New York Assemblyman Brian Kavanagh has introduced a bill that would require certain information on dietary supplement labels and require a disclosure that such products have not been preapproved by the federal government for effectiveness or safety.
Under Assembly Bill 7607, a dietary supplement in package form must bear a label containing the name and address of the manufacturer, the distributor and the packer—the facility that physically packaged the supplement, if there is one.
Furthermore, the supplement labels would need to include the national toll-free telephone number of the American Association of Poison Control Centers and further disclose, "Dietary supplements are not approved by the U.S. government for safety and effectiveness before they are marketed."
Assembly Bill 7607 was introduced May 3 at the request of the state health department and referred to the Committee on Consumer Affairs and Protection. The legislation states it is intended to facilitate investigations by New York agencies “into reports of illness caused by contaminated dietary supplements."
“Dietary supplements may provide health benefits to many people," the bill acknowledged. “However, instances of contaminated dietary supplements have in some cases caused serious injury to persons residing in New York, including permanent injuries to children. The accuracy and integrity of the ingredients of dietary supplements is a vital public health interest."
Mike Greene, senior vice president of government relations with the Council for Responsible Nutrition (CRN), who brought the bill to INSIDER’s attention, said his organization planned to visit the state legislature possibly next week to determine the motive behind the legislation.
“The bill is duplicative of current law," he said in a phone interview, “and we don’t see any rationale for giving New York greater authority over any of the other states or the federal government with regard to dietary supplements."
Greene called the legislation one of “great concern" for the supplement industry.
Representatives for Kavanagh and the state health department did not respond Thursday to requests for comment.
The labeling requirements raise questions as to whether they improperly occupy the authority of FDA and are preempted by federal law. The legislation would grant the commissioner of the state health department authority to petition U.S. government agencies like FDA for an exemption from provisions of federal law that would otherwise preempt the requirements in the bill.
Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), was struck by the provision above. The doctrine of preemption, he said, “has been upheld by the highest court in the land," namely the U.S. Supreme Court.
An FDA spokesperson said the agency had taken no position on the state bill.
Some industry sources argued the labeling provisions in the bill were unnecessary—considering federal labeling regulations and requirements under an adverse event reporting law.
Under federal regulations, a food label in packaged form must specify the name and place of business of the manufacturer, packer or distributor. Attorney Justin Prochnow, a shareholder in Denver with Greenberg Traurig LLP, observed Assembly Bill 7607 would require contact information for all three establishments on the label.
“I think that’s confusing and I don’t know what that will accomplish," said New York attorney Steven Shapiro, who noted such a requirement in state law could be preempted.
He also pointed out a federal law—the Dietary Supplement and Nonprescription Drug Consumer Protection Act—already requires that a supplement label include contact information for someone to report an adverse event.
Under the law, the label must include a domestic address or domestic phone number through which a “responsible person" may receive a report of a serious adverse event, such as an inpatient hospitalization. The responsible person is defined as the distributor, manufacturer or packer whose name appears on the dietary supplement label.
But Chuck Bell, programs director for Consumers Union, the nonprofit publisher of Consumer Reports magazine, said it was important that state public health officials have the ability to contact the manufacturer of the supplement in the event of a problem.
While a distributor may be liable for a product, “it doesn’t help in a public health emergency if you can’t … talk to the actual party that manufactured the product and put whatever the ingredients are in there that now are implicated in a … medical incident like that," Bell said.
The New York health department “needs that information," he added in a phone interview, “and we appreciate Senator Kavanagh’s efforts to require that."
Fabricant: Disclaimer ‘Never Going to See the Light of Day’
Fabricant expressed concern with the required disclaimer in the state bill—that “dietary supplements are not approved by the U.S. government for safety and effectiveness before they are marketed"—and how it would influence consumers’ perception of dietary supplements. Nonetheless, he is confident the disclaimer would not withstand judicial scrutiny due to protections offered commercial speech under the First Amendment, even if the bill was passed by the state legislature.
“It’s never going to see the light of day," declared Fabricant, former director of FDA’s Division of Dietary Supplement Programs, in a phone interview. “The thing’s dead on arrival."
Shapiro, who advises companies in the dietary supplement industry, also found the disclaimer disconcerting.
“A statement like this could indicate to people that dietary supplements are not required to be safe, which is not true," said the attorney, who is of counsel to Rivkin Radler LLP. “I would be concerned that people would not understand the statements.
“The law requires that all food products—including dietary supplements—be safe … and there’s a specific safety standard for dietary supplements," he added in a phone interview.
Moreover, as industry lawyers observed, dietary supplements making statements of nutritional support, or so-called structure/function claims, must disclose the statements haven’t been evaluated by FDA. Under federal law, the statements also must bear the disclaimer, “This product is not intended to diagnose, treat, cure, or prevent any disease."
Pieter Cohen, M.D., whose research over the years has helped spur FDA to take enforcement actions to remove illegal ingredients from supplements, viewed the legislation differently than some industry executives.
“Two important problems need to be addressed: Consumers are often under the misconception that supplements have been vetted by the FDA, and there exists no effective system to detect the most dangerous supplements," said Cohen, a physician in Somerville, Massachusetts and assistant professor of medicine at Harvard Medical School. “I strongly support thoughtful legislative initiatives that address these serious problems," he added in an email.
Cohen cited his own research published in The New England Journal of Medicine, which questioned the effectiveness of FDA’s post-market surveillance system to detect potentially harmful supplements.
Fabricant, however, claimed the requirement in Assembly Bill 7607 that labels include contact information for the American Association of Poison Control Centers (AAPCC) would not be helpful to his former employer, FDA.
In a 2013 report examining adverse event reports received by FDA related to dietary supplements, the Government Accountability Office (GAO) disclosed poison control centers generally don’t report health problems (involving supplements and managed as poison exposure cases) to FDA’s Center for Food Safety and Applied Nutrition.
“They never share their data with FDA," asserted Fabricant, who explained he requested data from poison control centers when he oversaw FDA’s dietary supplement division. “We had to work with certain people on [Capitol Hill] to get them to share it, to give us access to data, and they still wanted to sell it to us."
The AAPCC did not immediately respond Friday to a request for comment. But AAPCC representatives told the GAO in its 2013 report that “poison centers have shared information with FDA and other public health agencies, such as the Centers for Disease Control and Prevention, when they detect potential signals of an outbreak, such as a foodborne illness, based on a pattern of calls to their centers."
Cohen indicated the requirement in New York’s legislation that supplement labels include the poison control’s number could be helpful to consumers who fall ill after consuming a product.
“If a consumer were to become sick after taking a supplement and wonders if they should go to the emergency room, or a consumer's child just swallowed a dozen multivitamins, that is the correct number to call," the physician explained.
He nonetheless acknowledged the gap in communication between FDA and the poison control centers.
“The challenge is that the poison centers don't communicate with the FDA, so that would still leave the FDA in the dark as to which supplements were causing serious adverse events," he said. “But if the poison centers were to have all that information, I would suspect that there would then be the political will to ensure that the poison centers and FDA were communicating effectively. Therefore, I think this is a good first step in the right direction."
Amid the debate over the bill, the dietary supplement industry plans to keep close track of the legislation.
“Does this bill have legs?" CRN’s Greene asked in describing questions his trade organization examines when state legislation is introduced. “Is it going to get picked up by a senator? Is it going to move into committee quickly? And those are the things we have to deal with because everything moves quickly in the states."