Natural products quality expert on industry challenges 10-years after GMPs
September 5, 2017
by John Weeks, Publisher/Editor of The Integrator Blog News and ReportsMichael D. Levin’s career over the last two decades has included executive and consulting roles in the natural products industry with such leaders Tyler Encapsulations (now a part of Integrative Therapeutics), Cardinal Nutrition (now Bergstrom Nutrition), and at Cancer Treatment Centers of America. The long-time contributor to the Integrator Blog News and Reports brought to the industry his prior experience as an executive in mainstream pharma and medical devices.Levin has a passion for quality. Levin believes the industry faces a gathering storm. He speaks of the “holy trinity of quality” that is most important to practitioners and consumers, and how current regulations often miss the mark.Weeks: First, give me a little background on yourself.Levin: After moving over from pharma 20 years ago I quickly realized that we could use nutritional interventions to substantially reduce healthcare costs while improving quality of life in many areas. I also realized that the industry was in its infancy. It wasn’t ready for prime time. I’ve devoted myself since to working to promote its greater use—and that means educating, with a focus on guaranteeing quality and compliance.Weeks: Our conversation today was stimulated in part by reflecting a column you wrote a decade ago at the time that the FDA finally issued the Good Manufacturing Practices [GMPs] requirements required by the Dietary Supplement Health and Education Act of 1994. You gave the GMPs a mixed review – positive marks for setting a regulatory framework, negative because, as you wrote, the rule requires that manufacturers, not the FDA, define quality specifications for their products. Why is this a problem?Levin: First, big picture. We need to be very clear about what we mean in all our conversations about what we mean by quality. Our dialogue and efforts must be based on a real definition of quality rather than a regulatory definition of quality—or a manufacturer’s definition.Weeks: How do regulators and manufacturers fall short?Levin: Generally speaking, the FDA only requires manufacturers to consistently meet the specifications that the manufacturer has set. This doesn’t guarantee superior quality. If the manufacturer sets a low bar, and meets it, the manufacturer can boast cGMP compliance—without guaranteeing quality as the consumer or practitioner thinks about it. Under the FDA’s GMPs, each company decides its own specifications for ingredients and finished products and is simply held to those specifications.Weeks: I know in this talk you gave for Holistic Primary Care. that you have been something of a broken record on this - but what is the alternative?Levin: There is a clear and simple holy trinity of quality. Conversations about quality must begin with authenticity, potency and purity. That’s the holy trinity. Our conversations must begin there.Weeks: What is an example of something that the GMPs don’t necessarily touch.Levin: Let’s talk about proven freedom from low level contaminants. While many companies test ingredients for the presence of certain heavy metals, fewer companies test ingredients for pesticides, herbicides, solvent residues, etc. For integrative practitioners who understand the potential impact of these contaminants on health, testing matters to them. But, since many companies don’t always test, many companies don’t always know. Most recently, the threat of economic adulterants in the supply chain has become a very big deal, so much so that testing for economic adulterants is now in the new food cGMPs (which governs dietary ingredients).Weeks: You are talking about processes that will necessarily translate into higher costs for the consumers. How much will prices go up if we follow this model?Levin: Depends on the product. With single agent products with a controlled supply chain, not much. But if you have multiple ingredients, handled by many people, in potentially many countries, it can be much more expensive.Weeks: What has happened to prices over the last decade? Have they gone up?Levin: Depends on the market. Prices in mass market pharmacies and mail order companies have often gone down by 50 percent of so. Why? The products have been dumbed down. The manufacturers are lowering potencies. They are putting fewer caps in a bottle. The manufacturers may argue that it’s “pure” but it’s not “potent.” They are missing on the holy trinity.Weeks: I believe that our decision to do this interview began with you off-handedly saying you believe that the industry is about to face “shit-storm” of issues.Levin: Maybe not the best choice of words, but it works. We are increasingly moving into an era of quality transparency. Amazon has launched its Elements line in which Amazon Prime members can actually click through to examine the documentation behind products. The USP [United States Pharmacopoeia] has a plan for standards in development through which consumers can gain more confidence. Ten years ago, I said we’d be competing on the battlefield of quality and we are certainly moving toward that—in no small thanks to the action of the New York Attorney General.Weeks: But I understand that Attorney General Schneiderman’s highly publicized assault on manufacturers through the DNA testing method for product quality was pretty thoroughly dismissed. We ran a column taking it apart from Michael Tims in [Journal of Alternative and Complementary Medicine].Levin: But from the consumer perspective, that doesn’t matter. What they saw was four major retail chains slammed on not meeting their label claims with GNC capitulating like a guilty party and taking their products off shelves. Regardless of the merits, the issue is fueling the transparency issue. It’s all about consumer trust.Weeks: How will this come down for integrative practitioners.Levin: There are some products companies that have historically sought to and hit a high bar. Yet they have often not articulated their value proposition very well. Their customers don’t know enough, and they are not answering the right questions. When practitioners start demanding transparency, the differences will become much clearer.Weeks: Mark Blumenthal has been driving hard the program at the American Botanical Council on Botanical Adulterants that, while addressing the issue, is perhaps above all raising it.Levin: This is a tremendous service to the industry and it well serves consumers, physicians and all industry stakeholders to know about it. They are identifying adulterants and this is a key step toward keeping them the adulterants out of the supply chain.Weeks: What is the industry doing?Levin: Dan Fabricant, who was formerly with of FDA, and is now President of the Natural Products Association is promoting a Supplement Safety Compliance Initiative to boost transparency in quality assurance. You may remember how aghast Dan was at the poor compliance performance of the industry when he had his regulator’s hat. Perhaps more interesting is the work of Dietary Supplement Quality Collaborative that included the United Natural Products Alliance [with Larisa Pavlick, pictured, former consumer safety officer with FDA, now VP of Global Regulatory Compliance at UNPA] and multiple other stakeholders They are developing a “quality matrix” from a variety of sources—including GNC’s response to the New York Attorney General and documents developed through the American Herbal Products Association, among others. The activity is percolating. Practitioners can make a big difference by demanding transparency from their suppliers. Including proof of authenticity, potency and maximum freedom from chemical and biological contaminants.Weeks: I know you are about to escape into the Cascades for a camping trip. Any closing thoughts?Levin: What a long strange trip it's been!Editor’s note: This article is not edited and the authors are solely responsible for the content. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Integrative Practitioner.