Pharmacy group’s papers show marked ignorance of supplement industry, expert says

By Hank Schultz contact

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©Getty Images - Tom Werner
©Getty Images - Tom Werner

Related tags: Pharmacy

Recent position papers by a pharmacy group shows a startling lack of comprehension of dietary supplement regulation and quality, according to a prominent pharmacy professor.

An industry group called American College of Clinical Pharmacology recently published two position papers on dietary supplements. One calls into question the regulation of the sector, while another makes the case that pharmacists need more education on supplements.  Both papers were published in the Journal of Clinical Pharmacology​.

In the regulation paper, the authors argue that the federal oversight of the dietary supplement industry is insufficient to protect consumers.  But the reasoning given in the paper demonstrates a misunderstanding of the federal regulatory structure, according to Rick Kingston, PharmD, who is a  professor at the University of Minnesota.  Kingston is the president of scientific and regulatory affairs for SafetyCall International. 

Questionable claim about FSMA

As an example of the authors’ imperfect understanding of the regulatory regime, they presume the Food Safety Modernization Act (FSMA) was passed specifically to fix problems with DSHEA, the Dietary Supplement Health and Education Act, the overarching regulation of the dietary supplement industry.  

“Critiques of the DSHEA by professional organizations in the early and mid-2000s led Congress to enact the Food Safety Modernization Act in 2010,”​ they assert.

But FDA itself has nothing to say about supplements when it lists the reason for the need for FSMA: “Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.” ​(Emphasis from FDA.)

Optional testing?

The authors also make statements sure to raise eyebrows within the industry, such as: “Key differences between FDA-approved drugs that have to adhere to part 211 of the GMP guidance and dietary supplements that follow part 111 of the GMP guidance are in raw material and finished product testing, which are mostly optional for dietary supplements, no stability or shelf-life testing requirement, and no documentation of change control for dietary supplements.”

Kingston said he was concerned that a communication from a prominent professional group could get into publication with such glaring errors and omissions.

“They don’t seem to understand that these products are already regulated,”​ Kingston told NutraIngredients-USA. 

“The GMPs for supplements are actually pretty robust. Companies just need to follow them,” ​he added.

Incomplete mention of NYAG affair

The paper’s authors also dredged up the New York Attorney General affair in an uncritical manner.  By way of calling the quality of dietary supplements into question, the authors recount the early returns of that 2015 investigation led by then NYAG Eric Schneiderman which alleged that many of the supplements tested with a DNA technology were found to contain little to none of the stated bioactives in the bottles.

But the authors did not report on later developments in that investigation in which the DNA technology used was shown to be not fit for purpose​.  GNC, one of the four major retailers targeted in the investigation, came to an agreement in which Schneiderman admitted that GNC had done nothing wrong​. Schneiderman, while never admitting publicly that the investigation had been in error, essentially let the matter drop.

“They didn’t keep up with what happened with that,” ​Kingston said.

More education needed

Kingston was less critical of the second position paper, agreeing that many pharmacists need more training in the nature of and use of alternative therapies, including dietary supplements.

The authors state that many within the pharmacy field are aware that patients are increasingly looking to their pharmacists for information on dietary supplements. And while some education on the field has been available, many within the industry agree that it is insufficient.

Kingston noted that in many pharmacy curriculums, products like dietary supplements and herbal remedies are treated only in the most cursory fashion, if at all.

“Colleges of pharmacy should have more requirements for education on natural products. My course at the University of Minnesota is specifically dedicated to dietary supplements and natural medicine.  It would be better if more schools had courses like this because these products have become such a presence in the marketplace,”​ Kingston said.

But even in this paper, the authors’ imperfect understanding of the supplement industry came to the fore, via statements like “these non–governmentally regulated products.”

“I applaud the College for calling for more education. In fact, they might want to start with themselves,”​ Kingston observed.

Sources:Journal of Clinical Pharmacology
DOI: 10.1002/jcph.1982
Regulation of Dietary Supplements and Nutraceutical Products in the United States: An Argument for Greater Oversight and Uniform Standards
Authors: Grundmann O, et al.

Journal of Clinical Pharmacology
Front-Line Health Care Professionals Lack Critical Knowledge in Dietary Supplement and Nutraceutical Products: A Call to Action for Comprehensive Educational Opportunities
Authors: Rogge M, et al

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