Bill
S 3677
The bill requires FDA-mandated listings for all dietary supplements with full product, ingredient, labeling, and distributor details, plus a public searchable database.
Jurisdiction: United States (119th Congress) | Introduced: January 15, 2026 | Sponsor: Sen. Dick Durbin (Co-sponsor)
Intent
- To improve transparency and information availability about dietary supplements by creating a mandatory listing system with the U.S. Food and Drug Administration (FDA).
Key Provisions
1) New Dietary Supplement Listing Requirement (Section 403D)
- Starting date: As specified in subsection (b)(4), every dietary supplement marketed in the United States must be listed with the Secretary (FDA) under this section.
- Required listing information (for each marketed product):
- (A) Product name, statement of identity, brand name, and flavors if applicable.
- (B) Name and address of the responsible person (manufacturer/packer/distributor) and the owner/operator/agent in charge (including email address).
- (C) If the responsible person is foreign, the name, domestic address, and email of the U.S. agent.
- (D) The business name and place of business provided on the label under 403(e)(1).
- (E) An electronic copy of the product label.
- (F) Ingredient list (all ingredients required to appear on the label, per 21 CFR 101.4/101.36), including:
- (i) Proprietary blends and related labeling.
- (ii) Amount per serving of each listed ingredient.
- (iii) Percent daily value for each listed ingredient, if required.
- (iv) Amount per serving of ingredients within a proprietary blend (confidential; not publicly disclosed).
- (G) Number of servings per container.
- (H) Directions for use.
- (I) Warnings, notices, and safe handling statements as required by 21 CFR 101.17.
- (J) Allergen statements for major food allergens (per 21 CFR 403(w) and 403(x)).
- (K) Form of the dietary supplement (tablet, capsule, powder, liquid, softgel, gummy, etc.).
- (L) Any label/package claims about disease/health relationships or other claims subject to 403(r) notifications.
- (M) The FDA-assigned product listing number.
- Submission format: The Secretary may require electronic submissions; the FDA will notify the responsible person of receipt (complete or incomplete) and reasons for incompleteness.
- Scope of a single listing: One submission can cover multiple supplements with identical formulations or differing only in color, excipients, or flavor, in any package size.
2) Listing Content and Timing
- Timelines:
- For dietary supplements on the market as of enactment, listings must be submitted within 18 months after enactment.
- For new supplements not on interstate commerce by Jan 1, 2027, listings must be submitted at the time of introduction into interstate commerce.
- If a supplement is discontinued, the responsible person must notify the Secretary within 1 year.
- Changes to listing information must be submitted within 30 days after first introduction of the product with the change.
- Additional information requests: The Secretary may request location and production details (within 10 calendar days of request) about manufacturing, packaging, labeling, or sources of ingredients.
3) Dietary Supplement Product Listing Number and Public Database (Section 403D)
- The FDA will assign a dietary supplement product listing number (may apply to multiple supplements with identical formulations).
- The FDA must establish a publicly available electronic database within 2 years of enactment.
- The database will be searchable by listing number and various fields of information.
- Certain information (B, C, and specific items in F(iv) per subsection) may be withheld from public disclosure if it is confidential or otherwise restricted.
- Confidentiality: Information derived from listings that is confidential remains protected under applicable exemptions (e.g., 5 U.S.C. 552(b)(3)) and other related laws.
- The public database will not reveal sensitive details such as the identity or location of a registered person or facility not listed on the label, or the exact quantity of ingredients in a proprietary blend.
4) Misbranding and Compliance (Sections added to existing law)
- Misbranding: If a responsible party fails to file or update a listing as required, the supplement may be deemed misbranded.
- Debarment: The act adds a new prohibition on introducing or delivering for interstate commerce a dietary supplement manufactured or held with the assistance of a person debarred under a separate provision (to prevent shipments from debarred entities).
5) Funding (Authorization of Appropriations)
- Initial appropriation: Approximately $7.87 million for FY 2026.
- Ongoing funding: Approximately $6.62 million for FY 2027–2030 to implement the listing program and hire staff.
What This Bill Would Change
Affected Parties
Procedural and Timeline Highlights
Overall, S. 3677 aims to enhance transparency and consumer access to dietary supplement information by mandating FDA registration of all products, detailing comprehensive labeling and ingredient disclosures, and creating a centralized public database.
Compiled from official sources — confirm details with the bill’s official record.
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