By Wes Siegner –
Dan Fabricant has now left FDA. In his short tenure as FDA division head and spokesperson on dietary supplement matters, the agency devoted more resources to dietary supplement enforcement matters. Moreover, the industry was routinely criticized for failing to file new dietary ingredient notifications ("NDINs") and serious adverse event reports ("SAERs"), as well as, most recently, for widespread “noncompliance” with good manufacturing practices ("GMPs"). In each case, FDA used numbers to illustrate what the agency perceived to be a problem -- but there were also obvious problems with FDA’s numbers:
- NDINs – The high numbers of “expected” NDINs that FDA has repeatedly cited was based on FDA’s controversial interpretations of DSHEA that were published in a draft guidance in July, 2011. Comments from all of the industry trade associations, from Congress and from this firm uniformly criticized FDA’s interpretations as untenable and urged FDA to withdraw the draft guidance. Although FDA has tacitly acknowledged problems with the draft guidance and committed to issuing a new draft, FDA is still basing its accusations of failure to comply with the NDIN requirements on the number of notifications FDA would expect to receive if industry complied with the disputed guidance.
- SAERs – FDA, in advocating passage of the law requiring these reports, argued that the burden on industry would be light because, consistent with the safety of these products, very few reports of serious adverse events would need to be filed. Nonetheless, FDA now points to the low numbers of SAERs to support claims of widespread noncompliance.
- GMPs – FDA’s recent statements on percentages of industry “noncompliance” apparently refer to inspections that result in one or more “observations” by an FDA investigator that a GMP regulation has been violated. Such “observations” are not FDA “findings” of a violation, but are merely the view of one individual FDA employee. FDA’s regulations state that such individual views are not binding on the agency. Rather, these written “observations” are meant to begin a discussion between the inspected company and FDA, and to encourage voluntary corrections when needed. Further, for any FDA-regulated industry, receipt of a 483 is far from exceptional, particularly in cases, as is true with dietary supplements, where an entire industry is subject to new and very detailed GMP regulations, which FDA inspectors are still struggling to understand and apply in a consistent manner.
Companies that choose to ignore the rules deserve to be singled out. However, FDA should not use misleading raw numbers to unfairly stigmatize the entire dietary supplement industry, or any FDA-regulated industry. We hope that future FDA numbers relating to dietary supplement industry compliance will be more balanced.