Governor Kathy Hochul (D-NY) signed A.5610/S.5823 into law last Oct. 2022 with the law set to begin in April. In response, CRN plans to move quickly with seeking a preliminary injunction first followed by a permanent injunction.
The law will prohibit a broad group of dietary supplements under the claim these products will contribute towards eating disorders among minors, which CRN alleges is “not based on truth.”
Mister emphasized CRN research that determines there is no evidence that dietary supplements cause eating disorders.
“Anyone who understands the brutal complexity of those conditions knows the solution, unfortunately, is just not that simple,” Mister said.
He continued, “This law does not provide an answer, it merely offers a scapegoat: the supplement industry.”
CRN alleges that the law is in violation of free speech and due process rights, adversely impacting both the rights of businesses and individuals.
Given the lack of clarity around the law, Mister explained that STRIPED’s database, the Dietary Supplement Label Explorer, which identifies eligible products for age restriction, will only create more confusion. (STRIPED is the Strategic Training Initiative for the Prevention of Eating Disorders, a “public health incubator” based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital.)
The database, Mister said, “covers a really broad collection of products that make no claims for weight loss or muscle building,” and includes ingredients like magnesium and calcium for bone health or green tea extract for energy, adding to the confusion for consumers and businesses.
CRN also alleges that that the law’s ambiguous language “fails to provide a clear demarcation for what is restricted or even a rational basis for the broad net that it would cast,” risking the removal of otherwise legitimate products from self service shelves and placed either in locked cases, behind the counter or removed from the retailer entirely.
For manufacturers, retailers and distributors, Mister explained that the law’s vagueness will not only prevent compliance for those who wish to participate but will violate the free speech clause of the first amendment around legitimate advertisement, preventing consumers access to safe supplements.
“The law unavoidably chills legitimate and truthful commercial speech, denying marketers from making these claims and consumers from receiving this truthful information. Restrictions on free speech must address a clear harm and be narrowly tailored to only illegitimate speech. This law does neither,” he stated.
Additionally, the law’s vagueness and subjectivity violate due process under the 14th amendment which Mister explained fails to provide adequate clarification around which products require compliance.
CRN also alleges that the law’s age restriction is in violation of the Supremacy Clause of the US Constitution, which creates “burdens on lawful and truthful claims that are clearly permitted as structure-function claims under the Federal Food, Drug and Cosmetic Act. This improperly infringes on federal authority and is preempted by federal law,” said Mister.
In addition to opposing New York’s law, CRN has been involved in lobbying against similar laws in Massachusetts, Maryland and California for “five or six years now,” he said, highlighting the association’s efforts to provide educational insight to lawmakers.
The lawsuit, Mister hopes, will “send a very strong message that these bills are on flimsy ground,” to other states that may have other age restrictive bills.
NPA efforts
The CRN lawsuit follows an earlier legal attempt by the Natural Products Association (NPA), which filed suit in December. NPA's lawsuit argues that the Federal Food, Drug, and Cosmetic Act (FDCA) 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”.
As reported by NutraIngredients-USA, the NY AG's office requested a pre-motion conference last month regarding an anticipated filing of a motion to dismiss NPA's complaint.
