Please Note: I am a retired attorney at law with extensive management experience in natural products companies; I do not provide legal representation or legal advice.
From label compliance through web site "Red Flag" reviews; from FDA required Structure and Function Claims Notices, through SOP/cGMP Certification training; from claim substantiation through medical food use, the Vitamin Consultancy has the consulting services you need to keep your dietary supplement or health care practitioner business fully compliant.
"The FDA showed up unannounced. Said they'd be here for at least six days. We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph Any time during this, and he was there for us."
It took FDA a decade after the adoption of the Dietary Supplement Health and Education Act (DSHEA) in 1994, and amendments, to establish a series Regulations governing the dietary supplement business. With AER (Adverse Event Reporting), SOP (Standard Operating Procedures) and cGMP (Current Good Manufacturing Procedures) companies now find that the must keep certain crucial records, such as their Core Company Data Sheets (CCDS) and a host of logs, records and documents. My SOP system, vetted by previous FDA inspections of some of my clients, will make compliance easy.
FDA: "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training, the type of training, and the person(s) trained." Federal Register, page 34811
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 comply with FDA and FTC regulations.
The Vitamin Consultancy provides detailed webinar training in key areas relating to the marketing and use of dietary ingredients.
The trademark Vitamin Consultancy Oversight Seal assures your customers of regulatory compliance.
In addition to my work with dietary supplement and natural remedy purveyors, I work with emerging companies on Intellectual Property communication. When I was a lawyer, I was one of the first to handle what I call Internet Injunction cases, defending the rights of people to be free of Internet harassment.