Liar, Liar Pants on Fire!

Ensuring product integrity may be the industry’s biggest challenge yet.

By Paula Brown

“From Beijing to Baltimore, consumers are wondering why those who grow, make, sell and regulate foods cannot seem to prevent fraud, adulteration and incompetent regulation. In short, why can’t food be safer?”
—Loren Israelsen, February 2009

It is time to talk about a quality issue that is plaguing the dietary supplement industry: adulteration.

Before we go too far, let’s start by defining adulteration. Common usage inclines toward the belief that “adulteration” refers to some kind of intentional alteration of a product or ingredient such that it is inferior or harmful, and distinguishes adulteration from mere contamination. However, in the U.S., adulteration is a regulatory term of art.

Section 402(a) of the Food, Drug and Cosmetic Act deals with food safety and says that a food is adulterated if: it contains any poisonous or deleterious substance which may render it injurious to health; it bears or contains any added poisonous or deleterious substance (with exceptions) which is unsafe; it contains a pesticide which is not GRAS; it contains a food additive which is not GRAS; it contains an unapproved new animal drug; it consists in whole or in part of any filthy, putrid, or decomposed substance, or it is otherwise unfit for food; it is prepared, packed or held under insanitary conditions; or it has been irradiated without an FDA issued exemption.

Section 402(b) deals with economic adulteration and says that a food is adulterated if: any valuable constituent has been in whole or in part omitted or abstracted therefrom; any substance has been substituted wholly or in part therefore; damage or inferiority has been concealed in any manner; any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

And finally in consideration of dietary supplements, all of the above is applicable along with Section 402(f), which says a product is adulterated if it is a dietary supplement that presents a significant or unreasonable risk of illness or injury under label conditions or ordinary conditions of use. You’ll note that intent doesn’t really enter into most of the definition, and that even if, for example, melamine were the most inert and non-toxic substance known, its undeclared presence in foodstuffs still renders the product adulterated.

By now many have surmised why melamine (or cyanuric acid, or urea) is added to protein-based products such as powdered milk, wheat gluten and isolated soy protein. It is basic math—higher protein content means ingredients command higher prices in the marketplace. Protein content in foodstuffs is typically measured by the Kjeldahl test, which does not actually measure protein, but rather nitrogen. This non-specific approach assumes the only source of nitrogen is the protein itself. Alas, some malefactor turned this naive assumption on its head by adding cheap nitrogen sources, like melamine, to boost apparent protein content.

This history of economic adulteration is as old as commerce, having been addressed in Greek and Roman law that prohibited watering down of wine and U.S. State Food Law dating back to 1784 in Massachusetts. There has been a centuries’ long dance between cheaters and cops, including: depression era plaster of Paris sold as bleached wheat flour; sand added to powdered herbs; and ipecac adulterated with ephedrine. As methods of detection get better, adulteration becomes more
sophisticated, with each driving the evolution of the other.

Why the recent uproar, then? Well, the scale of international trade has made reporting on the discovery of these scams a global phenomenon. Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), has aptly compared the global food supply to a sushi combo plate by noting that, “It comes from everywhere, travels fast, and is hard to trace; you are not always sure that it is really Yellow Tail.”

Global recession has destabilized supply chains and traditional buying relationships. As suppliers dump inventory, the market is flooded with expired, low quality, blended down stock and even intentionally spiked material capable of faking many tests. Food and supplement supply chains may be setting themselves up for another crisis, such as the melamine and peanut disasters. When you poison pets and babies, you involve the broader press. Widespread coverage triggered recalls, public health alerts, lawsuits, and generated an epidemic of finger-pointing as human nature demands someone (preferably “them”) take the blame.

At the risk of blaming the victim, commerce is a two-way street and there are often warning signs that should be both noted and heeded. What sorts of signs? The first and most obvious is price. “If it seems too good to be true, it probably is”—while not always correct, it is often the case. Companies can and do produce marvelous breakthroughs that permit them to revolutionize pricing. This is rare enough, though, that a sudden and dramatic price breakthrough should trigger, if nothing else, a slew of investigative questions concerning the material.

Questions to Ask

A good place to start is the marketplace. What have historical prices for your ingredient been? Have they suddenly fallen or risen? If there is a sudden or dramatic change, is it industry-wide or restricted to a single company? What is the company’s history? Do you know how and where the ingredient is produced? Have there been recent advances in technology related to the ingredient production? If not, you might wish to learn more before buying on price alone.

Consider the case of contaminated heparin. Heparin is produced from Chinese pig intestines, so when a porcine disease decimated the raw material supply there was a sharp rise in price. In the midst of historically high prices, a much cheaper supply of heparin suddenly appeared as if by magic. The sudden dramatic price-drop could have been the result of an entrepreneur who located a disease-free swine herd in a different country, or not. A few questions by an alert purchasing agent may have answered that question.

Consult Your Own GMP Paperwork

When the melamine story broke the knee-jerk reaction across the board was to mandate testing for adulteration. But what do you test for? As noted above, there is a continuous ballet of test and deceive going on. It is quite possible the next generation of cheap nitrogen source is already in play. If it is toxic, it will likely be discovered quickly. If not, we may never know. When faced with the possibility that someone is “messing with your stuff” (a very technical term), you can always fall back on your specifications.

What exactly are the product specifications, and most importantly, how do you ensure the specifications have been met? What tests are being relied upon? The key to solving any potential dilemma is to know what each test employed can and cannot do. For example, if your specification calls for a certain protein content, you need to know if the test used specifically measures protein or a protein surrogate, like total nitrogen. If it is the latter, it would be prudent to use a more specific test or add additional tests that preclude the possibility of adulteration.

The use of non-specific tests is often a cause for concern. A spectrophotometric assay for bilberry is easily fooled by amaranth (Red No. 2). Hydrolyzing anthocyanins prior to testing renders it difficult to differentiate many berry and fruit extracts that are easily distinguishable by their intact anthocyanin profiles. The discovery that cheaper pure compounds such as rutin were being used to boost flavonol glycoside content in Ginkgo biloba products was only detected by careful analysis of each glycoside. Chondroitin sulfate adulteration by other polyanionic polymers, such as carrageenan and dermatin sulfate, is not detected by non-specific tests like size exclusion chromatography or the CPC method alone.

The bottom line is that methods lacking specificity are not appropriate to establish identity, nor should they be used to quantify specific content in raw material and finished products.

Go to the Source

Finally, you can visit the source of your ingredient or pay a third-party to visit and report back. This can be expensive and time-consuming, but if it keeps your company out of the headlines (and courts) it will be worth the expense. If you can’t get permission to visit, that information alone might be valuable.
You lock your car and take your keys.
You don’t leave unattended valuables lying about.
You look both ways before crossing the street.
In short, you take precautions. So why would you risk your business for a few bucks when you can take precautions there as well?
In closing, do not be passively aware of those who cheat and damage the reputation of the industry, and worse, harm the public; rather, be active in raising the bar on quality and consumer confidence.

“It is true that you may fool all the people some of the time; you can even fool some of the people all the time; but you can’t fool all of the people all of the time.”
—Abraham Lincoln