New York Governor Kathy Hochul signed the legislation into law at the end of October after vetoing a similar bill last year. Legislation A.5610/S.5823 is expect to go into effect in April 2024.
The law restricts the sale of weight loss and sports nutrition dietary supplements to New York consumers under the age of 18. It 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 ketone, Garcinia cambogia, and green coffee bean extract, according to the text of the bill.
“This is a category killer,” Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), told NutraIngredients-USA. “These bills are based on hysteria. There’s no scientific fact behind them. When you look at creatine, it’s one of the most studied ingredients on the planet.”
“Kudos to our board and council for their work on this [lawsuit],” he said. “Hopefully this gives other states pause on their efforts.”
Similar bills are also at various stages in Massachusetts, New Jersey, and California. Kyle Turk, NPA’s Director of Government Affairs, said there are 10 to 15 states that could realistically introduce these kinds of bills in their next legislative sessions.
While NPA has yet to conduct an assessment of the potential economic impact of these bills, Turk noted: “The three largest economies for our industry are New York, New Jersey, and California.”
Pre-emption of the FDCA
NPA has now filed a complaint, which calls for the law to be declared unconstitutional because of the following violations:
- The Federal Food, Drug, and Cosmetic Act (FFDCA) preempts enforcement of the Act.
- The Act’s definitions conflict with the definitions found in the FFDCA.
- The Act, 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.
- The provisions of the Act that conflict with the FFDCA or are left undefined will inevitably lead to improper, arbitrary, and capricious application of the law.
According to the complaint, NPA is seeking the following relief:
- Declare that the Act either is unconstitutional or is preempted by the Food Drug and Cosmetic Act.
- Declare the Act is unconstitutional because it discriminates against interstate commerce.
- An injunctive order restraining the Attorney General’s Office from enforcing the Act.
“Governor Hochul’s decision to flip-flop and cave to anti-supplement charlatans is evidence she cares more about politics than New Yorkers ability to stay healthy,” said Dr Fabricant.
“Not only is this unconstitutional, but this prohibition is a bad policy threatening the ability of nearly 80% of Americans to access wellness products they’ve relied on for their health routines. It also violates the U.S. Constitution because it hands the state’s executive branch unfettered discretion to restrict access to dietary supplements and relies on an absurd enforcement mechanism to enforce compliance. We believe the court will recognize the serious concerns raised and declare it unconstitutional.”
Natural Products Association vs Letitia James, in her official capacity as New York Attorney General, can be read HERE.