dicentra can assist companies in FDA Product Registration of their dietary supplements. We offer FDA regulatory consulting for companies involved in the manufacturing, packaging, labeling or holding of dietary supplement for distribution in the United States. Our function is to ensure that your business complies with the Dietary Supplement Health and Education Act (DHSEA) of 1994 and to assist in product registration.
Our services in FDA Product Registration include:
- FTC, FDA and DSHEA compliance
- Product formula review and classification
- Guidance on all aspects of labeling, marketing and advertising
- Development of the Supplement Facts box
- Structure/Function claim development and substantiation
- Guidance on New Dietary Ingredients (NDI) and Old Dietary Ingredients (ODI)
- Filing of FDA notifications
- Consulting on generally recognized as safe (GRAS) classification and development
- Quality assurance and product testing review
- Guidance on Adverse Event Reporting (AER) (See also Adverse Event Reporting)
- Ongoing liaison with government agencies and client representation