The office of New York Attorney General Letitia James anticipates filing a motion to dismiss a lawsuit that challenges a law restricting minors’ access to dietary supplements, according to a court document filed Wednesday.

A New York government lawyer requested the Federal District Court schedule a pre-trial conference concerning the anticipated filing of a motion to dismiss the complaint.

The Washington, D.C.-based Natural Products Association (NPA) filed a lawsuit in December challenging the constitutionality of New York Assembly Bill A5610, which prohibits the sale of an OTC diet pill or dietary supplement for weight loss or muscle building to an individual under the age of 18. The legislation is set to take effect in April, or 180 days after it was signed by Gov. Kathy Hochul.

James’ office has authority to seek an injunction for violations of the law, and if a New York court determines a violation has occurred, it can impose a civil penalty of up to $500.

Standing, ripeness

In a three-page letter dated Jan. 31, New York Assistant Attorney General Patricia M. Hingerton previewed the reasons for her anticipated motion to dismiss NPA’s complaint. Among her arguments submitted to the U.S. District Court for the Eastern District of New York, she claimed NPA does not have “standing to sue” and the lawsuit “is not ripe.”

NPA has failed to “sufficiently identify at least one member who has suffered or would suffer harm as a consequence of the Act or any action by AG James,” thereby lacking “associational standing,” according to Hingerton. “Relatedly, plaintiff has not sufficiently alleged an injury that is certainly impending or substantially likely to occur so as to constitute the requisite injury-in-fact.”

NPA’s “‘injury’ is merely a fear of future harm; i.e., the possibility that unidentified members may be subjected to lawsuits and/or fines if they violate the Act in an unspecified way with an undescribed product,” Hingerton wrote.

Additionally, she argued “there is no justiciable controversy ripe for this Court’s review” due to NPA’s “speculative concerns” regarding A5610 “and future harm.”

Her letter was addressed to Federal Judge Joan M. Azrack in Central Islip, New York.

“The NYAG did not raise anything in its pre-conference letter to the court that NPA and its counsel had not already prepared for,” NPA President and CEO Dan Fabricant told Natural Products Insider.

NPA’s allegations

NPA’s 13-page complaint alleged New York’s law is preempted by the Federal Food, Drug and Cosmetic Act (FDCA), which delegates regulation of dietary supplements to the Food and Drug Administration, based on the Supremacy Clause of the U.S. Constitution.

In addition, the lawsuit maintained the FDCA impliedly preempts A5610, declaring, in part, “The Act conflicts with, or inevitably will conflict with, the FDA's responsibility to police the manufacture, sale and distribution of dietary supplements in a way consistent with the judgment and objectives set forth in the FDCA.”

A5610 also allegedly violates the so-called Dormant Commerce Clause, which the lawsuit described as “inherent in the power granted to Congress under the Commerce Clause [of the U.S. Constitution] and provides that, even if federal law is silent on an area of interstate commerce, states may not enact legislation that directly regulates, discriminates against, and/or impermissibly burdens interstate commerce.”

NPA is seeking to have A5610 declared unconstitutional and requested an injunction to prevent enforcement of the law.

New York AG response

The office of the New York AG denies that the FDCA expressly or impliedly preempts A5610 or violates the Dormant Commerce Clause. A U.S. law that preempts a different labeling scheme not identical to a federal requirement — the Nutrition Labeling and Education Act (NLEA) — has no applicability to A5610 because the state law “is a sales regulation,” according to Hingerton’s letter. She also denied that the state law conflicts with the federal definition of a dietary supplement.

Regarding the Dormant Commerce Clause, Hingerton wrote in part, “The Act does not facially discriminate against interstate commerce because the complaint does not identify — as it must — any in-state commercial interest that is favored, directly or indirectly, by the Act at the expense of out-of-state competitors…. Instead, all vendors are treated the same, as both in-state and out-of-state vendors are subject to the same prohibitions.”

Growing concerns

Supplement retailers and manufacturers face growing concerns over state bills that have been introduced across the country to restrict minors’ access to certain dietary supplement products, namely those marketed for weight loss and muscle building.

Advocates of the bills maintain the restrictions are needed to protect young people, including those who suffer from eating disorders and may turn to diet pills and weight loss products that could harm their health. An organization leading the effort is known as STRIPED, or the Strategic Training Initiative for the Prevention of Eating Disorders, a graduate-level training initiative based at the Harvard T.H. Chan School of Public Health and Boston Children’s Hospital.

A5610 in New York is the only state law today that restricts minors’ access to weight loss and muscle-building supplements. However, the California General Assembly recently passed AB 82, which would prohibit the sale of supplements for weight loss or OTC diet pills to anyone under the age of 18 without a prescription. Similar bills have been introduced in Maryland, New Jersey and Massachusetts.

“Collectively, these bills exemplify the fundamental long-term hazard that state dietary supplement restriction laws present for the entire dietary supplement industry — the emergence of a highly inconsistent, 50-state patchwork of restrictions that cover different products and impose different burdens, maximizing the cost of making our products available to consumers nationwide,” argued Robert Marriott, director of regulatory affairs for the American Herbal Products Association (AHPA), in a column published Jan. 30 by Natural Products Insider.