Attorney at Law in NJ 1971 - 2006 / NJ Notary Public #2398815
We Are Your Compliance Experts!
FDA & FTC Are NOW Dramatically Increasing the Pressure
On All Dietary Supplement Label-Owners
To be in Compliance with All Applicable Regulations
TO IMPOSE THEIR NEW CONTROL SYSTEM
FDA HAS 7,000 NEW AGENTS
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Member Entry
Click Here
FDA & FTC Are NOW Dramatically Increasing the Pressure
On All Dietary Supplement Label-Owners
To be in Compliance with All Applicable Regulations
TO IMPOSE THEIR NEW CONTROL SYSTEM
FDA HAS 7,000 NEW AGENTS
-----------------------------------
Member Entry
Click Here
Dietary Supplement Companies: CLICK HERE.
NEW FDA REQUIREMENTS - "...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 |
WHY DID THE FDA HIRE 7,000 NEW AGENTS?
5.10.13 -- NEW FDA warning letter: obligations of private label distributors A new FDA warning letter outlines the obligations of private label distributors to ‘ensure that all phases of the production of [a] product are in compliance with dietary supplement CGMP requirements’. http://www.nutraingredients-usa.com/Regulation/FDA-warning-letter-highlights-obligations-of-private-label-distributors |
The Network
The Regulatory Compliance Network™ was initiated by Ralph Fucetola JD for mutual collaboration among natural product, dietary supplement, advanced healthcare ("CAM") practitioners. The Goal of the Network is to be a "one stop" center for regulatory compliance. The Vitamin Lawyer Consultancy is a founding member of the Network.
It is being established to marshal the professional resources needed by start-up and established vitamin companies, non-medical devices companies and healthcare practitioners such as physicians, naturopaths, chiropractors, nutritionists and others. I offer my SOP Certification and other Vitamin Lawyer Consultancy services while other members will offer other services, such as substantiation research, clinical studies and label designs.
It is being established to marshal the professional resources needed by start-up and established vitamin companies, non-medical devices companies and healthcare practitioners such as physicians, naturopaths, chiropractors, nutritionists and others. I offer my SOP Certification and other Vitamin Lawyer Consultancy services while other members will offer other services, such as substantiation research, clinical studies and label designs.
"The Network links Label Owners/Distributors, Manufacturers and Industry Professionals together, leveraging their collaboration to enable regulatory compliance for the dietary supplement and medical food industry." rf
Sher Komisar: 914-966-8053
[email protected]
Program Investment Cost: Click Here
Click Here for: Services for Dietary Supplement Companies
Click Here for: Services for Contract Manufacturers
R. Fucetola JD
Sher Komisar: 914-966-8053
[email protected]
Program Investment Cost: Click Here
Click Here for: Services for Dietary Supplement Companies
Click Here for: Services for Contract Manufacturers
R. Fucetola JD