At the NBJ Summit this summer, Dr. Daniel Fabricant, Ph.D., director of the FDA’s Division of Dietary Supplement Programs, was asked his opinion on the status of the dietary supplement industry’s compliance with current good manufacturing practices (cGMP). In response to this question he quoted his mother, stating the following, “if a boat sinks 70% of the time, would you still get on it?” This comment is related to Dr. Fabricant’s belief that the FDA is becoming frustrated with the fact that the same companies are repeat offenders, continually failing to comply with cGMPs. In order to address this situation Dr. Fabricant has indicated that such repeated non-conformance will eventually lead to criminal prosecution. However, the question that many are wondering is whether these observations will lead to further regulation? Or, could it be possible that the FDA agrees with the dietary supplement industry that the Dietary Supplement Health and Education Act of 1994 (DSHEA) gives the FDA ample authority to ensure dietary supplements are safe and are manufactured and sold in compliance with cGMPs?
Dr. Fabricant has now been in office nearly 1.5 years, and he has pointed out that although “there has been no new statutory or regulatory authority since he took office, the FDA has simply been doing a lot more with what’s on the books.” By this statement, and with all of the recent warning letters, FDA has made it evident that under DSHEA, the agency is able to and does address safety, quality and labeling issues to protect the public from adulterated and mislabeled dietary supplements. Maybe now we can finally debunk the myth that the dietary supplement industry is unregulated.
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com