Dietary Supplement GMPs: Repeat Offenders Beware

By Ricardo Carvajal - 

Recent FDA actions suggest that dietary supplement firms who fail to correct deficiencies in their GMP’s do so at their peril.  For example, FDA recently filed a complaint for permanent injunction against ATF Fitness Products, Inc. et al. ("ATF"), a manufacturer and distributor of dietary supplements.  The complaint alleges that a recent inspection found numerous deviations from the GMP requirements at 21 C.F.R. Part 111.  The complaint further alleges that ATF engaged in substitution of dietary ingredients and dietary supplements so as to render misbranded certain of its products, and that ATF failed to reports serious adverse events.  The complaint contends that ATF “did not respond to the Form FDA-483 or promise to correct all of the deficiencies,” and that a prior audit by a consultant had identified numerous significant GMP deviations that were the same as those identified by FDA.

As another example, FDA filed a seizure complaint against dietary supplements manufactured and distributed by Syntec Nutraceuticals that are alleged to have been prepared, packed or held under conditions that do not meet GMP requirements.  According to the complaint, FDA’s most recent inspection identified a number of significant violations that were similar to those identified in two previous inspections.  Some of the supplements are also alleged to have been marketed as unapproved new drugs.

When coupled to DOJ’s announcement of prison terms in another case arising in part from GMP violations (see our prior blog posting here), the ATF and Syntec cases suggest that significant and continuing alleged GMP violations can be expected to weigh heavily into FDA’s decision to pursue court action.