The United Natural Products Alliance conducted surveys during its November 2015 summit on analytical testing and February 2016 summit on raw materials & supply chain issues. Approximately 130 people attended the November event, with about 140 at the February event. Survey responses averaged approximately 100 for each question, said UNPA. Israelsen presented the results of the surveys at the recent Annual International Conference on the Science of Botanicals in Oxford, Mississippi.
Attendees at UNPA Raw Materials & Supply Chain Summit were asked if it was realistic for the dietary supplement industry to move toward a single seal of quality, with 45% saying yes, and 55% saying no.
“This answer surprised us,” Loren Israelsen, UNPA’s President, told us. “We think it speaks to a couple of issues for product manufacturers and brand holders: the lack of consumer and market awareness of credible certification seals for supplement products and what that means, the large number of bogus and meaningless quality seals that currently appear on supplement labels, and perhaps more importantly, a lack of agreement from manufacturers about the standards and requirements of the credible certifiers.”
But when asked if it was realistic, would the single quality seal be an existing seal or a new one, 81% thought it would have to be a new seal.
“This survey result should serve as a wake-up call to the existing and credible third-party certifiers,” said Israelsen. “If these results indicated that industry is in support of trying to reinvent a quality standard, no matter what we do going forward, it’s most important that we have a vigorous discussion around certifying to a ‘unified’ standard of quality that is agreed upon and understood by all stakeholders. Otherwise, any new seal is meaningless.
“Additionally, the creation of a new seal would necessitate a need to broadly communicate exactly what that quality standard is, how companies can achieve it and how consumers can recognize and choose quality products.”
Spiked products - the most serious threat to the industry?
The survey data also revealed that spiked products have replaced the FDA/FTC and State AGs as the most serious threat to the dietary supplements industry (see figure below).
“Based on the number of FDA warning letters issued for products spiked with illegal drugs posing as dietary supplements and the plethora of inaccurate news reports about ‘illegal supplements,’ this survey result isn’t really much of a surprise to us as the most serious threat to industry by the respondents,” said Israelsen.
“The summit attendees, who by their very presence at either or both of these quality-focused educational events represent companies that are highly interested in these issues, are rightfully concerned about the perception that dietary supplements do not adhere to rigid quality standards. They certainly do not want to be included with manufacturers and products that are not in compliance with the law.”
So what’s the answer? Judging by recent industry initiatives and the survey’s results, supply chain oversight is the key to improving product quality (see figure below).
“After DSHEA was passed in 1994, FDA chose to not include oversight of ingredients and the ingredient supply chain in its DS regulatory structure. We saw this as an unfortunate omission that created a regulatory ‘hole’ in the supply chain,” explained Israelsen. “The enactment of FSMA in 2011 has gone a long way toward correcting this situation as it mandates that suppliers confirm the identity of all dietary ingredients and control of the ingredient supply chain. But these mandates are just now being enforced, and it’s clear that much of the DS supply chain is not familiar with these FSMA regulations.
“Additionally, the intentional or unintentional economic adulteration of botanical ingredients is a challenge, as testing methodologies must evolve to keep up with being able to detect the increasingly sophisticated adulterants being used.
“The bottom line: the need for quality ingredients and transparency within the supply chain is an additional resource burden for the entire supply chain and is causing many companies to review and evaluate their sourcing, supply control and testing protocols. We support these initiatives, which are in alignment with UNPA’s mission to provide consumers with natural health products of superior quality, benefit and reliability.”
Support for GNC’s initiative
Front and center among the supply chain initiatives has been GNC’s Guidelines for Botanical Raw Materials GMPs, which were unveiled at UNPA’s Raw Materials and Supply Chain Summit in February.
The summit’s attendees were asked if they would participate in an industry working group as outlined by the GNC presentation, and 82% said yes.
Speaking with us at the Expo West show recently, GNC’s CEO Mike Archbold said that the response from the industry has been “really good”, which he says is because the company has engaged the industry and worked with the experts. “This was really a product from the industry for the industry,” he said.
“Across the board, we’ve had over 80 different companies involved in the consortium ranging from our fellow retailers to the raw material manufacturers to the pharmaceutical companies to the MLM companies, even to the mass market players in the space,” he said. “Everyone knows that the time is right for us to do something, and credit to the industry for coming together and making this happen.”
There was also overwhelming support for considering a product registry among the UNPA Raw Materials and Supply Chain Summit attendees when asked if they would consider this proposal, as outlined by former FDA official Dr Joshua Sharfstein, MD, in a paper he co-authored in Drug Testing and Analysis.
Momentum for a new product registry for dietary supplements has increased in recent months, with the Council for Responsible Nutrition announcing that its Board had unanimously authorized the creation of a dietary supplement product registry to be launched by the end of the year.