The Trust Proposition

The value of nutraceutical products should only be communicatedif there is a trustworthy supply chain.

ByErik Goldman

There’s a lot of talk in the nutraceuticals industry these days about the “Value Proposition,” and how it needs to be re-established.

Industry leaders say that consumer confidence in nutraceuticals and botanical medicines is at an all time low. Negative press about “a few bad ap­ples,” a spate of unfavorable studies, and a rough overall economy are making for flat sales.

Those who would re-write DSHEA need not look too hard for evidence to make their case, and this has Washington-watchers a bit nervous. All in all, the current state of affairs has lot of industry folk yearning wistfully for the “Golden Age” of the mid-1990s, when the public professed its undying love, new regulations were opening up new and lucrative markets, the race to big box retail had not yet commodified nutritional products to the point of diminishing return, and nobody was asking hard questions.

The answer to the industry’s current woes, say the pundits, is to re-establish the Value Proposition. Y’know, take a healthy dose of favorable science, like studies showing how much disease could be prevented with a few key supplements, blend in some safety data, suspend it all in a rich, flavorful emulsion of PR, encapsulate it into easy-to-swallow info-caps and distribute it as widely as possible.

Do this right, and the public should come away convinced (once again) that supplements are safe, effective, and well-worth their hard-earned dollars. That will not only help sales, it will help fend off regulators who’d like nothing better than to bury much of this industry. After all, it was public support that helped pass DSHEA, and it’ll take a lot of public support to defend it.

I’m all for the industry’s effort to re-establish its value, but what of its own values? Before we can get down to the Value Proposition, we need to re-establish the “Trust Proposition.” Simply put, how can people value a product, or an industry for that matter, when they cannot even rest assured they are actually getting what they are buying?

You can cuss ConsumerLab.com all you want. You can question its methodologies and motives. You can bicker about reference standards. But the bottom line is ConsumerLab.com buys nutraceutical products off the retail shelves, analyzes the constituents and boils it all down to a simple question: Do the pills or capsules contain what the labels say they do? Far too often, the answers are coming up negative. And that hurts the Trust Proposition.

In the healthcare practitioner channel the trust factor is essential. People go to doctors because they’re sick and wishing to be well, or they’re worried about getting sick and want to prevent illness. It’s a serious business. People consent to become patients believing that practitioners have their best interests at heart, and that their actions and recommendations are guided by all the intelligence, training, ethics and experience they can bring.

Practitioners, in turn, must trust that the products they prescribe or recommend are developed, researched and produced with the same high intentions and ethical guidelines. By asking healthcare practitioners to recommend or sell your product to their patients, you are asking them to put their professional lives and licenses on the line. You are asking them to trust you—in a big way. But should they?

I recently had some very troubling conversations with the president and chief medical officer of an emerging practitioner channel nutraceutical company. They were describing the woes they encountered in working with one of the industry’s leading contract manufacturers.

At issue was the formulation and post-production quality testing of a multi-mineral formula, part of the company’s suite of products designed to balance tissue pH and optimize cellular function. The formulas are very carefully developed by the company’s chief medical officer, an MD, PhD, who has extensive experience in clinical practice and has devoted decades to the study of nutritional biochemistry.

The contract manufacturer is, by all available information, an industry leader claiming the highest standards in good manufacture, standard operating procedure and quality control. And it guarantees that the products it manufactures can pass any independent analysis.

The purchase order for this mineral formula, which the company shared with me, specified very definite amounts of magnesium, calcium and zinc lactates, as well as potassium bicarbonate, each of which was to be sourced from specified raw material providers. The chief medical officer also requested chemical analysis of the potassium, magnesium, calcium and zinc content of the final blend to be assayed within +/- 5% of the amounts specified on the product label. The manufacturer assured that this would be done, and that the manufacturing facility had the requisite capabilities for testing.

Problems started to arise with the first batch of product manufactured last Fall. The manufacturer reluctantly tested the product using an outside lab, and only after the chief medical officer sent out a sample at his own expense. Fortunately, the samples contained the proper a­mounts of each mineral.

The second round was not so favorable. After a second order was produced, the chief medical officer again requested analytical testing. The manufacturer again resisted, but eventually provided a report from a third party analytical lab. Problem was, the zinc content of the formula was around 0.999 mcg/g, a figure that borders on nothing, and certainly not in accordance with the specified formula.

The contract manufacturer insisted this was a testing error, and only after repeated discussions, agreed to re-blend the formula. Again, a post-production analysis was requested. The contract manufacturer sent samples out to a third party lab, but only obtained testing for the zinc component, which this time turned out to be 12% over the specified amount.

Concerned about the overall quality and consistency of the blend, the chief medical officer insisted on analyzing all of the minerals in the final blend. The contract manufacturer did not retest the zinc, but returned figures for magnesium, calcium and potassium, two of which were over spec, with the third being under.

This led to a series of heated phone conversations, letters and emails be­tween the parties, with the contract manufacturer informing the finished product company that its requests for testing were unusual and unreasonable. In the end, the contract manufacturer’s management stated in an email that it refused to reblend or retest, and furthermore would not accept anymore purchase orders from the company.

Though I’ve left out names for legal reasons, this story is very real. I know the chief medical officer personally, and I can vouch for his meticulous attention to detail and his concern for public well-being. Why else would anyone bicker over analytical testing like this?

There may be sides to this story of which I’m unaware, but I do not understand why a leading contract manufacturer, one that touts the highest quality standards and production integrity, would fight so hard against a client that is simply trying to do the right thing on behalf of his company’s customers. In the end, we’re talking about tests that cost a few hundred dollars to ensure the quality of products that may impact the health of thousands of people.

Contract manufacturers are the invisible hand in this industry. Most supplement users, and certainly most practitioners, do not even know they exist. The average person simply assumes that the company whose name is on the label makes the stuff that’s in the bottle. I’m guessing that is actually the case for only a small percentage of finished products. I don’t have exact figures, but I’m betting that most supplement products are made by contract manufacturers that are well-shielded from liability because, from a labeling viewpoint, they don’t exist.

So now there’s another link in the chain of trust. Patients must trust their practitioners or their health food store advisors. Practitioners and store personnel must trust their nutraceutical providers. And you, the nutraceutical manufacturer, must trust your contract manufacturers and raw material suppliers. But should you?

I hope the situation described in this column is an aberration, but I fear that it is not. I worry that far too many finished product companies work in a comfortable “Don’t ask, don’t tell, and whatever you do, don’t test,” collusion with their contract manufacturers, all the while everyone claims to have “the highest quality.”

The trust proposition in healthcare has been eroding on all fronts for a long time. Look at the ways pharmaceutical companies stack the research decks, hypnotize the public and manipulate medical judgment. Look how insurance/managed care imperatives have twisted the fragile hu­man bond between the healer and the hurting into episodes of crude commerce. Look how ordinary folks game the system, demanding that doctors medicate them out of disorders they “lifestyled” their way into.

The holistic health movement, of which the nutraceutical industry is a significant part, was a grassroots effort to right some of those wrongs. Yes, of course, it’s also a business, and everyone has to make a living. But need we abandon core principles to do so? Is it wrong for a customer to expect that a health product contain what the label says it should? Is it unreasonable for a formulator to demand from a contract manufacturer a clear assurance that specifications have been met? I certainly hope not.

The good news is that my friends were able to find another contract manufacturer to make their mineral formulas, one who shares their ideals, not to mention their penchant for analytical chemistry. It’s re-assuring to know they are out there. But how many contractors or raw material suppliers simply don’t care? How many nutraceutical company executives are either oblivious or playing dumb and hoping no one will notice?

If you want to improve the industry’s Value Proposition, you’re going to have to re-establish and safeguard that chain of trust. You get there through serious science and a real engagement in public health, not through over-hyped PR campaigns full of empty language.

You get there through vision that ex­tends further than next quarter. You get there by collaborating across industry sectors with public well-being in mind, not by skimping on the important things—like good raw materials and meticulous quality assurance—and hoping that colorful public service announcements and well-placed blind eyes will safeguard your future.NW