FDA/FTA Regulatory Compliance
The Mission of the Vitamin Consultancy is to enable industry actors, such as dietary supplement companies and health care practitioners with their own labeled products, to effectively and efficiently operate their businesses to FDA and FTC standards.
Third-Party Audit of Contract Manufacturer / Packager / Shipper Facilities for FDA GMP standards.
I review your product copy, including your sales sheets, web sites and labels for FDA standards.
Claim substantiation must meet both FDA and FTC regulatory standards. My mission is the enable all dietary supplement purveyors to meet those standards.
In 2000 FDA issued the Structure and Function Claims Regulation which tells dietary supplement purveyors how they can make the ordinary support claims that are typical for dietary supplements. The Regulation requires companies to file Claims Notices with FDA for every claim they make for every product, by ingredient. The industry has not paid enough attention to this required Notice, but the FDA has begun to enforce the rule by expecting to see the proper Notices when the company is inspected, as all owners of labels will be.
FDA Good Manufacturing and Marketing Practices required dietary supplement purveyors to document the way they do business, since the companies are considered food-handling operations. This means thorough Standard Operating Procedures. My SOP format has been vetted by FDA inspection. The twenty SOPs cover the full scope of activities from sourcing ingredients, through manufacturing, packaging, shipping and customer service... all the factors over which the label-owner is expected by FDA to be "in a state of control." This document is essential for the operation of your business.
My Red Flag review takes into account FDA and FTC guidelines regarding claims. This includes careful consideration of testimonials.