12.05.23
The Natural Products Association (NPA) filed a complaint in the U.S. District Court for the Eastern District of New York, which asserts that the recently-passed New York law which places an age restriction on certain dietary supplements is unconstitutional.
With several other similar age-restriction bills on the docket in many other states, New York became the first state to enact a bill which would prohibit dietary supplements marketed for weight loss or muscle building purposes from being sold to anyone under the age of 18. Governor Kathy Hochul signed the bill into law at the end of October, and it’s slated to go into effect in April 2024.
The law bans both in-person and internet/mail order sales of dietary supplements and other “diet pills” to consumers under 18, and requires age verification as a means of enforcement.
The bill, now signed into law, only named a small handful of ingredients, and banned products were mostly defined based on the nature of how they’re marketed. While protein was explicitly exempted, in products that otherwise aren’t in violation, the bill directly named creatine, green tea extract, raspberry ketone, garcinia cambogia, and green coffee bean extract as ingredients subject to age restriction.
Failure to comply with the law results in fines for each infraction.
“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 Daniel Fabricant, PhD, president and CEO of NPA. “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.”
In sum, the Federal Food, Drug, and Cosmetic Act (FFDCA) “includes an express preemption provision which precludes states from imposing, directly or indirectly, any requirement as to the labeling of dietary supplements,” the suit says. The New York law’s definitions of dietary supplements also differ from the definitions found within FFDCA.
The suit also claims that the Act, in combination with other provisions in New York’s General Business Law, improperly allows for private causes of action (in which a plaintiff can bring an action based on a public statute, the Constitution, or federal law), in matters which are exclusively under the purview of the U.S. Food and Drug Administration (FDA).
Further, provisions of the act which are in violation of the FFDCA or are otherwise undefined will inevitably lead to improper, arbitrary, and capricious application of the law, NPA said. The suit notes that the terms “muscle building” and “weight loss” aren’t defined, nor does the New York law explain how these terms relate to dietary supplements in a way that allows retailers, consumers, and others to make sense of the law.
The suit also notes that the New York legislature hasn’t established a correlation or basis for causation between the likelihood of developing an eating disorder as a result of using weight loss products.
With several other similar age-restriction bills on the docket in many other states, New York became the first state to enact a bill which would prohibit dietary supplements marketed for weight loss or muscle building purposes from being sold to anyone under the age of 18. Governor Kathy Hochul signed the bill into law at the end of October, and it’s slated to go into effect in April 2024.
The law bans both in-person and internet/mail order sales of dietary supplements and other “diet pills” to consumers under 18, and requires age verification as a means of enforcement.
The bill, now signed into law, only named a small handful of ingredients, and banned products were mostly defined based on the nature of how they’re marketed. While protein was explicitly exempted, in products that otherwise aren’t in violation, the bill directly named creatine, green tea extract, raspberry ketone, garcinia cambogia, and green coffee bean extract as ingredients subject to age restriction.
Failure to comply with the law results in fines for each infraction.
“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 Daniel Fabricant, PhD, president and CEO of NPA. “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.”
Complaint Details
The complaint asserts that the New York age restriction law is unconstitutional on multiple grounds.In sum, the Federal Food, Drug, and Cosmetic Act (FFDCA) “includes an express preemption provision which precludes states from imposing, directly or indirectly, any requirement as to the labeling of dietary supplements,” the suit says. The New York law’s definitions of dietary supplements also differ from the definitions found within FFDCA.
The suit also claims that the Act, in combination with other provisions in New York’s General Business Law, improperly allows for private causes of action (in which a plaintiff can bring an action based on a public statute, the Constitution, or federal law), in matters which are exclusively under the purview of the U.S. Food and Drug Administration (FDA).
Further, provisions of the act which are in violation of the FFDCA or are otherwise undefined will inevitably lead to improper, arbitrary, and capricious application of the law, NPA said. The suit notes that the terms “muscle building” and “weight loss” aren’t defined, nor does the New York law explain how these terms relate to dietary supplements in a way that allows retailers, consumers, and others to make sense of the law.
The suit also notes that the New York legislature hasn’t established a correlation or basis for causation between the likelihood of developing an eating disorder as a result of using weight loss products.
Relief Sought
The complaint seeks that the court:- Declares that the New York law is either unconstitutional or is preempted by the FFDCA;
- declares that the act is unconstitutional because it discriminates against interstate commerce;
- Issues an injunctive order restraining the Attorney General’s Office from enforcing the law.
