New York Law and Legal Challenges. In October 2023, the state of New York enacted Assembly Bill A5610D (A5610D), which prohibited the sale of over-the-counter diet pills and dietary supplements marketed for weight loss or muscle building to consumers under the age of 18, effective in April 2024.
The provisions in the current bill are substantially similar to those in A5610D. According to the authors of the model legislation, the legislation has also been introduced in California, Massachusetts, New Jersey, and Virginia.
A5610D has been challenged in two separate actions, one filed by the Natural Products Association against the New York attorney general in the United States District Court for the Eastern District of New York, and another filed by the Council for Responsible Nutrition against the attorney general of New York in the United States District Court for the Southern District of New York.
Claims raised by the Natural Products Association included that A5610D was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) and that it violated the Dormant Commerce Clause by regulating interstate commerce. In June 2024, the district court denied Natural Products Association's motion for a preliminary injunction and dismissed the action for a lack of subject matter jurisdiction.
Claims raised by the Council for Responsible Nutrition included that the law violated the First Amendment relating to commercial speech; that the law is void-for-vagueness under due process under the Fourteenth Amendment; that the law constitutes an excessive use of police powers; and that it is preempted under the FDCA. Following the district court's dismissal of all claims but the First Amendment claim, the Council for Responsible Nutrition appealed to the United States Court of Appeals for the Second Circuit, where the case is currently pending.
Prohibition Against the Offer or Sale of Over-the-Counter Diet Pills or Dietary Supplements for Weight Loss or Muscle Building to Persons Under the Age of 18. The bill prohibits a person from selling, offering to sell, or giving away, as either a retail or wholesale promotion, an over-the-counter diet pill or dietary supplement for weight loss or muscle building within this state to any person under 18 years of age.
Over-the-counter diet pills are defined as a class of drugs labeled, marketed, or otherwise represented for the purpose of achieving weight loss that can be obtained without a prescription and is not restricted to use by prescribing practitioners.
A dietary supplement for weight loss or muscle building is defined as a dietary supplement that is labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building. It does not include protein powders, protein drinks, or foods marketed as containing protein unless the protein powder, protein drink, or food marketed as containing protein contains an ingredient other than protein which would, considered alone, constitute a dietary supplement for weight loss or muscle building.
A dietary supplement is defined as any product, other than tobacco, intended to supplement the diet that contains one or more of the following dietary ingredients:
In addition to meeting the above, a dietary supplement must also be:
A person includes any individual, firm, corporation, partnership, association, limited liability company, or other entity.
Factors in Considering the Represented Purpose of Over-the-Counter Diet Pill or Dietary Supplements. The bill provides that when a court is determining whether an over-the-counter diet pill or dietary supplement is labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building, the court must consider at least the following factors:
Requirement of Proof of Legal Age for Retail Establishments. Retail establishments must require proof of legal age for the purchase of over-the-counter diet pills and dietary supplements for weight loss or muscle building.
A retail establishment is defined as any vendor that, in the regular course of business, sells dietary supplements for weight loss or muscle building or over-the-counter diet pills at retail directly to the public, including pharmacies, grocery stores, other retail stores, and vendors that accept orders placed by mail, telephone, email, a website, online catalog, or software application.
Identification Requirements. The bill provides that proof of legal age includes any of the following officially issued identification that shows the purchaser's age and bears the purchaser's signature and photograph:
Identification is not required of any individual who reasonably appears to be at least 25 years of age. The bill provides that the appearance of the purchaser does not constitute a defense in any proceeding alleging the sale of any over-the-counter diet pills and dietary supplements for weight loss or muscle building to an individual under 18 years of age.
Use of Transaction Scan Devices. The bill provides that any person operating a retail establishment may perform a transaction scan as a precondition for the purchase of over-the-counter diet pills or dietary supplements for weight loss or muscle building.
If the information deciphered by the transaction scan fails to match the information printed on the driver's license or nondriver identification card or if the transaction scan indicates that the information is false or fraudulent, the attempted transaction must be denied.
Affirmative Defense. In any proceeding brought by the attorney general to enforce the provisions created by the bill, it is an affirmative defense that the purchaser produced one of the above listed identification, successfully completed that transaction scan, and that over-the-counter diet pills or dietary supplements for weight loss or muscle building were sold, delivered, or given to the purchaser in reasonable reliance on the identification and transaction scan.
The bill requires the court to take into consideration any written policy adopted and implemented by the seller to carry out the provisions created by the bill. Use of a transaction scan may not excuse any person operating a retail establishment from the exercise of reasonable diligence otherwise required by the provisions created by the bill.
Restriction on the Use and Retention of Information from Transaction Scan Devices. The bill requires that a retail establishment or its employees may use only a transaction scan device capable of deciphering any electronically readable format and may use the information recorded and maintained using such devices only for the purposes contained in provisions created by the bill.
Retail establishments and their employees are prohibited from reselling or disseminating the information recorded during use of a transaction scan device to any third person, including any advertising, marketing, or promotional activities. Transaction information may be released under a court-ordered subpoena or a statute that specifically authorizes the release of the information.
A retail establishment or its employees may electronically or mechanically record and maintain only the following information from a transaction scan:
Requirements and Restrictions on Delivery Sellers. A delivery seller is defined as a vendor, including an online retailer, who makes delivery sales of over-the-counter diet pills or dietary supplements for weight loss or muscle building. It includes persons who accept orders placed by mail, telephone, email, a website, online catalog, or software application.
A delivery sale is defined as any sale of over-the-counter diet pills or dietary supplements for weight loss or muscle building to a consumer if:
A delivery seller, including an online retailer, who mails or ships over-the-counter diet pills or dietary supplements for weight loss or muscle building to consumers:
Enforcement by the Office of the Attorney General and Penalties. The Office of the Attorney General may investigate violations of provisions created by the bill and may bring actions to enforce compliance and enjoin further violations.
For violations of the restriction against reselling or disseminating transaction scan device information, a court may impose of penalty of up to $1,000 per violation. For all other violations of provisions created by the bill, the court may impose a penalty of up to $500 per violation.
PRO: This bill is about preventing negative outcomes for youth. Children are being intentionally targeted by companies that claim to promote wellness while advertising and selling dangerous and untested products. Adolescents, young adults, and women who use these diet pills have six times the risk of being diagnosed with an eating disorder. Young people who start to use muscle-building supplements are two to five times more likely than their peers to later use illicit anabolic steroids or similar substances. A study identified nine different dangerous stimulants not approved by the Food and Drug Administration (FDA) but used in dietary supplements, and the American Academy of Pediatrics has strongly cautioned against teens using these products.
We are high school students in Washington State. A Harvard study found that one in ten adolescents worldwide have used unregulated weight loss pills. These pills post significant risks to young people. According to the New England Journal of Medicine, dietary supplements led to 23,000 emergency room visits annually in the United States, particularly among young adults and unsupervised children. These pills can result in organ failure, hepatitis, heart attacks, strokes, and even death. Only 5 to 10 percent of adverse drug reactions are reported. According the National Institutes of Health, supplements are frequently laced with pesticides, heavy metals, anabolic steroids, and prescription drugs. Half of supplements marketed as containing Acacia rigidula actually contain a stimulant called BMPA, which is closely related to a banned compound DMAA associated with several deaths. There is not enough federal and state regulation for supplements and the FDA is not allowed to regulate them because of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This bill is not trying to regulate green tea or protein powder. Many of my friends fall victim to social media trends and struggle from eating disorders. Products are marketed specifically to kids and teens as pills or powders taken once a day, made of natural harmless ingredients, and promising miraculous results.
Americans spend about $30 billion annually on supplementary health approaches. Supplements and diet pills aren't regulated as heavily by the FDA as drugs. The 2018 National Health and Nutrition Survey reports 34 percent of adolescents have used a dietary supplement in the previous 30 days. Research published in Health Affairs Scholar projected that restricting minor access to these supplements will prevent over 57,000 cases of eating disorders nationwide. Passing this bill will also support minority populations. A study found that racially targeted marketing practices made Latinx adolescents 40 percent more likely to use over-the-counter diet pills compared to their White peers.
CON: The Natural Products Association opposes the bill because it seeks to impose unnecessary restrictions on the sale and access to dietary supplements. The bill fails to recognize the extensive regulatory framework that already governs the dietary supplement industry under both the FDA and the Federal Trade Commission (FTC). The industry is subject to stringent oversight under DSHEA. The FDA has broad authority to regulate dietary supplements, including enforcing good manufacturing practices, requiring premarket notification for new dietary ingredients, and mandating postmarket surveillance. The FTC further ensures marketing and advertising claims are truthful, nonmisleading, and substantiated by scientific evidence. There is no adverse event reporting or peer-reviewed scientific literature to support the claim that dietary supplements contribute to eating disorders.
The Association of Washington Business has concerns about the breadth of the definitions in the bill and the delivery and age verification requirements. It would open delivery carriers up to liability for the delivery of other noncovered products.
The Washington Food Industry Association represents independent grocers and convenience stores. The bill would provide significant challenges for small retailers. Many age-verified products in stores are secured in locked displays. Given the breadth of the bill and how many products it encompasses, it could be difficult for customers over the age of 18. Our members have expressed concerns that if they had to lock up the vast majority of the products encompassed in the bill, they would simply stop carrying the products. Identifying covered products by UPC codes would help us know exactly what this bill was supposed to encompass.
The Consumer Healthcare Products Association would be neutral on the bill if it applied only to supplements that were specifically marketed for weight loss or muscle building. Unfortunately, the bill is very expansive in its definitions. Creatine, for instance, is used by some individuals to support heart, cognitive, and bone health. Green tea extract is often used as an antioxidant to protect cells and tissues. Fiber is not expressly exempted from the bill. There is vague metabolization language in the bill as well.
I am opposed to the bill until the Legislature takes up as a whole our approach to when and where and how we should be protecting our minors.
PRO: Senator John Lovick, Prime Sponsor; Aden George; Vaishvi Vontela; Corlie Zhuang, Harvard STRIPED; Prithvi Dasan; Youlan wang; Komal Singh.