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Aug 19, 2023

N.Y. becomes 2nd state to veto bill restricting supplements to minors

Josh Long | Jan 03, 2023 New York Gov. Kathy Hochul recently vetoed a bill that

Josh Long | Jan 03, 2023

New York Gov. Kathy Hochul recently vetoed a bill that would prohibit the sale of over-the-counter diet pills or supplements for weight loss or muscle building to minors without a prescription from a health care provider.

While she expressed interest in addressing the marketing of such products to minors, Hochul said in a Dec. 23 memo that the agency tasked with determining what products are subject to the bill—the state health department—lacked "the expertise necessary to analyze ingredients used in countless products, a role that is traditionally played by the FDA."

Related: In N.Y. and N.J., minors may soon be unable to buy weight loss, muscle building supplements

"Without sufficient expertise, DOH is not equipped to create a list of restricted products," the governor wrote. "It would also be unfair to expect retailers to determine which products they can and cannot sell over the counter to minors, particularly while facing the threat of civil penalties."

However, Hochul noted she is concerned about the products targeted in the legislation she vetoed.

"I share the concerns of the sponsors of this bill, and desire to address the marketing of these diet pills and dietary supplements to minors," she wrote in her veto memo.

FDA, Hochul said, "does not have oversight over the safety and efficacy of these products, and concerns have been raised about dangerous ingredients and the links to eating disorders, particularly in young people."

"Protecting young New Yorkers from harm is a top priority," the governor added.

Hochul is the second governor to veto a bill that would have prohibited the sale of certain dietary supplements to minors without a prescription. Calif. Gov. Gavin Newsom did so in September. He noted AB 1341 would require the California Department of Public Health to assess "every individual weight loss and dietary supplement product for safety, which is beyond the scope of the department's capabilities."

The bills in California and New York reflect growing momentum in the U.S. to restrict access to OTC diet pills and dietary supplements marketed for weight loss and muscle building over concerns from certain organizations that the products are harmful to consumers who suffer from eating disorders.

Brianna Mullins, an employee of FEAST, a nonprofit that supports families affected by eating disorders, said a person with an eating disorder may ignore health risks due to their preoccupation with losing weight.

"Studies show that the brain is not fully mature at 16 but closer to 25," Mullins testified during a Dec. 15 hearing in the New Jersey Legislature before the Senate Health, Human Services and Senior Citizens Committee. The hearing was focused on S2387, which also would restrict minors’ access to OTC diet pills or supplements for muscle building.

"Planning, problem solving, emotion regulation, risk/reward and impulse are all areas that affect decision-making," Mullins testified. "Not being able to make an informed choice as to what is best and healthy for you— especially when the FDA does not regulate supplements and allows these companies to not report dangerous side effects, including death—is unconscionable."

According to dietary supplement industry trade groups, there is no evidence that dietary supplements cause or contribute to eating disorders.

"We are pleased Governor Hochul recognized that the proposal passed by the legislative chambers, while well intentioned, likely would not have much of an impact on the public health problem of increased eating disorders and body dysmorphia among young adults," Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said in a written statement. "It would impose an unfair burden on retailers that would be difficult for them to meet, but had little impact on products sold online, products that more often attract young people with aggressive claims."

Industry trade groups relayed concerns to New York lawmakers, as well as Hochul. For instance, Natural Products Association President and CEO Dan Fabricant wrote a six-page letter to Hochul, urging her to veto S16D/A431.

The legislation "fails to list specific ingredients or products of concern, nor does the sponsor point to any dietary supplements that are the genesis of this legislation during testimony in the assigned committees," Fabricant wrote. "Instead, S-16/A431 tasks the Department of Health to consult with the public to determine which dietary supplements shall be prohibited for sale to consumers under 18 without a prescription."

In his letter, Fabricant laid out the regulatory framework governing dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). He argued New York's legislation is preempted by federal law and is "ambiguous" and "vague" regarding the products it covers. Fabricant also raised additional legal concerns.

CRN expressed concerns as well to lawmakers and Hochul's office, according to Mister.

"Since the introduction of the bills in the New York Assembly and Senate, CRN has engaged with the sponsors and other lawmakers to relay concerns about the legislation as drafted, including the scope of the bill, its lack of online regulation, and absence of any scientific evidence that dietary supplements have any link to eating disorders or body dysmorphia in young adults," Mister said in his written statement. "When the legislation advanced through the legislative branch despite our concerns, we consulted with Governor Hochul's staff to provide scientific information on the safety and existing federal regulation of the affected products, along with information regarding the significant economic contributions that dietary supplement manufacturing and ingredient supply provides to New York. We appreciate that the governor listened to these objections and vetoed the bill."

Kyle Turk, director of government affairs with NPA, said advocates of the bills continue to ignore the fact that there's "zero correlation" between the dietary supplement products targeted in the bills and eating disorders.

"In 2019 and 2022, NPA filed Freedom of Information Act (FOIA) inquiries to the FDA to explore any adverse events for any cases involving eating disorders and weight-management or muscle-building products," Fabricant wrote to Hochul. "Making our point, according to the FDA, no data point connects eating disorders to weight management or muscle-building products."

A representative for an organization fighting eating disorders, STRIPED, countered FDA's MedWatch database "is not designed to capture mental health diagnoses and captures only adverse events that would be treated typically in an emergency department, like tachycardia."

"It would be like saying you looked in the phone book to find out the names of all the planets, but they weren't there so you conclude the planets don't exist," STRIPED Director Bryn Austin said in a 2022 email to Natural Products Insider.

In an interview, Turk maintained FDA has authority to remove dietary supplements from the market if there was a public health crisis linked to them. He referenced an FDA ban of supplements containing ephedrine alkaloids in 2004 and the agency's exercise of mandatory recall authority about a decade later over OxyElite Pro supplements tied to liver injuries in Hawaii.

The recent vetoes in California and New York aren't expected to end the debate over whether certain categories of supplements should be restricted to minors. For instance, Turk said he anticipated a bill in the Golden State targeting OTC diet pills and weight loss supplements—AB 82—would be formally introduced on Thursday when the California Legislature reconvenes.

"Lawmakers who continue to ignore the science and the regulatory authority of the FDA [are] not based in reality and [are] wasting valuable taxpayer resources," Turk said in a follow-up email to Natural Products Insider.

He described advocates of the bills, especially STRIPED, as "relentless." The Strategic Training Initiative for the Prevention of Eating Disorders is a graduate-level training initiative based at the Harvard T.H. Chan School of Public Health and Boston Children's Hospital.

"Over 1.7 million New Yorkers will have an eating disorder in their lifetime, and eating disorders, which are among the deadliest of any mental health condition, cost the state $3.9 billion each year," said Austin, professor of social and behavioral sciences at the Harvard T.H. Chan School of Public Health and professor of pediatrics at Harvard Medical School. "Yet with this veto, Gov. Hochul turned an indifferent eye on the mental health struggles of New York's children, allowing them to continue to be exploited by vendors who want to make a buck off the serious mental health vulnerabilities of children."

Austin provided an emailed statement after this article was first published.

"Putting in place basic protections for children is just commonsense, and it is what we do as a society every day," she added. "Given what we know about the continued reckless adulteration with some of these products, I implore all of us–including lawmakers, parents and retailers too–think of the children, your own children, and ask, What is our responsibility to keep them safe?"

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