On Feb. 4, Representative Nick Langworthy (R-NY) introduced H.R.7366 (www.congress.gov/bill/119th-congress/house-bill/7366/text), the “Dietary Supplement Regulatory Uniformity Act”, which he called “legislation to protect consumer health and rein in burdensome state overregulation.” (https://langworthy.house.gov/media/press-releases/congressman-langworthy-introduces-dietary-supplement-regulatory-uniformity-act).

The bill, which deserves the strong support of industry, is barely two pages long. If enacted, it would amend Section 403A of the Federal Food, Drug and Cosmetic Act (FD&C Act21 U.S.C. 343–1) to prohibit any state or local government within from establishing or continuing any requirement concerning a dietary supplement which is different from, or in addition to, or that is not otherwise identical with, a requirement applicable to a dietary supplement under the FD&C Act. If enacted, this would be a significant enlargement of federal preemption over dietary supplements. Federal preemption is the legal principle that federal law supersedes conflicting state or local laws.

The proposed legislation does allow for an exemption from federal preemption for “local” regulation of dietary supplements, but only upon application by the state or local government to, and notice and comment rulemaking by, the Secretary of Health and Human Services, if

“(A) such requirement is more stringent than the applicable requirement under Federal law; or

“(B) (i) such requirement addresses a compelling local condition; and

“(ii) compliance with such requirement does not render the dietary supplement out of compliance with Federal law.

Generally, the individual states have what are generally referred to as “police powers,” arising from the Tenth Amendment to the Constitution, which provides “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Such “police powers” enable the states to make laws for public health and safety.

Historically, the most widely regulated dietary supplement ingredient by individual states was ephedra. The first state to act was the Board of Pharmacy for the state of Ohio, which promulgated regulations limiting the serving size of ephedrine alkaloids, prohibiting sales to people under 18 and requiring a minimal warning. Subsequently far more extensive warning label requirements were promulgated by the Texas Department of Health. Eventually, other states including Illinois (the first state to ban the ingredient with a bill introduced by then state Senator Barack Obama), New York and California would prohibit or regulate the sale of dietary supplements containing the ingredient. It appears that no legal challenges were brought against these state and local restrictions.

Food and Drug Administration’s (FDA) initial inquiry into ephedra came by way of a working group of the Food Advisory Committee, which held a public meeting in October 1995. FDA issued a proposed regulation concerning ephedra in June of 1997 and a final regulation, 21 CFR 119.1, in February of 2004, which states that “dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use.” (www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-119). Obviously, with the FDA stepping in and banning the ingredient at the federal level, the state and local restrictions against ephedra became of little interest.

There are other state and local restrictions on certain dietary supplements that remain in existence and in effect. For example, in 1996 the state of California promulgated a regulation affecting foods and dietary supplements containing specified herbal stimulant laxatives, such as cascara sagrada, senna and aloe latex, requiring a boxed safety warning. (See: California Code of Regulations, Title 17, §10750. Label Requirements for Foods and Dietary Supplements —  www.cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/FoodSafetyProgram/DietarySupplements/StimulantLaxativeWarning.pdf).

California also has a regulation enacted in 2002 that restricts the sale of dietary supplements containing certain steroid hormones including DHEA (dehydroepiandrosterone) to people under 18 years of age and requires a rather lengthy label warning. (State of California, Dietary Supplement Labeling and Advertising, Health and Safety Code Sections 110422-110424 — www.cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/FoodSafetyProgram/DietarySupplements/WarningLabels.pdf).

So, if numerous states regulated ephedra and California have laws that restrict sales and require specific label language for certain dietary supplements, why is it a matter of urgency to enact federal legislation that may preempt much of the state and local government’s ability to regulate dietary supplements?

One reason is a law enacted by the state of New York in October 2023. Under New York General Business Law Section 391-oo, effective April 22, 2024, the state bans the sale of over-the-counter dietary supplements marketed for weight loss or muscle building to anyone under 18 years old. Retailers must verify age at purchase and online orders require proof of age 18 years or older and a signature upon delivery. Violations carry civil penalties up to $500.

One of the problems with the New York State law is the expansiveness of the products that potentially fall within the scope of the law. While the California laws discussed above require specific language on the label, which the New York law does not, the California laws only affect a small number of products with specific ingredients. The New York State Law, if enforced to its full effect, would affect a wide swath of products.

The New York restrictions include “Dietary supplements for weight loss or muscle building” which means products labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building, with the only exception for protein products that do not contain other ingredients for weight loss or muscle building. The law further states that when considering enforcement, the court shall consider

(a) whether the product contains:

(i) an ingredient approved by the federal Food and Drug Administration

for weight loss or muscle building;

(ii) a steroid; or

(iii) creatine, green tea extract, raspberry ketone, Garcinia cambogia, green coffee bean extract;

(b) whether the product’s labeling or marketing bears statements or images that express or imply that the product will help:

(i) modify, maintain, or reduce body weight, fat, appetite, overall metabolism or the process by which nutrients are metabolized; or

(ii) maintain or increase muscle or strength;

(c) whether the product or its ingredients are otherwise represented for the purpose of achieving weight loss or building muscle; or

(d) whether the retailer has categorized the dietary supplement for weight loss or muscle building by:

(i) placing signs, categorizing, or tagging the supplement with statements described in paragraph (b) of this subdivision;

(ii) grouping the supplements with other weight loss or muscle building products in a display, advertisement, webpage or area of the store; or

(iii) otherwise representing that the product is for weight loss or muscle building.

Consider how many of those factors could apply to almost any product. Many products with express claims to benefit nutrient metabolism have nothing to do with weight loss or muscle building. The factors that may be considered in determining enforcement are not limited to express statements specific to weight loss or muscle building. Enforcement actions may consider statements or images that imply that the product will help, among other things, maintain body weight, affect overall metabolism or the process by which nutrients are metabolized.

Does an image of healthy looking or even a “buff person” on the label or in marketing of a dietary supplement raise a red flag? Green tea serves as a potent antioxidant, that also enhances mental focus and is included in products that have nothing to do with weight loss or muscle building. And what about the risk to retailers? Grouping supplements together in a display is a risk of enforcement?

There seems to be no instances of enforcement of the New York State law to date, nor has there been any guidance from the New York State Attorney General as to how this law may be enforced.

The New York law may be the first of many state restrictions. Similar legislation has been proposed in numerous state legislatures including California, Massachusetts, Michigan, New Jersey, Texas and Virginia. If enacted, each state’s law could vary in terms of specific requirements or in how the individual state may choose to enforce it.

The Natural Products Association and Council for Responsible Nutrition have brought cases in New York Federal Courts seeking to strike down the law on various grounds including preemption and Constitutional commercial free speech grounds without success to date. (See: NPA Weighs Options Following Court Decision on NY Law — www.npanational.org/news/npa-weighs-options-following-court-decision-on-ny-law/ — Litigation Asserts New York’s Dietary Supplement Prohibition is Unconstitutional — https://www.npanational.org/news/litigation-asserts-new-yorks-dietary-supplement-prohibition-is-unconstitutional/ — CRN Petitions U.S. Supreme Court to Review New York Law Restricting Supplement Sales Based on Marketing Claims www.crnusa.org/newsroom/crn-petitions-us-supreme-court-review-new-york-law-restricting-supplement-sales-based — CRN Continues Supreme Court Fight Against New York Supplement Age-Restriction Law — www.crnusa.org/newsroom/crn-continues-supreme-court-fight-against-new-york-supplement-age-restriction-law).

Unfortunately, the states’ “weight loss and muscle building” dietary supplement legislation is only the beginning. A few examples — California also passed a law effective July 1, 2026, requiring that almost all food products with voluntary product dating, including dietary supplements, use specific language –”BEST if Used by” for quality dating and “USE by” for safety dating. An act to amend Sections 36004 and 82001 of the Food and Agricultural Code, and to amend Section 114057.1 of the Health and Safety Code, relating to food and beverage products. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB660.

The New York State Legislature has passed a similar voluntary food dating law affecting “food products for human consumption” [which seems to include dietary supplements but excludes infant formula and alcoholic beverages] on June 2, 2026, and is awaiting action by the Governor. New York Food Date Labeling Act (S7618B/A7291B).

Texas, Louisiana and other states are enacting laws either prohibiting the sale of certain food ingredients or requiring warning language on product labels.

At least seven states have enacted comprehensive Extended Producer Responsibility (EPR) laws requiring businesses to fund packaging recycling.

The bottom line is that foods generally, and dietary supplements specifically, are seeing an ever-increasing rise in state legislation with requirements that differ from federal regulation. While the “weight loss and muscle building” law enacted in New York, and introduced in other state legislatures, is expansive in scope and ambiguous in what they may cover, at least they, so far, do not restrict specific ingredients or require specific label language. Other laws, such as the California laws discussed, require specific warning language when certain ingredients are in a product. Other state laws may restrict the sale of certain ingredients, which remain available elsewhere.

Potentially, could be required to have different labeling or different formulations to satisfy individual state laws. Different states could easily enact conflicting laws. This could limit the availability of dietary supplements, increase costs and make it extremely difficult to market products on a national scale.

For these reasons, to the extent possible there should be one set of requirements that govern the regulation of dietary supplements. Federal preemption already exists for over-the-counter drugs under Section 752 of the FD&C Act (21 U.S.C. § 379r), which expressly prohibited states from establishing OTC drug labeling, packaging, or ingredient requirements that are different from, in addition to, or not identical with federal.

H.R. 7366, The Dietary Supplement Regulatory Uniformity Act, or similar legislation should be enacted as soon as possible. NIE

Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.