Loren Israelsen06.01.09
The term "spiking" has various meanings. Growing up in the California volleyball scene, I first knew it as the pleasant experience of driving a volleyball into your opponent's forehead. Unfortunately, I now know spiking as the unpleasant and sordid business of intentionally adding fake (and usually very cheap) substances into foods, drugs or dietary ingredients to sell them off at profitable prices.
Everyone decries this practice and many claim to be victims, yet no one confesses to doing this. Buying practices don't seem to change much, and the music plays on.
The outrage is that, like melamine, heparin and anti-malarial drugs (and many more examples), this is done intentionally. I define intent as purposeful action or active neglect on the part of those who know or should know this is going on. It is time to stop this before: People really get hurt; the plaintiff's bar finds their new ephedra; Congress (and key leaders specifically) take matters into their own hands; the national media finally prints the big expose that will damage the good name and reputation of many excellent companies along with those that deserve to be exposed; the economic rot so weakens ethical and principled companies that they are no longer competitive, and they write off the U.S. supplement industry as barren ground; consumers wonder why they don't see the benefits they were expecting; and natural healthcare professionals are stunned to find out that products they have sold or recommended are spiked, thus putting their reputation and possibly their license on the line.
Spiking is a form of food adulteration that has existed as long as anyone thought they could get away with it. It involves enough skill and cunning to fake lab tests, create false paperwork, phony seals, bogus logos, fictitious third party documents and even forged government certifications. The farther away buyers and consumers are, the better. The more the spiked goods change hands, the better. The more the real thing (e.g., roots, bark, flowers, seeds, etc.) is transformed into something else (e.g., powders, extracts), the better. The fewer tests your customer requires, the better. The more languages involved, the better. Sleeping or corrupt regulatory agencies are preferred. No physical addresses required. Cell phones, laptops and multiple business cards are tools of the trade.
Buyers are (to be blunt) willing dupes in this despicable practice. They know, or should know, you cannot buy 5:1 guarana extract for $8.50/kilo when guarana beans are $6.30/kilo. (These are real numbers.) Vanilla colored bilberry extract is an oxymoron. (Bilberry is deep purple, as is the extract.) And yet, I have with my own eyes seen vanilla colored "bilberry extract"-a physical impossibility. Natural ED (erectile dysfunction) supplements that actually work fast do not exist, yet these products continue to be bought and sold every day, which contain undeclared active drug ingredients. At the moment, this is the most serious and dangerous spiking problem going on.
We have several key problems to resolve before spiking ends once and for all. These include:
Stepped Up Regulation. We need an FDA that has money, manpower and motive to inspect, test, recall, shut down and prosecute spikers and their traffickers. We are now seeing exactly this happening. As of June 25, 2009 the second GMP compliance phase goes into effect. FDA has ramped up its inspection force and has trained it specifically to look for evidence of spiking and intentional adulteration. Companies that have seldom or never seen an FDA inspector soon will.
Powders and Chemical Markers. It is cheap and easy to spike powders. Ask any cocaine dealer. Once the plant parts are reduced to powders, the spiking party may begin. A favorite trick is adding cheap ingredients that mimic a chemical marker normally used to identify plant extracts. This is a particular problem with plant extracts that are dark red, blue or purple, especially because some tests use color spectra for identification. This is where dyes, colored sawdust and even crayons are used to imitate far more expensive extracts from fruits, berries, etc. (See Table 1 for examples.)
Laboratories can also be incompetent or careless. And it is not uncommon for companies to go lab shopping to find one that gives them pleasing results-not the truth, but the answer they are looking for.
Analytical Method Development. By now, it should be abundantly clear that you cannot detect what you cannot find. You cannot find something without a search tool. That is the analytical method. Developing such methods is thankless work. It is best done as an open and collaborative process, much like Wikipedia, and requires significant investment of time, thought and lab resources. Much has been done in the supplement industry over the past 15 years to develop better, cheaper, faster and more specific methods for a range of dietary ingredients. Yet, much remains to be done. When there is spiking, there is often a vulnerability in the analytical method process. Two examples illustrate this. Until a few years ago, the official USP method for saw palmetto berry extract did not detect the presence of palm oil. Big problem. That has now been fixed through an emergency process put together by a working group determined to solve this problem.
Similarly, the official USP method for heparin did not detect the presence of hypersulfated chondroitin (HSC). Disaster ensued when virtually all of the world's heparin supply became suspect after it was learned that the source material for heparin was virtually untraceable and some of it was spiked with HSC. Unfortunately, many people died. Governments and respected scientific organizations were deeply embarrassed, and today heparin quality systems have been profoundly changed.
Certificates of Analysis. Wisely, FDA has declared that under the new GMP regulation companies can no longer rely on a certificate of analysis to establish the identity of a dietary ingredient. Finally! Hopefully, we will see a surge in the number and quality of analytical reports (which are different from certificates of analysis) on every batch of inbound raw materials. This is great, but analytical methods are dependent on reference standards, without which meaningful test results are not possible. Spikers know this, and they fear honest and accurate certificates of analysis and authenticated reference standards, which make reliable or forensic (i.e., the process of trying to figure out what your ingredient really is) analysis possible.
Standardized Information Templates. If you have ever purchased a house, you probably recall the stacks of forms you had to sign. Bad as that was, imagine if all the bankers and real estate closing companies made up their own forms? Well, that's about where we are. Everyone has their own "closing" forms, and it's not helpful. A working group called SIDI (Standardized Information on Dietary Ingredients) has been organized to correct this. SIDI's goal is to establish uniform and informative documents that everyone can use to harmonize the type, quality and arrangement of critical information. Information on SIDI can be accessed through the Council for Responsible Nutrition (CRN) or the American Herbal Products Association (AHPA).
We will soon reach a tipping point on intentional adulteration. After years of acting with impunity, spikers will soon come to grief. How will this happen?
New Laws. Congress is serious about food safety legislation. Keep your eye on two bills: H.R. 759, "Food and Drug Administration Globalization Act of 2009," introduced by Congressman John Dingell and others, and S. 510, "FDA Food Safety Modernization Act," introduced by Senator Richard Durbin and others. Section 106 of S. 510 would require FDA, the Department of Homeland Security and the USDA to conduct vulnerability assessments and issue regulations to protect against the intentional adulteration of food. It is this kind of focus and serious Congressional mandate that can begin to turn the tables.
A New FDA. On May 1, 2009, FDA held a public meeting on economically motivated adulteration (a polite way of saying "spiking"). Fourteen presentations were made from diverse groups, all pounding away on the new strategies and approaches being developed to predict, inspect, test and prosecute economically motivated adulteration.
A New Attitude. Remember the classic 1976 film "Network," in which Howard Beale, a television network anchor, shouted, "I'm mad as hell and I'm not going to take it anymore?" Well, we are almost there. The critical elements of change are present. Outrage exceeds the fear of speaking out. The recognition of need for regulation exceeds laissez-faire opportunity. Collective action exceeds private gain, and political will to act exceeds reelection fears.
By this time next year, a transformation will be in process, and spiking (though not gone for good) will be an exception and not the assumption.
It will be a welcome day when spiking once again brings fond memories of summertime beach volleyball.
Everyone decries this practice and many claim to be victims, yet no one confesses to doing this. Buying practices don't seem to change much, and the music plays on.
The outrage is that, like melamine, heparin and anti-malarial drugs (and many more examples), this is done intentionally. I define intent as purposeful action or active neglect on the part of those who know or should know this is going on. It is time to stop this before: People really get hurt; the plaintiff's bar finds their new ephedra; Congress (and key leaders specifically) take matters into their own hands; the national media finally prints the big expose that will damage the good name and reputation of many excellent companies along with those that deserve to be exposed; the economic rot so weakens ethical and principled companies that they are no longer competitive, and they write off the U.S. supplement industry as barren ground; consumers wonder why they don't see the benefits they were expecting; and natural healthcare professionals are stunned to find out that products they have sold or recommended are spiked, thus putting their reputation and possibly their license on the line.
Spiking is a form of food adulteration that has existed as long as anyone thought they could get away with it. It involves enough skill and cunning to fake lab tests, create false paperwork, phony seals, bogus logos, fictitious third party documents and even forged government certifications. The farther away buyers and consumers are, the better. The more the spiked goods change hands, the better. The more the real thing (e.g., roots, bark, flowers, seeds, etc.) is transformed into something else (e.g., powders, extracts), the better. The fewer tests your customer requires, the better. The more languages involved, the better. Sleeping or corrupt regulatory agencies are preferred. No physical addresses required. Cell phones, laptops and multiple business cards are tools of the trade.
Buyers are (to be blunt) willing dupes in this despicable practice. They know, or should know, you cannot buy 5:1 guarana extract for $8.50/kilo when guarana beans are $6.30/kilo. (These are real numbers.) Vanilla colored bilberry extract is an oxymoron. (Bilberry is deep purple, as is the extract.) And yet, I have with my own eyes seen vanilla colored "bilberry extract"-a physical impossibility. Natural ED (erectile dysfunction) supplements that actually work fast do not exist, yet these products continue to be bought and sold every day, which contain undeclared active drug ingredients. At the moment, this is the most serious and dangerous spiking problem going on.
Issues to Resolve
We have several key problems to resolve before spiking ends once and for all. These include:
Stepped Up Regulation. We need an FDA that has money, manpower and motive to inspect, test, recall, shut down and prosecute spikers and their traffickers. We are now seeing exactly this happening. As of June 25, 2009 the second GMP compliance phase goes into effect. FDA has ramped up its inspection force and has trained it specifically to look for evidence of spiking and intentional adulteration. Companies that have seldom or never seen an FDA inspector soon will.
Powders and Chemical Markers. It is cheap and easy to spike powders. Ask any cocaine dealer. Once the plant parts are reduced to powders, the spiking party may begin. A favorite trick is adding cheap ingredients that mimic a chemical marker normally used to identify plant extracts. This is a particular problem with plant extracts that are dark red, blue or purple, especially because some tests use color spectra for identification. This is where dyes, colored sawdust and even crayons are used to imitate far more expensive extracts from fruits, berries, etc. (See Table 1 for examples.)
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Laboratories can also be incompetent or careless. And it is not uncommon for companies to go lab shopping to find one that gives them pleasing results-not the truth, but the answer they are looking for.
Analytical Method Development. By now, it should be abundantly clear that you cannot detect what you cannot find. You cannot find something without a search tool. That is the analytical method. Developing such methods is thankless work. It is best done as an open and collaborative process, much like Wikipedia, and requires significant investment of time, thought and lab resources. Much has been done in the supplement industry over the past 15 years to develop better, cheaper, faster and more specific methods for a range of dietary ingredients. Yet, much remains to be done. When there is spiking, there is often a vulnerability in the analytical method process. Two examples illustrate this. Until a few years ago, the official USP method for saw palmetto berry extract did not detect the presence of palm oil. Big problem. That has now been fixed through an emergency process put together by a working group determined to solve this problem.
Similarly, the official USP method for heparin did not detect the presence of hypersulfated chondroitin (HSC). Disaster ensued when virtually all of the world's heparin supply became suspect after it was learned that the source material for heparin was virtually untraceable and some of it was spiked with HSC. Unfortunately, many people died. Governments and respected scientific organizations were deeply embarrassed, and today heparin quality systems have been profoundly changed.
Certificates of Analysis. Wisely, FDA has declared that under the new GMP regulation companies can no longer rely on a certificate of analysis to establish the identity of a dietary ingredient. Finally! Hopefully, we will see a surge in the number and quality of analytical reports (which are different from certificates of analysis) on every batch of inbound raw materials. This is great, but analytical methods are dependent on reference standards, without which meaningful test results are not possible. Spikers know this, and they fear honest and accurate certificates of analysis and authenticated reference standards, which make reliable or forensic (i.e., the process of trying to figure out what your ingredient really is) analysis possible.
Standardized Information Templates. If you have ever purchased a house, you probably recall the stacks of forms you had to sign. Bad as that was, imagine if all the bankers and real estate closing companies made up their own forms? Well, that's about where we are. Everyone has their own "closing" forms, and it's not helpful. A working group called SIDI (Standardized Information on Dietary Ingredients) has been organized to correct this. SIDI's goal is to establish uniform and informative documents that everyone can use to harmonize the type, quality and arrangement of critical information. Information on SIDI can be accessed through the Council for Responsible Nutrition (CRN) or the American Herbal Products Association (AHPA).
Down the Road
We will soon reach a tipping point on intentional adulteration. After years of acting with impunity, spikers will soon come to grief. How will this happen?
New Laws. Congress is serious about food safety legislation. Keep your eye on two bills: H.R. 759, "Food and Drug Administration Globalization Act of 2009," introduced by Congressman John Dingell and others, and S. 510, "FDA Food Safety Modernization Act," introduced by Senator Richard Durbin and others. Section 106 of S. 510 would require FDA, the Department of Homeland Security and the USDA to conduct vulnerability assessments and issue regulations to protect against the intentional adulteration of food. It is this kind of focus and serious Congressional mandate that can begin to turn the tables.
A New FDA. On May 1, 2009, FDA held a public meeting on economically motivated adulteration (a polite way of saying "spiking"). Fourteen presentations were made from diverse groups, all pounding away on the new strategies and approaches being developed to predict, inspect, test and prosecute economically motivated adulteration.
A New Attitude. Remember the classic 1976 film "Network," in which Howard Beale, a television network anchor, shouted, "I'm mad as hell and I'm not going to take it anymore?" Well, we are almost there. The critical elements of change are present. Outrage exceeds the fear of speaking out. The recognition of need for regulation exceeds laissez-faire opportunity. Collective action exceeds private gain, and political will to act exceeds reelection fears.
By this time next year, a transformation will be in process, and spiking (though not gone for good) will be an exception and not the assumption.
It will be a welcome day when spiking once again brings fond memories of summertime beach volleyball.
