Dietary supplement GMP regulations have confused and challenged industry on several points, but one oft-cited issue I've heard from industry is the challenge in determining who is responsible for what parts of GMPs in situation involving manufacturing and other partnerships. For companies who partner with contract manufacturers to make private label supplements, the answer just got a little clearer.

Industry attorney Justin Prochnow, of Greenberg Traurig  LLP, highlighted several key sections of a recent warning letter that he says emphasizes a private label distributor/marketers' obligations under the GMPs. In the April 26, 2013 warning letter, FDA advised Pristine Bay LLC (dba Vianda): if you  distribute supplements that bear your name but are made by a contract manufacturer, you are still responsible for ensuring those supplements are made in compliance with supplement GMPs.

" Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplement products into interstate commerce in their final form for distribution to consumers," FDA wrote. "As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements."

FDA emphasized that a private label distributor/marketer may contract out its manufacturing but can't contract out its responsibility to ensure the private label supplements are not adulterated or in viiolation with GMP regulations.

" Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations," FDA wrote.

For more specific information on GMP responsibilities of private label marketers/distributors, check out the on-demand video by industry lawyer Marc Ullman, Esq., entitled, "GMP Responsibilities of Brand Owners," which is a part of INSIDER's recent Digital Summit on Contract Considerations & GMP Compliance. The summit also includes a video from Prochnow on forging a well-written contract with contract manufacturers.