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Levin: A Truth-Seeking Journey on Natural Product Quality Initiatives, Leiner, USP and ConsumerLab PDF Print E-mail
Written by John Weeks   

Integrator Columnist Levin: A Truth-Seeking Journey  on Natural Product Quality Initiatives, Leiner, USP and ConsumerLab 

Summary: Most integrative practitioners and consumers have some awareness that various forms of certification of product quality are increasingly available to natural products firms. Integrator adviser Michael Levin looks into the dependability of such certification. He begins with a comment from Alan Greenspan on trust, then goes down the rabbit hole into issues surrounding United States Pharmacopoeia, and the major supplement manufacturer Leiner. It's a fascinating and sobering journey.
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natural product quality, CAM USP, Leiner
Integrator columnist Michael Levin: a truth seeking journey
Integrator adviser Michael Levin, founder of Health Business Strategies, walks a fine line in this investigative and reflective report. He honors the work of natural products certifying agencies like the United States Pharmacopeia. Yet Levin takes us by the hand through a case history which suggests how far, yet, these agencies have to come in protecting the public. Levin's bottom line:
"The winners in integrative medicine will be those who under-promise and over-deliver."

Levin's background includes work as an executive in Big Pharma and in the natural products industry. He currently consults with CNCA, a natural products firm. Levin's other Integrator columns can be viewed here.


On Alan Greenspan, CAM and the Natural Products Industry – Reflections

Michael D. Levin, Founder, Health Business Strategies

In his autobiography, The Age of Turbulence, Alan Greenspan rightly observed that, for free markets to work efficiently, there must be trust amongst trading partners. He marveled at the implicit trust consumers have in healthcare providers, for example, using the pharmacist filling a doctors prescription accurately, to illustrate his point.

Trust is a five-letter word that spells the difference between business success and failure. How well has complementary and alternative medicine (CAM) and integrative medicine fared?
Looking Back: In reflecting on the advancements made by integrative medicine over the past decade, trust is one common denominator in success. Promises were delivered. Conversely, the mis-steps, the bad press, and the speed bumps that have prevented integrative medicine from realizing its full potential have in common many things, perhaps most prominent of which is a breach of trust. “Over promising and under delivering” has, indeed, proved itself a recipe for failure.

Worse still, deliberate breach of trust by one CAM stakeholder can spell disaster for all. The ex-con behind the headline-grabbing coral calcium cancer claims, fined and banned by the FTC and described as "selling cures to the desperate and gullible” is back again on TV, doing infomercials hawking free US government money programs. Freedom of speech allows people the freedom to be stupid.

Higher Standards? Some stakeholders have complained that CAM is held to a higher standard. It’s true. Why? To a large extent, this industry has not sufficiently proved its value to consumers and payers. We’re making advances, thank goodness, through the careful, sober, thoughtful efforts of well-intentioned practitioners, scientists, academicians and industry, but there is much work yet to be done.

I share these musings to underscore the responsibility and moral obligations we all must shoulder to advance the business (realize the vision?) of integrative medicine. And I use this background to alert you to a credibility land-mine that appears poised to explode.

Case Study: Trust in dietary supplements is warm and fuzzy at best, an oxymoron at worst. Consumers are understandably confused. Currently, there is no way for a consumer to objectively assess differences in the quality (authenticity, potency and purity) of products on store shelves. Consumers have a need that remains unfilled.

Consumer needs create business opportunities. In this case, Tod Cooperman, MD launched (CL) n August 1999 as an objective source for comparing the quality of products found in the marketplace. Great idea! His organization reported last year that 1 in 4 dietary supplements tested (at the time, N=1200), were subpotent, contaminated, or both. (Disclosure: The author consults to CNCA, a supplement company.) This report card did not inspire consumer confidence and gave the media ample ammunition by which to criticize the supplement industry.

That ammunition continues to this day. In a January 9, 2008 release, announced that one potassium product delivered only 18% of its label claim.

The Case Evolves: Seizing upon this consumer need, other organizations developed “product quality certification” programs. Examples include NSF International and United States Pharmacopeia (USP). Participation in these programs is both voluntary and expensive. It costs tens of thousands of dollars to get in and thousands of dollars per product. Participants gain differentiation by quality certifications that appear on product labels sounds like a great idea. Certifications can be useful tools for empowering consumers to make informed decisions.

Informed choice is a good thing, right?

And Devolves into A Credibility Landmine: In the case of USP dietary supplement certifications, recent events may have severely corroded the value of this well-intentioned program developed by the internationally respected USP. As of January 9th, 2008, USP names just eight participating companies one of which is Leiner Health Products. Leiner is a huge private label over-the-counter (OTC) and dietary supplement manufacturer, headquartered in California. With sales annualizing around $720 million in November 2006, a serious breach of trust appeared in early 2007.

An April 4, 2007 press release disclosed that Leiner halted OTC production after a FDA facility inspection disclosed serious quality violations. With roughly $200 million in affected OTC products, Leiner immediately ceased manufacturing OTC drugs but, remarkably, continued production of their vitamin, mineral, supplement (VMS) products. Leiner’s press release explained: “The lack of GMPs for supplements is partially responsible for exempting VMS products, which are 75 percent of Leiner’s business, from the recall.”

Do you think this was this an economic decision?

Big Maker Of OTC Store Brands Charged
With Falsifying Quality-Control Tests

The most serious alleged violations include:

Manipulating and falsifying purity test results.
- Not obtaining data to support expiration dates.
- Not obtaining data supporting the quality
  and safety of the products.
- Not recalling drugs already on store shelves.
- Failing to document out-of-specification
  test results.

Source available by clicking here.
Exactly what deficiencies were discovered became visible soon thereafter. Articles in the press[7] along with filings with the Securities and Exchange Commission, sufficiently disclose this tragic betrayal of consumer trust. (For those wanting to read the gory details, see the sidebar).

Suffice it to say that subpotent and potentially contaminated products were deliberately sold into the marketplace and there were serious gaps in their product stability programs. The Department of Justice began investigating Leiner in September 2007.

As this story unfolded, coincidentally reported finding a subpotent USP-Verified supplement. This was Costco’s Kirkland Signature brand. USP and communicated on this issue, USP retested the product and found it met specifications. (See the notice below, published with permission of In short, “continues to believe that some bottles of this product may provide less than the listed amount of folic acid” while USP disagrees. USP’s public statement can be found here.


Costco — Kirkland Signature® B-50 Formula
with 100% Folic Acid

November 12, 2007, updated December 6, 2007

USP, which is under contract to the manufacturer (Inverness Medical Innovations Inc), issued a news release claiming that its own testing shows the B-50 tablets to contain the required amount of folic acid. This is in contrast to CL’s findings of only 52.2% of the labeled amount of folic acid using the most appropriate and sensitive methods available, confirmation in a second laboratory.

In subsequent communications, representatives of USP told CL that it tested product of the same lot number as CL, but purchased at a different Costco location. USP claims to have used appropriate test methods. Because folic acid is susceptible to degradation due to heat or moisture, differences in the findings could have resulted from differences in how the products were warehoused, shipped, or shelved. continues to believe that that some bottles of this product may provide less than the listed amount of folic acid. To further investigate the matter, CL offered to swap samples with USP. USP declined this offer (emphasis by author). CL urges the distributor and retailer to investigate the conditions under which this product is held prior to being sold.


Seeking Truth from USP   I contacted USP in September 2007 and again in November 2007. I expressed my deep concern over USP-verified supplements being manufactured in facilities found to violate FDA cGMPs. How can this be? To preserve the good name and reputation of the USP, as well as the consumer value of the verification program, I invited USP to share their insights as to why they would continue to allow Leiner continued participation in their program in light of FDA findings. I feared that the well-deserved good name and reputation of these experts would be jeopardized by the alleged misdeeds of one company.

Perhaps due to contractual constraints or the implications of my inquiries, USP did not respond. Perhaps they believed that a response could only be made after the official investigations and negotiations were completed and that their best course of action regarding the subpotency reported by was the action that they later took. From a business perspective, that is perfectly understandable.
Latest News: Leiner reported on November 11, 2007 that they lost $26 million during the second quarter, 2008. On December 8th, they reported to the SEC that they have retained a firm to “assist the Company in considering strategic alternatives.” They further reported “[the firm's] liquidity requirements have recently increased primarily due to the delay in sales of new over-the-counter (OTC) products and re-proven OTC inventory, the increased costs and complexity of the previously-announced plant consolidations, as well as additional investments and on-going costs associated with implementing new dietary supplement compliance requirements that come into effect on June 25, 2008 (emphasis by author). The Company’s equity sponsors will be providing $6.50 million of capital to the Company during the month of December.

I had assumed, as any reasonable person might have assumed, that USP certification assured general compliance with good manufacturing practices. Apparently, these company disclosures proved I was mistaken.

On January 8th, Leiner announced their decision to consolidate OTC manufacturing into one plant while continuing an “enhanced focus on its Vitamin, Minteral (sic) and Supplement (“VMS”) manufacturing business in California.” 

I had hoped that third
party experts would
create a certification
program consumers
can trust. Apparently,
that has not yet

- Levin

Enhanced focus? Clearly, this USP-certified company is still manufacturing supplements under various private labels sold through chain drug stores in your neighborhood, today! You get what you pay for.

The Moral: Trust, once lost, is difficult to regain. In his recent article in the Integrator, Adrian Langford commented, “We need some quality standards for products or type of trusted accreditation that a (consumer) can identify. Until we get there, we as a profession will be weighed down by all the products that don't meet high standards.”

I agree. In the confusing world of dietary supplement quality, I had hoped that third party experts would create a certification program consumers can trust. Apparently, that has not yet happened. A program that allows continued participation by a firm continuing to manufacture “certified” products in facilities essentially shut down due to quality failures discovered by FDA simply does not warrant my trust.

All industry stakeholders – practitioners, researchers, academia, industry, lobbyists, and commentators alike – can advance our common goals to transform healthcare by applying the lessons of trust taught by Alan Greenspan in everything we do.

Trust: This article is not at all about bashing certifying agencies or participating companies. Rather, it’s about trust. It’s about doing the
The winners in integrative
medicine will be those who
under promise and over
deliver. They will drip
credibility and inspire trust.

- Levin
right thing.  The certifying bodies are a welcome step in the right direction. So, too, is the public service performed by The fact remains that there are good and bad products out there, some good ones are not certified, some bad ones are certified, and neither the consumer nor his doctor can tell the difference. In my view, that’s a serious problem that undermines consumer confidence.

Looking Forward: The winners in integrative medicine will be those who under-promise and over-deliver. They will drip credibility and inspire trust. They will deliver value to the customer and prove cost-savings to the payers. Yes, a very tall order. But life is a matter of choice. And the future of our industry simply lies in the choices each of us makes in the work that we do.  This stark reminder by Leiner and the USP teaches us that the future of public health lies in the choices we make each and every day.

Comment: I am probably like many of you who may have made it through this story: somewhat bewildered, a little embarrassed, not at all pleased with airing this dirty laundry; and still, enlightened about the status of action in an important corner of our universe. Thank you, Michael, for your effort to illuminate the truth here.

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