Claim substantiation is the scientific validation of product marketing statements such as “hydrating,” “hypoallergenic,” or “clinically proven.” It ensures that every claim is truthful, not misleading, and backed by credible evidence (clinical studies, instrumental data, or literature reviews). This process protects both consumers and brands while meeting regulatory expectations.

Robust substantiation safeguards consumer trust, brand reputation, and regulatory compliance. Without it, companies risk:

• Regulatory enforcement (warning letters, penalties, product withdrawal)

• Legal disputes (competitor or consumer litigation)

• Reputational harm (loss of consumer confidence and brand credibility)

Some key regulatory requirements for claim substantiation include:

·        EU: Cosmetic claims must meet the Six Common Criteria under Regulation (EU) No 655/2013.

·        USA: FDA requires claims to be truthful and not misleading; FTC requires “competent and reliable scientific evidence” for advertising.

·        Other Markets including LATAM and ASEAN increasingly mirror EU and US expectations, requiring documented, science-based substantiation.

All claims require evidence—from functional (“moisturizes for 24 hours”) to sensory (“non-greasy feel”) to clinical (“reduces wrinkles in 4 weeks”). Evidence may include:

• Clinical and consumer studies

• Instrumental testing

• Ex vivo or in vitro data

• Literature reviews and toxicological justifications

If you are interested in Claim Review and Substantiation services from SciQra, you can visit our website at www.sciqra.com and navigate to the Contact section. There, you will find information on how to contact SciQra and discuss your specific requirements. Our team will guide you through the process and provide tailored solutions to meet your needs.