- Safety of Chinese Herbal Dietary Supplements

Product Safety Update

From Mayway, Inc. importers & distributors of Plum Flower & Min Shan Chinese herbal products.

With the recent rise in alarming reports regarding Chinese imports, some of you, your patients or your customers may wonder if Chinese herbal medicines are at risk. Fortunately, throughout our almost forty years of importing and distributing traditional Chinese medicines, we have established many protocols for ensuring the safety of the products we distribute. These guidelines guarantee that the products we distribute are not only effective, but protected, safe, and of the highest quality possible. To learn more about these safeguards please read more below. We thank you for your concern, and for your continued patronage and confidence in our products.

Internationally Certified GMP Factories
Part of the quality assurance Plum Flower® brings to you is in the choosing of exceptional manufacturers to create our products. All of our manufacturers comply with the new stringent Chinese Good Manufacturing Practices (GMP), and have also been internationally certified by the Australian Therapeutic Goods Administration (TGA). TGA standards are among the highest in the world, as dietary and herbal supplements there are subject to the same guidelines as pharmaceutical drugs.

What is "GMP Certification?
GMP certification means that the site and methods employed in the production of our products has been subject to a thorough quality control investigation and is certified to be in compliance. The GMP certification process covers all aspects of manufacturing, including inspection of the building and grounds, the air and water purification systems, the handling and processing of raw herbs, the product manufacturing process, the operation and cleaning of equipment, the training of personnel and quality control testing and documentation. The adherence to guidelines established in the Chinese Pharmacopeia, and formal Manufacturing Instructions, Standard Operating Procedures and Quality Control Protocols ensures that every batch of product is safe and of the highest quality. These standards for manufacturing are the guidelines upon which our manufacturers base each decision, and allow us to have the confidence to say that they are some of the best herbal product manufacturers not only in China, but also in the world today.

Laboratory Testing Each of the internationally GMP certified factories where Plum Flower® teapills, tablets, extracts and liquid products are produced has an in-house lab where extensive quality control analysis is performed.

All raw materials are identified and basic tests are performed before use. Chemical analyses including TLC (thin layer chromatography) and HPLC (high performance liquid chromatography) are also used to confirm identification, ensure potency and to test for active constituents when necessary. Tests for moisture content, dissolution, heavy metals (lead, arsenic, mercury, cadmium) and microbial content are performed on every batch of finished product. Plum Flower® restrictions on heavy metal and microbial contaminants are stringent and in line with international requirements. Following extensive in-house testing, heavy metal testing is conducted again at third party labs to confirm results and to ensure that our standards of purity and safety are met. More sophisticated analyses, such as Aristolochic Acid testing and Chloramphenicol testing, are also conducted at certified third party labs. When the products arrive in the U.S. they are subject to an additional review by the FDA ensuring that the products you receive meet every safety standard.

Certificate of Analysis
Certificates of Analysis are provided to us for every lot of herbs, teapills, tablets, liquid extracts and concentrated extract powders we distribute.Counterfeiting
Some of the problems associated with substandard imports may lie with the prevalence of unlicensed, semi-defunct factories within China, sometimes called “Mountain Bandits Factories”. These disreputable operators produce counterfeits of established, well-known products and offer them at low prices. To increase profits, these substandard products are made using cheap non-Pharmacopeia grade herbs. Oftentimes, the products do not even contain the right ingredients or are made incorrectly. These “Mountain Bandit Factories” are producing “medicine” without the knowledge, experience, or quality control necessary to ensure public safety. For many years Mayway has strived to inform the public about the threat these illicit manufacturers pose for the Chinese medicine industry and has repeatedly warned practitioners of the risks associated with buying the substandard counterfeit products offered by such operators.