‘Resources are going to be needed’: The fight against state-led restrictions on supplements
“How is this not the biggest issue in sports nutrition right now?” asked Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA). “These are extinction level events for the sports nutrition category.”
The issue centers on efforts at the state level to restrict the sale of muscle building and/or weight management supplements to people under the age of 18, with proponents of the restrictions citing a purported link between the use of such products and the worsening of eating disorders.
The text of the bills in different states are not identical, but there are distinctive similarities, with the legislative efforts linked to special interest groups, principally the Strategic Training Initiative for the Prevention of Eating Disorders (STRIPED), launched as a “public health incubator” based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital.
“STRIPED is the origin of all of this legislation, but there are significant differences between the states,” explained Robert Marriott, director of regulatory affairs for the American Herbal Products Association (AHPA).
“Some of these differences are between versions of the model legislation that STRIPED distributes year over year: the costly requirement for age verification at the point of ‘delivery sale’, for example, is a recent addition and some states are still using an older version of the bill. Other differences (like the presence or absence of an exemption for protein products) are a matter of state negotiation.
“These inconsistencies of scope and burden reflect the fundamental problem of state-by-state restriction of a category of dietary supplements,” he added.
No scientific evidence to support a link
Industry groups have repeatedly stated that there is no scientific evidence linking dietary supplements to eating disorders. The Council for Responsible Nutrition commissioned a scientific review by Susan Hewlings, RD, PhD, and published in the scientific journal Nutrients in April, 2023 entitled “Eating Disorders and Dietary Supplements: A Review of the Science”, which concluded that such links are not “not supported by the scientific literature”.
People suffering from eating disorders might be using dietary supplements, but there is nothing to indicate causality, advocates say.
“If a dietary ingredient is tied to an eating disorder, where’s the paper trail?” asked Dr. Fabricant. “Where are the AERs [adverse event reports]?”
New York
One bill has already made it into law: New York Governor Kathy Hochul put her signature to it at the end of October 2023 after vetoing a similar bill in December 2022. The legislation is expected to go into effect in April 2024.
The New York bill defines dietary supplements for weight loss or muscle building as products labeled, marketed or otherwise represented for the purpose of achieving weight loss of muscle building, but not including protein powders, protein drinks and foods marketed as containing protein unless those products contain an ingredient other than protein which would, considered alone, constitute a dietary supplement for weight loss of muscle building.
Examples of those ingredients include creatine, green tea extract, raspberry ketones, Garcinia cambogia, and green coffee bean extract, according to the text of the bill.
“The New York bill leaves it to the Attorney General to determine what products are covered only through enforcement and does so in consultation with an overbroad set of factors,” explained AHPA’s Marriott.
“Additionally, the New York law applies an additional requirement that online supplement sellers must not only verify age at the point of sale but undergo the cost of verifying the age of the recipient at the point of delivery.”
The other states and counting
Similar bills are making their way through committees and legislative chambers in a number of other states, most notably California, New Jersey, Maryland and Massachusetts.
In California, AB 82 recently advanced through the state’s Assembly Health, Justice and Appropriations Committees, passing through each without modification. “The bill must pass the Assembly by the end of the month,” explained AHPA’s Marriott.
The new bill contains the same language as one that was vetoed by California Governor Gavin Newsom in September 2022 and again puts the onus on the State Department of Public Health to determine which dietary supplements for weight loss and over-the-counter diet pills will be subject to these restrictions.
“Governor Newsom called for the CDPH to form a workgroup that recommended actions to fulfill 1341’s goals without overburdening the agency,” Marriott said. “Their findings have not yet been publicized, and the California bill hasn’t been modified to reflect those findings (if, indeed, it will be modified). This means the State Assembly is effectively passing the bill without knowing what it will be.”
“This bill is being fast-tracked,” noted Kyle Turk, NPA’s Director of Government Affairs. “I expect it to get to the Governor’s desk.”
In Maryland, legislators had reintroduced SB 47 despite the same proposed restriction dying in the previous legislative session. NPA's Turk told us today that SB 47 has been pulled from the Maryland Senate Finance Committee meeting agenda, and a new bill (HB 739) introduced on January 29, 2024. "This bill will require the Maryland Department of Health to develop a mandatory listing of supplements that will be publicly accessible," said Turk.
In New Jersey, Marriott said that A 1848 has been reintroduced and referred to the Assembly Health Committee; no other action has occurred yet, he told us.
“In Massachusetts, S1465 was introduced last year and is the model legislation STRIPED most recently published. It has had an initial hearing in the Public Health Committee late last year.”
And it doesn’t stop with these states. There are 10 to 15 others that could realistically introduce these kinds of bills in their next legislative sessions, said Turk.
The FDA angle
NPA filed a lawsuit in the U.S. District Court for the Eastern District of New York asserting that the restrictive New York law is unconstitutional.
“Nobody else is stepping up,” Dr. Fabricant said. “Kudos to our Board on this—they saw the value in this and supported the lawsuit.”
Central to NPA’s legal argument is that the Federal Food, Drug, and Cosmetic Act (FFDCA) preempts enforcement of New York’s law. The association’s lawsuit also states that the new law, “in combination with other provisions in New York’s General Business Law, improperly allows for private causes of action, which are exclusively in the purview of the FDA”.
Dr. Fabricant said he has communicated with the FDA on this, but the Agency has not made any public statements about New York’s law. “Why are they silent on this?” he asked.
While careful to not talk about ongoing litigation, he said NPA expects New York State to file a motion to dismiss the association’s lawsuit.
“That then opens up a number of doorways. We’ll respond to their response,” he said. “Even if New York goes our way, there’s the possibility we may have to sue other States.”
The rise of GLP-1 agonists
These efforts are playing out against a backdrop of booming interest in GLP-1 agonist drugs, a class of pharmaceuticals with weight loss activity that some analysts predict could be worth $150 billion annually within 10 years (for perspective, the entire dietary supplements category is currently estimated to be around $60 billion a year).
The market is dominated by Novo Nordisk (Wegovy and Ozempic) and Eli Lilly (Mounjaro and Zepbound), and interest groups such as the American Medical Association have led efforts to expand insurance coverage for “evidence-based treatment of obesity, including FDA-approved medications without exclusions or additional carve-outs”.
Fighting the good fight
Dr. Fabricant said he is under no illusion about the threat posed by these bills and other special interest groups and called for all brands involved in sports nutrition and weight management to come to the table and join the fight.
“So many brands don’t belong to a trade association, any trade association, so what are they actually doing?” he asked. “Stop working on your social media profile and join the fight. We need help.”
