Herbal and Nutritional Medicine: Quality Assurance

Paul Reller, L.Ac.

The FDA, quality assurance and herbal/nutrient medicine

The United States is perhaps the last major industrial country to fail to adopt international standards concerning herbal quality and patient and public assurance. While there are many reasons for this shortcoming, perhaps the most important is money, and the growing industry of herbal and nutrient medicines, which now exceeds 19 billion dollars per year and is becoming dominated by the pharmaceutical industry. Now, unpatented herbal products and effective nutrient medicines are potentially causes of big losses in the pharmaceutical industry, which makes enormous profits from patented chemical medicines. The public is gaining a growing awareness of these issues and becoming curious concerning the actual quality and effectiveness of advertised herbal and nutrient medicines. The amount of advertising does not translate into assurance of quality.

The FDA, or U.S. Food and Drug Administration, regulates the realm of “dietary supplement products” under a different (and minimal) set of regulations than those covering prescription and over-the-counter drugs and “conventional” foods. The term dietary supplement product applies to both herbal and nutrient medicine. The only legislation mentioned by the FDA in regulating these medicines are the 1994 Dietary Supplement Health and Education Act (DSHEA), and the cynical “Final Rule” 21 CFR 111. These regulations, though, do not provide for actual assurance of quality and content. The 1994 act provides for assurance from the manufacturer that the product is safe before it is marketed. When a product is found to be unsafe, the FDA is responsible for taking action. Manufacturers do not need to register their products with the FDA or get approval before producing or selling these products, and an enormous number of companies and products now exist, much larger than the capability of the FDA for investigating reports of unsafe products. Large studies have determined that about 80 percent of products sold on the store shelf do not have the actual product or dosage of product listed on the label. There is no penalty for producing and marketing products that are not what they say they are.

After many years of concern about the unreliable quality and content of commercial herbal and nutrient medicine products, the FDA finally produced legislation calling for some mode of government regulation in the industry. The cynically entitled “Final Rule”, though, merely provides for a requirement of a yearly report describing the manufacturers adherence to production standards. These production standards benefit large producers over small companies, and do not supply any guarantee that the actual herbal extracts and nutrient medicines are of correct types or that they are free of contaminants, or that they are even actually in the product or at the declared dosage or concentration. If a serious adverse event is reported concerning these products, the distributor of the product is required to submit a report. By law, the manufacturer is responsible for ensuring safety, and there is no regulation of quality or actual content. The FDA states on its website that the question of reliability is a difficult problem, and recommends that the consumer contact the manufacturer to get information on safety, effectiveness and reliability of the product.

This is not to say that the FDA does not interfere with herbal and nutrient medicine products. The FDA states that a product sold as a dietary supplement must not promote on its label that it is a treatment, prevention or cure of any specific disease of medical condition, according to the provisions of the 1994 act (DSHEA). The label refers both to the label itself, an accompanying material that is provided with the product. The manufacturer of the herbal and nutrient medicine may make three types of claims: 1. health claims; 2. functional claims; and 3. content claims. These claims may link an herbal or nutrient medicine to a disease or health-related condition. When a functional claim is made of these medicinal chemicals, a disclaimer is required stating that the functional claim has not been evaluated by the FDA, and that the product is not intended to diagnose, treat, cure or prevent any disease. Now, it is obvious that these researched medicines are intended to treat diseases, but the law requires that all producers, distributors, and prescribers of these medicines lie about this, which is confusing for the patients and purchasers.

Claims of the actual effectiveness of herbal and nutrient medicines are made, and these claims are regulated not by the FDA, but by the FTC (Federal Trade Commission), which has its own laws and regualtions concerning these trade practices, and methods and reasons for enforcement. In other words, trade issues, dominated by big business, guide the enforcement of the claims of effectiveness and function of herbal and nutrient medicines. Only professional products, with quality assurance within the professional herbal medical arena, can be fully trusted to meet the standards of quality, dosage, and ingredient content.

Due to this unregulated herbal industry, commercial herbal products should be highly suspect. For example, the marketing of herbal supplements for erectile dysfunction, or rather products promoted to increase the libido, promote erections, or even increase the penile size, are now a very popular product, heavily advertised on the television and in print. On February 13, 2012, the FDA submitted an alert, showing that 101 of these products on the market contain an unlisted pharmaceutical chemical, an analog of sildenafil (Viagra), tadalafil, or vardenafil, or other phosphodiesterase-5 inhibitor, and the FDA warned patients that these supplements may seriously interact with prescription drugs such as nitrates, like Viagra (sildenafil) et al. The products, called herbal and natural, are actually prescription Viagra or other drugs for erectile dysfunction, sold without a prescription. Despite the fact that manufacturers of these products were already convicted and imprisoned for fraud, the FDA did not stop the industry from blatantly selling prescription chemicals as herbal products. The public has only one apparent protection from this type of herbal product fraud, purchasing the herbal medications from a professional licensed herbalist, i.e. a Licensed Acupuncturist or Naturopathic physician. The industry itself shows very little cause for trust.

The public has little to depend on in this system. One manner of dependability, though, would be to see whether a professional herbalist, with a business license and education, is prescribing and distributing the product, and is taking care to obtain the product from manufacturers that produce quality assured products. A number of professional herbal and nutrient medicine producers are run by experienced medical professionals that insure that the right herb is obtained, that it is of high quality, and that it is tested for contaminants. These small professional companies also provide assurance that the extraction methods for specific chemicals are appropriate. Nutrient supplement manufacturers also may provide assurance to the prescribing physician that they maintain high standards. Most importantly, though, is the fact that the prescribing physician has used these products for years and witnessed the effectiveness and safety. This is the greatest public assurance.

Inforation Resources

1. The FDA explanation of the regulation of dietary supplements, which includes herbal and nutrient medicine: http://www.fda.gov/Food/DietarySupplements/default.htm

The information on this website is not intended to be used as a specific medical advice or cure. Please consult with the practitioner or an appropriate physician, such as a licensed acupuncturist, naturopath, or medical doctor, to discuss the proper application of the information contained on this website.