January 27, 2022
The California State Assembly on Thursday passed a bill that would bar retail establishments from selling dietary supplements marketed for weight loss or over-the-counter (OTC) diet pills to anyone under the age of 18 without a prescription.
Under AB 1341, retail establishments would be required to limit access to weight loss products and “conspicuously post” a health-related notice from the state public health department. Retailers that run afoul of the requirements would be subject to a civil penalty of up to $1,000 for each violation.
AB 1341 passed by a vote of 55 to 13, according to lawmakers who sponsored the bill. The bill will be heard in June in the State Senate, according to Ashley Rachelle Labar, chief of staff for Assemblymember Cristina Garcia, a Democrat.
Among the products that could be defined as weight loss supplements: appetite suppressants, adulterated ingredients under U.S. law, hormones, lipotropics and thermogens. The state public health department would ultimately be responsible for determining which products are subject to the bill's restrictions.
‘Serious health risk’
“Weight loss supplements pose a serious health risk, especially to young people,” Assemblymember Cecilia Aguiar-Curry, a Democrat, said in an emailed statement to Natural Products Insider. “They receive constant pressure through the media and social media to ‘look this way.’ This can have devastating results for their health, leading to eating disorders and mental health challenges.”
The bill “guarantees that these supplements are only available under supervision from health professionals,” Aguiar-Curry added. “In a society where there is a constant drum beat that people must be ‘perfect,’ requiring youth to make health decisions with their doctor will help them live a more healthy life.”
In testimony last year in favor of the bill, Jason Nagata, M.D., assistant professor of pediatrics at University of California, San Francisco (UCSF), said research has found many weight loss supplements are tainted with such substances as stimulants, steroids and prescription drugs. “Rigorous” studies, he added, have shown such weight loss products “pose serious health risks to consumers.”
“We need to do more to protect our youth from the harmful effects that weight loss supplements and over-the-counter diet pills have on our youth,” Garcia said in a press release after the vote. “With easy access, our youth are subject to eating disorders and many other health implications. We need to stand up to an industry that puts profit over people.”
Supporters of the bill also have contended a link exists between the use of weight loss supplements and eating disorders.
“Body dissatisfaction is nothing new in our society. But young people are now faced with pressure to have an ‘ideal’ body based on what they see on social media, leading to eating disorders and mental health challenges,” Aguiar-Curry said in the news release issued with Garcia. “Access to dietary supplements has increased while supervision and regulations have decreased.”
The Strategic Training Initiative for the Prevention of Eating Disorders (STRIPED), which has been advocating for the legislation, argues weight loss supplements are insufficiently regulated by FDA and leave young people susceptible to deceptive marketing claims.
STRIPED is a graduate-level training initiative based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital. S. Bryn Austin is director of STRIPED, professor of Social and Behavioral Sciences at Harvard T.H. Chan School of Public Health, professor of Pediatrics at Harvard Medical School and a research scientist in the Division of Adolescent and Young Adult Medicine at Boston Children’s Hospital.
“The CDC estimates that 23,000 Americans are sent to emergency rooms every year due to supplements, with fully a quarter due to the weight-loss category alone,” Austin said in an email to Natural Products Insider. “This legislation offers a commonsense solution to protect our children by prohibiting the sale of supplements sold for weight loss to minors, just as we have done with other risky products like tobacco.”
‘Solution in search of a problem’
Kyle Turk, director of government affairs with the Natural Products Association (NPA), called the legislation “a solution in search of a problem.” In testimony last year, he said “there is no evidence of a linkage between dietary supplements and eating disorders.”
Turk said his organization in 2019 submitted a request to FDA under the Freedom of Information Act (FOIA) to explore whether there were adverse events in cases involving eating disorders and dietary supplements.
“The answer from the FDA is there is no linkage between eating disorders and supplements—period,” he said.
The Council for Responsible Nutrition (CRN) and American Herbal Products Association (AHPA) also have contended there is no credible science that weight loss products cause body dysmorphia or eating disorders, according to an analysis of AB 1341 summarizing arguments for and against it. And by requiring pharmacies to move weight loss products on the floor to behind the counter, the bill will reduce the time devoted to patient care and limit access to supplements crucial to the health and wellness of many Californians, argued the National Association of Chain Drug Stores.
Julia Gustafson, vice president of government relations with CRN, said her organization has expressed concerns about the bill’s text and testified last year during a hearing.
“We truly appreciate the sponsor’s willingness to discuss our concerns and look forward to further dialogue with Assemblymember Garcia as the bill works through the legislative process,” Gustafson said in an emailed statement.
California is not the only U.S. jurisdiction eying restrictions on dietary supplements. Other states, including New York, New Jersey, Missouri and Massachusetts, are considering similar legislation, according to NPA.
NPA CEO and former FDA official Dan Fabricant said the proposal was unnecessary and would not protect public health. His organization has launched a grassroots campaign in opposition to the bill that has produced 4,000 letters and 3,000 calls to elected officials in California, according to an NPA press release reacting to Thursday's vote.
“The federal government has in place vast enforcement powers and a long track record of punishing criminals who break the law,” Fabricant, who directed FDA's Division of Dietary Supplement Programs from 2011 to 2014, said in the release.
Fabricant made his remarks just hours before the U.S. Department of Justice (DOJ) announced the co-founder of a sports supplements brand had been sentenced to prison for selling illegal anabolic steroids and other illegal products marketed as dietary supplements.
“Selling products labelled as dietary supplements that actually contain controlled substances and unapproved drugs is illegal and potentially dangerous,” Acting Assistant Attorney General Brian Boynton of DOJ's Civil Division, said in a press release. “The Department of Justice will work with its law enforcement partners to prosecute dietary supplement makers who ignore the law and disregard public safety for monetary gain.”
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