Labeling and Manufacturing Compliance for Dietary Supplements is About More than Avoiding Characterization as a Drug

We are all accustomed to seeing Warning Letters issued by the Food and Drug Administration for products marketed as dietary supplements that make claims that the Agency believes cause the product to be an unapproved new drug or that contain ingredients that are banned or otherwise inappropriate for dietary supplements. The manufacturer of several dietary supplements recently received a Warning Letter that contained neither of those allegations, but focused, instead, on failures to follow current Good Manufacturing Process (cGMP) requirements and label omissions and errors. The Warning Letter reinforces the point that dietary supplement manufacturers must comply with all FDA requirements, not only those related to promotion.

Background

The Warning Letter stemmed from an inspection of a dietary supplement manufacturing facility at which FDA alleged some supplements were manufactured and others were received for distribution from other manufacturers. Quality deficits were cited in procedures related to both.

FDA included in the Warning Letter failures to have a number of written procedures in place to ensure the identity and proper packaging and labeling, for storage and distributing operations, and for handling of returned products, among others. For those dietary supplements that are manufactured by another manufacturer that the inspected company distributes, FDA noted that even if the company relies on others to manufacture and package, the company “introduces or delivers . . . the dietary supplement into interstate commerce in its final form for distribution to consumers.” As such, FDA reminds the company that it has “overarching and ultimate responsibility to ensure that all phases of production” comply with cGMPs and it cannot contract away its legal obligations.

FDA also stated that some of the dietary supplements were misbranded for label errors. These errors ranged from the failure to include ingredients on the label to omitting the number of servings. FDA also included a few comments about the labels that it did not identify as violations, such as a comment that the Supplement Facts were located on the wrong side of the label (to the left of the principal display panel, rather than to the right). This is a reminder that the technical detailed requirements also matter.

AGG Observations

• As we have seen it do in more and more Warning Letters for other regulated products (drugs and devices), FDA is reinforcing its position that companies cannot contract away their ultimate regulatory responsibility. For more on the inability to contract away responsibility for cGMPs for drugs and devices, as well, see our recent bulletin Get by with a Little Help from My Friends (Maybe Not): FDA Reiterates Reliance on Others Doesn’t Ensure Regulatory Compliance. 
• This Warning Letter serves as a reminder that even those dietary supplement manufacturers which make appropriate dietary supplement claims must continue to pay attention to the details of cGMP compliance and labeling. Presumably, the inspection that lead to the Warning Letter was not prompted by claims on the Internet or in other promotion, but FDA can still show up for an inspection and will look closely at labels, as well as at quality-related processes and procedures.