Industry stakeholders remain worried over states' bills to restrict access to supplements

A health committee in the Rhode Island state Senate has recommended to hold for further study a bill that industry stakeholders groused would impose sweeping and unwarranted restrictions on the sale of dietary supplements at brick-and-mortar retailers.

Lawmakers who have sponsored the bills have expressed concerns that supplements marketed for weight loss and muscle building, for example, could harm young people, including those suffering from, or susceptible to developing, eating disorders.

“Limiting access to dietary supplements can help deter abuse that could lead to serious health consequences,” Rhode Island state Senate Majority Leader Michael J. McCaffrey, one of the sponsors of the bill (RI SB2613), said in an email to Natural Products Insider. “These steps are particularly important for adolescents and people with eating disorders, who more than ever before are bombarded with images of unrealistic body standards.”

The March 24 recommendation by the state Senate Health and Human Services Committee to hold the bill for further study means it will not be presented to the full Senate at this time, said Greg Pare, a spokesman for the Rhode Island state Senate.

“It may be scheduled for further action at some point in the future, but at this time it is undetermined if and when there will be further action,” he added.

The Natural Products Association (NPA), whose members include brick-and-mortar retailers, considers SB 2613 an especially onerous piece of legislation, even when compared to similar bills that NPA has vociferously opposed in other states, including California and New York.

Dan Fabricant, president and CEO of NPA, urged industry members to join the grassroots effort to oppose bills he described as “death by a thousand cuts.”

“With this Rhode Island bill, we hope that’s starting to have a sobering effect on folks,” he said in an interview. “This is a do or die time for retail in a lot of ways.”

The Rhode Island bill would make it a misdemeanor to sell to minors any dietary supplement containing an ephedrine group alkaloid or any of the following ingredients: androstanediol, androstanedione, androstenedione, noradrostenediol, norandrostenedione and dehydroepiandrosterone.

Ephedrine has been off the market for many years, Fabricant noted. In a final published rule in 2004, FDA prohibited the sale of dietary supplements containing ephedrine alkaloids.

“What are you going to do,  dig it up, shoot it … and bury it again?” Fabricant asked, commenting on ephedrine alkaloids.

Unlike bills in other states that target specific categories of supplements—such as products marketed for weight loss and muscle building—RI SB 2613 would require all supplements essentially be placed behind the counter to prevent their abuse or misuse. Violators subject to the bill’s requirements would face a fine as high as $2,000.

Julia Gustafson, vice president of government relations with the Council for Responsible Nutrition (CRN), said the latest development in Rhode Island may give her trade association a chance to work with the bill’s “sponsors to express our concerns and offer language that works for all parties,” yet “we remain very concerned this time also allows the bill’s supporters to layer on more restrictions.”

“Unfortunately, the language is very broad and, if left as is, will create many unintended consequences like having all supplements stored behind counters,” she said in an email. “We support the safe use of supplements but believe restricting access behind counters is not necessary. Alcohol, for example, which can have for greater opportunity for abuse, does not have its access restricted by being behind counters.”

Fabricant questioned how the bill would address e-commerce sales, and he described its provisions as “Soviet supplement time” and “Nanny State scare tactics.”

Among its requirements: Retailers must post a notice at their counters conveying “certain over-the-counter diet pills, or dietary supplements are known to cause gastrointestinal impairment, tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death.”

Massachusetts, Missouri and New Jersey

Retailers would need to post the same notice under a bill introduced by Massachusetts State Rep. Kay Khan. The bill she introduced in December, H2331, would prohibit the sale to minors of supplements for weight loss or muscle building and assess a fine of up to $2,000 for violators. It would be up to the public health department, in consultation with FDA and other stakeholders, to determine which products are subject to the restrictions.

Under state Senate Bill 922 in Missouri, retail establishments would also face a fine of up to $2,000 for violating a similar restriction against the sale to minors of OTC diet pills or supplements for weight loss or muscle building. A bill sponsored in March in the New Jersey Legislature by Assemblyman Herb Conaway Jr. would impose a civil penalty of up to $750 for selling to a minor an OTC diet pill or dietary supplement for muscle building.

The New Jersey bill includes an exception to the above prohibition for when a licensed healthcare professional prescribes an OTC diet pill or supplement for muscle building.

Several lawmakers who supported the bills in Massachusetts, Missouri and New Jersey did not immediately respond to requests for comment for this story.

California and New York

In January, the California State Assembly passed a bill that would bar retail establishments from selling dietary supplements marketed for weight loss or OTC diet pills to anyone under the age of 18 without a prescription. The bill is scheduled to be heard in June in the state Senate, a legislative staff member told Natural Products Insider after the assembly vote.

New York has gotten the closest to imposing restrictions on the sale of dietary supplements. A bill (S16D) that would restrict the sale to minors of OTC diet pills and dietary supplements for weight loss or muscle building has passed both chambers of the state legislature and is awaiting delivery to Gov. Kathy Hochul.

“Our teens are heavily influenced by social media and are seeking ways to achieve unrealistic standards of beauty, including taking poorly regulated weight loss and muscle building supplements that can have serious health consequences, ranging from exacerbation of eating disorders to liver damage, to deadly heart attacks,” state Senator Shelley Mayer said in an emailed statement.

The Strategic Training Initiative for the Prevention of Eating Disorders (STRIPED), a graduate-level training initiative based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital, has supported legislation in New York and other states restricting access to supplements.

“Parents, clinicians and responsible members of the business community are working double time to address the crisis in teen mental health caused by the pandemic, with the Centers for Disease Control and Prevention reporting last month that emergency department visits for eating disorders in teen girls have doubled since the start of the pandemic,” Bryn Austin, director of STRIPED, said in a statement. “But companies that sell poorly regulated and potentially unsafe weight-loss supplements are just trying to cash in.”

Austin is professor of Social and Behavioral Sciences at Harvard T.H. Chan School of Public Health, professor of Pediatrics at Harvard Medical School and research scientist in the Division of Adolescent and Young Adult Medicine at Boston Children’s Hospital.

“Don’t our children deserve better?” the Massachusetts-based professor asked. “Sen. Mayer and lawmakers in New York have made it clear they are willing to fight for what’s right for children.”

Industry critics of the state bills argue they will not protect kids and will drive more of their purchases online, where potentially dangerous products marketed as dietary supplements are typically more accessible than at brick-and-mortar shops. They’re also worried about a patchwork of state laws regulating supplement sales to minors.

“If states believe this is needed legislation, we’d prefer to see one bill that addresses the concerns of responsible industry crafted with the same language being introduced and ultimately passed across the country,” CRN’s Gustafson said. “We want to work with sponsors, but we see a theme coming from an aggressive activist group that is not looking at the science of responsible products. Instead, they want a ‘one size fits all’ solution to a problem they have diagnosed.”

Research on eating disorders

STRIPED cites research showing a prospective link between youths starting to use over-the-counter diet pills and later diagnosis with an eating disorder. One of the research papers—published last year in the International Journal of Eating Disorders— measured the use of diet pills and laxatives and subsequent eating disorder diagnosis within five years.

“In this community-based sample of females, weight control product use predicted first-time ED [eating disorder] diagnosis within the next five years, with associations observed for both diet pill and laxative use, though the association for laxative use was only statistically significant when adjusting for covariates,” researchers wrote.

A previous study of young women, published in January 2020 in the American Journal of Public Health, also found a prospective link between use of weight control products and first-time diagnosis of eating disorders. The analysis included participants who provided data on past-year use of diet pills and laxatives and eating disorder diagnosis from 2001 to 2016.

“Among 7,564 responses included in diet pill analyses, 1.8% of these reporting diet pill use in the past year, compared with 1.0% of those not reporting diet pill use in the past year, subsequently reported a first eating disorder diagnosis from a health care provider in the next wave of data collection,” researchers wrote. “Those who used diet pills had more than five times adjusted odds … of receiving an eating disorder diagnosis from a health care provider within 1 to 3 years than those who did not.”

The studies, however, don’t mean the weight loss products caused the eating disorders, according to CRN President and CEO Steve Mister.

“It means these people have underlying eating disorders and they’re doing lots of things that are not healthy, including binging and purging, compulsive dieting, compulsive exercise and in some cases abusing weight loss supplements,” he said in an interview.

Fabricant described the studies as dated and pointed out the research on eating disorders referenced by advocates of the state legislation also covers a category of products beyond diet supplements: laxatives, marketed as OTC drugs.

Clashing of interests

It remains to be seen whether industry and STRIPED will continue to clash over the state bills or be able to find any common ground.

Asked whether CRN has had conversations with Austin, Mister responded, “STRIPED doesn’t seem to want to have an honest conversation about the facts…They themselves do not have any evidence that these products cause body dysmorphia, but they continue to tell legislators that’s the problem.”

Fabricant added of STRIPED, “They’re not interested in talking to us …. They don’t want to come up with a solution. They want press. They want power.”

On the other hand, Austin said she’s held a few meetings with industry stakeholders and has “never refused a meeting” with them.

“I am happy to talk with them and welcome their ideas on how to more effectively protect the health and safety of children,” she added.