Under the Dietary Supplement Health and Education Act (DSHEA), claims regarding the effect of a supplement ingredient upon the structure and function of the body are permitted provided the claims are supported by competent scientific evidence.
To include structure function claims on the labels and in promotional materials, companies must notify the FDA of the claims no later than 30 days after first marketing the supplement with the claims.
Companies must also have the necessary evidence to support your product claims and withstand FDA scrutiny.
Does your company have the technical and regulatory personnel needed to develop and substantiate structure function claims?
AER IS HERE
All serious adverse events must be reported to the FDA. Are your ready?
cGMP REQUIREMENTS
The rules apply to you even if you use contract manufacturing. Do your SOP's measure up?
CLAIMS DEVELOPMENT
Does your research support your claims? Let us do your research for you.