At this time, the same type of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations every other year.
With the threat of biological and chemical terrorism and warfare on US soil, Homeland Defense and Security and a number of Systems of Surveillance have been implemented to protect the safety of the public pertaining to consumable products. Quality monitoring is a must on all levels of transport and manufacturing.
Dietary Supplements with respect to R&D, GMP, GLP, Labels, and other are under the same guidance and scrutiny, regulatory rigor as performed with drug development. The fiduciary considerations are much the same. Zero tolerance for error.
Lets start slow...if you are involved in a holding company, a company that only sells, a company that does not modify any parameters or characteristics of a product once manufactured, to include but not limited to use, therapeutic value, composition, dosage, delivery methods, must follow exactly the same information provided them from the manufacturing company. A Food Facility as per FDA must register only once, however, section 102 of FSMA, requires your facility to renew its registration with FDA every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. A mandatory requirement.
The good news is that you are not required to resubmit all of the registration information during your renewal year unless the registrant made facility changes to initially submitted registration materials.
Who may register for the company? The owner, operator, agent in charge of operations, or an individual authorized by one of them, may register the FFA.
Since 2005, they is an industry push towards dietary supplements, in accordance with a change towards holistic, natural, organic, alternative approaches to to health rather than drugs manufactured with chemicals and ingredients unknown to human body systems. The public, perhaps a bit sooner than the industry began a more holistic, natural approach to health initiatives and changing life styles.
In the last 7 years, numerous pharmaceutical companies or brand start-up companies have asked a number of regulatory and compliance questions pertaining to dietary supplements and FFA. In the past decade, FDA is working on nonbinding recommendations and requirements for FFA and there are questionnaires pouring in from companies, old and new, as to what is allowed and what is not, what do we have to do, what is required, what is guidance, what is nonbinding, what are suggestions and what is not, are we in compliance? This year I will be writing a series of informational posts pertaining to FFA and FDA.
More to come... and welcome back!
A dietary supplement company just reviewed by Dante, myself, and our extended staff may be of interest to you, that is, visit www.activenoni.com.
