Is adulteration diminishing? Responses from labs show picture is mixed

There is a big caveat to this approach to the problem. Analytical labs of the reputable sort contacted by NutraIngredients-USA for this article tend to interact with mostly the higher level of companies.  Problems still crop up, but the kind of companies contracting with the top labs in the business, not seeking out the dry labbers, are generally speaking not the sort to intentionally skirt the rules. It’s somewhat akin to trying to make an epidemiological judgement about the prevalence of a disease based only on those patients seeking treatment. Nevertheless, analytical chemists have long experience in the kinds of adulteration problems that plague the industry and what solutions can be found. 

Adulteration in herbal ingredients can take a couple of forms. One is unintentional adulteration, in which extraneous plant material from perhaps closely related species is included in a lot. Another is intentional, in which lower grade material is added in to substitute for a more expensive botanical. The practice of some sports nutrition formulators to disguise synthetic stimulant ingredients as botanical in origin could be seen as another form of adulteration.

Adulteration will ever be with us

Sidney Sudberg, founder of Alkemist Labs, said unintentional adulteration will likely continue to be an issue. There are thousands of plant species used in the business, and with the variety of names used, accurate identification in the field or in the broker’s warehouse can be challenging.

“​Not infrequently we find that manufacturers from different parts of the world will use related species to the botanical in question, sometimes due to the fact that a common name is what dictates what botanical is chosen, but that may or may not be the correct Latin binomial, and it is the Latin name that is used for purposes of identification,”​ Sudberg told NutraIngredients-USA.

That confusion about species, plant parts and forms of products (powdered, dried whole, extract, etc.) can confound the identification process, said James Neal-Kababick, founder of Flora Research Laboratories.

“We need to know specific testing requested, specification values, and we want to see their product/formulation specification sheet and the raw material vendor Certificate of Analysis (COA). Often we will find significant issues there that tell us the requested test is not the correct one to conduct. When clients fail to provide this information or argue that it is not necessary, they can end up paying for testing that is not fit for purpose,​” ​he said.

“​As an example, a client sending a powdered form of fungi for microscopic identity testing that is actually a mycelium extract will receive a failing test result. They have paid for analysis that we would not have done if we looked at the COA and noted the fact that the product is an extract. We save some of our large clients tens of thousands of dollars a year just by catching such issues. Often the vendor proffering the product sent the wrong material for evaluation or did not understand what form was needed,​” ​Neal-Kababick said.

Global extract business complicates issue

But Sudberg said the problem of intentional adulteration has been discouragingly persistent. And in the modern marketplace, where more extract manufacturing is done overseas rather than shipping raw materials to the US or Europe for processing, the problem has potentially grown more difficult to combat.

“​One of the biggest difficulties I have been encountering in recent years is the poor quality of the botanical extracts that are entering the marketplace. The primary obligation and requirement the client has is to satisfy the 100% Identity Rule published in the 21 CFR part 111. That means that all herbal materials must be identified before use in the creation of a finished product. Ideally, this could be a simple process, if everyone is following the rules,”​ Sudberg said.

“​The problem we have been finding, and with increasing frequency, is that the quality of these extracts are, relatively speaking, so poor that their identity is indeterminable and must be considered out of specification. I would like to have clients realize that if they are paying less for their ingredients, there is probably a good reason for that and the consequences of paying less is that the low level of quality can interfere with the identification process,”​ he said.

Neal-Kababick said that the situation has been changing for the better in that more tests are conducted today than when he started in the business, and there appears to be more sophistication on the part of clients in understanding what’s needed.

“When I started doing botanical identity testing in the mid 1990​’​s for the industry, most companies were not doing much of any testing at all. A classic example of the issues that this caused can be seen in the massive recall of plantain in the late 1990​’​s resulting from adulteration with Digitalis lanata.  About 200 companies purchased and used or resold this material without testing it. Only one company that I know of rejected that material and that was based on a well-trained organoleptic evaluator.  Now we have millions of dollars of highly advanced equipment and a number of degreed scientists working full time to serve the industry.  It would have been impossible to support this laboratory set up back in the day.  So yes, testing has changed dramatically in these years,​” ​he said.

Does more testing mean a better industry?

It’s hard, though, to unequivocally say that this has resulted in an overall better industry. The call for more, and more sophisticated, tests could also be seen as an indicator of more sophisticated problems to solve. Cheaters have found ways to game the system by adding certain low cost adulterants to mimic chromatographic peaks that could make an extract appear to be something it’s not. Neal-Kababick said that he urges clients to opt for a testing regimen that includes multiple data points from different types of tests rather than going for a straight HPTLC readout.

“More and more, clients are not only asking what testing they should be doing but they are listening too.  However, they are often shocked at what they find when coming to Flora Research Laboratories and having us conduct expanded testing.  While some products test out just fine, others show very sophisticated adulteration that using just one test would completely miss,​” ​he said.

Spare the rod, spoil the company

Weaknesses in a company’s testing protocols have become a frequent feature of recent FDA warning letters. And plaintiffs law firms troll through warning letters much as sharks might patrol the wakes of fishing trawlers. The combined threat of regulatory action and civil litigation is starting to drag the industry up by its bootstraps, lab operators maintain.

“​Reputable,​ ​credible industry players are making transparency, compliance and the need for self-policing regular topics of discussion as a means to improve safety and quality, and enhance trust and consumer confidence within the industry.​  ​Most manufacturers are acutely aware of the risks associated with non-compliance, including of course the threat of legal action,​”​ said Will Black, vice president of sales and marketing for ChromaDex.

“The FDA​’​s increasing enforcement of the cGMP regulations has driven much of the rise in testing that we do today.  Many companies are shocked to get a 483 after one or more no observation FDA visits. Keep in mind that FDA is still ramping up enforcement and as they learn and grow their inspections intensify. However, the testing movement has also taken on a life of its own. That is, as companies start to do these tests and see what is going on, they realize that they have to continue to do these tests if they want to protect their bottom line and reputation,​” ​Neal-Kababick said.