FDA Dietary Supplement Compliance
In the United States, the Food and Drug Administration (FDA) governs Dietary Supplements. The Dietary Supplement Health and Education Act (DSHEA) which came into effect in 1994 passed by Congress. Dietary supplements are products whose route of administration is oral consumption and contain dietary ingredients such as herbals, botanicals, vitamins, minerals and amino acids as a few common category of ingredients.
Dosage forms for dietary supplements include capsules, tables, gummies, powders, liquids (in shot format). Dietary suplements are used for self care purposes. It is important to note that Dietary supplements are not meant to treat, diagnose, cure or alleviate the effects of diseases.
Quality Smart Solutions provides compliance solutions to gain entry into the U.S. market. We ensure your products are FDA and FTC compliant. Our solutions include:
- Dietary Supplement Label Compliance
- Supplement Facts Panel Creation
- Health Claims Substantiation dossier
- 30-day pre-market notification
- New Dietary Ingredient (NDI) notification
- Facility Registration and Renewal
- US Agent Service
With our US regulatory expert having reviewed over 1500 labels we have the experience and knowledge you can trust to ensure your Dietary Supplement is compliant in the eyes of the federal and state regulatory authorities.