Part 1 of a 2 part series:
Info taken from the AHPA
The use of herbs and herbal products such as Kratom and CBD has become broadly accepted in our contemporary culture. Consumer surveys consistently find that nearly half of all Americans now use herbs, a statistic that is particularly remarkable when we realize that today’s herbal products “industry” is just over a quarter century old. In spite of this widespread acceptance of herbal products in individual self-care choices, misconceptions exist as to the regulation, safety and effectiveness of herbal products.
This FAQ (Frequently Asked Questions) format has been developed by the American Herbal Products Association, which has a mission to promote the responsible commerce of herbs, botanicals and herbal products. AHPA is one of the leading organizations in the United States for establishing product integrity standards for herbal manufacturers.
Are herbs safe?
Are herbal supplement products safe?
Federal law requires that every food product, including herbal supplements, is free of “adulteration” and is not “misbranded.” This legal language translates into a requirement that all foods and supplements have a reasonable expectation of safety when offered for sale and when used as directed. So manufacturers of soups, cereals, and supplements all have an obligation to sell only safely made and properly labeled goods, and can find their products subject to seizure should they fail to do so.
In addition, manufacturers of herbal products are specifically required to limit their ingredients to either those that were already in the market prior to passage of landmark legislation in 1994 or those that a company can convincingly show, by providing information to the Food and Drug Administration, to be safe. What that means is that any manufacturer who wants to introduce a new herbal ingredient must first provide FDA with information that shows that the herb will be “reasonably expected to be safe.” Additionally, the safety of herbal products as a general class has been well established by both their long history of traditional use worldwide and by their broad contemporary use by a significant proportion of the population, estimated to be nearly half of the U.S. population.
There are so few credible reports of unexpected side effects due to herbal products that most experts consider problems with herbal products to be of only minor or occasional concern. Before his death in 2011, Norman Farnsworth, Director of the World Health Organization Collaborating Centre for Traditional Medicine and Research Professor of Pharmacognosy at the University of Chicago at Illinois, was generally considered to be one of the most respected experts on the scientific research of botanical medicines. In an article written on the subject of herbal safety, Dr. Farnsworth concluded, “…side effects or toxic reactions associated with herbal medicines in any form are rare.
In fact, of all classes of substances reported to cause toxicities of sufficient magnitude to be reported in the United States, plants are the least problematic.” This is not to say that every herbal ingredient that is sold as an ingredient in a supplement is appropriate for every consumer or in any quantity. Responsible and informed use by consumers is essential to ensure that herbal products maintain their established safety profile. Accurate product labeling must provide consumers with all information that is material to the use of the product, and such disclosure is required by Federal law.
To assist in assuring that herbal manufacturers provide material information about their products, the American Herbal Products Association (AHPA) has developed specific labeling guidelines for a number of botanical ingredients. Labeling recommendations exist for products containing chaparral (Larrea tridentata); comfrey (Symphytum spp.); kava (Piper methysticum); saw palmetto (Serenoa repens); and St. John’s wort (Hypericum perforatum), among others. In addition, AHPA published an entire volume of information related to established herbal safety concerns, entitled Botanical Safety Handbook.
This reference classifies over 500 herbs with safety categories that can assist both manufacturers in their labeling and consumers in making informed choices in their use of herbs. A general rule for assuring responsible use of an herbal product is to follow all of the labeled directions. If the product bears a caution that suggests that the product is inappropriate for your use, you should take that message seriously. More information can often be provided by a qualified expert, and often from well-informed retail personnel.
Are herbal supplements effective?
Botanicals have remained a primary source of traditional medicine for millennia. They have made contributions over the last centuries to the development of some of the most widely used and effective modern drugs. In the last several decades, there has been a resurgence of research in the clinical efficacy of herbs. The results of such studies often verify that the empirical observations of the past centuries were accurate. For example, recent studies on the effect of valerian (Valeriana officinalis) have produced results that led researchers to conclude that valerian root can produce “significant improvement in sleep quality” and that valerian root extract can be “recommended for the treatment of patients with mild psychophysiological insomnia.”
But can a consumer have confidence in the claims made for the products that are available in the market? To begin with, Federal labeling law and regulations for supplements limit allowable claims to those for which a manufacturer “has substantiation that such statement is truthful and not misleading.” The manufacturer therefore has a legal burden to assure that the claim that is made for their products has scientific evidence to back it up.
Because there is a greater acceptance of herbal therapies by conventional physicians in Europe, a significant body of clinical data supporting the use of herbs has been developed there. More recently, a number of U.S. companies have designed clinical studies for their branded products. It is estimated that there are over 1,000 clinical trials now being undertaken in the U.S. to increase our knowledge about herbs. The National Institutes of Health has even set up a center with a special focus on “alternative” medicine, and is now concentrating much of its resources on the study of herbal products.
