In recent weeks, New York Attorney General Eric Schneiderman has garnered a great deal of publicity with his claim that DNA barcode testing shows that many herbal products don't contain the ingredients on their labels. Although his testing methods seem flawed and inappropriate, he has refused to share any of the specifics of his methods, and has instead demanded that the companies he has targeted produce all of their manufacturing records, essentially putting the burden of proof on them. And he has ordered (without a trial) the products in question pulled from shelves in New York.
For several years now, I have seen a very steady drumbeat of articles in the mainstream media, claiming that the Dietary Supplement industry is “unregulated”, “unproven”, or even “unsafe”. The regularity with which these articles appear, the lack of even the most basic journalistic research that goes into them, and the general unwillingness to publish retractions or corrections for even the most basic errors, is sufficient evidence to convince me that many of the journals in which they appear are, in fact, simply bought and paid for by Big Pharma. The multi-page ads that drug companies run in those periodicals are prima facia evidence that they are not to be trusted for their journalistic independence.
But this latest attack is worse, when a government official declares in a public press conference that these dietary supplements are outright frauds, not even containing a shred of what they claim to contain on the label. And many consumers are only too willing to give AG Schneiderman the benefit of the doubt. Where there is smoke, they think, there must be fire. But is there really? Or is it all just smoke and mirrors (aka politics as usual)?
The Problem with DNA
DNA barcodes are only one of many methods used by manufacturers to confirm the identity of botanical ingredients. In fact, DNA barcoding is rarely used in the industry, for (at least) the following good reasons:
- DNA barcoding is relatively new, and relatively expensive.
- DNA is only found in the cell nucleus, which is often destroyed in processing and extraction.
- DNA is easily destroyed by heat and pressure, factors commonly used in botanical extraction.
- DNA barcoding can easily produce false readings from small amounts of contamination.
- DNA barcoding shows only presence or absence in the sample tested, not percentage.
- DNA tests species only, and says nothing about the quality, purity, or potency of the plant.
Because well-trained human sense organs are still many times more sensitive than all but the most expensive lab equipment, herbs are often still tested both for identity and quality by “organoleptic” methods-- using the senses of sight, smell, touch, and taste. Herb tasting is every bit as common in modern herbal product manufacture and quality assurance, as it still remains in similar fields such as coffee roasting, chocolate production, tea blending, or even cooking. We use it on every finished batch of our product, to ensure uniformity and quality.
For consumers that have been conditioned by years of “CSI”-style crime shows to believe that DNA evidence is infallible, AG Schneiderman's choice of shiny new DNA barcoding makes perfect sense. He appears to be the all-knowing government official who has caught several manufacturers with their hand in the cookie jar, producing what appear to be falsely-labeled products. He can now try these manufacturers in the court of public opinion, and get himself a reputation as a consumer rights watchdog (with a better chance of re-election), without ever having to go to trial or having to actually prove a case in court. But is this the right way to administer justice in America?
Schneiderman reinvents the wheel
Consumers should know that supplements are NOT in fact “unregulated.” In fact, they are one of the most highly-regulated industries in existence, and although they are not as closely regulated as drugs, they are certainly much more closely regulated than food, to which they are also often compared. And while most consumers eat several pounds of food and water every day, they consume a very small amount of supplements. Pound for pound, or milligram for milligram, however you choose to look at it, both drugs on the one hand, and food and drink on the other, pose a much higher risk of injury than do dietary supplements. Still, the Good Manufacturing Practice (GMP) regulations applied to supplements are closer in nature and extent to those of drugs than they are to the other elements of the diet (food and drink).
One of the GMP regulations applied to supplement manufacturers is that EVERY SINGLE ingredient, in EVERY batch, of EVERY supplement must have AT LEAST one test applied to determine its proper identity (11 CFR 111.75(a)(1)). Many manufacturers do additional optional testing of ingredients for identity, potency and/or purity. However, the basic identity test cannot be skipped for ANY ingredient without prior FDA approval (you can imagine how often THAT happens). The FDA also requires extensive record-keeping, and the results of every such identity test must be recorded with every batch record.
The FDA conducts regular inspections of manufacturing facilities, in which it audits these records to ensure that the tests are appropriate and validated, that the people doing the testing have been trained in the methods, and that the records are being kept as required. Any failure by the manufacturer to keep or maintain the required records or perform the required testing results in a written observation and warning by the FDA, and unless the problem is properly addressed, the results can include fines, seizures, shutdown of operations, and even criminal imprisonment.
Worse yet, any legitimate manufacturer who fails to properly test his ingredients, risks his reputation. We are a relatively small label, and so like many small labels, we create our own formulas, and then outsource the actual manufacturing to firms who specialize in production. Even so, we carefully vet each contract manufacturer, and they in turn carefully qualify their raw materials suppliers. Frequently, they turn away ingredients that fail to meet our ingredient specifications-- which delays production schedules, so we hear about it. Rarely, we have even had to reject a finished product, for failing to meet our specifications. Why would we reject a finished product, forcing the manufacturer to start over and risk running out of product to sell? Because anything less would endanger our customers, our reputation, and our livelihood.
So, is he right?
Under these circumstances, AG Schneiderman's allegations seem very improbable. For so many unrelated, large, reputable, and experienced companies to completely fail to have the correct ingredients in their bottles cannot be an isolated incident. Each company would have had to fail to perform the required identity tests (and worse, lie about the results) on hundreds of different batch records.
Not only are there consumer advocacy groups out there testing for quality problems with supplements (e.g. Consumer Reports, or ConsumerLab.com), but there are hundreds of class-action attorneys ready and willing to file suit on behalf of defrauded consumers. What large, established and reputable manufacturer of dietary supplements would ever consider taking such a risk?
There is a more likely and obvious explanation-- namely, there is a serious problem with AG Schneiderman's testing methods, but he is not willing to submit his methods to the same standard of scrutiny that he himself requires of the companies he has targeted. Apparently, as the law, he thinks he is above the law. He thinks he can score easy political points with consumers, with very little risk to himself.
All this is not to say that there is no adulteration in herbal supplements-- in fact, it is a battle we fight all the time. Natural products, after all, are grown in fields, not laboratories, and harvesting is not a perfect process. Have you ever mowed a entire lawn and not clipped an occasional dandelion too? Any unwanted ingredient is by definition an adulterant, and something careful manufacturers try very hard to eliminate, though rarely with absolutely 100% success. But we don't wage that battle with sound bites on TV.
Sometimes adulteration is more sinister and clearly intentional, like when unscrupulous manufacturers intentionally introduce drug ingredients, or herb suppliers cut the desired herbs with maltodextrin, or substitute cheaper, less desirable but similar herbs. In these cases, the government certainly has a role to play, but in the courtroom, not on TV.
But to find that most of the major manufacturers tested have no trace at all of the product that is on their label? Really? Whose testing methods are most in need of checking up on here, Mr. Schneiderman?
For the record, AG Schniederman has not targeted RidgeCrest Herbals so far. We just believe in a truthful, fair and honest playing field for all parties concerned.