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Aristolochic Acid and Chinese Herbs

A press release from KPC herbs

THE TURNING POINT

The recent meeting of manufacturers and distributors of Chinese herbal products concerning aristolochic acid brought some key issues to light. If, instead of reacting too strongly, we take a careful look at the situation perhaps solutions that will serve the Chinese medicine community in the years to come will surface.

Placing Blame

In the case of aristolochic acid, the mild action taken by the US FDA was the longest in coming, and least restrictive, action of any major government that regulates such things. England and the European Community have much stricter guidelines. With evidence from Europe, Japan and elsewhere pointing to possible harmful effects of aristolochic acid the FDA had little choice but to act. They did so with the tools they have available to them, in this case, a voluntary recall.

If it indeed turns out to be true that aristolochic acid causes irreparable damage won't this action help us all? What practitioner of Chinese medicine would prescribe these herbs if they thought there was even a remote chance that they could take a life? What company would want to provide such herbs? If it turns out that aristolochic acid is not harmful, what have we lost? It is only because of misidentification of Fang Ji and Mu Tong that the substance shows up anyway. Why not use the correct herbs and avoid the problem altogether?

Truly, since the labels of many products that were found to contain aristolochic acid had listed species that do not contain this substance, the FDA could have been much harsher in its actions. Civil suits are also possible against those who knowingly mislabel their goods. Some such suits are already in progress. The FDA's action can protect not only the public but also the companies whose products contain aristolochic acid.

Those companies whose products were found to contain aristolochic acid now have the chance to correct their mistake and begin using the correct herbs for Fang Ji and Mu Tong. This is a simple matter. To ignore this and argue that aristolochic acid is harmless is not an approach that considers the safety of the public and, in the long run, is thus bad for business.

If companies state on the label and in literature that their product does not contain agents with aristolochic acid and then, when it is discovered that the products indeed do contain aristolochic acid, they react by saying, "Well, it's not harmful anyway. The FDA is harassing us." This is not the type of responsible partner that the FDA is looking for in their goal of protecting the public. Nor is it the type of companies that our customers want us to be.

To exaggerate the actions of the FDA and make it seem as though its actions are an outright attack on Chinese medicine is both irresponsible and counterproductive. This "chicken little" approach only antagonizes authorities. Following the example set by APHA of engaging regulating agencies is a more productive and mature approach. We must transform our relationship with the FDA, not just engage in a negative campaign. They need our input. The pharmaceutical and nutrition industries have constructive relations with the FDA. Like them, we must transform our relationship from a reactive one to a construction one. Our political system permits and rewards this type of relationship.

Taking Responsibility

As manufacturers of Chinese herbal products we must begin to be more responsible for the accuracy of our labels and the quality control procedures in place in our manufacturing facilities. Standards imposed by the government are always met with resistance by manufacturers. But after some time the new standards become standard procedures and are not considered a hardship. This was certainly the case about fifteen years ago, when the government of Taiwan announced the enactment of the GMP law for pharmaceutical companies. Many feared that it was a terminal crisis for the industry. It was thought that the burden of heavy capital investment, manufacturing cost and laboratory overhead of the GMP standard would raise the price of herbs to a prohibitive level. It did not happen that way. The market accepts higher prices for better and safer herbs. What was then a crisis is certainly a blessing today. Without the GMP, all quality and safety issues we are facing today could have been many times worse, if indeed, we ever had made it to where we are at all.

If we establish industry standards and can present them to the FDA, we may then be seen as a qualified partner in regulating the safety and availability of Chinese herbs. Until that time, it is hard to imagine that government agencies would take seriously an industry that is not certain about what ingredients it is putting in its products.

Where do we go from here?

This crisis can be a blessing if we use it to unite the industry behind the commitment of using correct plants. If it unites and strengthens the TCM community it is a blessing. If it transforms our relationship to the FDA it is also a blessing.

While this type of crisis inspires us to create an effective public relations apparatus, the first message of that apparatus should be that we, as an industry, are committed to public safety through the use of correct plant species and truthfulness in labeling. This must be a strong and positive message. Effective public relations are essential for the healthy growth of our profession and industry.

We must change from reactive to preventative action. We should work together as an industry to spot potential problems and deal with them before they can become major issues. In this, the FDA can be our ally, and would be, if we act responsibly with them toward the common goal of protecting public safety.

It will benefit us to work with AHPA on this issue. AHPA already has a constructive relationship with the FDA. The TCM community and Chinese herb industry can benefit from this coalition. We must make use of the experience of AHPA. Though we may not be in agreement with all of AHPA's actions (their support of the use of Ma Huang in OTC products, for example, does not resonate with our concerns) we share many of the same technical and regulatory challenges.

AHPA counts in its membership numerous companies that also belong to AAOM. These joint members need to strongly support AHPA and AAOM in taking correct actions. The AAOM needs to make the best use of, and learn from, the experience and expertise of AHPA so they may take better independent action in the future.

We must also realize that our needs differ from those of AHPA in some important ways. The main one of those is that we sell products to practitioners who are (presumably) properly trained in the use of those substances. We assume that these practitioners should be able to give their patients items we would not feel comfortable seeing on a health food store shelf (Ephedra and Aconite come to mind). For these issues we need our organizations such as the AAOM to suggest bold plans that will, in the end, protect our privilege of using Chinese herbs as they have been used for thousands of years.

We need to follow AHPAπs example in becoming more of a self-regulating industry. In this, our first priority must be public safety. If the FDA can experience our industry in that way they will rely on us for information in the future. This more open, and less contentious relationship may obviate actions that we would conceive as intrusive.

The TCM community is concerned about losing larger and larger chunks of their herbal pharmacy. This is also an industry concern. Until the industry can assure that the correct plants are being used in its products we are in a weak position when it comes to arguing for establishing safe levels of use for AA or other substances.

Our mission is to look forward to a bright future, not to conceal an erroneous past. We can, and should, work together to make this crisis a turning point to our good.

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