Claim Substantiation

We'll help you determine which claims your product qualifies
for and what certification or substantiation is required.

According to Federal Trade Commission (FTC) rules, all claims must be truthful, not misleading and supported by data.  The claims that can be used on products such as drugs and medical devices, which must be reviewed by FDA prior to market entry are stipulated as part of the approval process. The claims that appear on food, dietary supplement and cosmetic products must also have supporting data, be certified by a third party or comply with detailed FDA rules. 

Claims such as ‘organic’, ‘gluten free’ and ‘non-GMO’ are certified by third party organization. Some claims regarding food effects on health have been pre-approved by FDA but there are very detailed requirements that must be met before the claims may appear on product labels, brochures and websites.

Improper claims not only expose your company to the risk of enforcement action from FDA or other Federal Agencies, they can also make you vulnerable to class action lawsuits.  Improper ‘natural’, ‘sustainable’ and ‘made in the USA’ claims have caused trouble for many companies in recent years.

View resources on Claim Substantiation.


Compliance Simplified

We'll help you cut through the red tape.