One of the many roles of government is to protect the people it serves. New York State Legislature is currently the epicenter of a flurry of proposed dietary supplement legislation that could prove to be a turning point for the industry. Since last month, New York State Assemblyman Felix Ortiz (D-51st District) has introduced four pieces of legislation aimed at ratcheting up supplement safety and accountability:

• Bill A3944: An act to amend the general business law with regard to the sale of dietary supplements with the purpose of preventing unsubstantiated claims for dietary supplements. The bill puts the burden on the FDA to prove the relative safety and efficacy of dietary supplements as opposed to drugs that require pre-market safety reviews and lengthy research studies to prove their work. It also stipulates that those selling dietary supplements that make health claims must have competent scientific evidence to back the claims. It also requires a warning statement on the product label, or a handout, if the product claim is not approved by the federal Food and Drug Administration (FDA), and contact information for the FDA. And finally, it asserts a civil penalty of not more than five hundred dollars per violation.

• Bill A4014: Would prevent school employees from selling or recommending dietary supplements to students and require schools to warn students of the risks of certain supplements. Specifically, this bill would prohibit coaches and other school employees from selling, distributing or endorsing the use of dietary supplements except as part of their official duties, and requires the Education Department to develop information to distribute to schools for coaches, health and physical education teachers, nurses and others to use in warning about risks from certain supplements

• Bill A3357: Proposes the establishment of a dietary supplements safety committee.

• Bill A2068: Would allow the consumer to know which products have been tested so that a more informed choice can be made when purchasing supplement products. This bill deals only with the analysis of the product for purity. It does not deal with any medicinal attributes of the product.

Assemblyman Ortiz contends there is much confusion in the realm of dietary supplements. Marketers are careful to avoid claims that would define their products as drugs but claims sometimes imply disease prevention or treatment. Despite the industry's efforts, the safety of certain supplements, their effectiveness, the scientific basis for health or medical claims, and the FDA's ability to oversee labeling prior to product marketing is still lacking. As spelled out by one of the bill's justifications, "Consumers may believe that the claims for dietary supplements are backed by the same type of research as drugs and that the FDA has investigated them. Those assumptions could lead to health risks if a person chose an ineffective supplement over an effective medical treatment or waste money if a consumer chose a product that had no chance of successfully fulfilling its claims."

Mr. Ortiz said he was motivated to delve into the supplement industry's shortcomings after reading numerous articles about the both the efficacy and lack of efficacy of dietary supplements. Prior to introducing the legislation, he held public hearings on supplements in NY State. "I finally made the decision that we needed to introduce pieces of legislation to, more than anything, bring awareness about the importance of supplements and for people to be cautious about supplements," he said. "Consumers should pay for something that they will benefit from…(and) it's imperative that consumers get as much information as they can (for example), whether or not the particular supplement has been verified or examined by the FDA. One of the bill mandates is that we should have a label stating that the supplement has been verified by the FDA.

"Sometimes a lot of the supplements don't even go through the FDA. It's very important that we begin to take a serious look and create serious measures on how to bring the invisible to visible, putting as much information at the consumer's fingertips as possible."

When interviewed for this article, Mr. Ortiz emphasized that he is not "anti-supplement." "I use ginseng and it's great for me," he said. "I just want to make sure consumers have adequate information in front of them."

What's apparent is that Mr. Ortiz, as the president of the National Hispanic Caucus State Legislature, wields a lot of clout. He's confident his bills are well-backed for passage. Moreover, he's confident the legislation is destined to be adopted by other state houses as well. He bases this opinion on his previous, and most well-known legislative acts. Mr. Ortiz was the legislator behind the introduction of the first cell phone ban in NY State, which quickly caught the attention of other states, leading to the adoption of similar bans nationwide. Likewise, he believes his supplement legislation will receive national attention, given his past involvement with ephedra. "I took on ephedra by holding a public hearing and a roundtable discussion," he said. "What I did was introduce the bill, and the federal government jumped on it very fast."

Industry Opposition Looms

But while Mr. Ortiz's constituency may be enamored by the Assemblyman's quest to make the supplement industry safer, representatives from the natural products industry aren't completely on-board with his point of view. "These bills are purportedly necessary to protect the public from 'unregulated' dietary supplements. One seeks to advise consumers that the FDA does not 'test' supplements. The other would establish a committee appointed by various politicians to evaluate supplement safety. It should be noted that FDA tests no consumer product including Tylenol and Coca-Cola," pointed out Marc Ullman, Esq., partner in New York City-based Ullman, Shapiro & Ullman, LLP. "The safety review panel looks like a good PR stunt for the bill's sponsors. All supplements (just like any other product marketed under the Food, Drug and Cosmetic Act) must be safe to be legally marketed. If they are not, they are considered adulterated. The sale of adulterated supplements (and other FDCA regulated substances) can be prosecuted as a criminal offense."

Mr. Ullman also speculated that Assemblyman Ortiz was probably motivated by a report produced by the New York State Task Force on Life and the Law last year. "That seriously flawed report was a biased attack on alleged issues relating to the safety and lack of benefits provided by supplements," he said. "Simply put, the Task Force ignored that the FDCA provides FDA with all of the tools necessary to police the supplement market and called upon New York State to create another, onerous, regulatory scheme."

What's more, Mr. Ullman warned that the bills are burdensome and have the potential to create a "very unfairly hostile environment for supplements in New York State."

All Sides Agree…

All sides seemed to agree that the overwhelming lack of enforcement on the part of the FDA is at the heart of the matter. "Tighter regulations is not the issue, enforcement of current regulations is what is needed," commented Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT. "FDA in particular must use its authority to enforce both the law and regulations; this is what industry and the consumer are looking for."

"Lack of enforcement by the FDA is absolutely hurting the supplement industry," agreed Mr. Ullman. "FDA's failure to take serious enforcement action against blatant scofflaws is shameful. The agency has abdicated its responsibility as a law enforcement/public health agency. It is simply scandalous."

Of the four bills, Mr. Ortiz said one in particular, involving a label bearing notice of FDA approval, was the most vital for passage. Committee meetings to discuss the merit of the bills are expected to commence in mid-March before the legislation moves forward.

While Assemblyman Ortiz is anticipating that his bills will not only pass in the state of New York but have the ability to possibly gain traction in Congress, Mr. Ullman and Mr. Israelsen aren't so certain. "I think it is unlikely that other states will follow New York's lead," said Mr. Israelsen. "Federal law should preempt state law with respect to dietary supplements given FDA's primary jurisdiction. New York has a history of doing this kind of thing, but is a typical of other states."

"The industry needs to be very aware of what is going on in Washington, and the Natural Products Association, American Herbal Products Association (AHPA) and Council for Responsible Nutrition CRN all do a superb job of informing their members," Mr. Ullman said adding that there might be something more that remains to be seen. "The problem is that FDA's refusal to enforce the law may set the stage for some criminal to introduce a substance masquerading as a dietary supplement onto the market which hurts somebody. In that event, all bets are off. DSHEA will be blamed, and there will be a strong push to change the law. A cynic would suggest that this is FDA's real agenda for supplements."