The paper, authored by USP’s Nandakumara Sarma, Gabriel Giancaspro, and Jaap Venema and published in Drug Testing & Analysis, points out that current Good Manufacturing Practices (cGMPs) are set by a manufacturer's own private specifications and these yield a lack of uniformity across the industry.
Dr Nandu Sarma, Director of Dietary Supplements at USP and lead author on the paper, told us: “We believe that the universal adoption of the USP–NF science-based public standards would serve regulators (e.g. the FDA), manufacturers and consumers by improving the consistency and quality of DS marketed in the USA.
“This may be accomplished by strengthening GMP provisions to require conformance with standards established by USP–NF or other compendia when a monograph title is used as the name of an ingredient or product. We advocate for the use of public standards during the discussions with the regulators and manufacturers.”
Dr Sarma said that they have received support for these proposals from several quarters and are pleased to know that these public standards and guidelines (best practices) are currently adopted voluntarily by several major manufacturers.
“It is uncertain if the wider industry will embrace these proposals at this time,” he added.
Commenting on the paper’s proposals, Dr Duffy MacKay, senior vice president of scientific & regulatory affairs at the Council for Responsible Nutrition (CRN), told us that making a compendial standard compulsory would require a change to the law, and that would probably include a robust discussion about many different issues, not just GMPs.
(Compendial standards are included in the Dietary Supplement Health and Education Act (DSHEA) under misbranding provisions. In other words, if a supplement product claims to conform with an official compendium (USP–NF) but in reality does not then the product is misbranded. USP argues that this creates a disincentive for manufacturers to claim compendial standards on their labels, which gives consumers less transparency.)
Dr MacKay said: “USP’s position is that the quality and consistency of dietary supplements are questionable without a compendial standard. But responsible companies allowed to set their own specifications are going to set reasonable specifications. There is nothing to stop a company using compendial standards, and many companies do. With botanicals people use monographs from AHP or AOAC, for example. They are one way to ensure quality but they’re not the only way.
“The industry has embraced this flexibility, particularly with botanicals,” he added.
“USP is required on the drug side, and the proposals made in this manuscript make sense for their business.”
The USP authors also discuss the topic of adulteration, and note that while USP public standards are intended to provide the analytical tools to detect adulteration the availability of these tools is not sufficient to prevent unscrupulous criminal supply of adulterated products.
“Therefore, the USP is developing a Dietary Supplements Adulteration Database of the incidences of DS adulteration to provide an easily searchable public database of the risks of adulteration and the available detection methods, similar to how the USP's Food Fraud Database has analyzed the economically motivated adulteration of food ingredients,” they wrote.
Dr Sarma told us that this new Dietary Supplements Adulteration Databaseis currently in development, and USP hopes to launch the database in Spring 2016.
Drug Testing & Analysis
The perspective paper is part of a special issue of Drug Testing & Analysis about dietary supplements edited by Pieter Cohen, Bastiaan Venhuis, and Simon Brandt.
“Some people look at the industry and propose a drug-like solution – what a product has to be like every time, how they have to be tested every time, and why this should be required,” said CRN’s Dr MacKay. “That’s a drug model. It’s easy to see how some critics have come to that conclusion. But viewing these products as foods and supplementing the diet make it a struggle to blend those two worlds.”
The dietary supplement issue of Drug Testing & Analysis is interesting, said Dr MacKay. “This journal has taken on supplements as one of their strategic initiatives, but this journal is called Drug Testing & Analysis. If there is a worry about Viagra showing up in dietary supplements, then I can see why there is an interest, but don’t let the tail wag the dog. It seems a little bit disingenuous to take the spiking issue to mean that there is a need to require compendial standards.
“But I appreciate that people are putting ideas out there, and it’s good to have dialogue in the peer-review literature.”
Source: Drug Testing & Analysis
Published online ahead of print, doi: 10.1002/dta.1940
“Dietary supplements quality analysis tools from the United States Pharmacopeia”
Authors: N. Sarma, G. Giancaspro, J. Venema