By Sean Moloughney, Editor04.22.24
U.S. District Court Judge Andrew L. Carter, Jr. has denied the Council for Responsible Nutrition’s (CRN) request for a preliminary injunction against New York’s state law, which as of Apr. 22, 2024 restricts the sale of dietary supplements “labeled, marketed or otherwise represented” for weight loss or muscle building to any person under 18 years of age.
In a 25-page ruling issued on Apr. 19, Carter ruled that the association has standing to sue on behalf of its members, allowing its case in the Southern District of New York to move forward. However, Carter said a preliminary injunction would not be in the public interest.
He also ruled that 1) CRN failed to show likelihood of success on its First Amendment claim that the law would restrict protected commercial speech, 2) CRN failed to prove irreparable harm, and 3) the statute is not “unconstitutionally vague” on its face.
"The announcement that we have standing is significant because it means that only CRN is positioned right now to go before the court on behalf of industry and argue the merits of what we believe is a strong case,” CRN President and CEO Steve Mister said in a statement.
“As for the preliminary injunction, we knew that asking for such extraordinary relief was a longshot,” he added, “although we respectfully disagree with the court. We will continue to pursue all available legal avenues to challenge this law and continue to believe it unfairly restricts consumer access to legitimate, beneficial health products and infringes upon the rights of businesses to engage in lawful commerce."
CRN’s request for a permanent injunction still remains before the court and CRN said it will file “a motion for clarification regarding points raised by the judge’s preliminary injunction opinion later this week.”
The Natural Products Association (NPA) has also filed suit, but in the Eastern District of New York, and said it plans to file for an injunction.
The law does not include a master list of ingredients or products that fall under the scope of “weight loss or muscle building,” but does explicitly name creatine, green tea extract, raspberry ketone, garcinia cambogia, and green coffee bean extract.
The statute says it applies to a product if it is “labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building” where its “labeling or marketing bears statements or images that express or imply that the product will help ... modify, maintain, or reduce body weight, fat, appetite, overall metabolism, or the process by which nutrients are metabolized” or “maintain or increase muscle or strength.”
Exempt from the state’s restrictions are "protein powders, protein drinks and foods marketed as containing protein unless the protein powder, protein drink or food ... contains an ingredient other than protein which would, considered alone, constitute a dietary supplement for weight loss or muscle building.”
The law applies to “retail establishments” including but not limited to “pharmacies, grocery stores, other retail stores, and vendors that accept orders placed by mail, telephone, electronic mail, internet website, online catalog, or software application.”
Mister said the language of New York’s law only muddied the waters in its attempt to define what type of products fit into the category. With such an “amorphous” class of products, retailers are in an unenviable position, he added.
STRIPED, the Strategic Training Initiative for the Prevention of Eating Disorders at the Harvard T.H. Chan School of Public Health, has been at the forefront of efforts to restrict weight loss supplements to minors and was active in getting the New York law passed.
Weeks ago, STRIPED temporarily published a website of supplements it considered to fall into this restricted class. Data appeared to be collected from the Dietary Supplement Label Database (DSLD) developed by the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH), which includes about 180,000 labels from current and discontinued products.
That webpage was then gated after a CRN member sent a letter to STRIPED from its attorney.
The “worst case scenario,” Mister said, would be if a retailer used STRIPED’s list of products in evaluating which supplements to restrict.
Rend Al-Mondhiry, partner at the recently-renamed law firm Amin Wasserman Gurnari, said New York’s law is “truly flawed” in that it is “poorly written with ambiguous language that makes compliance difficult.”
It may be easy enough to identify products within the scope of the law based on health claims. However, what about a product that may contain an ingredient called out in the law but doesn’t make any claims?
“Even the protein product exemption is confusing. If the lawyers can’t figure it out, this doesn’t bode well for the industry (or consumers),” she said.
Carlos Lopez, vice president, general counsel, and corporate secretary for The Vitamin Shoppe, said the prevalence of disordered eating among adolescents is “a serious public health concern.” But, he added, “there is no conclusive scientific evidence that dietary supplements cause disordered eating among teens. And by devoting public energy and resources to this new law that prohibits the sale of certain dietary supplements to teens instead of expending those resources to programs and policies that address the true causes of disordered eating, the New York Legislature and Gov. Hochul have done a disservice to at-risk adolescents.”
Meanwhile, the law “imposes a multitude of challenges” for retailers and dietary supplement brands, and “creates inconvenience and added cost to New Yorkers of all ages."
“The law prohibits the sale of nearly all dietary supplements for ‘weight loss or muscle building’ to anyone under 18, but it does not identify which supplements are actually restricted. Nor can it because the prohibition is driven exclusively by how products are labeled or marketed, not by what is in them. So, for example, two products containing identical ingredients might receive different treatment under the law if one has a claim of ‘muscle strength’ on the label and the other does not.”
“That means that every retailer must review its entire product assortment," Lopez said, "and make individualized decisions for thousands upon thousands of products based on the four vague and nebulous factors given in the statute as the only guidance offered by New York to determine what products are covered.”
Lopez said it took The Vitamin Shoppe months to conduct this “onerous analysis.”
“I believe The Vitamin Shoppe has made the right classification decisions, but other retailers and brands may have made different decisions and the result will be inconsistency and confusion in the marketplace,” Lopez said.
“In talking to clients that mainly sell affected or potentially affected products DTC, this requirement of obtaining a signature upon delivery of someone 18+ is an even greater challenge,” Al-Mondhiry said.
Lopez said this creates “a huge inconvenience and disincentive for online shopping for New Yorkers of all ages for several reasons. First, every shipment of a covered product within New York state requires an identification check and adult signature at the point of delivery. This means that whether you are 18 or 89, you cannot get a covered product delivered to you within New York unless you are home to receive it so that you can show your identification to the delivery driver and sign for it. If you are not home when the product arrives, you are out of luck.”
“Second, delivery via a method that requires adult signature is expensive so New Yorkers of all ages will have to pay more to get their supplements online,” he said.
Third, Lopez added, “most delivery services do not currently have a mechanisms for 18+ age verification. The ones that do have an adult signature option are set up for alcohol deliveries, so they can only verify 21+. As a result, New Yorkers between the ages of 18-21 will effectively be unable to order covered products online at all, even if they are willing to pay more.”
Finally, he noted, “this law ... treats dietary supplement like a vice, similar to alcohol or tobacco, without any evidence of a link between supplements and disordered eating. In doing that, the law shames young people who are trying to incorporate supplements into a healthy lifestyle and makes it more likely that they will instead continue unhealthy behaviors like snacking on ultra processed foods, which New York has opted not to regulate despite overwhelming evidence of the harm they cause.”
In a 25-page ruling issued on Apr. 19, Carter ruled that the association has standing to sue on behalf of its members, allowing its case in the Southern District of New York to move forward. However, Carter said a preliminary injunction would not be in the public interest.
He also ruled that 1) CRN failed to show likelihood of success on its First Amendment claim that the law would restrict protected commercial speech, 2) CRN failed to prove irreparable harm, and 3) the statute is not “unconstitutionally vague” on its face.
"The announcement that we have standing is significant because it means that only CRN is positioned right now to go before the court on behalf of industry and argue the merits of what we believe is a strong case,” CRN President and CEO Steve Mister said in a statement.
“As for the preliminary injunction, we knew that asking for such extraordinary relief was a longshot,” he added, “although we respectfully disagree with the court. We will continue to pursue all available legal avenues to challenge this law and continue to believe it unfairly restricts consumer access to legitimate, beneficial health products and infringes upon the rights of businesses to engage in lawful commerce."
CRN’s request for a permanent injunction still remains before the court and CRN said it will file “a motion for clarification regarding points raised by the judge’s preliminary injunction opinion later this week.”
The Natural Products Association (NPA) has also filed suit, but in the Eastern District of New York, and said it plans to file for an injunction.
Background: What Does the Law Require?
Under New York’s law, which Governor Kathy Hochul signed in October 2023, retail establishments must now require proof of age for purchase of weight loss and muscle building supplements. Violations could lead to a maximum fine of $500.The law does not include a master list of ingredients or products that fall under the scope of “weight loss or muscle building,” but does explicitly name creatine, green tea extract, raspberry ketone, garcinia cambogia, and green coffee bean extract.
The statute says it applies to a product if it is “labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building” where its “labeling or marketing bears statements or images that express or imply that the product will help ... modify, maintain, or reduce body weight, fat, appetite, overall metabolism, or the process by which nutrients are metabolized” or “maintain or increase muscle or strength.”
Exempt from the state’s restrictions are "protein powders, protein drinks and foods marketed as containing protein unless the protein powder, protein drink or food ... contains an ingredient other than protein which would, considered alone, constitute a dietary supplement for weight loss or muscle building.”
The law applies to “retail establishments” including but not limited to “pharmacies, grocery stores, other retail stores, and vendors that accept orders placed by mail, telephone, electronic mail, internet website, online catalog, or software application.”
Interpretation and Preparation
Before CRN’s request for preliminary injunction was denied, Mister said the organization was advising members to make a “good-faith effort” to identify which products in their portfolios are truly weight loss and muscle building supplements, because some retailers were asking for that information from brand owners.Mister said the language of New York’s law only muddied the waters in its attempt to define what type of products fit into the category. With such an “amorphous” class of products, retailers are in an unenviable position, he added.
STRIPED, the Strategic Training Initiative for the Prevention of Eating Disorders at the Harvard T.H. Chan School of Public Health, has been at the forefront of efforts to restrict weight loss supplements to minors and was active in getting the New York law passed.
Weeks ago, STRIPED temporarily published a website of supplements it considered to fall into this restricted class. Data appeared to be collected from the Dietary Supplement Label Database (DSLD) developed by the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH), which includes about 180,000 labels from current and discontinued products.
That webpage was then gated after a CRN member sent a letter to STRIPED from its attorney.
The “worst case scenario,” Mister said, would be if a retailer used STRIPED’s list of products in evaluating which supplements to restrict.
Rend Al-Mondhiry, partner at the recently-renamed law firm Amin Wasserman Gurnari, said New York’s law is “truly flawed” in that it is “poorly written with ambiguous language that makes compliance difficult.”
It may be easy enough to identify products within the scope of the law based on health claims. However, what about a product that may contain an ingredient called out in the law but doesn’t make any claims?
“Even the protein product exemption is confusing. If the lawyers can’t figure it out, this doesn’t bode well for the industry (or consumers),” she said.
Carlos Lopez, vice president, general counsel, and corporate secretary for The Vitamin Shoppe, said the prevalence of disordered eating among adolescents is “a serious public health concern.” But, he added, “there is no conclusive scientific evidence that dietary supplements cause disordered eating among teens. And by devoting public energy and resources to this new law that prohibits the sale of certain dietary supplements to teens instead of expending those resources to programs and policies that address the true causes of disordered eating, the New York Legislature and Gov. Hochul have done a disservice to at-risk adolescents.”
Meanwhile, the law “imposes a multitude of challenges” for retailers and dietary supplement brands, and “creates inconvenience and added cost to New Yorkers of all ages."
“The law prohibits the sale of nearly all dietary supplements for ‘weight loss or muscle building’ to anyone under 18, but it does not identify which supplements are actually restricted. Nor can it because the prohibition is driven exclusively by how products are labeled or marketed, not by what is in them. So, for example, two products containing identical ingredients might receive different treatment under the law if one has a claim of ‘muscle strength’ on the label and the other does not.”
“That means that every retailer must review its entire product assortment," Lopez said, "and make individualized decisions for thousands upon thousands of products based on the four vague and nebulous factors given in the statute as the only guidance offered by New York to determine what products are covered.”
Lopez said it took The Vitamin Shoppe months to conduct this “onerous analysis.”
“I believe The Vitamin Shoppe has made the right classification decisions, but other retailers and brands may have made different decisions and the result will be inconsistency and confusion in the marketplace,” Lopez said.
What About Online Sales?
Retailers selling products online must now use a method of mailing or shipping that requires a signature and photo ID that confirms the adult accepting delivery is at least 18 years of age.“In talking to clients that mainly sell affected or potentially affected products DTC, this requirement of obtaining a signature upon delivery of someone 18+ is an even greater challenge,” Al-Mondhiry said.
Lopez said this creates “a huge inconvenience and disincentive for online shopping for New Yorkers of all ages for several reasons. First, every shipment of a covered product within New York state requires an identification check and adult signature at the point of delivery. This means that whether you are 18 or 89, you cannot get a covered product delivered to you within New York unless you are home to receive it so that you can show your identification to the delivery driver and sign for it. If you are not home when the product arrives, you are out of luck.”
“Second, delivery via a method that requires adult signature is expensive so New Yorkers of all ages will have to pay more to get their supplements online,” he said.
Third, Lopez added, “most delivery services do not currently have a mechanisms for 18+ age verification. The ones that do have an adult signature option are set up for alcohol deliveries, so they can only verify 21+. As a result, New Yorkers between the ages of 18-21 will effectively be unable to order covered products online at all, even if they are willing to pay more.”
Finally, he noted, “this law ... treats dietary supplement like a vice, similar to alcohol or tobacco, without any evidence of a link between supplements and disordered eating. In doing that, the law shames young people who are trying to incorporate supplements into a healthy lifestyle and makes it more likely that they will instead continue unhealthy behaviors like snacking on ultra processed foods, which New York has opted not to regulate despite overwhelming evidence of the harm they cause.”
