Insuring Quality Control in Herb Importation: An Interview with Wilson Lau
Wilson Lau is the vice president of Nuherbs, a Chinese herb importation company based in San Leandro, California. Before joining Nuherbs, he trained as a lawyer specializing in FDA law. Wilson's parents, Pat Kwan and Henry Lau, a traditional herbal practitioner, started a small Chinese herb store in Oakland which, in 1979, became Nuherbs. Wilson Lau does not bring to Nuherbs an expertise as a TCM practitioner, but the experience and training of a FDA lawyer able to navigate the complex rules and regulations that have emerged nationally over the last 15 years. In the process, he has made it his mission to elevate Chinese herbs to higher standards than the industry has previously experienced. Wilson Lau sits on important national committees as an expert on laws pertaining to Chinese herbs, as well as issues concerning purity and quality of imported herbs. I spoke with Wilson on a variety of topics pertaining to our profession.
JPF: What are some of the new issues that have come up concerning the importing or availability of traditional medicinal herbs in United States?
Wilson Lau: The biggest change is the implementation of FSMA – the Food Safety Modernization Act. This is a recent act of Congress that has been created to insure the safety of food. It also governs all individual herbs, which now need to comply with FSMA rules and regulations. These rules are costly to comply with and time consuming, but basically protect the public in a meaningful way. Before, you only got in trouble if someone got sick. The new rules are in place to prevent people from getting sick. Every herb, whether sold individually, or used in an herbal product, has requirements insuring safety. There are written verifications at every stage. Under the new rules, there are serious criminal penalties for violation which are investigated by customs and the FDA.
What this means to the end consumer is safer foods at higher costs. Everyone in the supply chain has to perform their food safety analysis – the grower, importer, manufacturer and retailers. Everyone before the practitioner will have to provide paperwork and equipment testing, etc. Not only will it cause price increases on herbs and herbal products, but it will actually reduce the number of products on the market. The cost of FSMA compliance, compared to final sales, may not justify carrying the herb.
JPF: Does this apply to herbal products and formulas well?
Lau: Regulations apply to all of the individual ingredients. If the total demand for an isolated herb is there, the formulas will have to change or be discontinued. Dietary supplement cGMP already makes it harder to do smaller batch runs, because of fixed overhead associated with regulations. One bottle or 20,000 bottles – it's the same amount of work from a regulatory standpoint. So, less popular formulas are not going to be available. Every day, a smaller formula is on the carpet, and unpopular products will disappear or the cost will go up.
JPF: Are there any new herbs that have become prohibited to import from China?
Lau: Nothing new in the last five years. Everyone remembers the aristolochic acid scare back in 2004 – a number of popular herbs were pulled from the shelf, including xi xin (Radix/Rhizoma Asari). And of course ma huang (Radix Ephedrae), due to DEA concerns. As of 2004, no ephedrine alkaloids are allowed in dietary supplements. Also, USDA rules require that if a product contains more than 1% poultry, that it must be manufactured in FSIS facility. So products like Wu Ji Bai Feng Wan, which used to offer 33% chicken, now has to revamp its formula in order to enter the United States.
JPF: What is the status of herbs coming out of China?
Lau: Well, herb prices are certainly going up, because Chinese labor costs are going up. Also, China has to comply with FSMA rules before they can export, and this also raises the costs. And modernization has forced China to increase its own regulations. They reconfigured their own GMP (Good Manufacturing Practice) in 2004, which are very stringent and regimented. They are more detailed and prescriptive compared to Australia or the U.S. GMP, and this applies for their own domestic use as well as export.
JPF: What is the ratio of wild-crafted versus cultivated Chinese herbs coming in from China? When I was there in the late 80s, probably 60% were wild-crafted.
Lau: I don't know the exact percentage now, but certainly, more is cultivated and less is wild-crafted. And wild-crafted are allowed be certified as organic. For dang gui (Radix Angelicae Sinensis), sulfur is needed for slicing, and is necessary to know what part of the plant you are getting. The body, tail, and head all have different properties and uses. For shan yao (Rhizoma Dioscoreae), we offer both processed with sulfured or unsulfured. In medicinal soup, the sulfured processed version is preferred in order to hold its texture, and many of our customers prefer that. (Many Chinese herbs are traditionally prepared with powdered sulfur to aid in cutting, or preservation. Don't confuse "sulfured" with sulfites. Powder sulfur on herbs does not carry the health consequences of foods that contain sulfites.)
JPF: What is the situation regarding pesticide use China?
Lau: I know this is getting a fair amount of controversial press here in the United States. It costs $400 to do one pesticide screen on an herb. To confirm that a herb is pharmacopeia grade, many tests are required.
JPF: What about importation of endangered animal parts?
Lau: World Wildlife Fund (WWF) has listed all prohibited animals that have been used in Chinese medicine, and these are prohibited for import by U.S. law.
JPF: Where do you see our TCM profession going in the United States?
Lau: It's going to grow, most definitely. As Americans live longer, people will seek alternatives to the conventional "sick" approach for the alternative "healthy" approach. Because TCM can really deliver effective healing, at a much cheaper cost than the current medical model, the profession can only grow.