Manufacturer Verification & Approval Policy

Purpose and Status

This policy describes the verification, approval, ongoing monitoring, and potential suspension of dietary supplement manufacturers seeking to participate in the SupplementQuotes marketplace. It is intended to operate together with the Manufacturer Platform Agreement, Manufacturer NDA, and applicable laws.

1. Initial Manufacturer Verification Requirements

Before approving a manufacturer to access confidential requests for quotation (RFQs), SupplementQuotes (“SQ”) will request and review the following information, as applicable:

• Legal business name, including any applicable trade name or DBA.
• Business address and address of each manufacturing facility proposed for participation.
• Primary business contact name, business email address, and telephone number.
• Evidence of current business registration or comparable official documentation supporting the entity’s legal existence and active status.
• Description of manufacturing capabilities relevant to the products the manufacturer proposes to quote, including applicable dosage forms and packaging capabilities.
• Applicable FDA food facility registration information, where registration is required, and relevant current good manufacturing practice (cGMP) documentation or certifications, as applicable to the facility and its operations.

SQ will not require manufacturers to publicly enter or display an FDA food facility registration number on the website. Where verification is necessary, SQ may request appropriate registration evidence through a nonpublic process. FDA food facility registration is not an FDA approval or certification of the manufacturer, and the applicability of registration requirements depends on the facility and activities involved.

Prior to receiving access to confidential RFQs, the manufacturer must affirmatively accept the applicable Manufacturer Platform Agreement and execute or otherwise validly accept the Manufacturer NDA through SQ’s approved onboarding process. SQ will withhold confidential RFQ access until required agreements are in place and manufacturer approval has been granted.

Submission of information does not guarantee approval. Only an authorized SQ administrator may approve a manufacturer after completing the applicable verification review. Ongoing review and document renewal are addressed below.

2. Verification of Legal Business Existence

SQ will independently verify the manufacturer’s legal business name and current entity status through the applicable official Secretary of State, corporation commission, or comparable government business registry in the jurisdiction where the business is organized or registered.

SQ will compare the official registry information against the manufacturer’s submitted legal name, business address, and contact information, taking into account that registered-agent addresses and principal business addresses may differ.

When registry records are incomplete, unclear, unavailable, or raise questions, SQ may request articles of organization or incorporation, a certificate of good standing or existence, a foreign qualification record, or other comparable official documentation.

Material discrepancies, including unresolved differences in legal identity or business status, must be investigated and satisfactorily resolved before SQ approves the manufacturer for access to confidential RFQs.

SQ will maintain an internal record of the source, date, and outcome of the verification and securely handle any collected supporting documents. Verification of legal existence does not by itself establish FDA compliance, cGMP compliance, or manufacturing competence.

3. Manufacturing Facility Verification

Before approving a manufacturer for the applicable manufacturing work, SQ will verify the physical address and operating status of each proposed manufacturing facility, its stated manufacturing and packaging capabilities, and whether the manufacturer performs the work directly or uses a subcontractor. SQ may request documentation reasonably necessary to establish the identity and role of each facility.

Facility verification may include live video walkthroughs, facility photographs, relevant operating documents, third-party audit reports, or in-person visits when SQ considers them appropriate. SQ will select and document reasonable methods based on the facility, manufacturing activities, available evidence, and identified risks; a physical inspection is not automatically required in every case.

Manufacturers must disclose any subcontracted or outsourced facility proposed to perform manufacturing activities for an SQ order. SQ will separately evaluate the disclosed subcontracted facility for the applicable work before approving its use. A manufacturer may not substitute an undisclosed or unevaluated facility for approved work without SQ’s prior review and approval.

SQ will retain an internal record of the facility verification method, supporting evidence reviewed, date, findings, and any unresolved concerns. Facility verification is not a guarantee of regulatory compliance, product quality, or future performance; applicable regulatory and contractual obligations remain in effect.

4. FDA Food Facility Registration Verification

Where FDA food facility registration is required for a proposed manufacturing facility, SQ will request reasonable evidence of current registration through a secure, nonpublic verification process before approving that facility for applicable work. Manufacturers are not required to publicly enter or display their FDA registration numbers on the SQ website.

SQ will review the evidence supplied for consistency with the facility name, physical address, and relevant registration or renewal information, as applicable. SQ may request clarification or updated evidence where information is incomplete, inconsistent, or appears outdated. Registration applicability and any claimed exemption will be assessed based on the facility’s activities and applicable requirements.

SQ will maintain an appropriately restricted internal record of the verification date, evidence reviewed, outcome, and any follow-up required. Because FDA food facility registration records are not generally publicly searchable, SQ will not represent that it has independently confirmed a registration directly with FDA unless it has actually done so through an authorized means.

FDA food facility registration is not FDA approval, FDA certification, or evidence by itself of compliance with current good manufacturing practice requirements. SQ will not describe a facility as “FDA approved” merely because it is registered.

5. Current Good Manufacturing Practice (cGMP) Verification

Before approval for applicable dietary supplement manufacturing work, SQ will require each manufacturer to attest that its relevant operations comply with applicable current good manufacturing practice requirements, including 21 CFR Part 111 where applicable. An attestation alone will not automatically establish eligibility for approval.

SQ will request and evaluate reasonable supporting evidence appropriate to the facility and proposed manufacturing activities. Evidence may include recent cGMP audit reports, recognized third-party GMP certifications, relevant inspection or corrective-action documentation, or other credible compliance records. SQ may request additional information or clarification when the available evidence is incomplete or raises concerns.

A current third-party GMP certification is preferred evidence but is not universally required as a condition of approval. SQ will consider the scope, issuer, facility coverage, date, and limitations of the documentation reviewed, rather than treating a certification as conclusive proof of compliance.

Unresolved significant cGMP compliance concerns will prevent approval for the affected manufacturing activities until satisfactorily addressed. SQ will document its review, any follow-up requests, and its determination in restricted internal verification records. SQ verification does not constitute an FDA inspection, regulatory certification, or guarantee of continuing compliance.

6. Verification of Manufacturer Certifications

SQ will review documentation supporting certifications a manufacturer seeks to display or represent as verified on the platform, including claims involving NSF, UL, SGS, or other third-party certification bodies. SQ will assess the authenticity and identity of the issuer, the specific manufacturing facility covered, the certification scope and activities covered, and the issue and expiration dates.

When reasonably possible, SQ will independently confirm a certification’s current status with the issuing organization or through the issuer’s official verification directory. Where independent confirmation is not available, SQ will document the alternative evidence reviewed and will not designate a claim as verified unless SQ has sufficient reliable evidence of its validity and current status.

Only certifications SQ has verified as current and applicable to the relevant facility and scope may be presented on a manufacturer profile as “verified.” Expired, unverified, suspended, withdrawn, or out-of-scope credentials must not be represented as verified. SQ may request updated evidence, correct or remove a verification designation, or restrict a misleading certification claim pending review.

SQ will record the evidence reviewed, verification method, date, applicable facility and scope, expiration date, and review outcome. The ongoing monitoring and renewal requirements are set out in Section 7.

7. Ongoing Verification and Document Renewal

7A. Risk-based Insurance Verification. As a condition of approval and ongoing participation, manufacturers must maintain commercial general liability and product liability insurance appropriate to their actual operations and products. SQ does not impose a universal $1M per-occurrence/$2M aggregate minimum. During onboarding and re-verification, SQ may request and securely record certificates of insurance or comparable evidence, insurer, policy dates, coverage scope, relevant limits, and exclusions; SQ may set reasonable additional coverage or additional-insured conditions for specified higher-risk orders before acceptance. SQ shall track any coverage expiration dates it has collected, request renewals as needed, and document exceptions or corrective action. A manufacturer that does not maintain or substantiate required coverage may remain pending, have affected capabilities restricted, or be suspended under the Policy, with administrator review. A certificate is evidence of insurance, not a guarantee of coverage, and verification does not transfer manufacturer product liability to SQ.

SQ will conduct a documented re-verification review of each approved manufacturer at least once every twelve (12) months. The review will assess continued legal business status, facility information, manufacturing capabilities, applicable regulatory documentation, and any unresolved compliance or performance concerns.

SQ will track expiration and renewal dates for certifications and other time-sensitive documents and request updated evidence as needed, without waiting for the annual review. A certification that expires, is suspended, or can no longer be substantiated must not continue to be displayed as verified.

Manufacturers must promptly notify SQ of material changes affecting their eligibility or verified status, including changes in ownership or legal status, manufacturing location, use of subcontractors, certification suspension or withdrawal, and significant regulatory actions or compliance findings. SQ may request supporting evidence and perform an additional review whenever credible concerns arise.

SQ will document the review date, evidence considered, findings, follow-up items, and resulting status. Significant unresolved deficiencies may lead SQ to restrict relevant capabilities or access pending further review, in accordance with the approval and suspension procedures in Sections 8 through 10 of this Policy and applicable agreements.

8. Manufacturer Approval Authority and Access Control

Only an authorized SupplementQuotes (“SQ”) administrator may approve or reject a manufacturer application. An administrator will review the applicable verification checklist, supporting documentation, outstanding deficiencies, and any material compliance or eligibility concerns before recording an approval decision.

Until approval is expressly granted, the manufacturer account will remain in pending status and may not access confidential requests for quotation (RFQs), submit manufacturer quotes, or otherwise exercise approved-manufacturer permissions. Acceptance of the applicable Manufacturer Platform Agreement and Manufacturer NDA is required before confidential RFQ access is enabled, even if the verification review is otherwise complete.

SQ may request additional documents or clarification, defer a decision while concerns are resolved, or reject an application where requirements are not satisfied. Submission of a complete application does not create an entitlement to approval.

SQ will retain an internal record identifying the approving or rejecting administrator, decision date, verification materials considered, outcome, and any relevant conditions or follow-up requirements. Approval does not constitute SQ certification or a guarantee of manufacturer performance or regulatory compliance.

8A. Final Onboarding Discretion and Marketplace Capacity

Meeting the verification requirements does not entitle any applicant to approval or participation in the SupplementQuotes marketplace. SQ retains the ultimate discretion to decide whether to onboard, approve, defer, or decline a manufacturer, including when SQ has sufficient manufacturers, wishes to limit participation by manufacturing category or capability, cannot support additional onboarding, or determines that adding a manufacturer is not appropriate for legitimate business, operational, capacity, quality, or marketplace-management reasons. SQ is not obligated to accept new manufacturers or maintain an open enrollment period. Decisions must be made in good faith, consistent with applicable law and any binding commitments, and must not be based on unlawful discrimination or retaliation. An applicant that is not selected will not receive access to confidential RFQs unless and until SQ expressly approves the account and applicable agreements are accepted.

9. Incomplete Applications, Failed Verification, and Corrective Action

SQ may maintain a manufacturer application in pending status while requesting missing documentation, clarifications, or reasonable corrective action needed to satisfy the verification requirements in this Policy. Pending applicants are not approved and may not access confidential RFQs or submit quotes.

Except where immediate rejection is warranted by serious fraud, product-safety concerns, or comparable material risk, SQ will generally provide a reasonable opportunity to resolve identified deficiencies. SQ may establish a response deadline appropriate to the nature and seriousness of the issue, and may request evidence that corrective action has been completed.

SQ may reject an application if significant compliance concerns remain unresolved, required verification cannot be completed, information is materially false or misleading, or the applicant otherwise fails to meet applicable approval requirements. SQ may reject immediately where serious fraud or safety concerns justify prompt action.

An authorized SQ administrator will document material deficiencies, requests for clarification or corrective action, the applicant’s response, the final determination, and the reasons for any rejection. Reconsideration or a later application may be evaluated based on updated evidence, but approval is not guaranteed. Decisions under this section remain subject to applicable law and the Manufacturer Platform Agreement.

10. Suspension, Restriction, and Revocation of Manufacturer Approval

SQ may suspend, restrict, or revoke a manufacturer’s approved status or access to RFQs when credible information indicates significant regulatory or cGMP noncompliance, fraud, materially false or misleading information, undisclosed subcontracting, serious substantiated customer complaints, failure to maintain required verification documents, or other material risks to customers, product safety, confidentiality, or platform integrity. SQ will evaluate the severity, credibility, and scope of the concern and document its determination.

When reasonably necessary to protect customers, confidential RFQs, proprietary formulations, or the platform, an authorized SQ administrator may immediately restrict or suspend access while investigating. For less serious or remediable deficiencies, SQ may provide notice describing the concern and a reasonable opportunity to submit evidence or corrective action before deciding whether to restrict or revoke approval. Immediate action need not await that process where the risk warrants it.

SQ may require updated documents, an explanation, corrective-action evidence, additional facility verification, or other appropriate information before restoring access. Restoration is not automatic and requires an authorized SQ administrator’s documented determination that the relevant concerns have been adequately resolved. SQ may permanently revoke approval where material concerns remain unresolved or the manufacturer is no longer eligible.

For any active orders involving an affected manufacturer, SQ will conduct an order-specific review of product status, customer communications, confidentiality, deposits or other funds, and contractual obligations. Suspension or revocation does not automatically cancel an order, authorize SQ to retain or redirect customer funds, or eliminate accrued duties. Existing orders, payment handling, refunds, and dispute rights remain subject to the applicable Customer Terms, Manufacturer Platform Agreement, payment terms, and law.

SQ will retain an internal record of the concern, supporting evidence, actions taken, dates, notices where appropriate, remediation submissions, decision-maker, and final disposition, subject to SQ’s applicable retention and privacy policies.

11. Verification Records, Security, and Retention

SupplementQuotes (“SQ”) will maintain secure internal verification records sufficient to document its review of each manufacturer, including applicable official business-registry checks, business identity and contact information, facility verification findings, manufacturing and subcontracting disclosures, FDA food facility registration evidence where required, cGMP compliance evidence, third-party certifications, and the status and scope of any verified credentials.

SQ will record approval and rejection decisions, the responsible administrator, decision dates, deficiencies and corrective-action requests, periodic reviews, document renewals and expiration checks, reported material changes, and any suspension, restriction, reinstatement, or revocation actions, together with material supporting evidence and disposition.

Verification records will be accessible only to personnel with an authorized business need, subject to appropriate technical and organizational safeguards. SQ will handle nonpublic manufacturer documents and information in accordance with applicable confidentiality commitments, privacy requirements, and its internal access-control procedures. SQ will not publicly disclose FDA registration documentation or other sensitive verification materials solely because a manufacturer has submitted them.

SQ will maintain a documented records-retention and secure-disposal schedule that accounts for applicable legal obligations, legitimate operational needs, contractual commitments, and reasonably anticipated disputes. The precise retention periods and deletion procedures will be established in that schedule; this Policy does not impose a fixed retention period.

12. Public Manufacturer Verification Status

SupplementQuotes (“SQ”) may display an “Approved” or “Verified” manufacturer status on a manufacturer profile only after completion of SQ’s applicable internal verification and approval process. Such status reflects SQ’s review at the time performed and is not a continuing guarantee of manufacturer performance, product quality, safety, or regulatory compliance.

SQ will describe a certification as verified only if SQ has reviewed supporting evidence and confirmed that the certification is current and applicable to the relevant facility and scope. SQ will remove, qualify, or cease displaying a verified certification claim when it expires, is withdrawn, cannot be substantiated, or otherwise becomes inaccurate.

SQ will not publicly display FDA food facility registration numbers, nonpublic verification documents, confidential facility records, audit reports, or other sensitive manufacturer information through a verification profile unless a separate lawful basis and appropriate authorization permit disclosure.

An SQ verification designation does not mean that the FDA or another government authority has approved, certified, endorsed, or inspected the manufacturer for SQ purposes. Nor does it represent a guarantee of current cGMP compliance. SQ may revise or withdraw a verification designation if information changes or concerns arise.