamylamine), a compound some claim as derived from geranium and allegedly linked to some serious adverse events.
Based on the senator’s past remarks—at a March 6 press conference, he referred to “loosely regulated dietary supplements”—Senator Klein does seem distrustful toward dietary supplements, in general. (At press time, a staff member said the senator could not provide comments in time for publication.)
And as to why caffeine-containing liquid dietary supplements are excluded from the sports supplements bill, there is wide industry speculation that Klein is preparing to introduce yet another bill focused specifically on those products—although this has not yet been confirmed.
Industry reaction to the new bill was overwhelmingly characterized by concern. Mike Greene, vice president of government relations for the Council for Responsible Nutrition (CRN; Washington DC), tells Nutritional Outlook: “Well, I can be pretty clear that we are concerned about S.4151, the bill that regulates the sale and distribution of sports dietary supplements. We’re concerned for a couple of reasons. I think the first reason is that this is a bill that seeks to carve out sports dietary supplements from the general definition of dietary supplements and how they’re regulated.”
Also, because the bill would prohibit sale to those under age 18, Greene notes that “once you restrict products to those under 18, retailers generally have to put those products behind the counter to help protect those [customers], and ultimately you [end up] restricting products from responsible adults who may wish to purchase them.”
But does any state have the legal right to abrogate or usurp federal law or FDA regulations/definitions by introducing legislation such as S. 4151? “With regard to states’ rights versus federal preemption, really, there is no hard and fast law. There is no prohibition from states addressing these issues individually,” Greene says.
Attorney Jonathan Emord of Emord & Associates, located in Clifton, VA, chimes in, however, that “Under the doctrine of preemption, the states may not enact labeling laws that contradict the requirements of federal law.”
Greene points out, however, “We would argue that because FDA is unique, because what it does is unique, there should be federal preemption, but certain states don’t always believe it. We saw that in California with Prop 65, and certainly we’ve seen that in New York.”
Simply put, whether S. 4151 has the muscle to pass remains to be seen.