FDA sent the warning letter to the company Urban Moonshine in November. Urban Moonshine markets an array of digestive bitters and herbal tonics all based on the principle that bitter herbs have been excluded from the modern diet to the detriment of intestinal health. In its warning letter, FDA cited the company for a number of GMP violations, including a criticism of the company’s lack of specifications on incoming ingredients. In lieu of GMP-compliant specifications, the company had “only requirements for the finished product’s relative density, opacity, and organoleptic description. These specifications are inadequate to establish identity because these physical tests are not capable of identifying individual ingredients within a multi-ingredient product. Moreover, these specifications do not relate to the purity, strength, or composition of the finished product, nor do they establish limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of the dietary supplement,” the agency wrote.
Company officials complained in a USA Today story about the warning letter that FDA does not accept the fact that trained herbalists can recognize plants in the field, and requires lab work to verify the identity of the incoming raw material.
Still a valid method?
While it may be true that the agency puts more faith in chemistry, organoleptic testing as an identification method is far from dead, experts have said. But the key is to apply the method in a compliant manner. The old saw—if you don’t write it down, it didn’t happen—applies here just as much as in any other facet of the manufacturing process, they said.
“As a person who has been involved with the herbal community for a long time, I have a lot of understanding and compassion for people who are in that position,” Mark Blumenthal, founder and executive director of the American Botanical Council told NutraIngredients-USA. “There are companies that are very good at authenticating material via traditional methods. There are companies that grow their own herbs or wildcraft their own herbs. They can tell it’s dandelion root because they saw the plant.”
This would be especially true for categories of herbs that are not known to be subject to adulteration, Blumenthal said. In categories where adulteration has been known to occur, organoleptic testing might not be enough on its own to detect a substitution in those cases, and in any case, the method is only valid for whole plant parts for the most part.
“There have been cases of accidental substitution of one botanical for another. And when you start to cut things up, you have to start relying on the next level of identification, which is chemistry,” he said.
Whether a reliance on organoleptic testing will be cited on a 483 observation and possibly be part of a subsequent warning letter is partly a matter of luck, said Roy Upton, founder and executive director of the American Herbal Pharmacopoeia.
“It depends on the inspector. There have been some inspectors who have shot it down. Then there is the issue of whether FDA as a whole considers organoleptic identification as a viable method. The comments of a former director made it clear that he himself had no respect for the scientific validity of using morphology as a method for identifying plants,” Upton said.
Making the method valid
“The second question is whether a company has done it in a scientifically valid manner. That is a different issue,” Upton said.
Making organoleptic testing scientifically valid involves providing a document trail, a procedure, that shows how the identification was done and assures an inspector that the company is capable of reproducing that procedure every time. Records of training are important too, he said. To some old line herbalists at companies with which he as consulted, this hasn’t come easily, Upton said.
“At one of the companies that got whacked that I got involved with, they were basically saying ‘We know what it looks like, tastes like, smells like and we’ve been doing this for 25 years.’
“A different company in a different region that got a different inspector was able to document that they have been maintaining valid morphological specimens over a period of 30 years. And in that case, the particular inspector was kind of a ringer, in that this person had worked in the purchasing and QC side of the supplements industry,” he said.
Michael McGuffin, president of the American Herbal Products Association, agreed with Upton that proper documentation of the method is the way to reassure an inspector that the method is producing valid results.
“What I think is the real lesson here is not that organoleptic identification and macroscopy cannot be used, but rather that this like any other method must be properly documented and supported by proper training records,” McGuffin said.
“The way it used to be, a qualified herbalist could look at the material received and could make the determination that yes, that’s dandelion. What’s changed is that now the inspector has to be satisfied that you were accurate in that identification. You are going to have to show that you were doing that against a reference, such as a validated botanical reference material (BRM) or referring to the AHPA compendium,” he said.
“We don’t accept the idea that we are no longer allowed to use morphology and we must use chromatography instead. Even if you are using chromatography and you don’t know what you are doing, that is not good enough for FDA,” McGuffin said.
Valuable data
Upton made the point that organoleptic analysis adds valuable data to the identification process in the case of incoming whole plant parts, and that a reliance on chemical analysis alone might provide a false sense of security. Chemical fingerprints are all fine and good, he said, but the best that one can say is that they conform to what is expected of a given plant. Adding macroscopy to other tests adds additional data points, adding to the certainty of the identification.
“When you do a morphological examination of something, you are identifying the plant itself. When you do a chemical analysis of the material, you are no longer identifying the plant, you are identifying the surrogate chemical markers of the plant. We all know the chemical profile of plants varies with time of harvest and any number of factors, but the plant is still the plant. The most sure way of identifying it is to look at it.
“With morphology I’m going to look at it, taste it and smell it. Now I have three data points to add to chemical analysis,” Upton said.
Botanical Liaisons LLC, a company based in Boulder, CO, provides an array of validated BRMs that can be used in an organoleptic identification program. To access AHPA’s Botanical Identity References Compendium, click here.