Innovation reforming supply of botanical ingredients

The goal of these innovations is not to hit a new market niche with a hot new product but rather to boost supply chain traceability and transparency—words have been bandied about a lot within the industry in recent years.

Individual brand holders have offered compelling (and sometimes less than compelling) arguments about how they are applying these concepts within their own supply chains. Now these ideas are being elucidated by broad based industry groups, which will boost both believability and broader applicability of these efforts.

Botanical supply innovation​

Among these efforts are the supply chain verification procedures developed by the American Herbal Products Association (AHPA). There’s also an ongoing effort headed by the University of Guelph in Ontario to build out a set of best practices and references around the use of DNA technology in botanical ingredient identification. And the Botanical Adulterants Prevention Program has pulled together a consortium that is developing a way to make sure substandard or adulterated ingredients that are rejected by one customer are destroyed instead of being peddled to another customer farther down the value chain, only to end up on the shelf after all.

Jane Wilson, director of program development of AHPA, said that the association found itself in a unique position a few years ago when the industry was buffeted by the investigations launched by New York Attorney General Eric Schneiderman.

The probe took several retailers to task, GNC prominently among them, because DNA testing purportedly showed that there was little or none of the active ingredient of some botanical supplements within the bottles.

There was a lot of pushback about that initial investigation with the main assertion being that the DNA tests themselves were inappropriately applied and didn’t show what Schneiderman’s office claimed they did. But the episode, while traumatic, did have a positive side effect in that it reawakened brand holders to the potential risks within their supply chains and lit a fire under them to do something about it.

GNC came to a quick settlement with Schneiderman that included rapid development of a botanical GMP document for its supply partners. The document drew heavily from earlier work done by AHPA when it developed its Good Agricultural Collection practices guidance, which was released a number of years ago. AHPA eventually agreed with GNC to take over the revision and management of the GMP program.

“The GACP document has been out there a while. What the combined GACP/GMP document does is help industry understand what some of the intersections are between those requirements and what​​’s in the regulations,​​”​​ Wilson said.

In addition to helping suppliers comply with what GNC is looking for (which includes fit-for-purpose DNA testing where appropriate), Wilson said the document will also help them navigate the new world created by the advent of FSMA (the Food Safety Modernization Act).

“The ​ingredient supply people are now covered by Part 117 (FSMA) but they also have to keep an eye out toward dietary supplement GMPs,​”​Wilson said. “Our document will help them connect those dots. And it includes some easy-to-use forms so that companies can judge their own compliance.​​”​​

DNA project​

Dr. Steven Newmaster, PhD, a professor in the department of integrative biology at the University of Guelph is headed in a multifaceted project to build out best practices around the use of DNA testing within the dietary supplement industry.

He said that the project has been gathering steam and consists of three facets:  Building out a library of reference DNA samples; researching the presence of DNA within botanical extracts; and developing and validating a hand held device that can speed the use of DNA identification within the supply chain.

“We​’ve had quite a few industry leaders come on board to become members of our research alliance,​”​ Dr. Newmaster said. ​​“We are building the DNA library from specimens from raw material producers. We​’re validating those specimens and sequences. Naturex for example is a major sponsor and we have received material direct from their farms.​​”​​

Dr. Newmaster said the extract effort is ongoing. He has a research assistant devoted to the project and published a paper on it last year. And one of the most exciting and potentially impactful aspects of the effort is the validation of a handheld device that will greatly speed the use of the technology in the field. A big part of that is to have available references for use in the machine’s bins to compare against DNA extracted from incoming lots of material (that process has been streamlined, too).

“There will be a kit available to buy to use for each species tested in the machine. We are working with USP on the validation of each kit. By the second quarter of this year we plan to have 20 kits available for the most common species. By next year that will double. There are about 70 species used in the industry that represent about 70% of the commoditized trade.  We plan eventually to have kits for all of those,​”​ Newmaster said.

“There are at least 200 more species that are used in the trade. The DNA tests for those will still have to go to an outside lab,​” ​he said.

Rejected material SOP​

The third innovation, the standard operating procedure (SOP) on rejected material, is being put together by the Botanical Adulteration Prevention Program, which is a joint project of the American Botanical Council, the American Herbal Pharmacopoeia and the National Center for Natural Products Research at the University of Mississippi. 

Mark Blumenthal, founder and executive director of ABC, said the goal of the project is try to raise the floor of supply side of the industry, by making it clear that substandard or adulterated material will no longer be tolerated. 

Up to now, it has been one of the industry’s skeletons in the closet that this type of material never really goes away but after being once rejected subsequently gets shopped around until someone else agrees to take it. Blumenthal emphasized that this is not a matter of safety; there’s no evidence that these substandard materials pose a health risk. But they do represent fraud in that a diluted or substituted material won’t have the health benefits that are advertised.

“We don​’t have any real number on that. We don​’t know how often it happens, but we know it does happen,​”​ he said.

Blumenthal said the project is now refining the language of the SOP so that it can be plugged into supply contracts. It’s a delicate undertaking, because there is financial risk involved. 

The basic idea is that if a substandard lot comes in and is identified, it will be disposed of then and there, without being returned. And the supplier doesn’t get paid for that lot.

“We are currently working with our ad hoc legal committee of several experienced food and drug lawyers on the legal language. You have to make it as inclusive as possible but also as fair as possible for both parties,​”​ ​Blumenthal said. ​

“The focus would be on what we would call ​irreparable defective raw material. That could be material that either would be mislabeled becuase of the lack of an ingredinet or with the substitution of lower cost ingredinets. Or something that is irreparably contaminated. Really anything that could not be appropriately reconditioned to meet state and federal regulations,​” ​he said.