The pressure on the supply end of the dietary supplements industry has been mounting of late. Recently Cara Welch, the acting deputy director of FDA’s Division of Dietary Supplement Programs, gave out a GMP compliance report card, and while there may be some signs of progress, overall she said the industry appears to be stuck in neutral at an unacceptable failure rate. Chief among the specific deficiencies she mentioned were failures to test incoming raw materials and the lack of sufficient specifications.
And of course the activities of New York Attorney General Eric Schneiderman have shined a light on whether companies know for certain what’s in their bottles. While many experts have complained about his sometimes misguided approach, it has generated a pulse through the industry toward a better minding of the quality store.
In order to do proper testing and to write proper specifications, herbal industry experts have said that a verified BRM is a necessary starting point to be able to validate testing methods and procedures. It provides a solid baseline to be able to prove that you know what you are looking for and that you are actually finding it.
Mark Blumenthal, founder and executive director of the American Botanical Council, gave an address yesterday on the use of BRMs within the industry to a meeting sponsored by the National Institute of Standards and Technology in Washington DC. Blumenthal said the need for BRMs is an especially timely discussion given the questions swirling around quality.
“The reason people use these is to help validate laboratory methods before they start testing their materials. You use these to ensure that the methods you are using are actually fit for purpose for the identification of the material. It’s an internal control,” Blumenthal told NutraIngredients-USA.
Alkemist Labs, based in Costa Mesa, CA, recently announced a deal with the American Herbal Pharmacopoeia to distribute AHP-Verified BRMs. Alkemist CEO Elan Sudberg said the new offerings are an expansion of an existing partnership with AHP founder and renowned botanical expert Roy Upton.
“What we have done in the past is instead of working with just one sample of, let’s say Devil’s Claw, we’d go out to industry and get a number of samples of what’s on the market and we’d internally verify them. Then we’d combine them into a standard. I haven’t really pushed this hard, and it hasn’t been a big part of revenue,” Sudberg said.
But Sudberg said he and Upton saw that a new way to market Upton’s materials could benefit both entities and the industry as a whole.
“We have already worked with Roy in the past on some microscopy on some of the monographs he has put out,” Sudberg said. “We are a testing lab, and Roy is a botanical expert who is verifying material from the source up, with an accession of one.
“Now we can add the two credibilities together. We have the testing expertise, and Roy has oversight of the materials from the start, from an herbalist’s point of view adding organoleptic properties,” he said.
BRMs can come in a number of different forms, from whole plant materials available from sources such as Boulder, CO-based firm Botanical Liaisons, to the BRMs offered by the Alkemist/AHP partnership, to BRMs offered by Chromadex, USP and others that could include samples of extracts or even single compounds such as huperzine A. Even with all that supply of BRMs on the market, some in the industry don’t think enough use is being made of them. One of those who has been disappointed by the weak demand for these supposedly vital tools is ChromaDex CEO Frank Jaskch.
“We started created BRMs more than 10 years ago because everybody said there was a need for them. Economically it has been a horrible investment for ChromaDex. We spent more money developing these standards than we have sold,” Jaksch said.
“There is no real demand. There is a disconnect here between what people say ought to be needed and what people are actually buying. There are very few companies out there that are appropriately using these tools. With that being said, we have continued the program even though economically it has not been very fruitful,” he said.
Blumenthal said that fluctuations in demand could reflect more discrimination in the market as a sign of its maturity, as users search out the standards that seem to work best for them. He noted that NIST itself recently jumped into the game offering five new BRMs for the following botanicals: ginkgo, St John's wort, bilberry, saw palmetto and cranberry.
“There are conversations about the relative value of the materials from a number of suppliers. That’s where NIST comes in because presumably the NIST materials will be of the highest quality,” he said.
Blumenthal said he is hopeful that the recent pressures on quality will boost the demand for BRMs as a sign that companies are trying to do their testing correctly.
“Hopefully the conversation of the last six or eight months in the industry will lead to greater demand for these reference materials so that companies can verify their testing methodology. You can’t really know that what you stuck in the column is really saw palmetto unless you ran a standard first,” he said.
The goal, Sudberg said, is to help cultivate a better industry.
“Every year our sales of these materials has been better than the year before, which to me only means that the industry is getting better. Running a lab is not a way to get rich quick, and if that’s why I was in business I wouldn’t be in this business. It’s really about the passion to provide to industry the best tools we can,” Sudberg said.