Are Honey Packs Legal?

Honey packs marketed as dietary supplements are legal to sell in the United States under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This law allows supplements to be sold without FDA pre-market approval, provided they contain only dietary ingredients, are not marketed as drugs, and are accurately labeled.

However, when a honey pack contains undeclared pharmaceutical ingredients — as the FDA has found in over 100 products — it becomes an unapproved new drug and a misbranded product under the Federal Food, Drug, and Cosmetic Act. At that point, the product is illegal to manufacture, distribute, or sell. The distinction is critical: the product category is legal, but specific adulterated products within it are not.

The FDA has several enforcement tools for dealing with illegal honey packs: public safety notifications warning consumers about specific tainted products, warning letters to manufacturers and distributors, import alerts that authorize customs detention of flagged products at the border, and criminal prosecution for egregious violations.

However, the FDA's authority has significant limitations. It cannot mandate recalls of dietary supplements — recalls are technically voluntary, though most companies comply when pressured. It cannot require pre-market testing. And its enforcement resources are finite: with hundreds of thousands of supplement products on the market, the agency can test only a small fraction. This reactive enforcement model means illegal products can circulate for months or years before being identified.

Track the latest enforcement actions on our FDA enforcement timeline.

State laws add another layer of regulation — or lack thereof. Most states defer to federal FDA authority on supplement regulation, but some have taken additional steps:

• Several states have laws restricting the sale of sexual enhancement supplements at certain retail locations (e.g., requiring them behind the counter or limiting sales to licensed supplement retailers).
• State attorneys general can pursue consumer protection cases against sellers of adulterated supplements under state unfair-trade-practices laws.
• Some municipalities have enacted local ordinances restricting the display or sale of sexual enhancement products.

The patchwork of state and local regulation means that legality and availability vary by location. A product legal to sell in one state may face restrictions in another.

Most honey packs sold in the US are imported, primarily from Southeast Asia and the Middle East. US Customs and Border Protection (CBP) works with the FDA to intercept flagged products at entry points. The FDA maintains import alerts that authorize automatic detention of products from specific manufacturers, brands, or countries without physical examination.

However, the volume of imports is enormous, and not every shipment is inspected. Products that evade border screening enter domestic commerce and are effectively unregulated until an adverse event triggers FDA attention. Some importers use transshipment through third countries or relabeling to evade import alerts — practices that are themselves illegal but difficult to detect at scale.

Legislative proposals to reform dietary supplement regulation have been introduced in Congress multiple times but have not yet been enacted. Key proposals include mandatory product registration with the FDA, required pre-market safety testing for new dietary ingredients, mandatory (rather than voluntary) recall authority, and increased funding for FDA enforcement.

Industry groups have lobbied against stricter regulation, arguing it would increase costs and reduce consumer access to legitimate supplements. Consumer safety advocates counter that the current system allows dangerous products to reach consumers. Until legislation changes, the burden of safety verification falls primarily on the consumer. Our safety resource center helps you navigate this responsibility.