Dr Bimal Ashar focused on an example of selenium toxicity to demonstrate how the 1994 Dietary Supplements and Health Education Act (DSHEA) was a failing regulation and should be revamped in line with drug rules.
“The last decade and a half has been fraught with significant controversy surrounding the DSHEA,” Ashar said.
“With few exceptions, definitive evidence for the efficacy of dietary supplements for the treatment or prevention of any disease has been lacking, while reports of adverse effects continue to surface. “
“The fact that most patients do not experience adverse events (AERs) from their supplement use should not be solely sufficient to justify their promotion without premarket evaluation.”
Dan Fabricant, PhD, vice president of scientific and regulatory affairs at the National Products Association (NPA), questioned the attack on a regulation that had been shown to be effective in the instance cited.
"I think the time has come for authors who do not understand regulatory affairs, GMPs and pharmacovigilance to reassess writing stories like this,” he said.
“First, if the regulatory framework that was in place at the time of this incidence wasn't adequate or effective, as the authors dance around in their story, then they need to explain exactly how FDA was able to act so swiftly and accurately to identify the breakdown in the manufacturing process and effectively protect the consumer by having the specific batches of product removed from commerce.”
He added: “The agency used the signal from the AERS to distinguish the matter and then by reviewing the firms Good Manufacturing Practice (GMP) documents and records were able to indicate where there was an accidental overage and alert the consumer accordingly. The laws and regulatory framework worked to protect the consumer, that is the only intelligent conclusion that can be drawn in this case."
The chief executive and founder of the American Botanical Council, Mark Blumenthal, said the study misinterpreted the manner in which DSHEA had passed into being and functioned.
GMPs were not, as Ashar suggests, a reaction to recent contamination cases – they had in fact been written into the original legislation in 1994, but their creation was delayed.
“As long as the GMPs were not issued and eventually enforced, many quality-related problems related to dietary supplements continued, many of which could have been prevented with earlier issuance and enforcement of GMPs,” Blumenthal said.
“The author exaggerates the manufacturing and safety issues when he implies that the unfortunate situation in which a rogue company added a toxic level of selenium to a liquid dietary supplement is typical of the dietary supplement industry.”
He said the company in question had poor GMP measures in place.
“The public and regulators are justified in being alarmed by the selenium case, but it is in no way typical of the ethical, responsible manufacturers which constitute a significant portion if not large majority of the supplement industry.”
Archives of Internal Medicine
‘The Dietary Supplement Health and Education Act: Time for a Reassessment
Comment on "Acute Selenium Toxicity Associated With a Dietary Supplement"'
Author: Bimal H. Ashar, MD, MBA.