What responsibilities do retailers and foreign manufacturers have under the Dietary Supplement and Nonprescription Drug Consumer Protection Act?

1. What the statute makes the “responsible person” do

The Act amends the Federal Food, Drug, and Cosmetic Act to require that a nonprescription drug or dietary supplement marketed in the United States bear on its label a domestic address or phone number through which the responsible person may receive reports of serious adverse events, and to require that the responsible person submit any serious adverse event reports it receives to the Secretary of Health and Human Services within defined timeframes, provide follow-up medical information received within a year, maintain related records for six years, and permit inspection of those records ^{[4] [2] [5]}.

2. Retailer responsibilities and the delegation carve‑out

A retailer whose name appears as a distributor on the label can avoid direct reporting obligations if it enters an agreement authorizing the product’s manufacturer or packer to submit required reports, provided the retailer directs all adverse-event reports that come to the retailer’s listed address or phone number to that manufacturer or packer and provides notice of all adverse events reported to the retailer ^{[2] [6]}. That delegation reduces some operational burdens for retailers but creates a continuing duty to funnel consumer reports to the contracted responsible person, and the statute bars retailers from simply refusing to permit access to required records or failing to maintain or make required reports if they remain the responsible person ^[3].

3. How the law reaches foreign manufacturers

The committee report and statutory text make clear Congress intended the law to cover foreign manufacturers that market products in the U.S.; the Act authorizes FDA to act when the Secretary has credible information that a responsible person has not complied with the Act or has denied access to records, including prohibiting importation of the product in such circumstances, thereby creating an enforcement path against non‑compliant foreign firms ^{[7] [3] [2]}. The Senate report also notes the committee’s expectation that FDA could exercise authority under section 801 of the FD&C Act with respect to foreign manufacturers, signalling an enforcement leverage point though practical execution can depend on interagency and international realities ^[7].

4. Practical compliance tools and FDA’s expectations

FDA guidance explains implementation details—such as the use of MedWatch Form FDA 3500A for serious adverse event reports and practical labeling placement of the domestic number or address—and answers industry questions about how to comply, while reiterating that guidance documents convey the agency’s current thinking and suggestions rather than creating independent legal obligations ^{[5] [1] [8]}. The Federal Register and FDA guidance also set expectations for timing of enforcement and industry comment periods around label enforcement dates ^{[4] [9]}.

5. Stakes, industry response, and limits of the statutory frame

Industry groups and trade associations have framed the law as strengthening consumer confidence by ensuring FDA receives reports of serious adverse events, and many manufacturers support the law’s post‑market reporting goals while emphasizing compliance with existing DSHEA rules and GMPs ^{[10] [11]}. At the same time, the statute expressly preempts state or local mandatory adverse-event reporting systems that are not identical to its provisions, concentrating federal standards but also limiting subfederal initiatives ^{[3] [2]}. The reporting and label requirements apply to dietary supplements and OTC drugs, not to other foods, which remain subject to separate FD&C Act reporting mechanisms ^[5].