Experts “Somewhat Aghast” at Dietary Supplement Non-Compliance with cGMP

In a recent webinar organized by the National Products Association (NPA), Dr. Dan Fabricant, Ph.D., Director of the FDA’s Dietary Supplements Program, said he was “somewhat aghast” at the level of non-compliance with dietary supplement cGMP (current good manufacturing practice). Although he said progress had been made to raise awareness about cGMP, the same mistakes were being made over and over.

Dr. Fabricant stated:

“I’m somewhat aghast at the degree of non-compliance. We’re seeing some of the same mistakes from warning letter to warning letter and that’s concerning. Whether it’s failure to prepare batch records, problems with specifications. There’s failures of adequate quality control… If people are letting material out the door that’s out of spec, that’s a real concern… It’s the old adage with GMPs — if you don’t write it down, it’s not happening.”

Some of the safety issues cited by Dr. Fabricant stemmed from a lack of reporting about adverse events. Because only a small fraction of events are ever reported, it is essential to keep an accessible database. However, Dr. Fabricant was aware of the following problems:

  • Under-reporting of adverse events, which could hide severe safety issues associated with a dietary supplement
  • Failing to provide an address or phone number for people to call to report serious adverse events
  • Manufacturers listing the FDA’s adverse event phone number instead of their own

During the webinar, some were also concerned about the practice of dry labbing. First exposed by NBC’s Dateline, dry labbing is the practice by which drug manufacturers hire laboratories that fraudulently conduct testing regarding the potency and identity of labeled ingredients in a supplement. The FDA does not investigate such laboratories. Instead, the FDA trusts the manufacturers to hire good labs to perform such testing. According to Dr. Fabricant, “we focus on manufacturers and distributors because they introduce products into interstate commerce.”

Another issue, brought up by Aaron Secrist, a quality and regulatory manager, regarded the FDA’s 483 forms. After the FDA inspects a dietary supplement manufacturer, the 483 form is used to communicate the inspector’s concerns. The manufacturer is not legally obligated to comply with the suggestions. Mr. Secrist said that companies were still failing to comply with “basic cGMP tenets.” These include failing to prepare master records of the drug formula, failing to create and document specifications, and failing to adequately sample the product to ensure quality.

Do I Have a Dietary Supplement Lawsuit?

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If you or a loved one has suffered from severe side effects after taking a dietary supplement, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.