SupplySide West Update: Quality Assurance The Promise Made to Congress and ConsumersSupplySide West Update: Quality Assurance The Promise Made to Congress and Consumers
GMPs (good manufacturing practices) and quality assurance (QA) are still the biggest issues the dietary supplement industry faces.
February 2, 2016
Editor’s note: 2016 marks the 20th SupplySide West, and INSIDER is celebrating all year. We asked speakers from the first SupplySide to update the industry on the topic. In 1997, Alexander Schauss spoke on Quality Assurance & ISO 9000.
It was an honor to speak at the first SupplySide West in 1997 on quality assurance (QA) and GMP (good manufacturing practice) issues. Prophetically, it remains one of the most important, if not the most important, issue the industry faces today.
During Sen. Orrin Hatch’s (R-Utah) discussion on the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) in 2014, he expressed concerns with the problem of spiked products: “One continual thorn in the side of responsible dietary supplement manufacturers is reports that illegally spiked products are being sold as dietary supplements." He expressed concern that “responsible manufacturers are unknowingly receiving tainted ingredients. That is why testing and quality controls have to be an important component of manufacturing."
On the day in October 1994 that the House of Representatives passed DSHEA without objection, and the bill was forwarded to President Bill Clinton for his signature, Sen. Hatch, the bill’s sponsor in the Senate, asked key leaders who worked with him and Rep. Bill Richardson (D-New Mexico), the House sponsor, to meet the Senator at his office.
Many of us at that meeting focused our efforts and resources in early 1992 to seek passage of DSHEA to establish a regulatory framework for dietary supplements, rather than let it be subjected to draconian regulations applied to drugs.
Just a month before Sen. Hatch introduced the Health Freedom Act of 1992, which became DSHEA, I was recruited by the board of directors of Citizens for Health (CFH), a 501c4 nonprofit organization, to become the executive director of the national grassroots organization. As Sen. Hatch stated on Oct. 27, 2014, during his reflection on the passage of DSHEA 20 years earlier, “Perhaps most importantly, there was unprecedented grassroots support.… The mail was crushing," he said commenting on the huge amounts of mail that consumers sent to Congress in support of the supplement industry.
Shortly after taking on the helm of CFH, I met with the Speaker of the House, Congressman Tom Foley (D-Washington), to seek bipartisan sponsorship of Sen. Hatch’s bill in the House. I learned that CFH would have to convince Rep. Richardson—a key member of Congress—to support Hatch’s legislation.
As I had earned two degrees at the University of New Mexico and worked for the state’s court system after graduation, I contacted Rep. Richardson to discuss the merits of the bill, and the problems faced not only by industry, but by consumers if a regulatory structure for dietary supplements wasn’t passed by Congress. After protracted discussions over the next two months, he made the announcement on National Public Radio (NPR), during the Democratic National Convention in New York, that he would sponsor DSHEA in the House of Representatives, finally giving bipartisan support to the legislation.
Rep. Richardson represented the 3rd District of New Mexico, which just happened to be where the first cases of deaths associated with eosinophilia myalgia syndrome (EMS) occurred. EMS is a painful and disabling condition that was eventually associated with an L-tryptophan ingredient supplier in Japan that had used a novel fermentation method using genetically modified organisms (GMOs) that reached American ingredient suppliers, and eventually found its way into dietary supplements.
If anyone in Congress wanted to regulate supplements as a drug, it was Rep. Richardson. In one conversation, he described the grief and anger expressed by families in his district who asked him why Congress and FDA hadn’t done more to regulate supplements, which in the case of the L-tryptophan incident, resulted in more than 30 deaths and thousands of emergency medical service (EMS) cases nationwide.
It took considerable time and effort for Rep. Richardson to understand the problem was not the industry, but a problem related to QA. Pass DSHEA, impose GMPs on the industry, and thereby significantly reduce the risk of such tragedies, and maybe such incidents could be prevented. That, along with 20 years of reports from the Centers for Disease Control and Prevention (CDC) showing supplements rarely caused serious adverse events, along with a strong grassroots movement organized by CFH in his district, ultimately led to Richardson’s decision to become the sponsor in the House, and give the bill bipartisan support.
Now, let’s move the clock forward to the day DSHEA passed, and consider what Sen. Hatch told the supporters of DSHEA, including leading trade associations, invited to his office. I will never forget what he said at the end of the meeting: “Be sure everything the industry says is truthful and not misleading, or don’t come back to ask for my help again."
As veterans of the industry know, “Truthful and not misleading" is the foundation upon which the industry represented to Congress that it would abide by if given the opportunity to have supplements regulated like foods rather than drugs.
Let’s think what “truthful and not misleading" means, both in the context of the presentation on QA made at SupplySide West in 1997, and today.
It means that everything a manufacturer and/or distributor states about the supplement must be truthful. As recommended in 1997, we need to use every tool at our disposal to verify the information on the label is what it claims. And to do that, manufacturers and distributors had to establish rigorous quality control (QC) and assurance standards built into every phase of the product’s creation.
To emphasize the state of the industry’s ability to support label claims, I released the results of 10 independent lab analyses performed prior to my 1997 presentation. The supplements selected were all manufactured by leading industry companies and readily available to the public through thousands of outlets. Without mentioning company names, the results illustrated the industry had a serious problem. One that would subject the industry to repeated criticism if not resolved. It would undermine the efforts of companies that set aside resources to implement effective QC/QA standard operating procedures (SOPs) and GMPs.
One of the slides I presented quoted specific provisions in DSHEA related to GMPs. Upon reading them, it was obvious that industry should not delay implementing GMPs or wait for FDA to promulgate GMP regulations, but take steps to get certified as GMP-compliant using third-party certifying agencies, such as had been development by the National Nutritional Foods Association (NNFA), now the National Products Association (NPA).
As one of the six ad hoc members that worked for two years in developing GMPs for the supplement industry in the mid-1990s, through our voluntary membership on the Compliance and Label Integrity Committee (ComPLI) at NNFA, key provisions of NNFA’s GMPs were presented to the audience to illustrate key elements essential to establishing GMPs.
To illustrate the importance of truthfulness as it relates to adulteration, a case history was presented. It occurred at a trade show when a woman presented a sexual enhancement product she claimed contained ingredients her husband had discovered that were “100 percent natural, made from herbs and as effective as Viagra®." She guaranteed the product would work within 30 minutes. She provided six tablets as a sample along with some literature that included a list of the ingredients.
Three capsules were sent to one of two labs. One of the labs called a few days later and informed me that the tablet contained sildenafil (Viagra®)—lots of it, far more than the highest dose sold by prescription. Astounded, I contacted the company and asked to speak to the supplement’s formulator, who denied it was possible. It wasn’t long before FDA took action against the company.
What should worry us as well is that the second lab had not detected the presence of the approved pharmaceutical ingredient (API), even after having the tablets for three weeks before issuing their report confirming the presence of the listed ingredients.
Here we are 20 years later, and guess what? The problem of product adulteration continues. And the need for industry-wide effective QA is as important as ever. But what can be done to deal with industry outliers who unknowingly or knowingly adulterate supplements?
With the announcement on Dec. 20, 2015, that FDA elevated the Division of Dietary Supplement Programs status to the Office of Dietary Supplement Programs (ODSP), it became clear that it will take numerous actions to protect the public health, including enforcing dietary supplement compliance with GMPs, and giving priority to cases in which GMP violations:
• Potentially compromise product safety;
• Fail to ensure product identity, potentially jeopardizing consumer safety; and
• Result in consumer deception, when, for example, manufacturers do not verify the identity of their raw materials.
With the agency’s announcement emphasis, hopefully by the time SupplySide West celebrates its 25th anniversary, adulteration and contaminant issues will be a thing of the past. GMP compliance will be the standard industry-wide. Every supplement’s ingredients will be within acceptable ranges as claimed on the label. And consumer confidence will be at an all-time high.
Alexander G. Schauss, Ph.D., FACN, CFS, has been studying nutrition and botanical medicine since his 1969 landmark study of high-dose ascorbic acid consumption and its effect on opiate receptors. A former clinical professor of natural products research, associate professor of research, and adjunct research professor of botanical medicine, he is currently the senior director of research at AIBMR Life Sciences (aibmr.com), and a research associate in the College of Science at the University of Arizona. A prolific research scientist, he is the author/co-author of nearly 250 publications, including 23 books and 34 chapters, in the fields of nutrition and botanical medicine.
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