ReguSift FDA Disclaimer

The Service provides automated informational compliance screening based on publicly available U.S. Food and Drug Administration ("FDA") regulations, guidance documents, and 21 CFR labeling rules. The Service does not constitute legal advice, attorney representation, regulatory consulting, paralegal service, or any other form of professional practice regulated by any U.S. state, federal, or non-U.S. jurisdiction. No attorney-client, regulator-consultant, or other privileged relationship is created by your use of the Service. You should independently determine whether to upload, process, modify, export, market, distribute, label, or rely on any output of the Service and bear the corresponding regulatory and legal consequences. When necessary, you should consult a qualified U.S.-licensed attorney, a regulatory affairs consultant (RAC), or other appropriate professional advisor.

LabelSift is not affiliated with, owned by, sponsored by, endorsed by, approved by, or in any way authorized by the U.S. Food and Drug Administration ("FDA") or any other U.S. federal, state, local, or non-U.S. regulatory authority. References to FDA regulations, 21 CFR provisions, guidance documents, warning letters, or compliance policies in the Service are made solely for the purpose of providing automated informational analysis based on publicly available government publications. LabelSift does not issue, and is not authorized to issue, any FDA clearance, approval, registration, listing, or any other regulatory determination. Any output, badge, score, status, certificate, watermark, or label that appears in or is exported from the Service (including but not limited to "compliance score," "ready to publish," "FDA-style label," or similar terminology) reflects LabelSift's automated pattern-matching analysis of publicly available regulatory text and does not represent a regulatory outcome, government endorsement, or any form of certification. You may not market, advertise, or describe any LabelSift output as "FDA approved," "FDA recognized," "FDA cleared," "FDA registered," "FDA compliant," "endorsed by the FDA," or using any other language that suggests a regulatory or governmental endorsement.

ReguSift is a software-as-a-service tool that performs three categories of activity: (1) automated text and image analysis of label artwork, formula sheets, and Certificates of Analysis that you provide; (2) generation of suggested label layouts in FDA-style formats (e.g., "Supplement Facts" panel) using a rule-based engine trained on publicly available 21 CFR formatting conventions; and (3) generation of suggested rewording of structure/function claims and ingredient declarations. The Service is provided to business users (dietary supplement and food brands, contract manufacturers, private-label sellers, and regulatory consultants) for use as an internal drafting and review aid. It is not a substitute for legal counsel, regulatory affairs consulting, FDA registration, third-party certification, or pre-market notification.

Under the Dietary Supplement Health and Education Act of 1994 ("DSHEA") and 21 CFR 101.93, structure/function claims (such as "supports immune function," "promotes healthy digestion," or "helps maintain cognitive health") must be accompanied by the mandatory FDA disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." The disclaimer must appear on the same panel as the claim, in a type size no smaller than the claim itself. LabelSift's AI-assisted rewriter only suggests semantic structures and rewording based on regulatory text patterns. It is your sole and absolute responsibility to ensure that the final product label displays the exact, legally required DSHEA disclaimer in the required font size, position, and prominence. LabelSift does not automatically insert, validate the placement of, or guarantee the formatting of the DSHEA disclaimer on your final physical or digital packaging. You are also solely responsible for (a) submitting the required notification to the FDA of any structure/function claim at least 30 days before marketing under 21 USC 343B, and (b) retaining the substantiation evidence supporting the claim.

The Federal Trade Commission ("FTC") regulates advertising claims (including online marketing copy, social media posts, Amazon listings, influencer content, and email campaigns) under the FTC Act and the Dietary Supplement Health and Education Act. The FTC requires that advertisers possess "competent and reliable scientific evidence" (typically randomized, controlled human clinical trials) substantiating any objective health, performance, or efficacy claim before the claim is disseminated. LabelSift's AI rewriter may suggest claim language based on regulatory text patterns and common industry usage, but it does not perform, evaluate, or warrant the existence of competent and reliable scientific evidence supporting any claim. You are solely responsible for (a) maintaining documentary substantiation for every claim you publish, (b) ensuring the claim is truthful and not misleading, (c) complying with FTC endorsement guides regarding testimonials and influencer disclosures, and (d) the consequences of any FTC enforcement action, civil investigative demand, or consumer protection lawsuit. LabelSift does not provide FTC compliance review, advertising claim substantiation analysis, or marketing copy approval services.

LabelSift provides automated ingredient and allergen screening based on text you provide. The U.S. Food Allergen Labeling and Consumer Protection Act ("FALCPA") and the Food Allergy Safety, Treatment, Education, and Research Act ("FASTER Act," effective January 1, 2023) require disclosure of the nine major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. LabelSift's screening reflects these requirements as of the effective date of these regulations. However, due to variations in ingredient sourcing, supplier reformulations, "may contain" precautionary labeling ("PAL"), cross-contact in shared manufacturing facilities, and the inherent limitations of automated text analysis, LabelSift's allergen identification is a screening aid only and does not constitute a determination of the actual allergen content of your product. You remain solely responsible for: (a) confirming allergen declarations with your ingredient suppliers and Certificate of Analysis, (b) evaluating cross-contact risk in your manufacturing environment, (c) deciding whether to include precautionary allergen labeling, and (d) complying with FALCPA, FASTER Act, and equivalent state and non-U.S. allergen labeling requirements.

ReguSift does not warrant, guarantee, or represent that use of the Service will result in (a) acceptance of a product label, listing, or registration by the FDA or any other regulator; (b) avoidance of a Form 483 observation, Warning Letter, untitled letter, Import Alert, or other regulatory enforcement action; (c) absence of consumer complaints, class actions, or product liability claims; (d) successful Amazon listing acceptance or ASIN creation; (e) passage of a third-party lab test; or (f) compliance with any specific retailer or marketplace requirement. Compliance with the Federal Food, Drug, and Cosmetic Act, FDA regulations, FTC Act, FSMA Food Safety Modernization Act, Food Allergen Labeling requirements, FTC endorsement guides, USP standards, state food and drug laws, or any other legal requirement is your sole and continuing responsibility.

ReguSift uses AI technologies trained on regulatory data to accelerate your compliance drafting workflow. As with any AI-assisted system, the Service's outputs — including claim rewrites, suggested disclaimer text, ingredient declarations, Supplement Facts panel drafts, allergen flags, risk scores, and compliance status indicators — are inherently probabilistic and intended to serve as an efficiency-enhancing drafting aid rather than a definitive compliance determination. Such outputs may contain errors, omissions, formatting issues, out-of-date regulatory references, or recommendations that are inappropriate for your specific product. You must independently verify, manually check, and exercise professional judgment before adopting any output into a final product, label, or marketing material. The Service is an "informational screening aid," not a regulatory decision-making tool.

LabelSift is a business-to-business ("B2B") compliance tool and is not a HIPAA-covered entity, business associate, or business associate subcontractor. The Service is not designed, marketed, certified, or warranted as compliant with the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), the Health Information Technology for Economic and Clinical Health Act ("HITECH"), the EU General Data Protection Regulation ("GDPR") provisions governing health data, or any other law regulating the processing of personal health information. You are strictly prohibited from uploading, submitting, transmitting, or processing through the Service any "Protected Health Information" ("PHI") as defined under 45 CFR 160.103, any "personal health data" subject to GDPR Article 9, any "consumer health data" subject to the Washington My Health My Data Act or similar state laws, or any other data subject to heightened health-data legal protections. The Service may be used only with formulation, ingredient, manufacturing, and business information that is not personal health information.

The Service does not provide medical, nutritional, dietary, health, or therapeutic advice to any individual. The Service is not a substitute for a licensed dietitian, nutritionist, physician, pharmacist, or other healthcare professional. If you are an individual consumer considering the use of a dietary supplement, consult a qualified healthcare provider. The Service is offered to business users for B2B compliance work and is not intended for use by individual consumers seeking personal health guidance.

Before your first use of the AI Rewriter, AI Scanner, AI Fixer, or first non-watermarked label export, the Service will present an in-app clickwrap dialog. By clicking "I Acknowledge" (or otherwise indicating assent in that dialog), you confirm that you have read, understood, and agreed to this FDA Disclaimer Addendum. The following three subsections describe the exact scope of your acceptance, what we will record, and the consequence of declining.

YQGate Inc. may update this FDA Disclaimer Addendum from time to time. Material changes will be announced through in-product notifications and, for existing users who have previously given clickwrap assent, will trigger a re-consent flow. Your continued use of the AI-powered features of the Service after a re-consent prompt constitutes acceptance of the updated version. The version date, version number, and content hash of the disclaimer in effect at the time of your acceptance are recorded in our audit log.