With the growing number of players in the herbal industry and the concern for quality material, one company is attempting to clear up the confusion and clean up the herbal industry's act. Paracelsian, Inc., Ithaca, NY-which started out as a toxicology and drug discovery biotech company-has turned its efforts toward the herbal industry with the establishment of its "BioFunctional Integrity Tested (BioFIT)" quality assurance program. BioFIT was developed to address the question of whether or not a particular product works.

When the company first embarked on the quest to help herbal companies create a better reputation for themselves and the industry as a whole, it began developing bioassays for what its scientists determined to be the two primary mechanisms of action for five of the market's most popular herbs: St. John's Wort, echinacea, panax ginseng, ginkgo biloba and saw palmetto. According to Dr. Joseph Rininger, senior scientist, development of BioFIT began over two years ago. "Conducting research into the mechanisms of action of medicinal herbs and the subsequent establishment and validation of bioassay methods as a means of quality assurance takes a lot longer than the industry understands," said Dr. Rininger. "Establishing and validating two bioassay protocols for each of our first five herbs took us approximately a year and a half to complete."

The BioFIT process is conducted in three phases, research and development of bioassays, certification, and verification of herbal products. During the research and development phase the product's mechanism of action is defined on the basis of a review of scientific studies (clinical and mechanistic) done on an herbal product. Based upon the review of the scientific literature, bioassays are developed to model a particular mode of action. A desired level of activity is determined based upon responses elicited by products that have a demonstrated clinical track record, which are then used as reference standards in the bioassays.

The second phase of the BioFIT program, certification, assesses product(s) submitted for testing. Products being evaluated must show levels of activity equivalent to the reference standard in order to be certified BioFIT. The third phase of the BioFIT process, verification, involves batch-to-batch testing of the product to ensure consistent activity.

The BioFIT process also evaluates functional activity following product preparation through a simulated digestion protocol. This allows for a more 'realistic' representation for what happens to the product once consumed. According to Dr. Rininger, Paracelsian's coupling of a simulated digestion step with bioassays is one of the main factors that differentiates its quality assurance program from others. He said, "To my knowledge we are the only ones in the industry to use a digestion model for most of our herbs. These models help to parallel in vitro findings to in vivo reactions and results," he said. Furthermore, Paracelsian scientists are employing an intestinal absorption model system to provide insights into the absorption of botanical constituents, an area virtually devoid of information in the industry.

In addition, BioFIT is the only quality assurance program to test the "whole product as consumed" for activity. Other programs analyze products for their "parts" and standardize activity based on a product's "marker" content. Many experts feel that botanical products work synergistically and cannot be separated into active "parts."

Why The Need For BioFIT?

As many in the herbal industry know, producing consistent quality material from batch to batch is paramount. However, recent news stories have questioned the quality of material because consumers buying herbal products have reported little or no benefit. In addition, results of herbal product screening from websites like ConsumerLab.com and SupplementWatch.com have deterred consumers from purchasing herbs. Jeffrey Morrison, director of business development, said, "Unless this industry does everything possible to provide consumers with confidence that there is consistency from the products they purchase, herbal sales will go down." Rather than wait for the U.S. government to get involved, companies like Paracelsian are trying to help solve the problem themselves.

The BioFIT quality assurance program is the first of its type to offer products that are not only tested using traditional analytical techniques for marker compounds but also for functional biological activity associated with structure/function claims. However, warned Dr. Rininger, "While BioFIT testing has demonstrated that chemical standardization does not ensure consistent functional activity, it is not designed to replace chemical analysis, but serves to augment it by combining the attributes of both biology and chemistry. In addition, BioFIT certification cannot supplant clinical trials; however, we believe it to be a predictive measure of clinical outcome based upon the design of the program." The BioFIT program will allow consumers to identify a consistent quality product, help manufacturers differentiate their products in a cluttered marketplace and help the industry in creating a uniform standard of quality. Finished product manufacturers can send herbs to Paracelsian to be tested; however, according Mr. Morrison, only companies involved in licensing agreements will be able to place the BioFIT logo on their labels. So far licensing agreements have been signed between Paracelsian and contract manufacturer RP Scherer, Tampa, FL, and manufacturer ExtractsPlus, Vista, CA. Paracelsian is reportedly in discussions with several other companies.

As the herbal industry continues to wrestle with consumer acceptance, government assistance (or lack thereof) and weeding out inferior material, Paracelsian will continue to develop BioFIT assays for additional herbs. According to Mr. Morrison, Paracelsian is working to develop bioassays covering approximately eight or nine more herbs in the future.

-R.M