Tighter regulations on the sale of dietary supplements proposed by the New York City Council's Committee on Consumer Affairs could prove extremely difficult to enforce, the city's Department of Health told the committee at a Feb. 10 hearing.

The session addressed Introductory Bill 583, which would require retailers to post warning signs discussing the possible risks associated with some dietary supplements and advising consumers to speak with a health care professional before taking any supplement product.

The bill also would ban the sale of ephedrine- or ephedra-containing products marketed as street drug knock-offs and prohibit selling the botanical ingredient to minors in New York City (¹ Also see "New York City Pondering Tighter Dietary Supplement Regulation" - Pink Sheet, 20 December, 1999.).

While the health department "agrees with the intent" behind requiring specific and general warning signage in retail establishments, the regulation would be "exceedingly difficult for the department" to enforce, Deputy Commissioner Benjamin Mojica, MD, stated.

The proposed requirement for signage warning of possible dangers associated with specific supplements would apply to those singled out as potentially dangerous by FDA. However, "there is simply no definitive, comprehensive listing of official, FDA-sanctioned warnings on dietary supplements, much as we would like it to be otherwise," Mojica pointed out.

Thus, the health department "would have to dedicate staff to conduct contacts with FDA scientists and regulatory officials and research literature on a regular basis, as well as make scientific assessments," he said.

"The department does not possess the in-house scientific expertise required to conduct research and assess findings so as to first make a determination whether a given subject meets the criterion of being the subject of an FDA warning, and then determine precisely what information should be posted regarding a given substance, as would be required by Intro. 583," the deputy commissioner stated.

Regarding the general warning signage, the department believes the clause is "warranted," but may be "overly broad," Mojica continued. Because dietary supplements are so widely sold, the requirement might mean "that not only every health food store and herb shop, but also every supermarket, most grocery stores, perhaps many mom and pop stores and bodegas and even some newsstands, would have to carry this warning," he maintained.

The signage might become "so ubiquitous as to be largely disregarded by the vast majority of consumers, while unnecessarily imposing a significant compliance burden on a large class of business owners and operators," Mojica cautioned.

The DoH views the bill's intended restrictions on ephedrine as "reasonable and appropriate measures that will reduce risks," the deputy commissioner said.

However, "with regard to enforcement, the majority of violations involving either sale of ephedrine to minors or prohibited claims for the products would occur in establishments that are not regularly subject to the health department's inspectional, administrative or adjudicatory activities," he noted.

Mojica stressed that the health department's reservations about the proposal as written reflect concerns with the bill's practicality rather than doubts about the importance of its objectives.

"Our poison control center received at least 15 calls involving ephedrine in 1999," he reported, adding the department has reason to believe there are "many more adverse incidents involving ephedrine that the center is not informed about."

Also testifying at the hearing, Council for Responsible Nutrition President and CEO John Cordaro argued the bill does not "provide any new consumer protection and most likely will scare people away from using supplements that significantly enhance their health and well-being."

Rather than enacting requirements for retailers, "the more appropriate approach is to place the responsibility on the manufacturer to provide the consumer with accurate, timely, useful and science-based information on which to base marketplace decisions," Cordaro insisted. This can be accomplished through labeling, pamphlets and other means of education, he said.

Speaking on behalf of the American Herbal Products Association, attorney Marc Ullman (Ullman, Shapiro & Ullman, New York City) echoed that the onus for marketing safe, well-labeled products should be placed on the manufacturer rather than the retailer.

"It is misguided to disparage an entire class of consumer goods, as the signage requirement...surely would, due to the concerns the city may have about specific products within this category," he added.

Addressing Resolution 912, also under consideration at the hearing, Cordaro asserted that dietary supplements "are extensively regulated by both state and federal laws and regulations."

The resolution would express the council's belief that FDA does not have adequate regulatory authority over supplements. Cordaro's remarks on the resolution and bill echoed written comments submitted to the committee by the trade group in December (² Also see "CRN Ephedra Study Could Help NYC Council Take "Balanced" Approach" - Pink Sheet, 3 January, 2000.). CRN has about 15 member companies in the New York metropolitan area.

Responding to Cordaro's testimony, Councilman Howard Lasher suggested that by opposing the bill, the dietary supplement industry is shirking its duty.

"Young people are taking [ephedrine], and young people are getting hurt by it, and there is no place for it in our society," Lasher asserted. "You're the ones who are putting it in their hands. You can't walk away from your responsibility."

Councilwoman Karen Koslowitz, who chairs the consumer affairs committee, suggested placing too much faith in labeling could be dangerous, as it may be ignored by teenagers or skipped over by seniors with bad vision. "Even I can't read this label," she said, holding up the packaging for an ephedra-containing product.

Other industry groups testifying against the bill and resolution included the Consumer Healthcare Products Association and the National Nutritional Foods Association. A number of health care professionals, educators and family members who had suffered losses due to ephedrine-related illnesses or fatalities expressed their support for the proposed measures.

NYC Proposed Supplement Restrictions May Be Unenforceable - Health Dept.

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