CLEAR LABELS Act
- Bill Number
- H.R. 8269
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Commerce
- Status
- Introduced
- Latest Action
- 2026-04-14: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-06-04T08:08:49Z
AI-Generated Summary
Summary of H.R. 8269: CLEAR LABELS Act
Purpose
The legislation aims to increase transparency in the pharmaceutical supply chain by requiring drug labels to disclose the original manufacturers of active pharmaceutical ingredients (APIs, the key chemical components in drugs) and finished drug products, along with related supply chain details. This helps consumers, healthcare providers, and regulators trace drug origins.
Key Provisions
- Labeling for Packaged Finished Drugs: Labels must include the name, business location, and unique facility identifier (a specific code for the production site) of the manufacturer, packer, or distributor, or provide a link, barcode, QR code, or similar to an online searchable portal. Labels must also state the quantity of contents (with allowances for minor variations or small packages via FDA rules).
- Labeling for APIs: Accompanying labels and certificates of analysis (documents verifying drug quality) must list the original manufacturer's name, location, and unique facility identifier.
- Labeling for Finished Drug Products: Labels must identify:
- Original manufacturer of each API.
- Original manufacturer of the finished drug.
- Packer or distributor (if applicable).
- Or link to an electronic portal with this information.
- If multiple API makers are possible, all must be listed.
- Access to Information: Details must also be available in a package insert or as a paper copy upon request.
- Definition: "Original manufacturer" is the last facility performing major production steps before the drug enters interstate commerce (sales across state lines).
- Implementation: FDA must issue regulations for API and finished drug labeling, effective no sooner than 1 year after final rules, applying to drugs made after that date. Regulations may allow flexibility, like electronic options.
- Customs Exemption: Finished drugs compliant with the new labeling rules are exempt from standard U.S. customs requirements to mark the country of origin.
Significant Changes to Existing Law
- FD&C Act (Section 502(b)): Completely rewrites this section, expanding beyond basic quantity and manufacturer info to mandate detailed supply chain disclosure, including APIs and original producers—previously, labels only needed current packer/distributor details.
- Tariff Act of 1930 (Section 304): Adds an exemption for compliant drug products from country-of-origin marking at import, simplifying customs for these items.
Potential Impacts
- Government Agencies: FDA gains new regulatory duties (rulemaking, enforcement); U.S. Customs and Border Protection sees reduced marking enforcement for drugs.
- Citizens/Consumers: Easier access to supply chain info could build trust, aid in spotting counterfeit or low-quality drugs, and inform choices (e.g., avoiding certain foreign sources).
- Industry: Pharmaceutical companies face new compliance costs (label updates, portals), but streamlined imports.
- International Relations: May indirectly pressure foreign suppliers for better traceability; eases U.S. imports without origin marks.
Main Stakeholders Affected
- Drug Manufacturers/Suppliers: Original API and finished drug makers must disclose facilities.
- Packers/Distributors: Required to list or link to info.
- Consumers and Healthcare Providers: Gain transparency tools.
- FDA: Oversees rules and enforcement.
- Importers/Customs: Benefit from exemptions.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens FDA oversight of drug safety and authenticity; supports anti-counterfeiting efforts without new penalties (relies on existing mislabeling violations).
- Constitutional: No apparent issues; fits Congress's authority over interstate commerce and food/drug regulation.
- Political: Bipartisan sponsors (Rep. McCormick and Rep. DeLauro); promotes supply chain accountability amid concerns over foreign (e.g., Chinese) APIs, potentially influencing trade policy. Referred to House committees on Ways and Means (trade/tariffs) and Energy and Commerce (health/FDA).
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. McCormick, Richard [R-GA-7]
Cosponsors (2)
Rep. DeLauro, Rosa L. [D-CT-3], Rep. Fuller, Clay [R-GA-14]
Recent Actions
- 2026-04-14: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-04-14: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-04-14: Introduced in House
- 2026-04-14: Introduced in House
Bill Versions
- Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings Act — issued 2026-04-14 — PDF (4 pages)