FDA Product Classification

FDA Product classification is based on many things including, the product ingredients, claims, and application. The FDA regulates foods, dietary supplements, OTCs, drugs, medical devices and cosmetics under different sets of rules and regulations dicentra assists clients in classification of their products and will establish a pathway to authorization and marketing of their products, including related regulatory obligations.

Our services for FDA Product Classification include the following:

  • Assessing product classification as to whether a product is dietary supplement, food, cosmetic, OTC or drug and advising on the benefits and risks of each;
  • Providing options for qualification into a specific classification
  • Providing the regulatory framework and roadmap for the product classification to sell and market the product compliantly

We encourage companies to invest the time to determine the most appropriate market placement and to be aware of the advantages and disadvantages of a particular route.