As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer. In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge. Most dietary supplement marketers have demonstrated adequate control over their contractors, but FDA still issues Warning Letters for firms who are not providing proper oversight of the contractors. These Warning Letters often admonish the firms for not knowing the “what and how” their products are manufactured, i.e., they abdicate their responsibility for compliance, expecting the contractor to take all responsibility for GMP compliance and quality. This “what and how” requirement is mentioned in the FDA’s response to Comment 27 of the Preamble to the GMPs, published in 2007:
“In cases where a distributor contracts with a manufacturer to manufacture a dietary supplement that the distributor then distributes under its own label, the distributor has an obligation to know what and how manufacturing activities are performed so that the distributor can make decisions related to whether the packaged and labeled product conforms to its established specifications and whether to approve and release the product for distribution.”
The more compliant dietary supplement firms partner with the contractor and exercise oversight for the manufacturing and testing of their products. They know the “what and how” for their products. This includes an understanding of:
- The source of components, ingredients, and packaging materials;
- Manufacturing and packaging controls;
- Testing controls;
- Any problems during manufacture;
The Quality Assurance department from the marketer must release the product for distribution.
There is a cost involved in providing the proper oversight, but the oversight gives you the peace of mind in knowing you are marketing a quality product which is GMP compliant.
For more information on the GMP requirements for dietary supplement virtual companies, contact Lachman Consultant Services, Inc. at 516 222 6222, Eric Richmond at e.richmond@LachmanConsultants.com, or Mike Plover at m.plover@LachmanConsultants.com.